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Table 3 MyComrade study process evaluation framework, including implementation outcomes framework

From: The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial

Process evaluation framework and implementation outcomes framework MyComrade process evaluation questions Intervention or control Data source to answer process evaluation question
Interview Other sources
Domain
 1. Recruitment of clusters How were practices sampled and recruited? Both No Study records
Why did practices agree to participate (or not)? Both GPs/PBPs
Practice administrative staff
 
 2. Delivery to clusters How was MC delivered to the practices? Intervention GPs/PBPs Study records
 3. Response of clusters How has completing trial-related work impacted the practice?
At the practice level, how is MC and related research work perceived?
How has the practice been found working with the research team?
Time taken to complete study activities?
Both Practice administrative staff
GPs/PBPs
 
How were patients identified/reviewed?
Are they representative/is there a selection bias?
Time taken to complete?
Both Practice administrative staff
GPs/PBPs
 
What were the processes involved in addressing the recruitment packs and conducting mail-outs and what was the time taken to complete? Both Practice administrative staff
GPs/PBPs
 
What is the practice level protocol for usual care? Control Practice administrative staff
GPs/PBPs
 
 4. Recruitment and reach in individuals Who within each practice actually received the MC training? Are they representative/is there a selection bias? Intervention Practice administrative staff
GPs/PBPs
Study records of attendance at the intervention introduction session
 5. Delivery to individuals Implementation outcomes framework
1. Fidelity
What do GPs/PBPs implement as usual care? Control GPs/PBPs  
How are GPs/PBPs implementing MC? How many BCTs did pairs implement the following? Intervention GPs/PBPs  
i. Plan reviews: restructuring social environment, Action planning Intervention GPs/PBPs Checklist completion
GP fellow calls
ii. Conduct reviews: social support Intervention GPs/PBPs Checklist completion
GP fellow calls
Scanned checklists to patient record
iii. Use checklist: prompts/cues Intervention GPs/PBPs Checklist completion
Scanned checklists to patient record
iv. Submit for annual appraisal or points/reimbursement: self-incentives; material incentive Intervention GPs/PBPs Submission of MC activities for annual appraisal
Receipt of reimbursement
 6. Response of individuals 1. Acceptability
2. Adoption
3. Appropriateness
4. Feasibility
Is MC acceptable/agreeable/satisfactory to GPs/PBPs?
What was GP/PBP initial intention/plan for MC?
Did implementation of MC change over the course of the study (e.g. use of checklist)?
Is MC compatible/relevant for general practice and multimorbidity?
Is MC practical/feasible for GPs/PBPs to implement?
Intervention GPs/PBPs  
  Has the GP/PBP ever reviewed their medication with them?
How do they feel about two GPs, or GP and PBP discussing their medications without them?
Did they experience any changes to their medication during the course of the study?
Both Patients  
 7. Maintenance 1. Acceptability
2. Adoption
3. Appropriateness
4. Feasibility
Has MC become integrated into practice over the course of the study? What components?
Do GPs/PBPs think MC could become routine practice?
Are there any opportunity costs of implementing MC?
Intervention GPs/PBPs  
 8. Unintended consequences Were there unintended consequences, outcomes or changes in the processes? Intervention GPs/PBPs  
 9. Theory Proposed mechanisms of impact:
How did GPs/PBPs feel about formally allocating time to review medications?
Did the MC intervention help in any way in dealing with that uncertainties related to medications and considering options?
Has taking part in the trial had any impact on the way GP/PBP communicates with their patients about their medications?
Did GP/PBP submit details of their MC involvement as part of annual appraisal submission?
Intervention GPs/PBPs  
 10. Context What are the differences in experiences between the NI and ROI practices in all of the framework domains, e.g.:
Practice resources
prescribing guidelines
practice context, e.g. practice size and setting
Both All Practice profile questionnaire
 11. Effectiveness Did pairs complete active medication reviews?
Were there changes made to the number of repeat medications prescribed (additions and de-prescribing)?
Were there changes related to potentially inappropriate prescribing?
Both GPs/PBPs Checklist completion
GP fellow calls
Patient record
Patient outcomes:
Quality of life
Multimorbidity treatment burden
Both Patient Patient questionnaires
Patient record