Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure Health Quality Ontario & Ministry of Health and Long-Term Care April 2013 Table of Contents Table of Contents ........................................................................................................................................ 2 List of Abbreviations .................................................................................................................................. 3 Preface.......................................................................................................................................................... 5 Key Principles ............................................................................................................................................................... 6 Purpose ........................................................................................................................................................ 8 Introduction to Quality-Based Procedures ............................................................................................... 9 What Are We Moving Towards? ................................................................................................................................. 10 How Will We Get There? ............................................................................................................................................ 11 What Are Quality-Based Procedures? ......................................................................................................................... 12 How Will Quality-Based Procedures Encourage Innovation in Health Care Delivery? .............................................. 15 Methods...................................................................................................................................................... 16 Overview of the HQO Episode of Care Analysis Approach........................................................................................ 16 Defining the Scope of the Episode of Care .................................................................................................................. 19 Developing the Episode of Care Pathway Model ........................................................................................................ 20 Identifying Recommended Practices ........................................................................................................................... 21 Description of Congestive Heart Failure ................................................................................................ 25 Recommended CHF Cohort Definition and Patient Grouping Approach .......................................... 26 Initial CHF Cohort Inclusion/Exclusion Criteria ......................................................................................................... 26 Inclusion/Exclusion Criteria for QBP Funding Purposes ............................................................................................ 28 CHF In-Hospital Patient Journey................................................................................................................................. 31 Factors Contributing to CHF Patient Complexity ....................................................................................................... 33 Recommended Practices for CHF ........................................................................................................... 35 Development of the Episode of Care Pathway ............................................................................................................ 35 CHF Episode of Care Pathway Model ......................................................................................................................... 39 Performance Measurement ...................................................................................................................... 57 Performance Indicators ................................................................................................................................................ 59 Implementation of Best Practices ............................................................................................................ 61 Special Considerations for Cost Bundling ................................................................................................................... 61 Implementation of Best Practices ................................................................................................................................ 63 Role of Multidisciplinary Teams ................................................................................................................................. 64 Service Capacity Planning ........................................................................................................................................... 64 Expert Panel Membership ....................................................................................................................... 65 Appendices ................................................................................................................................................. 67 Appendix I: CHF Patient Group—ICD-10-CA Details ............................................................................................... 67 Appendix II: Rapid Review Methodology ................................................................................................................... 71 Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 2 List of Abbreviations ACC/AHA American College of Cardiology/American Heart Association ACE Angiotensin-converting enzyme ALC Alternate level of care ARB Angiotensin receptor blocker BIPAP Bilevel positive airway pressure CACS Comprehensive Ambulatory Care Classification System CCI Canadian Classification of Health Interventions CCS Canadian Cardiovascular Society CHF Congestive heart failure CIHI Canadian Institute for Health Information CMG Case Mix Group COPD Chronic obstructive pulmonary disease CPAP Continuous positive airway pressure DAD Discharge Abstract Database DRG Diagnosis-Related Group ECFAA Excellent Care for All Act ED Emergency department EHMRG Emergency Heart Failure Mortality Risk Grade ESC European Society of Cardiology Expert Panel Episode of Care for Congestive Heart Failure Expert Advisory Panel HBAM Health-Based Allocation Model HFSA Heart Failure Society of America HIG HBAM Inpatient Grouper HQO Health Quality Ontario HSFR Health System Funding Reform HSIMI Health System Information Management and Investment ICD-10-CA International Classification of Diseases, 10th Revision (Canadian Edition) ICES Institute for Clinical Evaluative Sciences IDEAS Improving the Delivery of Excellence Across Sectors IV Intravenous LACE Length of stay, acuity of admission, comorbidity of patient, emergency department use LHIN Local Health Integration Network LTC Long-term care Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 3 MCC Major Clinical Category Ministry Ministry of Health and Long-Term Care MLPA Ministry-LHIN Performance Agreement NACRS National Ambulatory Care Referral System NICE National Institute for Health and Clinical Excellence OCCI Ontario Case Costing Initiative OHTAC Ontario Health Technology Advisory Committee PBF Patient-Based Funding QBP Quality-Based Procedures QIP Quality Improvement Plan STEMI ST segment elevation myocardial infarction THETA Toronto Health Economics and Technology Assessment Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 4 Preface The content in this document has been developed through collaborative efforts between the Ministry of Health and Long-Term Care (“Ministry”), Health Quality Ontario (HQO), and the HQO Episode of Care for Congestive Heart Failure (CHF) Expert Advisory Panel (“Expert Panel”). The template for the Quality-Based Procedures Clinical Handbook and all content in Section 1 (“Purpose”) and Section 2 (“Introduction”) were provided in standard form by the Ministry. All other content was developed by HQO with input from the Expert Panel. To consider the content of this document in the appropriate context, it is imperative to take note of the specific deliverables that the Ministry tasked HQO with developing for this Clinical Handbook. The following is an excerpt from the HQO–Ministry Accountability Agreement for fiscal year 2012/13: To guide HQO’s support to the funding reform, HQO will: 1. Conduct analyses/consultation in the following priority areas in support of funding strategy implementation for the 2013/14 fiscal year: a) Chronic Obstructive Pulmonary Disease, b) Congestive Heart Failure, and c) Stroke. 2. Include in their analyses/consultation noted in clause 21, consultations with clinicians and scientists who have knowledge and expertise in the identified priority areas, either by convening a reference group or engaging an existing resource of clinicians/scientists. 3. Work with the reference group to: a) Define the population/patient cohorts for analysis, b) Define the appropriate episode of care for analysis in each cohort, and c) Seek consensus on a set of evidence-based clinical pathways and standards of care for each episode of care. 4. Submit to the Ministry their draft report as a result of the consultations/analysis outlined in clause 22 above on October 31st and its final report on November 30th, and include in this a summary of its clinical engagement process. Following sign-off on the Accountability Agreement, the Ministry subsequently asked HQO to also develop the following additional content for each of the 3 assigned clinical areas: a) Guidance on the development of performance indicators, aligned with the recommended episodes of care to inform the Ministry’s Quality-Based Procedure (QBP) Integrated Scorecard. b) Guidance on the real-world implementation of recommended practices contained in the Clinical Handbook, with a focus on implications for multi-disciplinary teams, service capacity planning considerations and new data collection requirements. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 5 Key Principles At the start of this project, discussions between HQO, the 3 Episode of Care Expert Advisory Panels and the Ministry established a set of key principles or “ground rules” to guide this evolving work: HQO’s work will not involve costing or pricing. All costing and pricing work related to the QBP funding methodology will be completed by the Ministry using a standardized approach, informed by the content produced by HQO. This principle also extended to the deliberations of the Expert Panels, where discussions were steered away from considering the dollar cost of particular interventions or models of care and instead focused on quality considerations and non-cost measures of utilization, such as length of stay. The scope of this phase of work will focus on hospital care. Given that the Ministry’s QBP efforts for 2013/14 focus largely on hospital payment, HQO was asked to adopt a similar focus with its work on episodes of care. Notwithstanding, all 3 Expert Panels emphasized the importance of extending this analysis beyond hospital care alone to also examine post-acute and community care. CHF is a chronic disease that spans all parts of the continuum of care, with hospitalization being only one piece of this continuum; future efforts will also need to address community-based care to have full impact on all parts of the health system. Recognizing the importance of this issue, the Ministry has communicated that, following the initial phase of deliverables, work will continue in all 3 clinical areas to extend the episodes of care to include community-based services. Recommended practices, supporting evidence, and policy applications will be reviewed and updated at least every 2 years. The limited 4-month timeframe provided for the completion of this work meant that many of the recommended practices in this document could not be assessed with the full rigour and depth of HQO’s established evidence-based analysis process. Recognizing this limitation, HQO reserves the right to revisit the recommended practices and supporting evidence at a later date by conducting a full evidence-based analysis or to update this document with relevant new published research. In cases where the episode of care models are updated, any policy applications informed by the models should also be similarly updated. Consistent with this principle, the Ministry has stated that the QBP models will be reviewed at least every 2 years. Recommended practices should reflect the best patient care possible, regardless of cost or barriers to access. HQO and the Expert Panels were instructed to focus on defining best practice for an ideal episode of care, regardless of cost implications or potential barriers to access. Hence, the resulting cost implications of the recommended episodes of care are not known. However, all 3 Expert Panels have discussed a number of barriers that will challenge implementation of their recommendations across the province. These include gaps in measurement capabilities for tracking many of the recommended practices, shortages in health human resources and limitations in community-based care capacity across many parts of the province. Some of these barriers and challenges are briefly addressed in the section “Implementation of Best Practices.” However, the Expert Panels noted that, with the limited time they were provided to address these issues, the considerations outlined here should only be viewed as an initial starting point towards a comprehensive analysis of these challenges. Finally: HQO and the CHF Episode of Care Expert Panel recognize that given the limitations of their mandate, much of the ultimate impact of this content will depend on subsequent work by the Ministry to incorporate the analysis and advice contained in this document into the Quality-Based Procedures policy Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 6 framework and funding methodology. This will be complex work, and it will be imperative to ensure that any new funding mechanisms deployed are well-aligned with the recommendations of the Expert Panel. Nevertheless, the Expert Panel believes that, regardless of the outcome of efforts to translate this content into hospital funding methodology, the recommended practices in this document can also provide the basis for setting broader provincial standards of care for CHF. These standards could be linked not only to funding mechanisms, but to other health system change levers such as guidelines and care pathways, performance measurement and reporting, program planning and quality improvement activities. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 7 Purpose Provided by the Ministry of Health and Long-Term Care This Clinical Handbook has been created to serve as a compendium of the evidence-based rationale and clinical consensus driving the development of the policy framework and implementation approach for CHF patients seen in hospitals. This handbook is intended for a clinical audience. It is not, however, intended to be used as a clinical reference guide by clinicians and will not be replacing existing guidelines and funding applied to clinicians. Evidence-informed pathways and resources have been included in this handbook for your convenience. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 8 Introduction to Quality-Based Procedures Provided by the Ministry of Health and Long-Term Care Quality-Based Procedures (QBPs) are an integral part of Ontario’s Health System Funding Reform (HSFR) and a key component of Patient-Based Funding (PBF). This reform plays a key role in advancing the government’s quality agenda and its Action Plan for Health Care. HSFR has been identified as an important mechanism to strengthen the link between the delivery of high quality care and fiscal sustainability. Ontario’s health care system has been living under global economic uncertainty for a considerable time. Simultaneously, the pace of growth in health care spending has been on a collision course with the provincial government’s deficit recovery plan. In response to these fiscal challenges and to strengthen the commitment towards the delivery of high quality care, the Excellent Care for All Act (ECFAA) received royal assent in June 2010. ECFAA is a key component of a broad strategy that improves the quality and value of the patient experience by providing them with the right evidence-informed health care at the right time and in the right place. ECFAA positions Ontario to implement reforms and develop the levers needed to mobilize the delivery of high quality, patient-centred care. Ontario’s Action Plan for Health Care advances the principles of ECFAA, reflecting quality as the primary driver to system solutions, value, and sustainability. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 9 What Are We Moving Towards? Prior to the introduction of HSFR, a significant proportion of hospital funding was allocated through a global funding approach, with specific funding for some select provincial programs and wait times services. However, a global funding approach reduces incentives for health service providers to adopt best practices that result in better patient outcomes in a cost-effective manner. To support the paradigm shift from a culture of cost containment to that of quality improvement, the Ontario government is committed to moving towards a patient-centred, evidence-informed funding model that reflects local population needs and contributes to optimal patient outcomes (Figure 1). PBF models have been implemented internationally since 1983. Ontario is one of the last leading jurisdictions to move down this path. This puts the province in a unique position to learn from international best practices and the lessons others learned during implementation, thus creating a funding model that is best suited for Ontario. PBF supports system capacity planning and quality improvement through directly linking funding to patient outcomes. PBF provides an incentive to health care providers to become more efficient and effective in their patient management by accepting and adopting best practices that ensure Ontarians get the right care at the right time and in the right place. Current State How do we get there? Transparent, evidence-based to better reflect population needs Based on a lump sum, outdated historical funding Fragmented system planning Funding not linked to outcomes Does not recognize efficiency, standardization and adoption of best practices Maintains sector specific silos Future State Strong Clinical Engagement Current Agency Infrastructure System Capacity Building for Change and Improvement Knowledge to Action Toolkits Supports system service capacity planning Supports quality improvement Encourages provider adoption of best practice through linking funding to activity and patient outcomes Ontarians will get the right care, at the right place and at the right time Meaningful Performance Evaluation Feedback Figure 1: Current and Future States of Health System Funding Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 10 How Will We Get There? The Ministry of Health and Long-Term Care has adopted a 3-year implementation strategy to phase in a PBF model and will make modest funding shifts starting in fiscal year 2012/13. A 3-year outlook has been provided to support planning for upcoming funding policy changes. The Ministry has released a set of tools and guiding documents to further support the field in adopting the funding model changes. For example, a QBP interim list has been published for stakeholder consultation and to promote transparency and sector readiness. The list is intended to encourage providers across the continuum to analyze their service provision and infrastructure in order to improve clinical processes and, where necessary, build local capacity. The successful transition from the current, provider-centred funding model towards a patient-centred model will be catalyzed by a number of key enablers and field supports. These enablers translate to actual principles that guide the development of the funding reform implementation strategy related to QBPs. These principles further translate into operational goals and tactical implementation (Figure 2). Principles for developing QBP implementation strategy Cross-Sectoral Pathways Evidence-Based Balanced Evaluation Operationalization of principles to tactical implementation (examples) Development of best practice patient clinical pathways through clinical expert advisors and evidence-based analyses Integrated Quality Based Procedures Scorecard Alignment with Quality Improvement Plans Transparency Publish practice standards and evidence underlying prices for QBPs Routine communication and consultation with the field Sector Engagement Clinical expert panels Provincial Programs Quality Collaborative Overall HSFR Governance structure in place that includes key stakeholders LHIN/CEO Meetings Knowledge Transfer Applied Learning Strategy/ IDEAS Tools and guidance documents HSFR Helpline; HSIMI website (repository of HSFR resources) Figure 2: Principles Guiding Implementation of Quality-Based Procedures Abbreviations: HSFR, Health System Funding Reform; HSIMI, Health System Information Management and Investment: IDEAS, Improving the Delivery of Excellence Across Sectors; LHIN, Local Health Integration Network; QBP. Quality-Based Procedures. