Objective: To describe the challenges of conducting a large randomized controlled trial (RCT) to assess the effectiveness of an intervention to prevent recurrent pressure ulcers among a high-risk population of subjects with spinal cord injury (SCI).
Design: Prospective multisite, randomized design comparing outcomes of patients who received individualized education and structured telephone counseling follow-up with those of patients receiving customary care. This study was stopped early because of unanticipated recruitment problems.
Setting: Six Veterans Affairs SCI specialty centers.
Participants: Veterans (N=150) treated for stage III or IV pelvic pressure ulcers.
Interventions: Not applicable.
Main outcome measure: Recurrence (defined as new skin breakdown in the pelvic area) and time to recurrence. The study was stopped early because of slow recruitment, so the focus of this study is lessons learned, not the main planned outcome measures.
Results: Subject recruitment did not meet original expectations because almost 50% of those enrolled left the hospital with the study ulcer unhealed (having a healed ulcer was a requirement for participation). No significant differences were observed between groups on rate of or time to recurrence at the time the study was stopped. Among the 6 sites, variability in ulcer management (eg, length of stay, receipt of medical vs surgical treatment, sitting tolerance before discharge) and time to recurrence (median, 4mo) were observed.
Conclusions: RCTs in real-world settings are the most robust method of assessing the effectiveness of prevention strategies. However, in complex, rapidly changing health care organizations, blinding is infeasible, it may be impractical to control for every variable that influences a study's outcome, and any assumptions that usual care is static are probably mistaken. Investigators must be prepared to use innovative approaches to maintain the integrity of the study design, including flexibility in inclusion and exclusion criteria to support accrual, obtaining a better understanding of the important aspects of usual care that may need to be standardized, continuous improvement within the intervention arm, and anticipation and minimization of risks from organizational changes. With attention to these delivery system issues and the usual design features of randomized trials, we believe real-world care settings can serve as important laboratories to test pressure ulcer prevention strategies in this population.