Engagement of key stakeholder groups is critical across the research continuum, from making sure the right questions are asked to ensuring that study findings make it into the hands of health and healthcare decision-makers. Three broad stages for involving stakeholders include: 1) planning the study, 2) conducting the study, and 3) disseminating the results (PCORI 2015). Ways in which stakeholders might contribute at each stage are presented in the Figure and summary below.
- 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 Demonstration Projects 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. Prior history of collaboration among investigators and support from senior officers in the healthcare system was instrumental in obtaining 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. 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 retentionThe 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.
- Solving problems and removing barriersAfter experiencing issues with study implementation, the STOP CRC research team partnered with practice improvement facilitators who were trained in the plan-do- 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.
- 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 to policies and guidelines
Planning the Study
Engagement of key stakeholder groups ideally begins with the selection of a research topic, and many organizations employ a multi-stakeholder process of topic prioritization (National Institute for Health Research 2016; PCORI). This ensures that resources are allocated to studies that will answer questions of greatest importance to decision-makers, and also increases the likelihood that a study will receive the support it needs for successful implementation. As noted above, PCTs that answer questions that matter to healthcare delivery organizations, clinicians, and patients are more likely to garner support. In choosing whether to support a PCT, it is recommended that decision-makers respect, promote, or represent the interests of those likely to be directly or indirectly affected; advance organizational mission and values; and consider stewardship of resources (financial, human, and organizational) (Whicher et al. 2015).
Once a research question has been selected, stakeholders can contribute to study planning in a number of ways. For example, patient representatives can identify health outcomes that are important to them that researchers may not have thought to measure. A different set of outcomes related to resource utilization may be important to healthcare payers. Involving clinicians and other clinic staff in designing the study protocol can help minimize the trial’s impact on clinical workflow, which is particularly important for PCTs.
Conducting the Study
Stakeholders can continue to play an important role during study implementation. While not everything about a PCT will work as initially planned, seemingly insurmountable problems usually have solutions, and well-established engagement throughout a trial can help prevent or overcome such roadblocks. Because healthcare systems are dynamic, PCTs require continued efforts to establish, maintain, and re-establish engagement through leadership or staff changes. Patient and clinician stakeholders can contribute to the development of communication materials and data collection instruments that are understandable and easy to use. Patients and patient advocates can also provide valuable insight regarding strategies that will motivate patients to enroll in the study and remain engaged throughout the study. Once data collection is completed, stakeholders can help to plan analyses and interpret results.
Disseminating the Results
Stakeholders can enhance dissemination by helping to translate study findings for diverse audiences and identifying avenues for dissemination beyond the traditional scientific literature. The PCORI Dissemination and Implementation Framework provides detailed information and tools for designing and implementing a robust dissemination strategy informed by multiple stakeholder groups. Additional information can also be found in the Living Textbook chapter, Dissemination Approaches for Different Stakeholders.
Living Textbook chapter
Provides information and tools for designing and implementing a robust dissemination strategy informed by multiple stakeholder groups
National Institute for Health Research. 2016. The James Lind Alliance Guidebook. www.jla.nihr.ac.uk/jla-guidebook/downloads/JLA-Guidebook-Version-6-February-2016.pdf. Accessed May 9, 2017.
PCORI. 2015. PCORI Engagement Rubric. www.pcori.org/sites/default/files/Engagement-Rubric.pdf. Accessed May 9, 2017.
PCORI. Generation and Prioritization of Topics for Funding Announcements. http://www.pcori.org/research-results/how-we-select-research-topics/generation-and-prioritization-topics-funding-4. Accessed May 9, 2017.
Whicher DM, Miller JE, Dunham KM, Joffe S. 2015. Gatekeepers for pragmatic clinical trials. Clin Trials. 12:442–448. doi:10.1177/1740774515597699. PMID: 26374683.