Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial.

TitleDevelopment and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial.
Publication TypeJournal Article
Year of Publication2014
AuthorsBhatnagar S, Hoberman A, Kearney DH, Shaikh N, Moxey-Mims M, Chesney RW, Carpenter MA, Greenfield SP, Keren R, Mattoo TK, Mathews, iv R, Gravens-Mueller L, Ivanova A
JournalClin Pediatr (Phila)
Volume53
Issue2
Pagination151-7
Date Published2014 Feb
ISSN1938-2707
KeywordsChild, Humans, Multicenter Studies as Topic, Patient Selection, Pediatrics, Program Development, Program Evaluation, Randomized Controlled Trials as Topic
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.

DOI10.1177/0009922813506961
Alternate JournalClin Pediatr (Phila)
PubMed ID24151147
PubMed Central IDPMC4086359
Grant ListU01 DK074053 / DK / NIDDK NIH HHS / United States
U01 DK074059 / DK / NIDDK NIH HHS / United States
U01 DK074059 / DK / NIDDK NIH HHS / United States
U01 DK074062 / DK / NIDDK NIH HHS / United States
U01 DK074063 / DK / NIDDK NIH HHS / United States
U01 DK074064 / DK / NIDDK NIH HHS / United States
U01 DK074082 / DK / NIDDK NIH HHS / United States
UL1 TR000005 / TR / NCATS NIH HHS / United States
UL1TR000003 / TR / NCATS NIH HHS / United States