“Treating an Illness Is One Thing. What About a Patient With Many?” MULTIPLE CHRONIC CONDITIONS: INCLUDING PEOPLE WITH REPRESENTATIVE COMORBIDITIES: CREDITS Cynthia M. Boyd, MD MPH Dr. Boyd is a co-author of a chapter on multimorbidity for UptoDate, for which she receives a royalty. She has received funding from the National Institutes of Health, Agency for Healthcare Research and Quality, the National Quality Forum and the Patient-Centered Outcomes Research Institute (PCORI) for work related to trials, systematic reviews, guidelines and people living with multiple chronic conditions. “Treating an Illness Is One Thing. What About a Patient With Many?” Image: Brendan Smialowski for the New York Times, March 31, 2009 It’s Not Easy Living with Multiple Chronic Conditions Time Medications Non-pharmacologic Therapy All Day Periodic 7 AM Ipratropium MDI Alendronate 70mg weekly Check feet Sit upright 30 min. Check blood sugar Joint protection Pneumonia vaccine, Yearly influenza vaccine 8 AM 12 PM Eat Breakfast HCTZ 12.5 mg Lisinopril 40mg Glyburide 10 mg ECASA 81 mg Metformin 850mg Naproxen 250mg Omeprazole 20mg Calcium + Vit D 500mg 2.4gm Na, 90mm K, Adequate Mg, ↓ cholesterol & saturated fat, medical nutrition therapy for diabetes, DASH Eat Lunch Ipratropium MDI Diet as above Energy conservation Exercise (non-weight bearing if severe foot disease, weight bearing for osteoporosis) Muscle strengthening exercises, Aerobic Exercise ROM exercises Calcium+ Vit D 500 mg Avoid environmental exposures that might exacerbate COPD 5 PM Eat Dinner Wear appropriate footwear 7 PM Ipratropium MDI Metformin 850mg Naproxen 250mg Calcium 500mg Lovastatin 40mg 11 PM Diet as above Albuterol MDI prn Limit Alcohol Maintain normal body weight Ipratropium MDI Boyd et al. JAMA 2005;294:716-724 All provider visits:Evaluate Selfmonitoring blood glucose, foot exam and BP Quarterly HbA1c, biannual LFTs Yearly creatinine, electrolytes, microalbuminuria, cholesterol Referrals: Pulmonary rehabilitation Physical Therapy DEXA scan every 2 years Yearly eye exam Medical nutrition therapy Patient Education: High-risk foot conditions, foot care, foot wear Osteoarthritis COPD medication and delivery system training Diabetes Mellitus How Applicable are Clinical Practice Guidelines (CPGs) for People with MCCs? • Reviewed 9 CPGs for chronic conditions • Most single disease CPGs fail to give adequate guidance for older patients with MCCs 5 Boyd et al. JAMA 2005;294:716-724 Multiple Chronic Conditions is Common Percentage of Major Chronic Disease in Isolation Among Women Aged 65 or Older: NHANES, 1999-2004 % with only 1 disease of 5 possible diseases Arthritis Coronary Heart Disease 47% 17% Chronic Diabetes Lower Respiratory Tract Disease 19% 17% Stroke 15% Weiss CO et al. JAMA 2007;298:1160-1162 Prevalence of Comorbidities in Adults with Coronary Heart Disease Aged ≥ 45 in NHANES, 1999-2004 60.0 50.0 40.0 30.0 % 20.0 10.0 0.0 Diseases Boyd et al JAGS 2011 May;59(5):797-805 Clinical Factors Health Status Factors What Do Clinicians Need to Best Care for the People with MCCs? • Maximize use of therapies likely to benefit • Minimize use of therapies unlikely to benefit or likely to harm • An understanding of what outcomes matter most • Incorporate patient preferences and values regarding burdens, risks, and benefits INDIVIDUALIZED DECISIONS Don’t Screen/treat Do Screen/treat Likelihood of Benefit Likelihood of Harm Patient Preferences (moveable fulcrum) Slide Courtesy of Louise Walter, UCSF How can we better address people with MCCs across translational path? Study Design and Analysis Systematic Review and MetaAnalysis Clinical Practice Guideline Development Clinical DecisionMaking Integrated Care Performance Measurement AHRQ R21, EPC Methods, NIH CTSA, NQF via HHS, NIA JGIM Supplement, 2014. Boyd and Kent, Uhlig et al, Trikalinos et al, and Weiss et al. WHAT COMORBIDITIES MATTER? • Prevalence • Important interactions –condition-condition –condition-treatment –treatment-treatment Uhlig et al JGIM April 2014 Choosing Topics: Focus Comorbid Condition Morbidity/Risk Index Condition Comorbid Condition Comorbid Condition Index Condition/Risk Condition MCCs Condition Condition Uhlig et al JGIM April 2014 • Evaluating interventions requires meaningful outcomes • No standard quality metrics or outcomes to guide care for the MCC population • Minimal evidence associating recommended MCC care processes with outcomes • New interest in outcomes that reflect patientcentered constructs Slide courtesy of Elizabeth Bayliss OUTCOMES • Deciding what outcomes matter to people – More likely to be less disease-specific • Surrogates may have a different relationship to patient-important outcomes in people with MCCs • Risks of outcomes may be different in people with MCCs • A hard look at exclusion criteria may point to what outcomes should be measured MEASURING OUTCOMES IN PEOPLE WITH MCCS • Deciding what outcomes matter