Pragmatic and Adaptive Approaches Accelerate Recruitment of Adolescents in Asthma Intervention Trial (Puff City in the Clinic)

Background/Aims: Recruitment of patients for randomized clinical trials (RCT) remains a challenge for investigators. “Puff City in the Clinic” is multisite, open-label, randomized Phase II/III trial designed to evaluate a clinic-based asthma management intervention targeting urban youth. Pragmatic and adaptive approaches were used to accelerate recruitment for this RCT. Methods: Using our electronic medical record (EMR), study eligibility criteria were applied to our patient population in order to establish a pool of potentially eligible patients and the clinics in which they were being seen. Clinical sites seeing the bulk of patients were identified, recruited, initiated and trained. Potentially eligible patients are identified through our automated appointment scheduling process and approached for enrollment at a scheduled visit. Enrollment goals were 250 patients in Phase II and 500 for total Phase II/III enrollment. Enrollment began in the second quarter of 2013. Using only onsite clinic staff to conduct recruitment, study enrollment was below target after 12 months of recruitment (57%; 63 patients). To improve recruitment, several strategies were implemented. Recruitment reports by clinic were generated weekly to note successes as well as missed opportunities. We made use of the automated scheduling system to better identify patients with same-day appointments. We deployed research staff to compensate for staff shortages at the clinical site. Per-patient payment and responding to feedback from the clinical site helped to maintain site engagement. Results: Enrollment rates have increased after implementation of these strategies, with 110 patients recruited in just 9 months (total to date: 106%; 173). Real-time monitoring of patient recruitment allowed us to optimize recruitment strategies as needed, including use of the scheduling system and EMR. Key in improving recruitment is clinical site engagement, resource provision and flexible staff support. Discussion: Onsite recruitment of patients during routine clinical care has been feasible for the RCT of an asthma intervention. Integration of the automated scheduling system allowed the identification of missed opportunities and the need for more resources. Together, these strategies have increased patient recruitment rates.