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Challenges and successes of recruitment in the “angiotensin-converting enzyme inhibition in infants with single ventricle trial” of the Pediatric Heart Network

Part of: Pediatric Heart Network

Published online by Cambridge University Press:  05 July 2012

Nancy A. Pike ,
Victoria Pemberton ,
Kerstin Allen ,
Jeffrey P. Jacobs ,
Daphne T. Hsu ,
Alan B. Lewis ,
Nancy Ghanayem ,
Linda Lambert ,
Kari Crawford  and
Teresa Atz
...Show all authors
Nancy A. Pike*
Affiliation:
School of Nursing, University of California Los Angeles, Los Angeles, California, United States of America
Victoria Pemberton
Affiliation:
National Heart, Lung, and Blood Institute/National Institute of Health, Bethesda, Maryland, United States of America
Kerstin Allen
Affiliation:
New England Research Institutes, Watertown, Massachusetts, United States of America
Jeffrey P. Jacobs
Affiliation:
The Congenital Heart Institute of Florida, All Children's Hospital, Saint Petersburg, Florida, United States of America
Daphne T. Hsu
Affiliation:
Division of Cardiology, The Children's Hospital at Montefiore, Bronx, New York, United States of America
Alan B. Lewis
Affiliation:
Division of Cardiology, Children's Hospital of Los Angeles, Los Angeles, California, United States of America
Nancy Ghanayem
Affiliation:
Division of Critical Care, Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States of America
Linda Lambert
Affiliation:
Division of Pediatric Cardiothoracic Surgery, Primary Children's Medical Center, Salt Lake City, Utah, United States of America
Kari Crawford
Affiliation:
Division of Pediatric Cardiology, Levine Children's Hospital, Charlotte, North Caroline, United States of America
Teresa Atz
Affiliation:
Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, South Caroline, United States of America
Rosalind Korsin
Affiliation:
Division of Pediatric Cardiology, Columbia University, New York, New York, United States of America
Mingfen Xu
Affiliation:
Division of Pediatric Cardiology, Duke University Medical Center, Durham, North Carolina, United States of America
Chitra Ravishankar
Affiliation:
Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America
James Cnota
Affiliation:
Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States of America
Gail D. Pearson
Affiliation:
National Heart, Lung, and Blood Institute/National Institute of Health, Bethesda, Maryland, United States of America
*
Correspondence to: Dr N. Pike, PhD, RN, UCLA School of Nursing, 700 Tiverton Avenue, Factor Building Room no. 3-938, Los Angeles, California 90095, United States of America. Tel: 310 206 3683; Fax: 310 267 0413; E-mail: [email protected]
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Abstract

Objectives

Identify trends of enrolment and key challenges when recruiting infants with complex cardiac diseases into a multi-centre, randomised, placebo-controlled drug trial and assess the impact of efforts to share successful strategies on enrolment of subjects.

Methods

Rates of screening, eligibility, consent, and randomisation were determined for three consecutive periods of time. Sites collectively addressed barriers to recruitment and shared successful strategies resulting in the Inventory of Best Recruiting Practices. Study teams detailed institutional practices of recruitment in post-trial surveys that were compared with strategies of enrolment initially proposed in the Inventory.

Results

The number of screened patients increased by 30% between the Initial Period and the Intermediate Period (p = 0.007), whereas eligibility decreased slightly by 7%. Of those eligible for entry into the study, the rate of consent increased by 42% (p = 0.025) and randomisation increased by 71% (p = 0.10). During the Final Period, after launch of a competing trial, fewer patients were screened (−14%, p = 0.06), consented (−19%, p = 0.12), and randomised (−34%, p = 0.012). Practices of recruitment in the post-trial survey closely mirrored those in the Inventory.

Conclusions

Early identification and sharing of best strategies of recruitment among all recruiting sites can be effective in increasing recruitment of critically ill infants with congenital cardiac disease and possibly other populations. Strategies of recruitment should focus on those that build relationships with families and create partnerships with the medical providers who care for them. Competing studies pose challenges for enrolment in trials, but fostering trusting relationships with families can result in successful enrolment into multiple studies.

Keywords

Congenital heart diseaseclinical trialsfunctionally univentricular heart
Type
Original Article
Information
Cardiology in the Young , Volume 23 , Issue 2 , April 2013 , pp. 248 - 257
Copyright
Copyright © Cambridge University Press 2012 

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