to people – More likely to be less disease-specific • Surrogates may have a different relationship to patient-important outcomes in people with MCCs • Risks of outcomes may be different in people MEASURING OUTCOMES IN with MCCs WITHcriteria may point to • A hard lookPEOPLE at exclusion MCCS what outcomes should be measured In addition…. Outcomes relevant to MCCs should be: • Relevant to patients • Relevant to health care systems • Relevant to clinicians • Easy to collect, store, and extract • “Validated” – Associated with other meaningful constructs – Sensitive to change over time • Likely to be a function of the intervention Two commonly used outcomes for studies of multimorbidity • Disease-specific outcomes • Utilization – Hospital – Emergency services – Primary care – Specialty care • • • • • EXAMPLE OUTCOME DOMAINS IMPORTANT TO COMPLEX PATIENTS Pain Function Energy Mortality Treatment burden – Medication side effects – Lifestyle modification • Others…. C. Boyd. PCORI ME-13-0-07619 • Deciding what outcomes matter to people – More likely to be less disease-specific • Surrogates may have a different relationship to patient-important outcomes in people with MCCs • Risks of outcomes may be different in people MEASURING OUTCOMES IN with MCCs WITHcriteria may point to • A hard lookPEOPLE at exclusion MCCS what outcomes should be measured Addressing Comorbidities in PICO Questions Population: Define conditions of interest Intervention and Comparators: effect modification Outcomes: choice & ranking of relevant outcomes harms, burdens, benefits non-disease specific and disease specific linkage between surrogate and clinical outcomes “Effect of treatment on the final outcome may be small even if there are strong associations between treatment and the surrogate and between the surrogate and the patient-important outcome” Walter SD et al 2012 Sep;65(9):940-5 Timeframe for considering outcomes: risk prediction tradeoffs Trikalinos et al JGIM April 2014, Uhlig et al JGIM April 2014 • Deciding what outcomes matter to people – More likely to be less disease-specific • Surrogates may have a different relationship to patient-important outcomes in people with MCCs • Risks of outcomes may be different in people MEASURING OUTCOMES IN with MCCs WITHcriteria may point to • A hard lookPEOPLE at exclusion MCCS what outcomes should be measured Sample 1: centered, but fails to reflect the diversity of the population Sample 2: individuals who much more net benefit from the treatment than does average member of population Sample 3: broadly representative of the population in terms of risk, responsiveness, and vulnerability • Deciding what outcomes matter to people – More likely to be less disease-specific • Surrogates may have a different relationship to patient-important outcomes in people with MCCs • Risks of outcomes may be different in people MEASURING OUTCOMES IN with MCCs WITHcriteria may point to • A hard lookPEOPLE at exclusion MCCS what outcomes should be measured How can inclusion/exclusion criteria help us understand what outcomes matter to people with MCCs? • survey of trials reporting on drug and non-drug interventions in patients with four common chronic diseases – COPD, heart failure, stroke and type II diabetes mellitus. • Not a systematic review • based the selection of randomized controlled trials (RCTs) on 11 Cochrane Reviews that systematically identified and summarized RCTs – effectiveness of diuretics, metformin, anticoagulants, longacting beta agonists alone or in combination with inhaled corticosteroids, lipid lowering agents, and the non-drug interventions exercise and diet for each of the four diseases Boyd, Vollenweider, Puhan PLOS One 2012 % of trials excluding patients with specif ic comorbidities Renal Insufficiency Liver Insufficiency Insulin Therapy Coronary ArteryDisease Type I Diabetes Serious concom itantdiseases(unspecified) Age >65 Age <40 Diabeticnephro-,retino-orneuropathy Hypertension Cardiac disease (unspecified) Cancer(unspecified) Oral steroid use Unable to exercise (unspecified) HeartFailure Anem ia Musculoskeletal diseasesordisabilities Psychiatricillness Peripheral vasculardisease Neurologicdisabilities COPD or Em physem a DIABETES TRIALS Im paired m ental status 0 10 20 30 40 50 Boyd, Vollenweider, Puhan PLOS One 2012 % of trials excluding patients with COPD trials specific comorbidities Oxygen therapy Musculoskeletal diseases or disabilities Serious concomitant diseases (unspecified) Age <40 Age >65 Lung disease other than COPD Coronary Artery Disease Oral steroid use Unable to exercise (unspecified) Cardiac disease (unspecified) Heart Failure Cancer (unspecified) Peripheral vascular disease Psychiatric illness Impaired mental status Neurologic disabilities Hypertension Type II Diabetes Mellitus Renal Insufficiency NYHA IV 0 10 20 30 40 50 Boyd, Vollenweider, Puhan PLOS One 2012 It’s Not Easy Living with Multiple Chronic