Background: Poor transitions adversely affect stroke survivors and contribute to readmissions and poor quality of life. More randomized trials are needed to identify effective interventions to improve patient wellbeing during the transitional period. However, the post-discharge period is complex and presents many practical challenges for transition trials when patients move between different care settings. We report on recruitment and retention challenges in the Michigan Stroke Transitions Trial (MISTT) designed to improve the transition experience of stroke survivors.
Methods: MISTT, a 3 group pragmatic randomized trial, tested the efficacy of an in-home social work case management (SWCM) program and SWCM with an informational website against usual care. Eligible subjects were acute stroke patients discharged directly home or who had an expected rehab stay <4 weeks. Randomization occurred the day subjects were discharged home. Patient-centered outcomes were collected by phone 90-days later.
Results: Figure 1 shows recruitment and retention data during the first 15 months. Of 242 subjects enrolled, 40 (17%) were dropped pre-randomization largely due to extended rehab stays. Of 136 subjects randomized to SWCM or SWCM+website, the intervention was not started in 14 (10%) due to early withdrawals or unwillingness to participate. A total of 188 subjects were eligible for 90 day follow-up. Lost to follow-up (n=43) occurred in 20%, 24% and 21% of the usual care, SWCM, and SWCM+Website groups, respectively. Half of the LTFU was due to patient withdrawals (n=23); reasons included study demands (n=9), protocol deviations (n=6), and deteriorating health conditions (n=5).
Conclusion: The complexity of stroke transitions creates challenges for recruiting and retaining study participants in transition trials. These issues are important to consider in future study design and are relevant to understanding the validity of study results.