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 11 What Are Quality-Based Procedures? QBPs involve clusters of patients with clinically related diagnoses or treatments. CHF was chosen as a QBP using an evidence- and quality-based selection framework that identifies opportunities for process improvements, clinical redesign, improved patient outcomes, enhanced patient experience, and potential cost savings. The evidence-based framework used data from the Discharge Abstract Database (DAD) adapted by the Ministry of Health and Long-Term Care for its Health-Based Allocation Model (HBAM) repository. The HBAM Inpatient Grouper (HIG) groups inpatients based on their diagnosis or their treatment for the majority of their inpatient stay. Day surgery cases are grouped in the National Ambulatory Care Referral System (NACRS) by the principal procedure they received. Additional data were used from the Ontario Case Costing Initiative (OCCI). Evidence in publications from Canada and other jurisdictions and World Health Organization reports was also used to assist with the patient clusters and the assessment of potential opportunities. The evidence-based framework assessed patients using 4 perspectives, as presented in Figure 3. This evidence-based framework has identified QBPs that have the potential to both improve quality outcomes and reduce costs. • Does the clinical group contribute to a significant proportion of total costs? • Is there significant variation across providers in unit costs/ volumes/ efficiency? • Is there potential for cost savings or efficiency improvement through more consistent practice? • How do we pursue quality and improve efficiency? • Is there potential areas for integration across the care continuum? • Is there a clinical evidence base for an established standard of care and/or care pathway? How strong is the evidence? • Is costing and utilization information available to inform development of reference costs and pricing? • What activities have the potential for bundled payments and integrated care? • Are there clinical leaders able to champion change in this area? • Is there data and reporting infrastructure in place? • Can we leverage other initiatives or reforms related to practice change (e.g. Wait Time, Provincial Programs)? • Is there variation in clinical outcomes across providers, regions and populations? • Is there a high degree of observed practice variation across providers or regions in clinical areas where a best practice or standard exists, suggesting such variation is inappropriate? Figure 3: Evidence-Based Framework Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 12 Practice Variation The DAD stores every Canadian patient discharge, coded and abstracted, for the past 50 years. This information is used to identify patient transition through the acute care sector, including discharge locations, expected lengths of stay and readmissions for each and every patient, based on their diagnosis and treatment, age, gender, comorbidities and complexities, and other condition-specific data. A demonstrated large practice or outcome variance may represent a significant opportunity to improve patient outcomes by reducing this practice variation and focusing on evidence-informed practice. A large number of “Beyond Expected Days” for length of stay and a large standard deviation for length of stay and costs are flags to such variation. Ontario has detailed case-costing data for all patients discharged from a case-costing hospital from as far back as 1991, as well as daily utilization and cost data by department, by day, and by admission. Availability of Evidence A significant amount of Canadian and international research has been undertaken to develop and guide clinical practice. Using these recommendations and working with the clinical experts, best practice guidelines and clinical pathways can be developed for these QBPs, and appropriate evidence-informed indicators can be established to measure performance. Feasibility/Infrastructure for Change Clinical leaders play an integral role in this process. Their knowledge of the patients and the care provided or required represents an invaluable component of assessing where improvements can and should be made. Many groups of clinicians have already provided evidence for rationale-for-care pathways and evidence-informed practice. Cost Impact The selected QBP should have no fewer than 1,000 cases per year in Ontario and represent at least 1% of the provincial direct cost budget. While cases that fall below these thresholds may, in fact, represent improvement opportunity, the resource requirements to implement a QBP may inhibit the effectiveness for such a small patient cluster, even if there are some cost efficiencies to be found. Clinicians may still work on implementing best practices for these patient subgroups, especially if they align with the change in similar groups. However, at this time, there will be no funding implications. The introduction of evidence into agreed-upon practice for a set of patient clusters that demonstrate opportunity as identified by the framework can directly link quality with funding. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 13 Cost Impact • 19,396 annual acute inpatient hospitalizations for CHF • Total acute inpatient cost: $166.985M, extensive postacute care costs in rehabilitation, home care and LTC • 4th highest costing CMG by total cost • 26,829 ALC days, costing ~$17M • Highest readmissions within 30 days at 21% representing for a total acute inpatient cost of $37.87M Feasibility /Capacity for Change • Baker Report singled out CHF as key condition to focus on • Indicators for CHF readmissions currently in MLPA and QIPs • Tools such as LACE screening index currently being tested • Key focus area for Avoidable Hospitalizations Living Labs Communities; clinical expert table will be established to secure agreement on care pathway and quality markers • Coordinated table to discuss options related to payment approaches (e.g. bundled payments across acute and post acute physician services) to follow development of quality standards • THETA recently completed a report on Heart Failure Clinics Availability of Evidence • Evidence demonstrating significant reduction in CHF readmissions is possible through implementation of interventions that include: • use of heart failure clinics, • outpatient follow up, • care coordination post discharge, • telehealth interventions • Transitional Care intervention for CHF used advanced practice nurses to achieve 34 per cent reductions in readmission and 39 per cent reduction in mean total cost • University of Ottawa Heart Institute’s Telehealth program reduced 30-day readmissions by 54 percent with savings up to $20,000 per patient Practice Variation • Hospitalization rates vary from 39.43 to 96.68 per 100,000 residents across LHINs • Readmission rates vary from 18% to 25% across LHINs • Large variations in ALC rates for CHF patients across LHINs and hospitals • Inconsistent use of heart failure clinics and cardiac rehab across the province • Inconsistent access to cardiologists across province • Upcoming discussions with ICES scientific experts to take place to identify clinical variation in outcomes for CHF patients Figure 4: Quality-Based Procedures Evidence-Based Framework for CHF Abbreviations: ALC, alternate level of care; CHF, congestive heart failure; CMG, Case Mix Group; ICES, Institute for Clinical Evaluative Sciences; LACE, length of stay, acuity of admission, comorbidity of patient, emergency department use; LHIN, Local Health Integration Network; LTC, long-term care; MLPA, Ministry-LHIN Performance Agreement; QIP, Quality Improvement Plan; THETA, Toronto Health Economics and Technology Assessment. Source: Ministry of Health and Long-Term Care Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 14 How Will Quality-Based Procedures Encourage Innovation in Health Care Delivery? Implementing evidence-informed pricing for the targeted QBPs will encourage health care providers to adopt best practices in their care delivery models and maximize their efficiency and effectiveness. Moreover, best practices that are defined by clinical consensus will be used to understand required resource utilization for the QBPs and further assist in developing evidence-informed pricing. Implementation of a “price x volume” strategy for targeted clinical areas will motivate providers to: adopt best practice standards re-engineer their clinical processes to improve patient outcomes develop innovative care delivery models to enhance the experience of patients Clinical process improvement may include better discharge planning, eliminating duplicate or unnecessary investigations, and paying greater attention to the prevention of adverse events, that is, postoperative complications. These practice changes, together with adoption of evidence-informed practices, will improve the overall patient experience and clinical outcomes and help create a sustainable model for health care delivery. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 15 Methods Overview of the HQO Episode of Care Analysis Approach In order to produce this work, Health Quality Ontario (HQO) has developed a novel methodology known as an episode of care analysis that draws conceptually and methodologically from several of HQO’s core areas of expertise: Health technology assessment: Recommended practices incorporate components of HQO’s evidence-based analysis methodology and draw from the recommendations of the Ontario Health Technology Advisory Committee (OHTAC). Case mix grouping and funding methodology: Cohort and patient group definitions use clinical input to adapt and refine case mix methodologies from the Canadian Institute for Health Information (CIHI) and the Ontario Health-Based Allocation Model (HBAM). Clinical practice guidelines and pathways: Recommended practices synthesize guidance from credible national and international guideline bodies, with attention to the strength of evidence supporting each piece of guidance. Analysis of empirical data: Expert Advisory Panel recommendations were supposed by descriptive and multivariate analysis of Ontario administrative data (e.g., Discharge Abstract Database [DAD] and National Ambulatory Care Reporting System [NACRS]) and data from disease-based clinical data sets (e.g., the Ontario Stroke Audit [OSA] and Enhanced Feedback For Effective Cardiac Treatment [EFFECT] databases). Clinical engagement: All aspects of this work were guided and informed by leading clinicians, scientists and administrators with a wealth of knowledge and expertise in the clinical area of focus. The development of the episode of care analysis involves the following key steps: 1. Defining cohorts and patient groups 2. Defining the scope of the episode of care 3. Developing the episode of care model 4. Identifying recommended practices, including the Rapid Review process The following sections describe each of these steps in further detail. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 16 Defining Cohorts, Patient Groups, and Complexity Factors At the outset of this project, the Ministry of Health and Long-Term Care provided HQO with a broad description of each assigned clinical population (e.g., CHF), and asked HQO to work with the Expert Panels to define inclusion and exclusion criteria for the cohort they would examine using data elements from routinely reported provincial administrative databases. It was also understood that each of these populations might encompass multiple distinct subpopulations (referred to as “patient groups”) with significantly different clinical characteristics. For example, the CHF population includes subpopulations with heart failure, myocarditis and cardiomyopathies. These patient groups each have very different levels of severity, different treatment pathways, and different distributions of expected resource utilization. Consequently, these groups may need to be reimbursed differently from a funding policy perspective. Conceptually, the process employed here for defining cohorts and patient groups shares many similarities with methods used around the world for the development of case mix methodologies, such as DiagnosisRelated Groups (DRGs) or the Canadian Institute for Health Information’s (CIHI) Case Mix Groups. Case mix methodologies have been used since the late 1970s to classify patients into groups that are similar in terms of both clinical characteristics and resource utilization for the purposes of payment, budgeting and performance measurement.1 Typically, these groups are developed using statistical methods such as classification and regression tree analysis to cluster patients with similar costs based on common diagnoses, procedures, age, and other variables. After the initial patient groups have been established based on statistical criteria, clinicians are often engaged to ensure that the groups are clinically meaningful. Patient groups are merged, split, and otherwise reconfigured until the grouping algorithm reaches a satisfactory compromise between cost prediction, clinical relevance, and usability. Most modern case mix methodologies and payment systems also include a final layer of patient complexity factors that modify the resource weight (or price) assigned to each group upward or downward. These can include comorbidities, use of selected interventions, long- or short-stay status, and social factors. In contrast with these established methods for developing case mix systems, the patient classification approach that the Ministry asked HQO and the Expert Panels to undertake is unusual in that it begins with the input of clinicians rather than with statistical analysis of resource utilization. The Expert Panels were explicitly instructed not to focus on cost considerations, but instead to rely on their clinical knowledge of those patient characteristics that are commonly associated with differences in indicated treatments and expected resource utilization. Expert Panel discussions were also informed by summaries of relevant literature and descriptive tables containing Ontario administrative data. Based on this information, the Expert Panels recommended a set of inclusion and exclusion criteria to define each disease cohort. Starting with establishing the ICD-10-CA2 diagnosis codes included for the population, the Expert Panels then excluded diagnoses with significantly different treatment protocols from the general population, including pediatric cases and patients with very rare disorders. Next, the Expert Panels recommended definitions for major patient groups within the cohort. Finally, the Expert Panels identified patient characteristics that they believe would contribute to additional resource utilization for patients within each group. This process generated a list of factors ranging from commonly occurring comorbidities to social characteristics such as housing status. In completing the process described above, the Expert Panel encountered some noteworthy challenges: 1 Fetter RB, Shin Y, Freeman JL, Averill RF, Thompson JD. Case mix definition by diagnosis-related groups. Med Care. 1980 Feb;18(2):iii, 1-53. 2 International Classification of Diseases, 10th Revision (Canadian Edition). Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 17 1. Absence of clinical data elements capturing important patient complexity factors. The Expert Panels quickly discovered that a number of important patient-based factors related to the severity of patients’ conditions or their expected utilization are not routinely collected in Ontario hospital administrative data. These include both key clinical measures (such as FEV1 / FVC for chronic obstructive pulmonary disease [COPD] patients and AlphaFIM®3 scores for stroke patients) as well as important social characteristics (such as caregiver status).4 For stroke and CHF, some of these key clinical variables have been collected in the past through the OSA and EFFECT datasets, respectively. However, these datasets were limited to a group of participating hospitals and at this time are not funded for future data collection. 2. Focus on a single disease grouping within a broader case mix system. While the Expert Panels were asked to recommend inclusion/exclusion criteria only for the populations tasked to them, the 3 patient populations assigned to HQO are a small subset of the many patient groups under consideration for Quality-Based Procedures. This introduced some additional complications when defining population cohorts; after the Expert Panels had recommended their initial patient cohort definitions (based largely on diagnosis), the Ministry informed the Expert Panels that there were a number of other patient groups planned for future Quality-Based Procedure (QBP) funding efforts that overlapped with the cohort definitions. For example, while the vast majority of patients discharged from hospital with a most responsible diagnosis of COPD receive largely ward-based medical care, a small group of COPD-diagnosed patients receive much more cost-intensive interventions such as lung transplants or resections. Based on their significantly different resource utilization, the Ministry’s HBAM grouping algorithm assigns these patients to a different HBAM Inpatient Grouper (HIG) group from the general COPD population. Given this methodological challenge, the Ministry requested that the initial cohorts defined by the Expert Panels be modified to exclude patients that receive selected major interventions. It is expected that these patients may be assigned to other QBP patient groups in the future. This document presents both the initial cohort definition defined by the Expert Panel and the modified definition recommended by the Ministry. In short, the final cohorts and patient groups described here should be viewed as a compromise solution based on currently available data sources and the parameters of the Ministry’s HBAM grouping methodology. 