Conditions Time Medications Non-pharmacologic Therapy All Day Periodic 7 AM Ipratropium MDI Alendronate 70mg weekly Check feet Sit upright 30 min. Check blood sugar Joint protection Pneumonia vaccine, Yearly influenza vaccine 8 AM 12 PM Eat Breakfast HCTZ 12.5 mg Lisinopril 40mg Glyburide 10 mg ECASA 81 mg Metformin 850mg Naproxen 250mg Omeprazole 20mg Calcium + Vit D 500mg 2.4gm Na, 90mm K, Adequate Mg, ↓ cholesterol & saturated fat, medical nutrition therapy for diabetes, DASH Eat Lunch Ipratropium MDI Diet as above Energy conservation Exercise (non-weight bearing if severe foot disease, weight bearing for osteoporosis) Muscle strengthening exercises, Aerobic Exercise ROM exercises Calcium+ Vit D 500 mg Avoid environmental exposures that might exacerbate COPD 5 PM Eat Dinner Wear appropriate footwear 7 PM Ipratropium MDI Metformin 850mg Naproxen 250mg Calcium 500mg Lovastatin 40mg 11 PM Diet as above Albuterol MDI prn Limit Alcohol Maintain normal body weight Ipratropium MDI Boyd et al. JAMA 2005;294:716-724 All provider visits:Evaluate Selfmonitoring blood glucose, foot exam and BP Quarterly HbA1c, biannual LFTs Yearly creatinine, electrolytes, microalbuminuria, cholesterol Referrals: Pulmonary rehabilitation Physical Therapy DEXA scan every 2 years Yearly eye exam Medical nutrition therapy Patient Education: High-risk foot conditions, foot care, foot wear Osteoarthritis COPD medication and delivery system training Diabetes Mellitus 5 Step Framework for Multimorbidity Consider Patient Preferences. Determine what outcomes are most important to the patient and his or her caregivers. Is the patient most interested in longevity? Quality of life? Limiting treatment side effects? Maximizing function? Clinicians need to recognize which decisions are “preference sensitive”, in other words decisions that involve a tradeoff between benefits and harms, and therefore the patient’s preference should be a key factor in the decision. Making sure that patients and their families understand anticipated benefits and harms of different treatment options is a key part of eliciting patient preferences. 5 Step Framework for Multimorbidity Review Relevant Evidence. The clinician needs to understand the evidence for a treatment, including whether that evidence applies to the patient in question. Key questions to consider include: o Did the trials of the treatment include older patients? Patients with this patient’s comorbidities? o What does the evidence say about side effects and potential harms? o How long were the trials? What is the time horizon to benefit? 5 Step Framework for Multimorbidity Estimate Prognosis. Many validated tools exist for estimating life expectancy and mortality. Students will have an opportunity to practice with these tools during the session. Spend some time going over the figure in the Water and Covinsky article,2 helping students understand what sorts of factors determine whether a patient is in the upper or lower quartile of life expectancy for his or her age. For example the presence and severity of comorbidities such as diabetes with complications, chronic kidney disease, congestive heart failure, COPD, cancer, and dementia will influence life expectancy. Also, functional limitations such as dependencies in ADLs and IADLs or reduced exercise tolerance influence our estimates of life expectancy. Patients who have severe comorbidities and functional impairments are likely in the lowest quartile of life expectancy, while patients who have few life-limiting comorbidities or functional impairments are likely in the upper quartile of life expectancy. You should help students understand the limitations of tools for estimating prognosis. Faculty who want more information on the tools found on the eprognosis website (http://eprognosis.ucsf.edu/) ,3 may wish to consult Yourman et al.’s systematic review on prognostic tools.4 5 Step Framework for Multimorbidity Consider clinical feasibility. Engage the patient and his or her caregivers in a discussion regarding their ability to implement the treatment plan. More complex regimens are high risk for nonadherence, treatment interactions, impaired quality of life, caregiver strain, and financial costs. Consider whether the patient has cognitive deficits or functional limitations that make some treatments impractical without strong family or home-based support 5 Step Framework for Multimorbidity Develop a plan of care that optimizes benefits and minimizes harm for the patient. This step brings it all together. All of the steps above will help a clinician devise a plan, together with the patient and his or her caregivers, that will honor preferences, maximize benefit, minimize harm, and enhance quality of life. The physician should engage the patient and his or her caregivers in shared decision making, laying out the evidence and alternatives and making a decision together about which course to pursue.
