Stakeholder Engagement Across the Research Continuum
- Choosing a research question
- Designing the intervention and informing on potential sustainabilityThe TiME trial study design was developed through a collaborative effort among research teams at the dialysis provider organizations and academic investigators. Some of the many decisions made together include the specifics of the intervention, methods for informing potential participants, approaches to enrolling and training facilities, which data elements to collect, and how to transfer the data. Source: PI interview.
- Selecting outcome measures
- Determining inclusion and exclusion criteria
- Designing the study protocol to minimize burden for patients and cliniciansThe PPACT trial has an intervention that is delivered in the primary care setting where schedules are busy and space is tight. The research team partnered with clinicians to understand the clinical workflow. They scheduled study-related patient visits during slower clinic periods and held patient visits in less conventional ways, such as after hours and by having groups meet in lobby spaces. Source: Lessons Learned Document.
- Determining study requirements (e.g., regulatory)All NIH Collaboratory PCT NIH Collaboratory Trials had teleconferences with the Office for Human Research Protections during study planning to discuss ethical and regulatory issues associated with the PCTs (see minutes). In addition, the TSOS project met with a liaison for their study’s DSMB to clarify reporting requirements and the monitoring plan before enrollment began.
- Promoting and supporting the studyIn the ICD-Pieces trial, approval of the study was delayed because different departments within a single healthcare system were unable to initiate approval without the other departments going first. The team facilitated in-depth discussions of the project with all the relevant stakeholders on the phone at the same time; this, along with support from senior officers in the healthcare system, helped to secure study approval. Source: Lessons Learned Document.
- Drafting/reviewing study materialsThe SPOT research team included individuals with experience of self-harm or suicidal ideation in the process of developing and refining the outreach messages that are part of the trial’s suicide prevention interventions. These outgoing messages are sent through the patient portal in the electronic health record. For example, “You told your doctor you were having thoughts about harming yourself, and we’d like to help you.” Multiple rounds of pilot testing were done to refine the outreach programs. They sought to find a balance between being assertive while not being overly intrusive. Source: PI interview.
- Providing resourcesFor the STOP CRC trial, which aims to improve rates of colorectal cancer screening in patients at Federally Qualified Health Centers, some patients lacked health insurance coverage to pay for follow-up colonoscopy after a positive fecal test. The advisory board included legislators who changed state law to require commercial insurance plans to cover a follow-up diagnostic colonoscopy with no patient out-of-pocket costs. Some local community organizations also provided a free colonoscopy through a network of donated care, and Medicaid expansion resulted in higher insurance coverage rates. Source: Lessons Learned Document.
- Developing recruitment strategies
- Promoting and assessing compliance with study requirements (e.g., regulatory)
- Serving as study championsThe ADAPTABLE pragmatic trial has a Steering Committee that includes a representative from the American College of Cardiology, the professional organization that develops the cardiac guidelines that may be influenced by the study results. Source: ADAPTABLE website. The trial collaborates with this organization and the American Heart Association “to generate study awareness and education among patients with heart disease and the healthcare providers that treat them.” These organizations help promote the study through their scientific conferences and social media channels. Source: ADAPTABLE website.
- Assisting with strategies for participant retentionAfter experiencing issues with study implementation, the STOP CRC research team partnered with practice improvement facilitators who were trained in the plando- study-act (PDSA) method. The facilitators held in-person meetings with leadership teams from all sites and asked the sites to submit a PDSA plan for issues with the trial. For example, when there were too many fecal kits submitted without a collection date, the plan was to test new materials that prompted patients to write the collection date on the kits. PDSA cycles empowered clinics to identify and address local problems and provided information about implementation challenges. Source: Lessons Learned Document.
- Solving problems and removing barriersThe ADAPTABLE pragmatic trial has a Retention Working Group, which includes patient representatives. To assist with retention, the working group suggested a newsletter to engage participants. The trial’s patient advisers provide input on the newsletter, including contributing topic ideas. Source: ADAPTABLE website.
- Considering privacy and data sharing issues
- Advising on analyses
- Interpreting study results
- Determining key messages for different stakeholder groups
- Identifying avenues for dissemination
- Assisting with the development of manuscripts and other dissemination materials
- Sharing findings via professional networks and social media
- Supporting implementation or de-implementation of intervention
- Considering changes