Why Do Patients Decline Heart Failure Trials, and What Should We Do About It?

Background: Low patient enrollment in randomized clinical trials (RCTs) escalates costs, leads to under-representation of real-world patient populations, and delays generation of knowledge. Limited data exists on why patients decline participation in RCTs and what factors may lead to increased participation rates. Methods: In-person and telephone interviews were conducted with 19 patients with congestive heart failure who declined participation in RCTs. Interviews were conducted using a structured interview guide. Interviews were transcribed verbatim, and qualitative descriptive analysis was performed. Results: Participants’ median age was 63 years (IQR 51.5-69), 42% were female, and 53% were Black or African-American. Only 6 participants could accurately describe the intervention and clearly understood design of the trial in which they were asked to participate. Most participants made the decision not to participate quickly; only 1 participant took time to deliberate. The most common reasons for not participating were concern for adverse events from the intervention being studied (n=15) and perception of participation being too burdensome (n=10). The most common suggestion provided to increase participant recruitment was involving primary care physicians or cardiologists known to the patients. Conclusion: These findings suggest that patients often decide not to participate in clinical trials quickly, with relatively minimal understanding of the trial. Reasons for declining were heterogeneous, but the most common suggestions for improvement were engaging physicians known to them in the process of recruitment and making participation less burdensome. Addressing these issues may reduce barriers to participation and enhance respect for patients.