3 The Functional Independence Measure (FIM) is a composite measure consisting of 18 items assessing 6 areas of function. These fall into 2 basic domains; physical (13 items) and cognitive (5 items). Each item is scored on a 7-point Likert scale indicative of the amount of assistance required to perform each item (1 = total assistance, 7 = total independence). A simple summed score of 18–126 is obtained where 18 represents complete dependence / total assistance and 126 represents complete independence. 4 For a comprehensive discussion of important data elements for capturing various patient risk factors, see Iezzoni LI, editor. Range of risk factors. In Iezzoni LI (Ed.) Risk adjustment for measuring health care outcomes, 4th ed. Chicago: Health Administration Press; 2012. p. 29-76. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 18 Defining the Scope of the Episode of Care HQO’s episode of care analysis draws on conceptual theory from the emerging worldwide use of episodebased approaches for performance measurement and payment. Averill et al,5 Hussey et al,6 and Rosen and Borzecki7 describe the key parameters required for defining an appropriate episode of care: Index event: The event or time point triggering the start of the episode. Examples of index events include admission for a particular intervention, presentation at the emergency department (ED) or the diagnosis of a particular condition. Endpoint: The event or time point triggering the end of the episode. Examples of endpoints include death, 30 days following hospital discharge, or a “clean period” with no relevant health care service utilization for a defined window of time. Scope of services included: While an “ideal” episode of care might capture all health and social care interventions received by the patient from index event to endpoint, in reality not all these services may be relevant to the objectives of the analysis. Hence, the episode may exclude some types of services such as prescription drugs or services tied to other unrelated conditions. Ideally, the parameters of an episode of care are defined based on the nature of the disease or health problem studied and the intended applications of the episode (e.g., performance measurement, planning, or payment). For HQO’s initial work here, many of these key parameters were set in advance by the Ministry based on the government’s QBP policy parameters. For example, in 2013/14 the QBPs will focus on reimbursing acute care, and do not include payments for physicians or other non-hospital providers. These policy parameters resulted in there being limited flexibility to examine non-hospital elements such as community-based care or readmissions. Largely restricted to a focus on hospital care, the Chairs of the Expert Panels recommended that the episodes of care for all 3 conditions begin with a patient’s presentation to the ED (rather than limit the analysis to the inpatient episode) in order to provide scope to examine criteria for admission. Similarly, each of the Expert Panels ultimately also included some elements of postdischarge care in the scope of the episode in relation to discharge planning in the hospital and the transition to community services. 5 Averill RF, Goldfield NI, Hughes JS, Eisenhandler J, Vertrees JC (2009). Developing a prospective payment system based on episodes of care. J Ambul Care Manage. 32(3):241-51. 6 Hussey PS, Sorbero ME, Mehrotra A, Liu H, Damberg CL (2009). Episode-based performance measurement and payment: making it a reality. Health Affairs. 28(5):1406-17. 7 Rosen AK, Borzecki AM Windows of observation. In Iezzoni LI, ed. Risk adjustment for measuring health care outcomes, 4th ed. Chicago: Health Administration Press; 2012. p. 71-94. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 19 Developing the Episode of Care Pathway Model HQO has developed a model that brings together the key components of the episode of care analysis through an integrated schematic. The model is structured around the parameters defined for the episode of care, including boundaries set by the index event and endpoints, segmentation (or stratification) of patients into the defined patient groups, and relevant services included in the episode. The model describes the pathway of each patient case included in the defined cohort, from initial presentation through segmentation into one of the defined patient groups based on their characteristics, and finally through the subsequent components of care that they receive before reaching discharge or death. While the model bears some resemblance to a clinical pathway, it is not intended to be used as a traditional operational pathway for implementation in a particular care setting. Rather, the model presents the critical decision points and phases of treatment within the episode of care, respectively referred to here as clinical assessment nodes and care modules. Clinical assessment nodes (CANs) provide patientspecific criteria for whether a particular case proceeds down one branch of the pathway or another. Once patients move down a particular branch, they then receive a set of recommended practices that are clustered together as a care module. Care modules represent the major phases of care that patients receive within a hospital episode, such as treatment in the ED, care on the ward, and discharge planning. The process for identifying the recommended practices within each CAN and care module is described in the next section. Drawing from the concept of decision analytic modelling, the episode of care model includes crude counts (N) and proportions (Pr) of patients proceeding down each branch of the pathway model. For the 3 conditions studied in this exercise, these counts were determined based on annual utilization data from the DAD, NACRS, and (for CHF and stroke) clinical registry data. Figure 5 provides an illustrative example of a care module and CAN: Responding to treatment (N = 20,000; Pr = 85%) Patient presents at the emergency department Care Module N = 43,000 Pr = 1.0 CAN Responding to treatment (N = 23,000; Pr = 15%) Figure 5: Sample Episode of Care Pathway Model Abbreviations: CAN, clinical assessment node; N, crude counts; Pr, proportions. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 20 Identifying Recommended Practices Each CAN and care module in the episode of care model contains a set of recommended practices reviewed and agreed upon through the Expert Panel. The end goal communicated by the Ministry for the QBP methodology is to develop cost estimates for the recommended practices and aggregate these to determine a total “best practice cost” for an ideal episode of care to inform the pricing of the QBP. In keeping with HQO’s mandate to support evidence-based care, considerable attention has been paid to ensure that the recommended practices here are supported by the best available evidence. For this process, HQO considers the gold standard of evidence to be official OHTAC recommendations. While there are many other organizations that release high quality clinical guidance based on rigorous standards of evidence, OHTAC recommendations are considered the highest grade of evidence in this process for several reasons: Consistency: While many guidance bodies issue disease-specific recommendations, OHTAC produces guidance in all disease areas, providing a common evidence framework across all the clinical areas analyzed. Economic modelling: OHTAC recommendations are generally supported by economic modelling to determine the cost-effectiveness of an intervention, whereas many guidance bodies assess only effectiveness. Contextualization: In contrast with recommendations and analyses from international bodies, OHTAC recommendations are developed through the contextualization of evidence for Ontario. This ensures that the evidence is relevant for the Ontario health system context. Notwithstanding these strengths, it is also crucial to mention several important limitations in the mandate and capacity of OHTAC to provide a comprehensive range of evidence to support HQO’s episode of care analyses: Focus on non-drug technologies: While evidence shows that various in-hospital drugs are effective in treating all 3 of the patient populations analyzed, OHTAC traditionally does not consider pharmaceuticals under its mandate. Recently, OHTAC has reviewed some drug technologies in comparison with non-drug technologies for a given population as part of megaanalyses. Capacity constraints: There are a considerable number of candidate practices and interventions that require consideration for each episode of care. As OHTAC makes recommendations largely based on evidence-based analyses supplied by HQO, it may be limited in its capacity to undertake new reviews in all required areas. Focus on high quality evidence: OHTAC uses the GRADE criteria8 to assess the strength of evidence for an intervention, with randomized controlled trials (RCTs) considered the gold standard of evidence here. Not every practice within an episode of care may be appropriate or feasible to study through an RCT. For example, some interventions may be regarded as accepted clinical practice, while others may be unethical to evaluate as part of a clinical trial. Thus, in situations where OHTAC recommendations do not exist, HQO’s episode of care analysis makes use of other sources of evidence: 8 Guyatt GH, Oxman AD, Schunemann HJ, Tugwell P, Knottnerus A. GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology. J Clin Epidemiol. 2011;64(4):380-2. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 21 Guidance from other evidence-based organizations: Each of the Expert Panels recommended credible existing sources of evidence-based guidance, such as the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for COPD. Recommendations from these bodies were included along with their assessment of the evidence supporting the recommendation. Analysis of empirical data: The Expert Panels reviewed the results of descriptive and multivariate analysis using empirical data, including administrative data sources and clinical data sources such as the EFFECT database. Expert consensus: In areas that the Expert Panels saw as important but where evidence was limited or nonexistent, the Expert Panels relied on consensus agreement while noting the need for further research in these areas. Evidence-based practices for COPD Long-acting maintenance bronchodilators OHTAC mega-analysis Long-term oxygen therapy Community-based multidisciplinary care Community-based diagnosis and assessment QBF episode of care Non-invasive Ventilation Short-acting bronchodilators Pulmonary rehabilitation following acute exacerbation Corticosteroids Pulmonary Vaccinations rehabilitation for stable COPD patients Antibiotics In-hospital diagnostics Figure 6: Example Illustrating the Alignment of OHTAC COPD Practice Recommendations with the Scope of Practices Reviewed Through the COPD Episode of Care Abbreviations: COPD, chronic obstructive pulmonary disease; OHTAC. Ontario Health Technology Advisory Committee; QBF, Quality-Based Funding. The process for identifying recommended practices involves the following steps: 1. Reviewing existing guidance from OHTAC and other selected evidence-based bodies and extracting all candidate practices for each care module and CAN; 2. Consulting with members of the Expert Panel for additional candidate interventions not included in the guidance reviewed; 3. Reviewing and summarizing the strength of evidence cited for each candidate intervention in the guidance literature, where it exists and is clearly stated; 4. Summarizing the results of steps 1 to 3 above for each phase of the episode of care model and presenting the summary to the Expert Panel for review; 5. Facilitating discussion by the Expert Panel members on contextualizing the candidate practices for the Ontario health system and arriving at a consensus recommendation; and 6. Identifying gaps in the evidence that the Expert Panel agreed are high value candidates for research questions for rapid reviews (see below) and future evidence-based analyses. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 22 Rapid Reviews In order to address cases where a gap in the evidence is identified and prioritized for further analysis in step 6 (above), HQO has developed a rapid evidence review process that is able to operate within the compressed timeframe of this exercise, recognizing that a full evidence-based analysis would be impractical given the short timelines. For each question, the rapid review analysis began with a literature review using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 1, 2000, to October 2012. Abstracts were reviewed by a single reviewer and full-text articles were obtained for those studies meeting the eligibility criteria. Reference lists were also examined for any additional relevant studies not identified through the search. Articles were reviewed if they were: English language full-text reports published between January 1, 2008, and October 2012 health technology assessments, systematic reviews, and meta-analyses If systematic reviews were not available, RCTs, observational studies, case reports, and editorials were selected. The methodological quality of systematic reviews was assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) measurement tool.9 The quality of the body of evidence for each outcome was examined according to the GRADE Working Group criteria.8 The overall quality was determined to be very low, low, moderate, or high using a step-wise, structural methodology. Study design was the first consideration; the starting assumption was that RCTs are high quality, whereas observational studies are low quality. Five additional factors—risk of bias, inconsistency, indirectness, imprecision, and publication bias—were then taken into account. Limitations or serious limitations in these areas resulted in downgrading the quality of evidence. Finally, 3 factors that could raise the quality of evidence were considered: large magnitude of effect, dose response gradient, and accounting for all residual confounding.8 For more detailed information, please refer to the latest series of GRADE articles.8 As stated by the GRADE Working Group,7 the final quality score can be interpreted using the following definitions: 9 Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of sytematic reviews. BMC Med Res Methodol. 2007;7(10). Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 23 High Very confident that the true effect lies close to the estimate of the effect Moderate Moderately confident in the effect estimate—the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low Confidence in the effect estimate is limited—the true effect may be substantially different from the estimate of the effect Very Low Very little confidence in the effect estimate—the true effect is likely to be substantially different from the estimate of effect Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 24 Description of Congestive Heart Failure CHF is a complex clinical syndrome of symptoms and signs suggesting that the heart muscle is weakened and the heart as a pump is impaired; it is caused by structural or functional abnormalities and is the leading cause of hospitalization in elderly Ontarians. Between 1997 and 2007, there were 419,552 cases of heart failure in Ontario, with 216,190 requiring admission to hospital.10 Slightly more women (51%) than men had heart failure, and 80% of the overall cohort was age 65 or older.10 The prognosis for patients is poor; CHF is associated with high mortality. 10 Yeung DF, Boom NC, Guo H, Lee DS, Schultz S, Tu J. Trends in the incidence and outcomes of heart failure in Ontario, Canada: 1997 to 2007, CMAJ 2012. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 25 Recommended CHF Cohort Definition and Patient Grouping Approach Initial CHF Cohort Inclusion/Exclusion Criteria The CHF pathway has been developed for adult patients presenting to Ontario’s EDs with a major diagnosis of CHF. These patients are admitted to an inpatient bed, transferred to another hospital, or discharged from the ED. Patients with a primary diagnosis of CHF received from another hospital or who develop CHF during their stay in hospital are not included in this pathway. For QBP funding purposes, cases are included only if CHF-related diagnoses are assigned as the “Most Responsible Diagnosis” for an acute inpatient (DAD data) or as the “Main Problem” for an ED patient (NACRS data) and have not had a “major qualifying procedure” performed. The following age ranges, diagnosis codes (International Classification of Diseases, 10th Revision (Canadian Edition) [ICD-10-CA]), and diagnosis types were used to define the CHF population for this episode of care analysis: a) Age: Persons aged 20 years and older. CHF is predominantly a disease of older individuals; the largest cohort of patients is those 75 years of age or over. Patients under age 20 with CHF are quite rare, and their disease tends to result from congenital factors; the care pathway and treatment protocols for such patients are likely to be substantially different. The Expert Panel developed the CHF care pathway for adult patients using the 20-year age threshold used in many Institute for Clinical Evaluative Sciences (ICES) studies. b) Diagnosis codes: The ICD-10-CA codes used to define the cohort of patients with CHF are listed below. I50.x Heart failure, left ventricular dysfunction, etc I25.5 Ischemic cardiomyopathy I40.x, I41.x Myocarditis I42.x, I43.x Cardiomyopathies I11.x plus I50.x (secondary Dx) Hypertensive heart disease plus heart failure, left ventricular dysfunction I13.x plus I50.x (secondary Dx) Hypertensive heart disease and renal disease plus heart failure, left ventricular dysfunction) Appendix I shows the ICD-10-CA details for the CHF patient groups. c) Diagnosis types: The following diagnosis types are included in the CHF patient definition: • Acute inpatient cases include Most Responsible Diagnosis codes—the diagnosis determined as the diagnosis or condition held most responsible for the greatest portion of the length of stay or greatest use of resources. • Emergency department cases include Main Problem codes—the diagnosis or condition determined to be most responsible for the greatest proportion of the length of stay or greatest use of resources. