Table 2 Participatory Action Research (PAR) Informed Approach to Stakeholder Panel Engagement, by Clinical Trial Stage
From: Stakeholder-engaged process for refining the design of a clinical trial in home hospice
PAR Cycle Phase | Stakeholder Panel Start-Up | Trial Stage | ||
|---|---|---|---|---|
Refining Protocol and Design | Trial Execution | Dissemination | ||
Plan | • Recruit key members • Plan timing and process/ procedures | • Define a priori protocol and design questions for panel input | • Plan for updates and check-in | • Plan for interpretation of analysis/results |
Action | • Define rules for engagement and communication • Personalize approach to facilitate inclusion and participation | • Present goals, questions/challenges • Invite additions to agenda setting from panel • Execute recommendations from prior cycles PAR cycles (if applicable) | • Present updates for recruitment, acceptability, feasibility | • Present interim analysis/results • Engage in plan for presentation and dissemination |
Reflection | • Discuss, reflect and make recommendations for refining process | • Discuss, reflect and make recommendations for challenging issues, addressing gaps | • Invite feedback on successes and challenges | • Invite interpretation of interim analysis and results |
Evaluation/ Observation | • Record process and minutes from stakeholder meetings • Check in with panelists and investigator team | • Record process and minutes from stakeholder meetings • Review of protocol by investigators, IRB, study safety officers, and stakeholders | • Record process and minutes from stakeholder meetings • Measures of trial benchmarks (e.g. retention, adherence to intervention) | • Record process and minutes from stakeholder meetings • Peer review of research manuscripts and meeting presentations |