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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