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 26 As noted above, using the DAD and the NACRS databases, the following codes defined the CHF population: • Most responsible diagnosis of “I50.X” “I25.5” “I40.X” “I41.X” “I42.X” “I43.X” OR • Most responsible diagnosis of “I11.X” and comorbidity “I50.X” code OR • Most responsible diagnosis of “I13.X” and comorbidity “I50.X” code It should be noted that comorbidity diagnoses are only with diagnosis type “1” pre-admit comorbidity, “2” post-admit comorbidity, or “W”, “X”, “Y” service transfer diagnosis. d) Typical CHF patients: In the DAD, typical patients include those coded as both “typical” and “short stay” using the Health Based Allocation Model Inpatient Grouper (HIG). Deaths, transfers, sign-outs, and long-stay outliers are considered atypical cases. Table 1 shows the breakdown of CHF patients by type and distribution of the resource intensity weights for 2010/11. Table 1: CHF Patients for 2010/2011 Case Type Number of Cases Weight (Mean) Weight (Minimum) Weight (50th Percentile) Weight (Median) Weight (75th Percentile) Weight (Maximum) All 22,342 1.89 0.24 0.98 1.06 1.84 134.77 Atypical 3,298 4.76 0.24 1.04 2.85 5.38 134.77 Typical 19,044 1.39 0.26 0.98 1.06 1.29 40.66 Abbreviation: CHF, congestive heart failure. Data source: DAD 2010/11. The Expert Panel considered both typical and atypical patients in the development of the CHF care pathway. The Expert Panel felt that smaller hospitals would need to transfer patients to other acute care hospitals with more appropriate resources, such as catheterization laboratories. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 27 Inclusion/Exclusion Criteria for QBP Funding Purposes During the development of the episode of care pathway, the MOHLTC representatives explained the challenges of the CHF cohort definitions into the QBP funding methodology. To align the CHF cohort to the present HIGs, the following ICD-10-CA diagnosis codes, diagnosis types, and ICD-10 Canadian Classification of Health Interventions (CCI) intervention exclusion criteria are recommended for the purposes of funding CHF through the QBP funding mechanism: a) Age: Age greater than or equal to 20 years at time of admission. b) Diagnosis codes: The ICD-10-CA most responsible diagnosis codes are listed below. I50.x Heart failure, left ventricular dysfunction, etc I40.x, I41.x Myocarditis I25.5 Ischemic cardiomyopathy I42.x, I43.x Cardiomyopathies I11.x plus I50.x (secondary Dx) Hypertensive heart disease plus heart failure, left ventricular dysfunction I13.x plus I50.x (secondary Dx) Hypertensive heart disease and renal disease plus heart failure, left ventricular dysfunction) c) Intervention: Patients are not assigned to an intervention-based HIG cell, given the current methodology. (i.e., Major Clinical Category [MCC] partition variable is not “I”) CMG algorithms used by the Ministry for QBP funding typically assign cases to groups based on either principal intervention (typically a major qualifying procedure, such as a surgery) or in cases where there is no major qualifying procedure, by Most Responsible Diagnosis. There is a need for CMGs to be mutually exclusive: that is, the logic of the grouping algorithm should assign a case to 1 group or another—not both. When the MCC partition variable “I” is included, CHF patients fall into many HIGs. Table 2 shows the HIG distribution of CHF inpatients; using the existing CMG funding methodology and 2011/12 inpatient data, most of the 22,435 admitted CHF patients as defined by the Expert Panel fall into 3 HIGs (highlighted). Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 28 Table 2: CHF Cohort Distribution by Health-Based Allocation Model Inpatient Groupers, 2011/12 HIG 143 160 161 162 163 164 166 167 168 172 173 174 175 176 177 178 179 180 181 182 183 185 195 196 197 209 571 600 601 617 905 992 COUNT PERCENT HIG Description 0.0 4 Disease of Pleura 0.2 36 Heart or Lung Transplant 1.3 300 Implantation of Cardioverter/Defibrillator 0.0 11 Cardiac Valve Replacement 0.2 42 Major Cardiothoracic Intervention with Pump 0.1 15 Major Cardiothoracic Intervention without Pump 0.0 4 Coronary Artery Bypass Graft with Coronary Angiogram with MI/Shock/Arrest with Pump 0.0 1 Coronary Artery Bypass Graft with Coronary Angiogram with MI/Shock/Arrest without Pump 0.0 2 Coronary Artery Bypass Graft with Coronary Angiogram without MI/Shock/Arrest with Pump 0.0 6 Coronary Artery Bypass Graft without Coronary Angiogram without MI/Shock/Arrest with/without Pump 0.0 6 Minor Cardiothoracic Intervention 0.8 174 Pacemaker Implantation/Removal Except Cardioverter/Defibrillator Implant 0.4 95 Percutaneous Coronary Intervention with MI/Shock/Arrest/Heart Failure 0.0 6 Percutaneous Coronary Intervention without MI/Shock/Arrest/Heart Failure 0.0 11 Management of Pacemaker Battery/Epicardial Lead 0.0 Percutaneous Transluminal Cardiothoracic Intervention except Percutaneous Coronary Intervention 11 0.1 13 Cardiac Conduction System Intervention 0.0 4 Amputation of Limb except Hand/Foot 0.0 1 Abdominal Aorta Intervention 0.0 4 Bypass/Extraction of Vein/Artery of Limb 0.0 4 Amputation of Hand/Foot 0.1 32 Other/Miscellaneous Vascular Intervention 4.4 979 Heart Failure with Coronary Angiogram 86.3 19,368 Heart Failure without Coronary Angiogram 0.4 81 Hypertensive Disease except Benign Hypertension 4.5 1,000 Other/Miscellaneous Cardiac Disorder 0.0 1 Newborn/Neonate 1500+ gm with Major Cardiovascular Intervention 0.0 1 Newborn/Neonate 2500+ grams, Other Moderate Problem 0.0 1 Newborn/Neonate 2500+ grams, Other Minor Problem 0.0 1 Intervention with Blood/Lymphatic System Diagnosis except Neoplasm 1.0 220 MCC 05 Unrelated Intervention 0.0 1 Stillbirth Abbreviations: CHF, congestive heart failure; HIG, HBAM Inpatient Grouper; MCC, Major Clinical Category; MI, myocardial infarction. Data source: DAD 2011/12. Cases assigned to an intervention-based HIG cell are likely to be more advanced and funded using a different episode of care pathway (to be developed in the future). As a result, for funding purposes, the MCC partition “I” has been excluded from the current pathway. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 29 Table 3 shows the distribution of CHF inpatients across the included (i.e., non–intervention-based) HIGs to be used for QBP funding. Table 3: Distribution of CHF Patients Across Included HIGs HIG 143 195 196 197 209 600 601 992 HIG_desc Disease of Pleura Heart Failure with Coronary Angiogram Heart Failure without Coronary Angiogram Hypertensive Disease except Benign Hypertension Other/Miscellaneous Cardiac Disorder Newborn/Neonate 2500+ grams, Other Moderate Problem Newborn/Neonate 2500+ grams, Other Minor Problem Stillbirth COUNT PERCENT 4 0.0 979 4.6 19,368 90.4 81 0.4 1,000 4.7 1 0.0 1 0.0 1 0.0 Abbreviations: CHF, congestive heart failure; HBAM, Health-Based Allocation Model; HIG, HBAM Inpatient Grouper. Data source: DAD 2011/12. Table 4 shows the distribution of CHF patients in the ED using the Comprehensive Ambulatory Care Classification System (CACS). Table 4: Distribution of CHF Patients in ED Across CACS Cells CACS CACS Description Patients with CHF Diagnosis Codes, n All Patients in These CACS Cells, n A001 Dead on arrival 8 696 A002 Left without being seen or triaged and not seen 2 193,799 B001 Cardiovascular condition with acute admission/transfer 18,506 97,974 B051 Emergency visit interventions 233 73,648 B053 Interventions generally performed by non-emergency department service: other 19 1,559 B121 Congestive heart failure 8,645 8,645 B122 Other disease or disorder cardiac system 203 278,635 C154 Pleurocentesis 3 41 E201 Cardiovascular disorders 4 115 E202 Congestive heart failure 27 27 Abbreviation: CACS, Comprehensive Ambulatory Care Classification System; CHF, congestive heart failure; ED, emergency department. Data source: NACRS 2011/12. For funding purposes, the Ministry will be considering methods of dealing with low-volume CACS cells. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 30 CHF In-Hospital Patient Journey At the initial Expert Panel meetings, the CHF patient journey was mapped out. Patient presentation at the ED with suspected CHF was established as the index event, and administrative data were used to inform and guide the CHF patient journey in hospital. Using CIHI administrative databases, the disposition of ED patients and admitted patients was reviewed. In 2010/11, 62.5% of patients presenting to the ED with main problem reported as CHF were admitted (Table 5). Table 5: ED CHF Patient Visit Dispositions, Ontario, 2010/11 Visit Disposition Frequency % 8,819 30.54 02 – Client register, left without being seen, or treated by a service provider — — 03 – Client triaged and then left the emergency department; not seen by physician or primary care provider 2 0.01 04 – Client triaged, registered and assessed by a service provider and left without treatment 7 0.02 05 – Client triaged, registered, and assessed by a service provider and treatment initiated; left against medical advice before treatment completed 101 0.35 06 – Admitted into reporting facility as an inpatient to critical care unit or operating room directly from an ambulatory care visit functional centre 2,151 7.45 07 – Admitted into reporting facility as an inpatient to another unit of the reporting facility directly from the ambulatory care visit functional centre 15,895 55.05 08 – Transferred to another acute care facility directly from the ambulatory care visit functional centre 818 2.83 09 – Transferred to another non-acute care facility directly from an ambulatory care visit functional centre 28 0.1 10 – Death after arrival (DAA)—patient expires after initiation of the ambulatory care visit; resuscitative measures (e.g., CPR) may occur during the visit but are not successful 78 0.27 11 – Death on arrival (DOA)—patient is dead on arrival to the ambulatory care service; generally there is no intent to resuscitate (for example, perform CPR); includes cases where the patient is brought in for pronouncement of death 8 0.03 12 – Intra-facility transfer to day surgery 2 0.01 13 – Intra-facility transfer to the emergency department — — 14 – Intra-facility transfer to clinic 42 0.15 01 – Discharged home (private dwelling, not an institution; no support services) Abbreviations: CHF, congestive heart failure; CPR, cardiopulmonary resuscitation; ED, emergency department. Data source: NACRS 2010/11. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 31 The Expert Panel also investigated CHF patients transferred from other facilities, and the types of facilities transferring patients. For 2010/11, 13% of transferred CHF patients were from acute care facilities. Table 6 shows the number of CHF patients transferred to Ontario’s acute care hospitals in 2010/11, as reported in the DAD. After careful consideration, the Expert Panel opted to treat CHF patients transferred from other institutions as a special cohort; these patients are excluded from the episode of care pathway model developed for this report. Table 6: CHF Patients Transferred From Other Institutions, 2010/11 From Institution by Type Frequency Percent 1 0.02 1 – Acute care 722 13.06 2 – General rehabilitation facility 111 2.01 3 – Chronic care facility 108 1.95 1,189 21.5 5 – Psychiatric facility 16 0.29 6 – Unclassified or other type of facility 71 1.28 7 – Special rehabilitation facility 11 0.2 8 – Home care 577 10.43 9 – Home for the aged 1,563 28.26 N – Ambulatory care 1,161 20.99 0 – Organized outpatient department of reporting facility 4 – Nursing home Abbreviation: CHF, congestive heart failure. Data source: DAD 2010/11. Finally, the Expert Panel reviewed discharge disposition data for CHF patients admitted from the ED (Table 7). The majority of admitted CHF patients are discharged home, with 21% requiring supportive services. Table 7: Discharge Disposition for CHF Patients, 2010/11 Discharge Disposition Total Percent 863 3.84 2,858 12.73 03 – Transferred to other (palliative care/hospice, addiction treatment centre, etc.) 103 0.46 04 – Discharged to a home setting with support services (senior’s lodge, attendant care, home care, Meals on Wheels, homemaking, supportive housing, etc.) 4,716 21.01 05 – Discharged home 11,719 52.20 169 0.75 07 – Died 2,022 9.01 Total 22,450 100.00 01 – Transferred to another facility providing inpatient hospital care (includes other acute, sub-acute, psychiatric, rehabilitation, cancer centre/agency, pediatric hospital, etc.) 02 – Transferred to a long-term care facility (personal care home, auxiliary care, nursing home, extended care, home for the aged, senior’s home, etc.) 06 – Signed out (against medical advice) Abbreviation: CHF, congestive heart failure. Data source: DAD 2010/11. Based on the above data, the Expert Panel established the ED visit disposition to include patient returning home or to his/her place of residence, patient transferred to another acute care facility, admission to the hospital, or death. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 32 Factors Contributing to CHF Patient Complexity Using 2010/11 DAD data, the Expert Panel reviewed pre- and postadmission comorbidities. Preadmission comorbidities are conditions that existed prior to admission and have been assigned an ICD-10-CA code that satisfies the requirements for determining cormorbidity (Table 8). Similarly, postadmission comorbidities are conditions that arise following admission (Table 9). Table 8: CHF Preadmission Comorbidities, Top 30 ICD-10 Description Number Percent I48.0 Atrial fibrillation 3,977 9.61 J18.9 Pneumonia, unspecified 2,076 5.02 N17.9 Acute renal failure, unspecified 1,898 4.59 I10.0 Benign hypertension 1,224 2.96 N39.0 Urinary tract infection, site not specified 1,162 2.81 D64.9 Anaemia, unspecified 1,042 2.52 E11.52 Type 2 diabetes mellitus with certain circulatory complications 969 2.34 J90 Pleural effusion, not elsewhere classified 959 2.32 Z51.5 Palliative care 951 2.30 I25.10 Atherosclerotic heart disease of native coronary artery 802 1.94 J44.1 Chronic obstructive pulmonary disease with acute exacerbation, unspecified 796 1.92 E11.23 Type 2 diabetes mellitus with established or advanced kidney disease (N08.3-) 740 1.79 J44.0 Chronic obstructive pulmonary disease with acute lower respiratory infection 718 1.74 I21.4 Acute subendocardial myocardial infarction 693 1.67 J44.9 Chronic obstructive pulmonary disease, unspecified 559 1.35 E11.64 Type 2 diabetes mellitus with poor control, so described 556 1.34 E87.1 Hypo-osmolality and hyponatraemia 523 1.26 N18.9 Chronic kidney disease, unspecified 517 1.25 E87.6 Hypokalaemia 478 1.16 I35.0 Aortic (valve) stenosis 430 1.04 L03.11 Cellulitis of lower limb 415 1.00 E87.5 Hyperkalaemia 385 0.93 I25.5 Ischaemic cardiomyopathy 352 0.85 I27.2 Other secondary pulmonary hypertension 349 0.84 I50.0 Congestive heart failure 349 0.84 I42.0 Dilated cardiomyopathy 298 0.72 I95.9 Hypotension, unspecified 282 0.68 I48.1 Atrial flutter 238 0.58 D50.9 Iron deficiency anaemia, unspecified 234 0.57 E86.0 Dehydration 232 0.56 Abbreviations: CHF, congestive heart failure; ICD-10, International Classification of Diseases, 10th Revision. Data source: DAD 2010/11. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 33 Table 9: CHF Postadmission Comorbidities, Top 20 ICD-10 Description Number Percent N39.0 Urinary tract infection, site not specified 530 8.03 N17.9 Acute renal failure, unspecified 341 5.16 E87.6 Hypokalaemia 261 3.95 I95.9 Hypotension, unspecified 205 3.10 J18.9 Pneumonia, unspecified 203 3.07 I48.0 Atrial fibrillation 168 2.54 I46.9 Cardiac arrest, unspecified 139 2.10 R33 Retention of urine 110 1.67 E11.63 Type 2 diabetes mellitus with hypoglycaemia 109 1.65 E87.5 Hyperkalaemia 105 1.59 A04.7 Enterocolitis due to Clostridium difficile 104 1.57 J96.0 Acute respiratory failure 102 1.54 E87.1 Hypo-osmolality and hyponatraemia 100 1.51 F05.9 Delirium, unspecified 99 1.50 I46.0 Cardiac arrest with successful resuscitation 93 1.41 A09.9 Gastroenteritis and colitis of unspecified origin 90 1.36 I21.4 Acute subendocardial myocardial infarction 85 1.29 J96.9 Respiratory failure, unspecified 77 1.17 R57.0 Cardiogenic shock 77 1.17 I47.2 Ventricular tachycardia 75 1.14 Abbreviations: CHF, congestive heart failure; ICD-10, International Classification of Diseases, 10th Revision. Data source: DAD 2010/11. Pre- and postadmission comorbidities are not included in the current episode of care pathway for the “typical” CHF case. Following completion of the current pathway, the Expert Panel may consider the implications of commonly occurring comorbidities, such as pneumonia, acute renal failure, and diabetes. While it is expected that the foundational pathway will remain the same, the inclusion of comorbidities may result in the recommendation of additional interventions in each care module. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 34 Recommended Practices for CHF Development of the Episode of Care Pathway As discussed in the Methods chapter, the Expert Panel developed the episode of care pathway by reviewing the literature related to quality of care for CHF patients; CHF clinical practice guidelines; and the results of analyses performed on empirical data from the EFFECT database at ICES. The following sections describe the evidence review and analyses performed. Review of Literature The Expert Panel identified areas in which a review of the evidence was important to the development of the CHF pathway. The research questions and related grades of evidence are shown Table 10. A description of the rapid review methodology is provided in Appendix II. The full rapid reviews for each question are provided in Appendix III. Table 10: Rapid Review Research Questions and Quality of Evidence Research Question Quality of Evidence What is the diagnostic accuracy of in-hospital BNP measurement for HF? What is the prognostic accuracy of BNP for triage of HF patients when used in the emergency department? No studies were identified that specifically assessed the prognostic accuracy of BNP for triage of HF patients when used in the emergency department or in-hospital BNP measurement for HF before hospital discharge. What is the prognostic accuracy of in-hospital BNP measurement for HF before hospital discharge? There is moderate quality evidence that BNP testing to diagnose HF in patients presenting to the emergency department with acute dyspnea does not significantly reduce mortality or rehospitalization. What is the diagnostic accuracy of a chest x-ray for identifying pulmonary infection as a precipitant of an acute HF episode? No studies that examined the accuracy of x-rays for diagnosing pneumonia as the precipitant of an acute HF event were identified. What is the effectiveness of coronary revascularization in ischemic heart failure patients? Moderate-quality evidence suggests that coronary revascularization improves survival compared to medical therapy in patients with CAD and significant left ventricular systolic dysfunction, and for those in whom treatable targets are identified. Decisions to perform revascularization in these patients should not be overly influenced by imaging-defined myocardial viability status, as an association with clinical outcomes was not shown. The routine use of SVR as an adjunct to CABG coronary revascularization is not supported by the evidence. What is the safety and effectiveness of EMAA in hospitalized acute HF patients? No studies were identified that examined the safety and effectiveness of EMAA in hospitalized acute HF patients What is the effectiveness of ECG telemetry monitoring among patients hospitalized with acute HF in comparison to standard care? No high-quality evidence was identified that evaluated the effectiveness of ECG telemetry monitoring among patients with acute HF. What is the effectiveness of in-hospital insertion of an ICD or of CRT in patients hospitalized for acute CHF compared with those patients not hospitalized for acute CHF who receive the device or the procedure via pre-planned, elective surgery. No studies were identified that examined the effectiveness of in-hospital insertion of an ICD or CRT in patients hospitalized for acute CHF compared with those patients who receive the devices via pre-planned, elective surgery. All of the guidelines reviewed comment on the importance of diagnosing pulmonary infections such as pneumonia as a potential precipitant of an acute heart failure event. Based on expert opinion, clinical practice guidelines recommend the use of continuous ECG monitoring among patients with acute HF. The AHA practice standards for in-hospital ECG monitoring and the CCS recommend continuous ECG monitoring among all patients with acute HF. The ESC and HFSA guidelines recommend continuous ECG monitoring among acute HF patients treated with inotropes, based on the increased risk of arrhythmia and myocardial ischemia associated with these agents. