Methodological Investigation of Cochrane reviews of Complex Interventions (MICCI) Version 1: Data-extraction template for describing complex interventions Worked example 1 A reengineered hospital discharge program to decrease rehospitalisation: a randomised trial. Jack et al 2009 Dimension 1: Discrete, active components included in the intervention compared with the control (or usual care). List each component. A component is defined as a discrete, active element of the intervention that could be implemented independently of other elements e.g. an educational booklet for consumers; clinical guidelines for Level of practitioners; a single drug intervention; a discrete surgical procedure. complexity Include dose, frequency, and duration of intervention if applicable. If the intervention comprises usual care plus something else, list “usual care” as one component. Control (or usual care) Intervention Usual care (discharge from hospital) not described. Assumed to be an administrative process including supply of medication and/or outpatient appointment if appropriate and minimal advice Reengineered hospital discharge comprising in-hospital components delivered by trained Discharge Advocate (DA): 1. Educate patient about diagnoses 2. Co-ordinate appointments for follow-up and post-discharge testing at convenient times for patient; discuss importance of follow-up, access to transport and other potential barriers 3. Discuss pending tests and nature of follow-up with results 4. Organise post-discharge services, ensure patient understands and can access them 5. Confirm and explain medication plan, ensure patient understands schedule, purpose, how to take correctly and side effects, and can obtain further supplies 6. Reconcile discharge plan with national guidelines and critical pathways 7. Instruct patient in appropriate actions if a problem arises 8. Transmit detailed discharge summary to physicians and services responsible for on-going care 9. Assess patient’s understanding of the plan and contact family if necessary 10. Give patient detailed a written discharge plan including follow-up information and calendar Simple Complex Post-discharge telephone call to the patient from a pharmacist to reinforce discharge plan, review medications and solve problems The above are not all discrete elements, there is some overlap. They could be grouped as organisational, patient-education and follow-up. i.e. 3 components. 1 Methodological Investigation of Cochrane reviews of Complex Interventions (MICCI) Dimension 2: Behaviours or actions of intervention recipients or participants to which the intervention is directed. List each behaviour or action. Behaviours or actions include taking a medication, changing a particular practice, improving knowledge or Level of undergoing a surgical procedure. Consider whether behaviours are single, complexity repeated, or linked. Control (or usual care) Patient is discharged from hospital with a prescription / follow-up appointment / advice as appropriate Simple Intervention Targeted actions to reduce readmissions are: Patients attend follow-up appointments and understand the importance of test results etc. Patients take medication correctly, know how to obtain more when needed, recognise side-effects Patients seek appropriate help when problems arise Complex Dimension 3. Organisational levels targeted by the intervention Indicate which level(s) are targeted. Level refers to whether the intervention was directed at one of more of the following strata: individuals (consumers, professionals, policy makers); groups or teams of individuals (a clinic, patient support group etc.); systems (health systems, communities, policy networks). Level of complexity Control (or usual care) Patients Simple Intervention 1 Patients Simple Dimension 4. The degree of flexibility or tailoring permitted across sites or individuals in intervention implementation / application. Indicate the degree of flexibility. Flexibility includes variation in implementation from site to site permitted and / or intervention designed to Level of tailor to individuals or specific implementation settings (there could be a complexity rigid protocol where no variation is permitted or a loose protocol i.e. most components of the intervention are tailored / flexible). Control (or usual care) Usual discharge procedure is not described but it is assumed to be a standardised administrative protocol with scope for tailoring its delivery (amount and type of advice given etc). Simple Intervention The intervention comprises a detailed protocol that has to be adhered to, though there is scope for tailoring patient-specific content Simple 2 Methodological Investigation of Cochrane reviews of Complex Interventions (MICCI) Dimension 5. The level of skill (defined as the ability to do something, arising from training, practice or experience) required by those delivering the intervention. Indicate the level of skill required i.e. new skills in addition to expected existing skills AND / OR the extension of existing skills to a highly specialised area AND / OR skills requiring extensive additional training. Level of Indicate whether the required skills are multi-disciplinary, complexity interdisciplinary or single disciplinary. Note: there may be no new skills required. Control (or usual care) No new skills required Simple Intervention Nurse Discharge Advocates were specially recruited and trained to deliver the in-hospital intervention Complex Dimension 6. The skills required for the targeted behaviour when entering the study by those receiving the intervention in order to meet the intervention’s objectives. Describe or list the skills required (defined as the ability to do something, arising from training, practice or experience) for the targeted behaviour Level of when entering the study by those receiving the intervention (consumers, complexity professionals, planners) in order to meet the intervention’s objectives. Note: there may be no specialist skills required Control (or usual care) No specialist skills required Simple Intervention No specialist skills required Simple Dimension 7. The interaction between intervention components Describe the interaction between intervention components. Note: Interaction may not be reported or may be implicit or suggested in the discussion; components may have an aggregative effect or be independent Level of complexity Control (or usual care) No interaction Simple Intervention There is some interaction in that the educational component equips patients with knowledge and understanding that promotes the desired behaviour, the organisational component facilitates that behaviour, and the post-discharge follow-up reinforces it. Complex 3 Methodological Investigation of Cochrane reviews of Complex Interventions (MICCI) Dimension 8. The interaction between the intervention and the context or setting in which it is implemented Indicate which (if any) effects of the intervention are dependent on context or setting. E.g. would the same intervention have the same effects in primary care clinics and tertiary level hospitals, or in one country Level of compared to another. Would the same intervention have the same effects complexity on different groups (e.g. issues of equity need to be explained) Control (or usual care) Could be delivered in any hospital Simple Intervention Could be delivered in any hospital Simple Dimension 9. The ways in which the effectiveness of an intervention is modified by patient, provider and health care delivery factors Indicate the ways in which the effectiveness of an intervention is modified Level of by patient, provider and health care delivery factors (e.g. complexity duration/intensity of the intervention, person who delivers the intervention Control (or usual care) The effect of standard hospital discharge protocols on readmission rates could be modified by the person who effects the discharge. i.e. by giving advice about medication, appointments etc. informally in addition to the official procedure. Moderately complex Intervention The protocol is very detailed and there is little chance of impact on effectiveness Simple Dimension 10. The ‘causal pathway’ between the intervention and the outcome it is intended to effect. Describe the causal pathway between the intervention and the outcome it is Level of intended to effect. The pathway may or may not be linear and there may complexity be more than one causal pathway. It may be helpful to use diagrams. Control (or usual care) Pathway is short and linear. Health care professional completes discharge procedure → patient is discharged Simple Intervention The pathway is not a single straight line. Elements of the intervention form an educational component and organisational component that run parallel and are complementary (one informs the other facilitates). Both impact on behaviour that is then reinforced by the post-discharge component. Ed → Pos-dis → behaviour Org → Moderately complex 4