Purpose: The purpose of this study was to assess if changes are needed in a research study design, methods and outcomes when transferring interventions used in a multisite urban/community study to rural hospital settings through clinician and patient engagement with people with heart failure (HF).
Design, Sample and Setting: A working session was first conducted with stakeholders (six Registered Nurse clinician study team members) to review the study protocol, discuss the clinical context and determine if protocol changes were needed. Next, structured interviews were conducted with HF patients admitted with a diagnosis of HF to determine if additional changes to the protocol were required. The setting was two rural hospitals.
Method: Changes to the protocol were made after stakeholder engagement based on group consensus. Next, eight patient subjects completed structured interviews. A content analysis of theme responses were summarized by frequency.
Results: Stakeholders recommended three changes [add health literacy assessment (vs education completed), add medication adherence questions post discharge and delete the patient HF knowledge post-test). Patients verified the recommended changes obtained from stakeholder engagement, but identified one additional area that should be added to the study protocol (symptom experience).
Conclusion: Stakeholder and patient engagement validated that the intervention, methods and outcomes were important, but four changes to the protocol were recommended before study implementation.
Implications: Including the perspective of stakeholders and patients is essential to guide investigator approaches to design, methods and outcomes in pragmatic studies. Stakeholder and patient engagement has a significant role in designing implementable pragmatic studies whose results are important to clinicians and patients.