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 35 Research Question What is the diagnostic accuracy of an ECG for identifying ischemia as a precipitant for an acute HF episode? Quality of Evidence No studies were identified that examined the accuracy of ECGs for diagnosing ischemia as the precipitant to an acute HF event in a HF population. All 5 of the guidelines reviewed commented on the importance of using ECG in diagnosing the precipitants for an acute HF event. Are in-hospital performance indicators for the inhospital management of heart failure effective at improving patient outcomes? There is very low quality evidence that in-hospital performance indicators for in-hospital heart failure management are effective at improving patient outcomes, in particular, reducing mortality and rehospitalization. (GRADE: Very low) Is there an increased risk of mortality for HF patients administered dobutamine, milrinone, or nitroprusside in hospital? No studies were identified that examined in-hospital milrinone or nitroprusside therapy for the management of HF. In a meta-analysis of 3 identified RCTs, there was no evidence of a statistically significant increase in mortality risk compared with placebo for patients with moderate to severe heart failure who were administered dobutamine in hospital (GRADE quality of evidence: very low). Careful consideration is required in formulating recommendations regarding the clinical utility of dobutamine for moderate to severe heart failure decompensation in hospital, based on the quality of the body of evidence and the limitations of the component studies. What is the effectiveness of IABPs in the management of patients hospitalized with acute HF? No high quality evidence on the use of IABPs in hospitalized patients with HF was identified through the systematic literature search. Therefore no conclusions could be made on its use in hospitalized patients with HF. What is the effectiveness of PACs in patients hospitalized with acute HF? The RCTs identified in patients hospitalized with HF did not show a statistically significant mortality benefit with the use of PACs compared to clinical assessment. A higher rate of infections associated with the PAC compared to clinical assessment was reported in 1 RCT. Other complications associated with PACs were reported, but their rates were not compared to a control group. The RCT excluded patients who were likely to require PACs within 24 hours following randomization, possibly affecting the generalizability of the results. This is based on moderate quality evidence. No systematic reviews, meta-analyses, or health technology assessments on the safety and effectiveness of nitroglycerin or nesiritide were identified in the literature search. No RCTs were identified evaluating the safety of nitroglycerin. What is the effect of intravenous nitroglycerin or nesiritide on renal function and risk of mortality for heart failure inpatients? One large multicentre RCT addressed these questions with regard to nesiritide. (16) No statistically significant increase in risk of mortality (GRADE: moderate) or renal dysfunction (GRADE: high) was found, compared to placebo. Abbreviations: AHA, American Heart Association; BNP, B-type natriuretic peptide; CCS, Canadian Cardiovascular Society; CHF, congestive heart failure; CRT, cardiac resynchronization therapy; ECG, electrocardiogram; EMAA, early mobilization and ambulation; ESC, European Society of Cardiology; HF, heart failure; HFSA, Heart Failure Society of America; IABP, intra-aortic balloon pump; ICD, implantable cardioverter defibrillator; PAC, pulmonary artery catheter; RCT, randomized controlled trial. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 36 Review of CHF Clinical Practice Guidelines The Expert Panel reviewed CHF clinical practice guidelines from the following organizations: Canadian Cardiovascular Society (CCS)11,12,13 National Institute for Health and Clinical Excellence (NICE)14 European Society of Cardiology (ESC)15 Heart Failure Society of America (HFSA)16 American College of Cardiology/American Heart Association (ACC/AHA)17 A comparison chart of the various guidelines was created to guide the development of the CHF pathway. Review of Empirical Evidence The Expert Panel used real-world data to examine the prevalence of candidate processes of care in accordance with the domains described by consensus expert panels to assist with the following: assigning prevalence rates to various quality indicators according to unit of initial disposition understanding processes of care that are most strongly associated with outcomes (i.e., 30-day mortality or rehospitalization) identifying potential areas of need for further evaluation The analysis was done using the major diagnosis of CHF from the EFFECT data at ICES. The EFFECT data were collected in 2005 for 86 hospitals, using chart abstraction of 125 patients consecutive per hospital.18 The data were restricted to those admitted through ED and used the Framingham definition of heart failure (which represents 91% of all heart failure). The Expert Panel also reviewed the Emergency Heart Failure Mortality Risk Grade (EHMRG), a riskstratification method developed by ICES for the prediction of 7-day mortality in all patients with CHF who present to the ED. Risk-adjustment models for 30-day death or rehospitalization were developed, and the relationship between candidate process variables and risk-adjusted outcomes (30 day death or rehospitalization) were examined. The EMHRG score was developed from a multicentre study of 86 hospitals in Ontario.18 The study included a population-based random sample of 12,591 patients presenting to the ED from 2004 to 2007. Using a method of age-standardized coefficient–based weights similar to that used for the Framingham risk score, the researchers developed a scoring system calculated by summing integer scores for categorical variables and weights for the value of continuous variables (where the value of the continuous variable was multiplied by its weight). The variables used in the EMHRG calculation are patient age, systolic blood pressure, whether the patient was transported by emergency medical services, heart rate, oxygen saturation, creatinine, potassium and troponin concentration, if the patient has active cancer or receive metolazone at home. Although the EHMRG tool is well developed and validated, the ED 11 Canadian Cardiovascular Society Consensus Conference guidelines on heart failure, update 2009: Diagnosis and management of right-sided heart failure, myocarditis, device therapy and recent important clinical trials; Can J Cardiol Vol 25 No 2 February 2009. 12 Canadian Cardiovascular Society Consensus Conference guidelines on heart failure – 2008 update: Best practices for the transition of care of heart failure patients, and the recognition, investigation and treatment of cardiomyopathies; Can J Cardiol Vol 24 No 1 January 2008. 13 The 2011 Canadian Cardiovascular Society Heart Failure Management Guidelines Update: Focus on Sleep Apnea, Renal Dysfunction, Mechanical Circulatory Support, and Palliative Care; Canadian Journal of Cardiology 27 (2011) 319–338. 14 NICE Clinical Guideline No 108; Chronic Heart Failure National clinical guideline for diagnosis and management in primary and secondary care; August 2010. 15 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008, European Heart Journal (2008) 29, 2388–2442. 16 HFSA 2010 Guideline Executive Summary; Journal of Cardiac Failure Vol. 16 No. 6 2010. 17 2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: Developed in Collaboration With the International Society for Heart and Lung Transplantation; Circulation 2009;119;1977-2016. 18 Lee D et al., Prediction of Heart Failure Mortality in Emergent Care: A Cohort Study. Ann Internal Medicine 2012: 156(11):767-775. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 37 physician community needs to adopt this tool or a risk-stratification method to guide decisions about whether to treat the CHF patient in the ED or admit to hospital for treatment. The Expert Panel made the following conclusions after reviewing the results of the analyses. 1. It is possible to stratify and establish hospital disposition using variables in the EHMRG tool, other clinical variables and responsiveness to dieresis variable. 2. Precipitating factors by initial hospital disposition are ischemia and valvular heart disease. 3. End-of-life care by initial hospital disposition includes advanced-care directives. 4. High-cost technology/interventions by initial disposition include coronary angiography appropriateness for those with ischemia. 5. Discharge planning by initial hospital disposition should include physician follow-up and cardiology follow-up, particularly among higher-risk patients. 6. Discharge disposition by initial hospital disposition should include hospice/palliative care. 7. Quality indicators at discharge and follow-up should include angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) and diuretics management 8. In-hospital quality indicators by initial hospital disposition should include ACE inhibitors/ARBs and recording of daily weights 9. Counselling at discharge by initial hospital disposition should include medication management and activity. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 38 CHF Episode of Care Pathway Model The Expert Panel developed the CHF episode of care pathway model after carefully reviewing the evidence obtained in the rapid review process, the clinical practice guidelines, and the results of the analyses performed. A pathway using the principles of decision analytic modelling was developed, including clinical assessment nodes and care modules that list the resources required (including interventions, procedures, and diagnostics) based on the best available evidence, empirical evidence from ICES heart failure registry data, and expert consensus. Phases of the Patient Journey The Expert Panel recommended 4 phases of the patient journey while the patient is hospitalized and consuming resources in an inpatient bed: 1. Acute stabilization phase (first 12 to 24 hours after admission), where the clinical status of the patient is assessed and causes of symptoms are identified 2. Sub-acute stabilization phase (e.g., 24 to 96 hours after admission) 3. Discharge preparation phase (e.g., day 2 to hospital discharge) 4. Transitional care phase (e.g., hospital discharge or 24 hours prior to discharge to 8 to 12 weeks after discharge) Figure 7 shows the different phases of care. Times are displayed to illustrate the overlap of phases and have not been confirmed by the Expert Panel. Figure 7: Phases of the Patient Journey While Hospitalized Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 39 Episode of Care Pathway As described above, the Expert Panel developed the episode of care pathway for CHF patients as shown in Figure 8 using empirical evidence from the heart failure registry data and consensus of the Expert Panel members. The CHF patient population, defined by ICD-10-CA codes, was further refined by excluding special CHF patient cohorts. Special populations for whom the heart failure episode of care pathway should not apply include the following: 1. Primary dialysis patients 2. Pre-transplant patients (i.e., those actively being considered for cardiac transplantation or on the transplant list) and post-transplant patients 3. Patients transferred into hospitals from other institutions (i.e., in-hospital transfers) 4. Critical care outreach patients (i.e., higher-intensity patients managed in lower-intensity units due to limited coronary care or intensive care unit bed availability) 5. Patients with more additional active chronic medical condition(s) that require(s) acute stabilization management (e.g., active COPD, stroke, ST segment elevation myocardial infarction [STEMI], non-STEMI active bleeding, etc.). The care-pathway is intended to reflect the CHF-specific management stream only and does not take into account other active treatments that might affect human resources, investigations, treatment, length of stay, or quality of care. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 40 Figure 8: CHF Episode of Care Pathway Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 41 Clinical Assessment Node: ED Risk Stratification and Responsiveness to Diuresis When a patient presents in the ED with suspected CHF, a number of investigations are required as recommended by clinical guidelines and supported by the Expert Panel. Table 11 describes the initial investigations recommended in the CCS 2008 guidelines (similar to guidance from other organizations such as NICE, ESC, HFSA, and ACC/AHA). Table 11: ED Risk Stratification and Responsiveness to Diuresis—Recommended Practice Recommended Practice Initial investigations should include the following: Relevant Evidence Canadian Cardiovascular Society (CCS) serum creatinine and electrolyte levels troponin measurements National Institute for Health and Clinical Excellence (NICE) complete blood count European Society of Cardiology (ESC) electrocardiogram Heart Failure Society of America (HFSA) chest x-ray and an echocardiogram if no recent echocardiogram is available (class I, level C) Heart rate, blood pressure and oxygen saturation should be measured frequently until the patient is stabilized (class IIa, level C). American College of Cardiology/American Heart Association (ACC/AHA) The Expert Panel recommends that patients presenting to hospital with acute CHF be classified into the following 3 broad groups for the purposes of establishing care pathways and defining major groups for QBP funding: 1. Low-intensity: These patients can be treated in the ED or in outpatient settings and discharged home without requiring an inpatient admission. 2. Average-intensity: These patients require admission to inpatient care with normal nurse-topatient staffing. 3. High-intensity: These patients require ventilation (either noninvasive or invasive ventilation) and/or admission to an intensive care unit with higher nurse-to-patient staffing. It is recognized that these 3 patient groups are largely based on level of care. The Expert Panel has identified a number of high-risk markers: respiratory distress hypoxemia severity of pulmonary edema poorly responsive to ED Lasix hemodynamic compromise significant arrhythmias positive troponin concomitant acute life-threatening directives Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 42 The Expert Panel suggests that an acute heart failure risk score—for example, the EHMRG— be calculated to assist with clinical decision-making and predicting the 7-day mortality risk of CHF patients (predicted mortality risk increases incrementally with higher EHMRG risk score). As a general guide, patients who are low-risk (e.g., EHMRG quintiles 1 and 2) can be considered for discharge home if they have responded to initial treatment in the ED, provided that there are no other considerations (e.g., advanced-directives, severe dementia, estimated impact of admission on life-expectancy, bed-availability, etc.). Patients who are high-risk (e.g., EHMRG quintile 5) can be considered for admission to a higherintensity unit. Ultimately, the decision to admit is based on clinical judgment and the availability of hospital resources. Note: a full review of the evidence is required to determine the essential markers and defined thresholds for the 3 CHF patient groups (high-intensity, average-intensity, and low-intensity). Admitted Patients The Expert Panel identified 2 pathways branches for admitted patients based on severity: 1. High-intensity case-mix-adjusted patient 2. Average-intensity case-mix-adjusted patient The high-intensity case-mix-adjusted patient implies that a patient is high-risk enough to necessitate a 1:1 nurse-to-patient ratio. Similarly, the lower-intensity case-mix-adjusted patient implies that a patient is of sufficiently low risk to be managed with the usual hospital-ward 1:5 nurse-to-patient ratio. The case-mix adjustment implies that the high-intensity as well as average-intensity care pathway corresponds to an individual of average comorbidity for CHF patients in the province of Ontario. An individual who has higher-than-average or lower-than-average comorbidity would not necessarily alter the patient intensity level or the care pathway, but rather the cost bundle associated with the care pathway. The rationale for cost adjustments for case-mix variation is based on the understanding that care intensity and length of stay correlate with the management of other (non–heart failure–related) chronic conditions. Such management of other comorbidities is not taken into account in this care pathway. Case-mix cost attribution could use a number of different methodologies, including resource intensity weights. The mean total length of hospital stay for the high-intensity and low-intensity patients using the 2005 EFFECT database and the 2010/11 DAD database are: High-intensity (2005 EFFECT) High-intensity (2010/11) Low-intensity (2005 EFFECT) Low-intensity (2010/11) - 8.8 days (SD = 8) with mean length of ward stay of 5.0 days (SD = 8.2) 12.2 days (SD = 21.3) 8.5 days (SD = 10.7) 8.8 days (SD = 15.1) Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 43 Care Module: Acute Stabilization Phase Tables 12 and 13 highlight the Expert Panel recommendations based on the analysis of CHF registry data at ICES, expert consensus and CHF guidelines. The prevalence/proportions of patients have been included using ICES data. They are weighted to reflect 2 factors: Framingham-defined vs. total heart failure per hospital and the size of the hospital. Some of the recommendations in the tables are briefly discussed in the subsections below. Table 12: Acute Stabilization Care Module: High-Intensity Patient Mechanical ventilation (Pr = 9.5%) BIPAP (Pr = 25.95%) IV inotropes and/or IV vasodilators (Pr = 17.2%) Diuretic monitoring and management, acute phase Identifying and treating precipitating factors o Echocardiography o Cardiac catheterization o Noninvasive cardiac imaging Evidence-based pharmacotherapy management, acute phase Telemetry Advanced care discussions and directives (Pr = 13.96%) Noninvasive imaging for those who are not ideal candidates for cardiac catheterization Oxygen IV Lasix Ultrafiltration (consider if necessary) Intensive PA monitoring Other (IABP, assistive devices) Abbreviations: BIPAP, bilevel positive airway pressure; IABP, intra-aortic balloon pump; IV, intravenous; PA, pulmonary artery; Pr, prevalence. Table 13: Acute Stabilization Care Module: Low-Intensity Patient BIPAP (Pr = 4.47%) Telemetry Diuretic monitoring and management, acute phase Identifying and treating precipitating factors o Echocardiography (Pr = 50.1%) o Cardiac catheterization (Pr = 3.76%) o Noninvasive cardiac imaging Evidence-based pharmacotherapy management, acute phase Advanced care discussions and directives (Pr =13.8%) DNR (Pr =15.8%) PO Lasix Oxygen (consider if appropriate) IV Lasix Noninvasive imaging for those who are not ideal candidates for cardiac catheterization Abbreviations: BIPAP, bilevel positive airway pressure; DNR, do not resuscitate; IV, intravenous; PO, per os (by mouth); Pr, prevalence. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 44 Diuretic Monitoring and Management, Acute Phase Table 14 shows recommended practice for diuretic monitoring and management in the acute phase. Table 14: Diuretic Monitoring and Management—Acute Phase Recommended Practice Relevant Evidence Recording of: Canadian Cardiovascular Society (CCS) Daily weights 6-hour input/output National Institute of Health and Clinical Excellence (NICE) Salt restriction (2 g/day) (low level of evidence) European Society of Cardiology (ESC) Possible fluid restriction (2 L/day) Heart Failure Society of America (HFSA) Electrolytes Renal function American College of Cardiology/American Heart Association (ACC/AHA) Chest x-ray The frequency of laboratory and x-ray follow-up should remain discretionary. Each patient should have a daily record of weights and measurement of 6-hour input/output. The frequency of electrolyte and renal function monitoring depends on the dose and administration of Lasix (i.e., higher doses necessitate closer monitoring). The frequency of chest x-rays depends on the baseline extent of pulmonary edema, a patient’s clinical status, and his/her responsiveness to diuretics. Diuretic management approaches should take an “early and frequently” approach. Those at higher intensity should receive an intravenous (IV) Lasix bolus every 6 to 12 hours or a continuous IV infusion.19 Those at lower intensity should also begin with IV Lasix daily or BID. Guiding principles in patients hospitalized with acute heart failure The Expert Panel discussed the central importance of adequately relieving congestion during admission for CHF. A number of panel members further shared that there are likely to be opportunities to broadly improve the approach to diuretic use in hospitals by minimizing variation in diuretic management and possible underdosing of diuretics. Given this discussion, the Expert Panel explored building some general principles around diuretic-based management into the Expert Panel’s definition of an episode of care for CHF. Each Expert Panel member shared what he/she considered to be best practice general principles for diuretic-based management. Members gave advice on principles/guidance related to the following: 1. Common dosing regimens for diuretic-naive patients vs. diuretic-experienced patients 2. Special populations that require special consideration for diuretic dosing 3. Key monitoring parameters that should be used to adjust the diuretic treatment plan 4. Common scenarios that are often associated with diuretic management that is too conservative/underdosed 19 Felker, D.M et al.; Diuretic Strategies in Patients with Acute Decompensated Heart Failure, N Engl J Med 2011; 364:797-805, March 3, 2011. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 45 Table 15 shows the recommendations from the clinical practice guidelines on diuretics for CHF patients. Table 15: Diuretic Recommendations in Acute Heart Failure CCS 2006 ESC 2012 ACC/AHA 2009 HFSA 2010 NICE 2010 Tailored diuretic therapy is recommended for all symptomatic patients Class III/IV: combination diuretic therapy with spironolactone No specific dosage recommendations Includes table on practical considerations in the treatment of heart failure with loop diuretics (e.g., managing hypokalemia, renal failure, inadequate response to diuretic) No specific dosage recommendations for acute admissions for heart failure Starting dose for chronic heart failure: 20–40 mg Stage C (patients with current or prior symptoms): diuretics for fluid retention The hospitalized patient: IV loop diuretic at higher than or equal to chronic oral daily dose. If inadequate, response consider higher doses, addition of another diuretic (e.g., metolazone) or continuous infusion Initial IV doses for severe heart failure: furosemide 40 mg Loop diuretics for patients with fluid overload Acute decompensated heart failure: IV loop diuretics If inadequate response, consider Increasing dose, addition of metolazone or continuous infusion Diuretics routinely used for relief of congestive symptoms and fluid retention Abbreviations: ACC/AHA, American College of Cardiology/American Heart Association; CCS, Canadian Cardiovascular Society; ESC, European Society of Cardiology; HFSA, Heart Failure Society of America; IV, intravenous; NICE, National Institute for Health and Clinical Excellence. Identifying and Treating Precipitating Factors The Expert Panel recommended that efforts to identify precipitating factors should include exploration of all the usual known factors, including medication and dietary noncompliance. However, precipitating factors should focus on the identification of 2 particular prognostic indicators that have been shown to correlate with poorer 30-day outcomes of death or recurrent hospitalization: the presence of myocardial ischemia and/or the worsening of valvular heart disease, either of which would be severe enough to possibly warrant surgical or interventional procedures. Evaluation for precipitating factors must also include the application of a risk-stratification process, to help clinicians decide whether the patient should or should not undergo cardiac catheterization. For example, in a patient presenting to hospital with heart failure, positive testing for troponins and/or ECG changes that could be consistent with myocardial ischemia might indicate the presence of underlying acute coronary syndrome or extensive coronary ischemia. Many such patients may have had prior cardiac catheterization and may have already been deemed a patient best deemed for conservative medical management. For others (e.g., new heart failure in a patient who has not had prior cardiac catheterization), a positive troponin test may indicate the need for coronary angiography. Similarly, each patient should be screened for severe valvular heart disease or mechanical heart complications that may have served as a precipitating cause. Most patients should be considered for 2D echocardiography for assessment of left ventricular systolic and diastolic function and underlying valvular disease. Should severe valvular heart disease be found, the patient should be considered for cardiac catheterization. Nonetheless, as with coronary angiography above, many exceptions may occur, and each patient must be evaluated on a case-by-case basis. The Expert Panel recommended the implementation of a process that requires doctors to document that they have considered the patient for cardiac catheterization or noninvasive cardiac imaging for evaluation of coronary ischemia or valvular abnormality, and that the patient was deemed either an appropriate or an Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 46 inappropriate candidate, along with the reason. An implementation process such as the one suggested above will at least ensure that all providers think about precipitating factors and address the 2 that are most prognostically important. Yes Assessment for ischemia Clinical suspicion ECG abnormalities Troponin (+) New heart failure Eligible and appropriate for coronary intervention Coronary angiography +/revascularization; (Pr<15% cath; Pr<5% PCI; Pr<5% CABG); medical management for IHD may also be required. Uncertain Non-invasive risk-stratification should be undertaken either inhospital or during transition; medical management for IHD should be considered Reason must be done on chart (e.g., previously assessed and patient known to be medical management); medical management for IHD should be considered Assessment of LV function and valvular heart disease (e.g., 2D echocardiography) Eligible and appropriate for valve repair or surgery Yes Surgery or interventional cardiology (Pr:<5%) Uncertain Cardiology or cardiac surgery referral No Reason must be documented on chart Figure 9: Precipitating Factor Node Evidence-Based Pharmacotherapy Management, Acute Phase The timing for the initiation of ACE inhibitors/ARBs and β-blockers in acute heart failure is unclear. Patients who have been on these medications prior to hospital arrival should continue them during hospitalization. For patients who have been introduced recently to β-blockers and have acute decompensated heart failure associated with the increase, consideration should be given to cutting the dose in half if they are in severe pulmonary edema. However, health care providers should be discouraged from discontinuing ACE inhibitors/ARBs and β-blockers unless the patient is hemodynamically unstable. For those not already receiving these evidence-based medications, ACE inhibitors/ARBs should be initiated early if the patient is hemodynamically stable. However, initiation of β-blockers should begin only once patient has been diuresed and is stable from a pulmonary congestion standpoint. For both medications, doses should be started low and titrated slowly. The use of other evidence-based pharmacotherapy (e.g., aldosterone receptor antagonists ) should be left to the discretion of the health care provider. Telemetry No high-quality evidence was identified in the rapid review that evaluated the effectiveness of ECG telemetry monitoring among patients with acute CHF. Based on expert opinion, clinical practice guidelines suggest the use of continuous ECG monitoring among patients with acute CHF. The AHA Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 47 practice standards for in-hospital ECG monitoring suggest continuous ECG monitoring among all patients with acute CHF. The ESC and HFSA guidelines recommend continuous ECG monitoring among acute CHF patients treated with inotropes, based on the increased risk of arrhythmia and myocardial ischemia with these agents. The Expert Panel recommends the use of telemetry, but this intervention needs to be reassessed. Furthermore, hospitals using telemetry should develop policies identifying patients’ eligibility and timing for reassessment. A sample policy could read as follows: The physician or nurse practitioner who assumes responsibility for telemetry monitoring should review the telemetry record and assess the need for continued telemetry monitoring 48 hours after initiation and then every 24 hours thereafter. If a telemetry-monitored patient’s rhythm is unremarkable during a 24-hour period, the telemetry nurse may contact the responsible team to reassess the need for continued telemetry monitoring. The decision to discontinue telemetry will be made by the physician/nurse practitioner who assumes responsibility for telemetry monitoring, or the critical care unit staff cardiologist when the urgent need arises to clear channels for other patients. Summary Table 16: Summary of Recommendations for the Acute Stabilization Phase (First 12–24 Hours) Recommendations (Intervention/Resources) High-Intensity Case-Mix-Adjusted Patient Low-Intensity Case-Mix-Adjusted Patient Mechanical ventilation ✓ — BIPAP ✓ Consider if appropriate Oxygen ✓ Consider if appropriate IV Lasix ✓ Consider if appropriate IV vasoactive agents ✓ — ✓ PO Lasix Telemetry ✓ Consider if appropriate and available 1:1 nurse-to-patient staffing ratio ✓ No; typical inpatient medical ward staffing ratio acceptable Consider if appropriate Consider if appropriate — Consider if appropriate Consider if appropriate — Intensive PA monitoring ✓ — Other (IABP, assistive devices) ✓ — Monitor electrolytes, renal function, troponins, chest x-ray ✓ ✓ (chest x-ray if appropriate) Record fluid input/output ✓ ✓ Record weight — ✓ Other therapies (e.g., consider Aspirin, IV heparin, statins if troponins-positive) ✓ ✓ Assessment of precipitating factors ✓ ✓ Discuss advanced directives ✓ ✓ ACE inhibitors/ARBs β-blockers Ultrafiltration Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; BIPAP, bilevel positive airway pressure; IABP, intra-aortic balloon pump; IV, intravenous; PA, pulmonary artery; PO, per os (by mouth). Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 48 Clinical Assessment Node: Reassessment and Re-evaluation Tables 17 and 18 show the recommendations of the Expert Panel with respect to the reassessment and reevaluation clinical assessment node. Table 17: Reassessment and Re-evaluation: High-Intensity Case-Mix-Adjusted Patienta Re-evaluate underlying and precipitating cause o Echocardiography o Cardiac catheterization o Noninvasive cardiac imaging Screen for complications (e.g., arrhythmia, urosepsis, chronic obstructive pulmonary disease, renal failure, pneumonia) Continue management and monitoring as per care pathway Discuss advanced directives Withdrawal from therapy a Node 3, Figure 8, CHF episode of care pathway. Table 18: Reassessment and Re-evaluation: Low- Intensity Case-Mix-Adjusted Patienta aNode Re-evaluate underlying and precipitating cause o Echocardiography o Cardiac catheterization o Noninvasive cardiac imaging Screen for complications (e.g., arrhythmia, urosepsis, chronic obstructive pulmonary disease, renal failure, pneumonia) Continue management and monitoring as per care pathway Discuss advanced directives Withdrawal from therapy 5, Figure 8, CHF episode of care pathway. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 49 Care Module: Sub-acute Stabilization Phase The Expert Panel gave guidance on the management of CHF patients in the sub-acute management phase, as shown in Table 19. The CCS, NICE, ESC, HFSA, and ACC/AHA have all highlighted these areas in their guidelines. Table 19: Sub-acute Care Module Diuretic monitoring and management (sub-acute phase) Early mobilization Evidence-based pharmacotherapy management (sub-acute phase) Other heart failure management considerations Diuretic Monitoring and Management (Sub-acute Phase) Diuretic monitoring and management in the sub-acute phase is similar to that of the acute phase, recognizing that the patient is now more stable, has less pulmonary congestion and has been responsive to more intensive diuretics. Weight and input/output should still be recorded daily. Electrolytes and renal function can be monitored daily, every second day, or every third day, depending on the patient’s clinical status, dose of Lasix, responsiveness to therapy, and prior electrolyte or renal laboratory abnormalities. Early Mobilization The Expert Panel recommends early mobilization as a new approach to in-hospital heart failure management. The mobilization/activity care map should follow early-mobilization maps for other care pathways (e.g., COPD). Mobilization depends upon responsiveness to diuresis, and activities such as walking should not be encouraged for patients with severe residual pulmonary congestion or refractory heart failure. Nevertheless, for most patients, activities should be scaled from sitting up in bed to sitting in a chair with bathroom privileges, to walking (in the room and on the ward). Patients should be encouraged to mobilize (with walking) at least once every 6 hours during daytime waking hours. Evidence-Based Pharmacotherapy Management (Sub-acute Phase) Similar to the acute phase, patients in the sub-acute phase should be treated with β-blockers (assuming there is no absolute contraindication), and ACE inhibitors/ARBs. Nitrates ± vasodilators should be used in patients intolerant of or with contraindications to ACE inhibitors/ARBs. Again, the focus (in treatmentnaïve patients) should be on initiating therapy at low doses and titrating slowly. The use of aldosterone receptor antagonists should be left to the discretion of the treating health care providers. Other Heart Failure Management Considerations Other heart failure management considerations may include continuous positive airway pressure (CPAP) for patients with confirmed sleep apnea and as recommended by a sleep specialist. Nitrates can be considered for preload reduction. Digoxin can be considered for residual heart failure if symptoms persist despite otherwise optimal therapy. Patients can be considered for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) at the discretion of the treating physician. The decision to insert ICD/CRT devices should occur following optimization of heart failure therapy and reassessment of ejection fraction, unless the patient who requires the ICD presents with ventricular arrhythmia. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 50 Care Module: Advanced Heart Failure After reassessment and re-evaluation, a small number of patients (approximately 1.3%) may follow an advanced heart failure pathway. Table 20 shows some of the interventions included in the pathway. Table 20: Advanced Heart Failure Management Ultrafiltration or dialysis Cardiac resynchronization therapy PCI or CABG Valve repair/replacement Transplantation assessment LVAD Transplantation Abbreviations: CABG, coronary artery bypass graft; LVAD, left ventricular assist device; PCI, percutaneous coronary intervention. