Development and Impact of an Intervention to Boost Recruitment in a Multicenter Pediatric Randomized Clinical Trial. (February 2014)

• Record Type: Journal Article
• Authors: Bhatnagar, Sonika; Hoberman, Alejandro; Kearney, Diana H.; Shaikh, Nader; Moxey-Mims, Marva M.; Chesney, Russell W.; Carpenter, Myra A.; Greenfield, Saul P.; Keren, Ron; Mattoo, Tej K.; Mathews, Ranjiv; Gravens-Mueller, Lisa; Ivanova, Anastasia
• Is Part Of: Clinical pediatrics. Volume 53:Number 2(2014)
• Page Start: 151
• Page End: 157
• Publication Date: 2014-02
• Subjects: recruitment -- intervention -- clinical trial; Pediatrics -- Periodicals; 618.920005
• DOI: 10.1177/0009922813506961
• Languages: English
• ISSNs: 0009-9228

Abstract

Objectives . Our primary objective was to develop and evaluate an intervention to increase recruitment in a multicenter pediatric randomized clinical trial (RCT). Our secondary objective was to assess the impact beyond 120 days. Methods . The study was conducted at 17 academic centers participating in a pediatric RCT. The intervention consisted of utilizing a recruitment assessment tool at a site visit or teleconference with key site personnel. Results . We found a significant increase in the number of individuals enrolled for all 17 sites at 120 days postintervention (mean = 1.12 per site; median = 1 per site; 95% confidence interval = 1-2; P = .04). No significant differences were apparent beyond the first 120 days postintervention. Conclusions . Successful recruitment in RCTs is essential to the quality, generalizability, and cost-effectiveness of clinical research. Implementation of this recruitment intervention may effectively increase recruitment in RCTs. Beyond the first 120 days postintervention, repeated interventions may be required. What is new ? Despite general and pediatric-specific challenges to recruitment in RCTs, a paucity of evidence exists on effective recruitment strategies or assessment tools to reliably enhance recruitment. We developed a recruitment intervention for use in RCTs that enables clinical researchers to enhance recruitment.