Planning the Study

Engagement of key partner groups ideally begins with the selection of a research topic, and many organizations employ a multi-partner 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, partners 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

Partners 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 partners 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, partners can help to plan analyses and interpret results.

Informing and Delivering the Study Intervention

Patient and clinician partners may also play an important role in informing and delivering the study intervention or program. One way trial partners may inform how the intervention is delivered by testing and providing feedback on example materials or methods through focus groups, interviews, and other forms of testing. In addition to providing guidance on how the intervention is delivered, a trial may be designed with designated roles for health system provider support in delivering the intervention. It is important to clearly define roles and expectations, including compensation for research study support by health system partners. Once data collection is completed, partners can help to plan analyses and interpret results.

Disseminating the Results

Partners 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 partner groups. Additional information can also be found in the Living Textbook chapter, Dissemination Approaches for Different Stakeholders.