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 51 Care Module: Discharge Phase A sub-panel was created to review the discharge-planning phase and explore the transitional care phase, which is a continuation of the CHF episode of care into the community. The sub-panel adopted the Naylor et al. (2011) definition of transitional care as “a broad range of time-limited services designed to ensure health care continuity, avoid preventable poor outcomes among at-risk populations and promote the safe and timely transfer of patients from one level of care to another or from one type of setting to another.”20 The few available definitions of hospital discharge planning indicate that it is a process that takes place between hospital admission and the discharge event.21 Predischarge communication is important as a start to the transitional care process: it provides an opportunity to summarize the visit, teach patients how to safely care for themselves at home, and address any remaining questions or concerns. Discharge planning helps patients communicate with caregivers and primary care providers about how best to manage chronic needs after leaving the hospital.22 As shown in Figure 7, there are 2 discharge modules in the episode of care pathway: discharge from the ED and discharge after admission. To establish the discharge planning modules and to begin understanding the evidence relating to the transitional care phase, the sub-panel reviewed the OHTAC reports Discharge Planning in Chronic Conditions: An Evidence-Based Analysis23 and Recommendation: Specialized Community Based Care for Chronic Disease24, as well as the HQO BestPath Transitional Care report and the CCS, NICE, ESC, HFSA, and ACC/AHA guidelines. Through its review and consultation with experts in the field of transitional care, the sub-panel found that there were randomized controlled trials, systematic reviews and meta-analyses on inpatient hospital-to-home discharge planning, but no studies for ED-to-home discharge. The sub-panel decided that both discharge planning modules would be similar for this report. The OHTAC report Discharge Planning in Chronic Conditions: An Evidence-Based Analysis summarized the following interventions: Predischarge interventions – Patient education – Discharge planning – Medication reconciliation – Appointment scheduled before discharge Postdischarge interventions – Timely primary care physician communication – Timely clinic follow-up – Follow-up telephone call – Postdischarge hotline – Home visit Interventions bridging the transition – Transition coach – Patient-centred discharge instructions – Provider continuity 20 Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB. The care span: the importance of transitional care in achieving health reform. Health Aff. 2011;30(4):746-54. 21 Holland DE, Harris MR. Discharge planning, transitional care, coordination of care and continuity of care: clarifying concepts and terms from the hospital perspective. Home Health Care Serv Q. 2007;26(4):3-19. 22 Samuels-Kalow ME, Stack AM, Porter SC. Effective discharge communication in the emergency department. Ann Emerg Med. Forthcoming 2012. 23 Ontario Health Technology Assessment Series; Vol. 12: No. TBA, pp. 1–70, July 2012 24 Ontario Health Technology Assessment Series; Vol. 12: No. 20, pp. 1–60, November 2012 Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 52 Using the above interventions, clinical guidelines and expert advice, the sub-panel established the discharge-planning module for the episode of care pathway. Individualized discharge planning includes communication of weight and creatinine at discharge, evaluation of care needed at home and the ability to attend follow-up visits with a family physician and specialist. Table 21 shows the components of the discharge-planning module. According to the OHTAC report, the evidence supports the use of individualized discharge planning, and studies have shown a significant reduction in readmissions favouring individualized discharge planning. However, the risk of readmission prior to discharge should be assessed. Table 21: Discharge Planning Module Diuretic monitoring and management Evidence-based pharmacotherapy Other relevant medical therapies Counselling o Medication management o Lifestyle (alcohol, smoking) o Daily weight and self-monitoring o Diet o Physical activity o Advanced care directives Predischarge functional capacity and mobility assessment Predischarge cognitive and social support assessment Physician appointments o General practitioner/family physician identified, and follow-up visit scheduled within 2 weeks of discharge o Ambulatory care specialty follow-up (cardiology or internal medicine) Timely documentation o Discharge notes dictated and sent to primary care (and relevant other) provider(s) within 1 week (ideally within 48 to 72 hours of hospital discharge) Diuretic Monitoring and Management Patients should be on a standing Lasix order and followed by a heart failure clinic. Daily input/outputs and weights should be recorded. Evidence-Based Pharmacotherapy All patients without absolute contraindications should be receiving ACE inhibitors/ARBs and β-blockers. If patients cannot tolerate ACE inhibitors/ARBs or cannot take them due to contraindications, they should be receiving hydralazine and nitrates. The use of aldosterone receptor antagonists should be left to the discretion of the provider; the ESC 2012 guidelines recommend the use of aldosterone receptor antagonists. Other Relevant Medical Therapies Other heart failure management considerations may include CPAP for patients with confirmed sleep apnea, if recommended by a sleep specialist. Additional therapies may include statins and antiplatelets for patients with ischemic heart disease or anticoagulation for patients with atrial fibrillation. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 53 Counselling Education should be provided for patients and family members/caregivers on the symptoms and signs of worsening heart failure and how to respond. Consider also assessing health literacy: hospitals should adapt their education programs based on health literacy or learning disabilities and have materials available in different languages. The guidelines recommend counselling on medication management, lifestyle (e.g., smoking), daily weight and self-monitoring, diet (e.g., salt restriction, fluid intake), physical activity, and advanced care directives. The counselling strategy will likely require multiple in-hospital allied health professionals (e.g., pharmacists, social worker, nursing), and would incur costs. Medication reconciliation at discharge should involve the community pharmacist. Predischarge Functional Capacity and Mobility Assessment Available evidence has demonstrated that functional capacity is an important predictor of outcomes among patients with CHF, and accordingly, may be used to help prognostically risk-stratify hospitalized patients as they are discharged into community settings.25 For example, at least 1 study has determined that patients hospitalized with acute decompensated heart failure who cannot achieve 200 metres in a 6minute walk test (6MWT) at discharge have a significantly higher risk of death or rehospitalization than those able to achieve 200 metres or greater (equivalent to an activity intensity level of approximately 2 METs ).26 Although the 6 MWT is known to have prognostic value, implementing it in a clinical setting may be challenging. Additional challenges include potential delay in discharge due to lack of availability of staff to perform a proper 6 MWT, since the volume of CHF patients in a hospital can be significant, increasing the workload of physiotherapists and nurses. Accordingly, all patients (with the exception of those deemed to be at the end of life and those unable to mobilize due to neurologic or musculoskeletal abnormalities) should undergo some objective physical activity assessment prior to discharge. The Expert Panel recommends that the local hospital decide on the appropriate assessment. For example, clinicians can use a 6MWT or a low-level (modified) protocol on a treadmill or cyclometer exercise test. Patients unable to pass the mobilization test should either remain in hospital or be discharged under close supervision (i.e., rapid heart failure assessment clinic). The Expert Panel recommended that the costs for providing the above tests (with respect to human resources and equipment) for functional capacity assessment should be included in the care bundle for all eligible patients surviving to discharge. Predischarge Cognitive and Social Support Assessment Before discharge, patients will require cognitive and/or social support assessment. Cognitive assessment should be done by trained staff. The process will require additional human resources and should be included in the care bundle for all eligible patients surviving to discharge. Physician Appointments General practitioner/family physician follow-up The Expert Panel recommends that a primary care or specialty care visit should occur within 2 weeks of discharge. Each CHF patient discharged from hospital or the ED should be followed up by both their primary and specialty care providers. 25 Am Heart J. 2008 Feb;155(2):200-7. Epub 2007 Nov 26 26 J Card Fail. 2009 Mar;15(2):130-5. Epub 2008 Dec 5 Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 54 The Expert Panel recognized that the tagging of whether or not a patient has a primary care physician needs to be done consistently. Some patients do not have family physicians, making it impossible to schedule physician follow-up after discharge from hospital. The Expert Panel agreed that in such cases, the hospital should provide transitional care until the patient can be handed off. In addition, some primary care physicians may see CHF patients only rarely. It may be a challenge for such physicians to develop schedules that allow availability for follow-up of CHF patients discharged from hospital. Ambulatory care specialty follow-up The Expert Panel recommends that CHF patients discharged from hospital be referred to a specialized community-based heart failure clinic within 2 weeks of discharge. OHTAC recommends that “Mechanisms that enable rapid access (within 1–3 days) to specialized care should be built into the model of heart failure clinics.”27 Timely Documentation The Expert Panel recommends that discharge notes be dictated and sent to primary care (and relevant other) provider(s) within 1 week of patient discharge, but preferably within 48 hours. 27 Ontario Health Technology Assessment Series; Vol. 12: No. 20, pp. 1–60, November 2012 Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 55 Transitional Care Pathway Although there is a process for transitional care in approximately 80 to 90% of hospitals in Ontario, this practice is not standardized throughout the province (OHTAC, 2012).28 Through discussions at the subpanel meetings, it was established that transitional care in Ontario is likely more of an organic process, with varying elements tailored to suit the needs of the community (e.g., some hospitals may have discharge planners, while some may use the services of Community Care Access Centres). A multidisciplinary approach is suggested for transitional care, with the involvement of family physicians and family health teams, nurses (potentially through the Community Care Access Centres or other Local Health Integration Network–funded programs), community pharmacists, occupational therapists, social workers and dietitians. In Ontario, there are many interventions within a region addressing different aspects of transition of care, but there is a need for better coordination of care. Many issues were discussed related to the present transition of care models, including the lack of standardized interventions; the lack of risk stratification to prevent community nurses and therapists being deployed to all CHF patients on discharge; and the lack of cost analyses related to interventions. For these reasons, the Expert Panel supports the implementation of specialized community-based heart failure clinics in Ontario. 28 Ontario Health Technology Assessment Series; Vol. 12: No. 20, pp. 1–60, November 2012 Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 56 Performance Measurement The Expert Panel was requested by the Ministry to provide recommendations related to CHF performance indicators. The intent is for these recommendations to inform the development of a “QBF Integrated Scorecard” for CHF, which would track a number of indicators related to the episode of care and recommended practices for CHF. Similar scorecards are to be developed for other clinical areas that are subject to QBF funding. A rapid review of the evidence was done to investigate whether performance indicators for in-hospital heart failure management were effective at improving patient outcomes. No meta-analyses, health technology assessments or systematic reviews were identified, but 2 guideline reports were identified that reported on performance indicators for in-hospital heart failure management: the 2010 CCS guidelines for the diagnosis and management of heart failure update29 and the American College of Cardiology Foundation (ACCF)/AHA Task Force on Performance Measures and the American Medical Association– Physician Consortium for Performance Improvement (AMA-PCPI) 2011 Performance Measures for Adults with Heart Failure30. A summary of the performance indicators listed in the CCS guidelines is shown in Table 22. The ACCF/AHA–AMA-PCPI 2011 performance measures report similar performance indicators. Overall, the relationship between specific performance measures and patient outcomes remains unclear. Reasons for this include the following: Methodological limitations of the studies, such as nonrandomized designs and limited followup Many commonly assessed performance indicators have not been shown in clinical trials to reduce mortality and prevent hospitalization While some performance indicators may have been met (such as smoking cessation counselling), the manner in which they were delivered may have been suboptimal Baseline adherence to performance indicators such as ACE inhibitors in eligible patients was already high in some studies, making further improvements in patient outcomes more difficult to demonstrate 29 Howlett JG, McKelvie RS, Costigan J, Ducharme A, Estrella-Holder E, Ezekowitz JA, et al. The 2010 Canadian Cardiovascular Society guidelines for the diagnosis and management of heart failure update: Heart failure in ethnic minority populations, heart failure and pregnancy, disease management, and quality improvement/assurance programs. Can J Cardiol. 2010;26(4):185-202. 30 Bonow RO, Sadwin LB, Sikkema JD, Sincak CA, Spertus J, Torcson PJ, et al. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement. Circulation. 2012;125(19):2382-401. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 57 Table 22: Summary of Performance Indicators for Heart Failure by Development Group Indicator Canadian American Heart Joint Organized Program Assessing the Care Cardiovascular Association/ Commission on to Initiate of Vulnerable Outcomes American College Accreditation of Lifesaving Elders Project Research Team of Cardiology Healthcare Treatment in (ACOVE) (CCORT) (AHA/ACC) Organizations Hospitalized inpatient inpatient (JCAHO) Patients with Heart Failure (OPTIMIZE-HF) Therapeutics ACEi and/or ARB if LV systolic dysfunction in eligible patients x x Use of beta blockers in eligible patients x x x x x x x Use of statins in eligible patients if underlying CAD, PVD, CVD, or diabetes x Aldosterone antagonists for eligible patients x Anticoagulants for atrial fibrillation x x x Use of ICD in eligible patients Avoid 1st and 2nd generation CCBs if LV systolic dysfunction x Avoid type 1 antiarrhythmic agents if LV systolic dysfunction (unless ICD in place) x Investigations Outpatient assessment including or more of regular volume assessment, weight, blood pressure, activity level x x Appropriate baseline blood/urine tests, ECG, CXR x Appropriate biochemical monitoring of renal function and electrolytes x Assessment of LV function x x x x x x Measure digoxin levels if toxicity suspected Education and follow-up HF patient education/discharge instructions x x x x x x x x Outpatient follow-up within 4 weeks Advice on smoking cessation Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; CAD, coronary artery disease; CCB, calcium channel blocker; CVD, cardiovascular disease; CXR, chest x-ray; ECG, electrocardiogram; ICD, implantable cardioverter defibrillator; LV, left ventricle; PVD, peripheral vascular disease. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 58 Although there are measures in Ontario related to the quality of care provided to CHF patients, very few of the Expert Panel’s recommended practices can be captured in current Ontario hospital administrative datasets, and beyond routine administrative data. For example, ED risk stratification is a critical clinical assessment node in the care pathway model. It is important that all variables needed to derive the EMHRG score are mandatory so that they can be documented as process indicators. In this way, the EMHRG score can be derived in retrospect to see if/how patients are triaged according to these indicators. Clinical registries similar to the Ontario Stroke Audit or the EFFECT database for CHF need to be developed to routinely collect data and measure the quality of care provided to CHF patients. Performance Indicators The Expert Panel developed a list of quality indicators that can be used to measure whether patients follow the CHF episode of care pathway developed in this clinical handbook. Indicators were selected to reflect a few best-practice surrogates, which may provide a foundation for ensuring that hospitals are adhering to some general evidence-based principles across the CHF care pathway. With the compressed timelines for the selection of indicators, a scientifically validated methodology (such as a Delphi approach) for identifying and prioritizing current measures and new measures for development was not possible. However, using a similar process, the Expert Panel selected 11 indicators that are considered developmental. These indicators can be recalibrated using detailed chart abstraction if they do not serve as a surrogate for best-practice care. The indicators selected are shown in Table 23, below. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 59 Table 23: Proposed Performance Indicators Indicator Concept Clinical Assessment Node/Care Module Area of Interest for Measurement ED risk stratification and responsiveness to diuresis node Identification and documentation of risk (this will be important to the decision-making process) Was a risk-stratification method used to identify whether a CHF patient was high-intensity (risk) vs. average-intensity (risk) vs. low-intensity (ED observation and discharge)? Risk stratification should be based on the following parameters: oxygen saturation, serial troponin, renal function, responsiveness to ED diuresis, chest x-ray (alveolar pulmonary edema), etc. Acute stabilization module Diuretic management and monitoring Was the patient’s weight recorded daily? High-intensity CHF patients: Are serum electrolytes (sodium, potassium, renal function) being monitored daily for 3 days and then reassessed? Low-intensity CHF patients: Are serum electrolytes (sodium, potassium, renal function) being monitored every 1 to 2 days and then reassessed? Discharge phase module Evidence-based pharmacotherapy Was the patient given ACE inhibitors or ARBs at discharge if EF < 40%? Yes/No; if no, why not? Was the patient given β-blockers at discharge? Yes/No; if no, why not? Counselling Was medication counseling provided? Yes/No; if no, why not? Was end-of-life/advanced-care discussion at least once during hospitalization? Yes/No; if no, why not? Predischarge functional capacity and mobility assessment Walkability test (treadmill, 6MWT, walking on ward); did patient demonstrate that he/she can achieve ≥2 METs? Yes/no/not done; if no, physiotherapy assessment needed prior to discharge; if not done, state reason Physician appointments Is the patient given a confirmed scheduled appointment date with outpatient general practitioner, specialist or attending physician within 2 weeks of discharge? Is the patient referred to heart failure clinic? Yes/no; if no, state reason Predischarge cognitive and social support assessment Was CCAC/homecare assessment done? Abbreviations: 6MWT, 6 minute walking test; ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; CCAC, Community Care Access Centre; CHF, congestive heart failure; ED, emergency department; EF, ejection fraction; MET, metabolic equivalent. