Application of behavioral economic strategies to enhance recruitment into a pediatric randomized clinical trial for postoperative pain relief: A randomized clinical trial.

Introduction: A major challenge in conducting clinical trials is recruitment. Trial under-enrollment leads to underpowered studies. Behavioral economics offers strategies that may enhance trial recruitment. This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial assessing a biofeedback-based virtual reality intervention for postoperative pain management. We hypothesized the behavioral economics-informed approach would increase enrollment into the future trial, intention to adhere to therapy, acceptability of the intervention, and perceived efficacy while decreasing perception of treatment burden and risk.

Methods: This single-center, prospective, randomized trial recruited patients 12-18 years old undergoing surgery requiring postoperative admission and narcotic administration. Patient-parent dyads were randomized to watch a behavioral economics-informed (n = 64) or standard biological (n = 66) recruitment video about a study designed to assess impact of a virtual reality pain management intervention.

Results: There was no difference in rates of intention to enroll in the study between groups (behavioral economics: 75%, control: 79%, p = 0.744) or in median response scores to questions regarding intention to adhere to therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.084), acceptability of therapy (4.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p = 0.376), perceptions of treatment burden (3.0 [3.0, 4.0] vs. 4.0 [3.0, 4.0], p=0.251), and efficacy (3.0 [3.0, 4.0] vs. 3.0 [3.0, 4.0], p = 0.914). Patients in the behavioral economics group were less likely to perceive risk associated with virtual reality versus the control group (behavioral economics: 2.0 [1.0, 2.0], control: 2.0 [2.0, 3.0], p = 0.023).

Discussion: A behavioral economics-informed video did not increase patients' intentions to enroll into a clinical trial assessing the impact of virtual reality intervention for postoperative pain management.

Conclusion: Either approach would be sufficient for patient recruitment for this type of clinical trial since the overall intention to enroll rate was 77%.