Cardiology in the Young

Original Article

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

Nancy A. Pikea1 c1, Victoria Pembertona2, Kerstin Allena3, Jeffrey P. Jacobsa4, Daphne T. Hsua5, Alan B. Lewisa6, Nancy Ghanayema7, Linda Lamberta8, Kari Crawforda9, Teresa Atza10, Rosalind Korsina11, Mingfen Xua12, Chitra Ravishankara13, James Cnotaa14 and Gail D. Pearsona2 for the Pediatric Heart Network Investigators

a1 School of Nursing, University of California Los Angeles, Los Angeles, California, United States of America

a2 National Heart, Lung, and Blood Institute/National Institute of Health, Bethesda, Maryland, United States of America

a3 New England Research Institutes, Watertown, Massachusetts, United States of America

a4 The Congenital Heart Institute of Florida, All Children's Hospital, Saint Petersburg, Florida, United States of America

a5 Division of Cardiology, The Children's Hospital at Montefiore, Bronx, New York, United States of America

a6 Division of Cardiology, Children's Hospital of Los Angeles, Los Angeles, California, United States of America

a7 Division of Critical Care, Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States of America

a8 Division of Pediatric Cardiothoracic Surgery, Primary Children's Medical Center, Salt Lake City, Utah, United States of America

a9 Division of Pediatric Cardiology, Levine Children's Hospital, Charlotte, North Caroline, United States of America

a10 Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, South Caroline, United States of America

a11 Division of Pediatric Cardiology, Columbia University, New York, New York, United States of America

a12 Division of Pediatric Cardiology, Duke University Medical Center, Durham, North Carolina, United States of America

a13 Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America

a14 Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States of America

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.

(Received August 03 2011)

(Accepted April 09 2012)

(Online publication July 05 2012)

Keywords

  • Congenital heart disease;
  • clinical trials;
  • functionally univentricular heart

Correspondence

c1 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: npike@sonnet.ucla.edu

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