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 60 Implementation of Best Practices After formulating the majority of their recommendations, the Expert Panel was asked by the Ministry to provide high-level advice around implementation, including specific recommendations focused on the following areas: implementation of best practices impact on multidisciplinary teams system program and capacity planning required change management and support for change required Special Considerations for Cost Bundling 1. The current CIHI clinical administrative datasets informed the development of the CHF episode of care pathway. To use the pathway for funding purposes, additional data must be collected routinely. Cost datasets such as the Ontario Cost Distribution Methodology and OCCI have utilization information that can be helpful in the costing of the care pathway model. Although detailed microcosting and utilization data are available in hospitals’ OCCI data, the data submitted by hospitals to the Ministry is aggregated. A detailed data collection and submission plan must be developed to support the implementation of the CHF episode of care pathway model for funding purposes. 2. The care pathway model does not specifically take into account case-mix complexity from chronic conditions other than heart failure. Accordingly, we use the term case-mix-adjusted to reflect that this care pathway should represent an individual of “average” case-mix complexity. However, available evidence using Ontario data has demonstrated that length of stay within both high-intensity and low-intensity units is highly variable and depends on case-mix complexity and the number of coexisting chronic diseases. Cost bundling should continue to take into account the case-mix complexity/resource intensity weight methodology in some manner. 3. The care pathways in urban vs. rural hospitals may vary significantly because of differences in service availability and patient populations. CHF patients generally admitted to tertiary/teaching facilities have greater cardiac illness severity. Most importantly, the prevalence or proportions of patients expected to follow different pathway, investigative or treatment streams (i.e., in the diagram represented as Pr = ), will vary according to hospital type. Cost bundling should reflect such geographical and hospital-type differences. 4. Many quality-of-care variables will be expected to contribute minimally to costs (e.g., documenting daily weights), while other variables could have far-reaching cost implications to the system as a whole (increasing access to home-care, follow-up physician services, cardiac rehabilitation, etc.). Low-cost items could be included as “incentives” to the cost bundle, while higher-cost items may necessitate a different cost bundle strategy, with greater cost-estimate granularity and precision. 5. Counselling costs should be factored into the care bundle of all patients surviving to discharge. 6. It will not be possible to promote the movement of appropriate patients to ambulatory settings and achieve the associated cost efficiencies without addressing out-of-hospital incentives for best practices (examples of this include the development of specialized community-based heart failure clinics in Ontario). Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 61 Specialized Community-Based Heart Failure Clinics in Ontario The Expert Panel supports the implementation of specialized community-based heart failure clinics for transitional care. Based on moderate to high quality evidence of improved patient and health system outcomes through specialized community-based care (intermediate care), in 2012 OHTAC recommended the following31: Access to specialized community-based care (intermediate care) should be made available for patients with chronic diseases and whose diseases are becoming uncontrollable despite primary care. Recognizing that primary care is the optimal way of treating and coordinating care of patients with comorbidities, patients should be returned to primary care for further follow-up with a revised treatment plan once they have been stabilized in intermediate care. Recognizing the complexities of these recommendations, HQO should develop a high-level implementation plan that would provide advice regarding the adoption of these recommendations. In addition, Local Health Integration Networks should be approached to seek their interest in implementing OHTAC intermediate care recommendations in collaboration with experts. Evidence-based standards for multidisciplinary community-based care derived from EBAs, economic analyses, and field evaluation studies, as appropriate, should be derived for each of the chronic diseases. Health Quality Ontario should consider developing quality performance indicators based on these standards of care, tracking adherence to these standards and using this evidence base for developing quality-based funding. With respect to the CHF episode of care, OHTAC made the following recommendations relating to standards of care for specialized multidisciplinary heart failure clinics. These standards were endorsed by a CCN expert working group. The following is a summary from OHTAC Recommendation: Specialized Community Based Care for Chronic Disease.32 Evidence-Based Components 1. Active medication titration to evidence-based target doses should be a key priority of heart failure clinics. 2. Care should be consistent with evidence-based guidelines for the management of heart failure. 3. Health-care professionals should provide education, self-management training, and counselling to patients and their informal caregivers. Special efforts should be made to encourage informal caregivers to participate in patient management to ensure knowledge translation has been successful whenever possible. 4. Mechanisms that enable appropriately frequent follow-up should be built into the model of heart failure clinics. 31 32 http://www.hqontario.ca/portals/0/Documents/eds/ohtac-recommendation-specialized-care.pdf http://www.hqontario.ca/portals/0/Documents/eds/ohtac-recommendation-specialized-care.pdf Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 62 Expert Opinion-Based Components 1. Mechanisms that enable rapid access (within 1–3 days) to specialized care should be built into the model of heart failure clinics. 2. A structure of the roles and responsibilities, collaboration, and communication between heart failure specialists, primary care providers, and hospital inpatient physicians should be developed and implemented to facilitate efficient and effective seamless care. 3. Once the patients are stabilized, heart failure clinics need to demonstrate that patients are referred back to primary care with a care management plan. 4. HQO will work with experts, CCN and heart failure clinics to develop and promulgate standards to be followed by heart failure clinics and their referral base throughout the LHINs. The Expert Panel recommends that CHF patients discharged from hospital be referred to a specialized community-based heart failure clinic within 2 weeks of discharge. There was acknowledgement that more heart failure clinics need to be established throughout the province to prevent delays follow-up. Implementation of Best Practices Provincial Versus Local Care Pathways It should be recognized that the practices recommended in this clinical handbook have been defined at an aspirational provincial level to guide all hospitals across the province. This is not intended to be an operational care pathway: individual providers will have to implement these best practices based on their own local circumstances and available capacities. In many cases, implementation of these recommendations will be challenged by local arrangements or availability of services. For example, the Expert Panel discussed variation across the province in the provision of ventilation: while some hospitals provide noninvasive ventilation in a general medical ward, others only provide it in intensive care units. Track Current Practice Against Recommended Practices As discussed in Section 5, many of the practices recommended by the Expert Panel are not currently tracked in any consistent way at either the local or provincial level. Thus, it is difficult to know what the gap is between current and ideal CHF practice, and how much this gap varies across organizations and parts of the province. A key objective of developing a CHF performance measurement strategy should be to enable organizations to track, audit, and evaluate the implementation of care pathways and recommended practices at the organizational level. Through such monitoring, variances can be identified, progress monitored, and the pathway can be refined over time. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 63 Role of Multidisciplinary Teams One of the important issues in CHF care discussed by the Expert Panel is the lack of dedicated teams and resources in Ontario for CHF. In stroke care, for example, the Ontario Stroke Strategy has led to the widespread use of dedicated stroke units and interdisciplinary stroke teams. Such dedicated units and teams are much less common for CHF. The Expert Panel discussed a promising area for further research in evaluating the difference in outcomes between CHF patients cared for in nonspecialized teams and/or units with those cared for by specialized CHF teams and/or units (e.g., cardiology). Further work is required to define what constitutes a specialized team and to assess the feasibility of establishing these teams in hospitals of different sizes across the province. Service Capacity Planning The Ministry was interested in advice from the Expert Panel about capacity planning and shifts across care settings for CHF. The most important issue identified by the Expert Panel is inconsistent capacity in and access to ICU beds and heart failure clinics once patients are discharged. This is a major opportunity area for the Ministry, Local Health Integration Networks, hospitals, CCACs and other service providers to work together to improve outcomes for CHF patients and to also impact rates of unplanned readmissions. The Expert Panel supports the recommendation that the roles and responsibilities, collaboration, and communication between heart failure specialists, primary care providers, and hospital inpatient physicians should be developed and implemented to facilitate efficient, effective, seamless care. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 64 Expert Panel Membership Expert Panel for Health Quality Ontario: ‘Episode of Care’ for Congestive Heart Failure Name Role Organization Dr. David Alter Senior Scientist Institute for Clinical Evaluative Sciences Research Program Director and Associate Staff, The Cardiac and Secondary Prevention Program at the Toronto Rehabilitation Institute-UHN Associate Professor of Medicine, University of Toronto Dr. Douglas Lee Scientist Institute for Clinical Evaluative Sciences Dr. Catherine Demers Associate Professor Division of Cardiology, Department of Medicine McMaster University Dr. Susanna Mak Cardiologist University of Toronto, Department of Medicine, Division of Cardiology, Mount Sinai Hospital Dr. Lisa Mielniczuk Medical Director, Pulmonary Hypertension Clinic University of Ottawa Heart Institute Dr. Peter Liu President, International Society of Cardiomyopathy and Heart Failure of the World Heart Federation University of Ottawa Heart Institute Director, National CCHANGE Program Scientific Director/VP Research, University of Ottawa Heart Institute Professor of Medicine Dr. Robert McKelvie Professor of Medicine, Cardiologist McMaster University, Hamilton Health Sciences Dr. Malcolm Arnold Professor of Medicine University of Western Ontario, London Health Sciences Centre Dr. Stuart Smith Chief of Cardiovascular Services Director, Heart Failure Program St. Mary’s General Hospital Dr. Atilio Costa Vitali Assistant Professor of Medicine Division of Clinical Science Sudbury Regional Hospital Dr. Jennifer Everson Physician Lead Hamilton Niagara Haldimand Brant Local Health Integration Network Dr. Lee Donohue Family Physician Ottawa Linda Belford Nurse Practitioner, Practice Leader PMCC University Health Network Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 65 Jane MacIver Nurse Practitioner Heart Failure/Heart Transplant University Health Network Sharon Yamashita Clinical Coordinator, Critical Care Sunnybrook Health Sciences Centre Claudia Bucci Clinical Coordinator, Cardiovascular Diseases Sunnybrook Health Sciences Centre Andrea Rawn Evidence Based Care Program Coordinator Grey Bruce Health Network Darlene Wilson Registered Nurse Heart Function Clinic, Trillium Health Centre Kari Kostiw Clinical Coordinator Health Sciences North Ramsey Lake Health Centre Janet Parr CHF Patient Heather Sherrard Vice President, Clinical Services University of Ottawa Heart Institute Sue Wojdylo Manager, Case Costing Lakeridge Health Jane Chen Manager of Case Costing University Health Network Nancy Hunter LHIN Liaison & Business Development Cardiac Care Network of Ontario Gary Coleridge Senior Program Consultant Ministry of Health and Long-Term Care Louie Luo Senior Methodologist Ministry of Health and Long-Term Care Ministry Representatives Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 66 Appendices Appendix I: CHF Patient Group—ICD-10-CA Details I50 Heart failure Includes: Additional code from (E10-E14) with fourth and fifth digits .52 to classify any associated diabetes mellitus Additional code from (I11) (hypertensive heart disease) or (I13) (hypertensive heart and renal disease) for heart failure due to hypertension Excludes: Complicating: abortion or ectopic or molar pregnancy (O00-O07) (O08.8) obstetric surgery and procedures (O75.4) Following cardiac surgery or due to presence of cardiac prosthesis (I97.1) Neonatal cardiac failure (P29.0) I50.0 Congestive heart failure Includes: Congestive heart disease (CHF) Right ventricular failure (secondary to left heart failure) Excludes: fluid overload NOS (E87.7) I50.1 Left ventricular failure Includes: Cardiac asthma Left heart failure I50.9 Heart failure, unspecified Includes: Cardiac, heart or myocardial failure NOS I40 Acute myocarditis I40.0 Infective myocarditis Includes: Septic myocarditis Additional code (B95-B97) to identify infectious agent I40.1 Isolated myocarditis I40.8 Other acute myocarditis I40.9 Acute myocarditis, unspecified Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 67 I41 Myocarditis in diseases classified elsewhere I41.0 Myocarditis in bacterial diseases classified elsewhere Includes: Myocarditis: diphtheritic (A36.8) gonococcal (A54.8) meningococcal (A39.5) syphilitic (A52.0) tuberculous (A18.8) I41.1 Myocarditis in viral diseases classified elsewhere Includes: Influenzal myocarditis (acute): avian influenza virus identified (J09) other virus identified (J10.8) virus not identified (J11.8) Mumps myocarditis (B26.8) I41.2 Myocarditis in other infectious and parasitic diseases classified elsewhere Includes: Myocarditis in: Chagas’ disease: (acute) (B57.0) (chronic) (B57.2) toxoplasmosis (B58.8) I41.8 Myocarditis in other diseases classified elsewhere Includes: Rheumatoid myocarditis (M05.3) Sarcoid myocarditis (D86.8) I42 Cardiomyopathy Excludes: Cardiomyopathy complicating: pregnancy (O99.4) puerperium (O90.3) Ischemic cardiomyopathy (I25.5) I42.0 Dilated cardiomyopathy Includes: Congestive cardiomyopathy I42.1 Obstructive hypertrophic cardiomyopathy Includes: Hypertrophic subaortic stenosis I42.2 Other hypertrophic cardiomyopathy Includes: Nonobstructive hypertrophic cardiomyopathy Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 68 I42.3 Endomyocardial (eosinophilic) disease Includes: Endomyocardial (tropical) fibrosis Löffler’s endocarditis I42.4 Endocardial fibroelastosis Includes: Congenital cardiomyopathy I42.5 Other restrictive cardiomyopathy Includes: Constrictive cardiomyopathy NOS I42.6 Alcoholic cardiomyopathy I42.7 Cardiomyopathy due to drugs and other external agents Additional external cause code to identify cause I42.8 Other cardiomyopathies I42.9 Cardiomyopathy, unspecified Includes: Cardiomyopathy (primary) (secondary) NOS Additional code from category (E10-E14) with fourth and fifth characters .52 to classify any associated diabetes mellitus I43 Cardiomyopathy in diseases classified elsewhere I43.0 Cardiomyopathy in infectious and parasitic diseases classified elsewhere Includes: Cardiomyopathy in diphtheria (A36.8) I43.1 Cardiomyopathy in metabolic diseases Includes: Cardiac amyloidosis (E85.-) I43.2 Cardiomyopathy in nutritional diseases Includes: Nutritional cardiomyopathy NOS (E63.9) I43.8 Cardiomyopathy in other diseases classified elsewhere Includes: Gouty tophi of heart (M10.0) Thyrotoxic heart disease (E05.9) I25.5 Ischemic cardiomyopathy Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 69 Hypertensive heart disease and CHF patients These ICD-10-CA codes must include the CHF codes I50.X I11 Hypertensive heart disease Includes: Hypertensive heart disease NOS Use additional code to identify any (congestive) heart failure (I50.-) due to hypertension I13 Hypertensive heart and renal disease Includes: Any condition in I11 with any condition in I12 disease: cardiorenal cardiovascular renal hypertensive heart and renal disease NOS Use additional code to identify any: (chronic) kidney disease (failure) (N18.- , N19) due to hypertension heart failure (I50.-) due to hypertension Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 70 Appendix II: Rapid Review Methodology Table A1 outlines the process and components comprising the Evidence Development and Standards Branch Rapid Review process. Table A1: Rapid Review Methodology Steps Components 1. Develop research question 2. Conduct literature search 3. Screen and select studies 6. Write up findings Develop PICOS in consultation with experts, end users, applicant, etc. Limited scoping of question (e.g., Blue Cross Blue Shield, AETNA, CIGNA) Determine study selection criteria (inclusion/exclusion) Determine a maximum of 2 outcomes to GRADE in step 5 5 years English MEDLINE, EMBASE, Cochrane, Centre for Reviews and Dissemination SRs, MAs, HTAs (establish in advance that these study designs exist for your topic; if not, request RCTs and guidelines as well) Selection of SR, MA, HTA Rate SRs with AMSTAR Retrieve primary studies from SR, MA, HTA for step 4 analysisa Extract data on 2 outcomes from primary studies outcomesa GRADE maximum of 2 outcomes Write findings using Rapid Review template 4. Conduct data extraction and 5. Apply GRADE assessment Abbreviations: AMSTAR, Assessing the Methodological Quality of Systematic Reviews; HTA, health technology assessment; MA, meta-analysis; PICOS, population, intervention, comparison, outcome, setting; SR, systematic review. a These steps are required if the identified SR, MA, and/or HTA did not use GRADE to assess relevant outcomes. Quality-Based Procedures: Clinical Handbook for Congestive Heart Failure 71