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

Nancy A. Pike, Victoria Pemberton, Kerstin Allen, Jeffrey P. Jacobs, Daphne T. Hsu, Alan B. Lewis, Nancy Ghanayem, Linda Lambert, Kari Crawford, Teresa Atz, Rosalind Korsin, Mingfen Xu, Chitra Ravishankar, James Cnota, Gail D. Pearson

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)248-257
Number of pages10
JournalCardiology in the Young
Volume23
Issue number2
DOIs
StatePublished - Jan 2013
Externally publishedYes

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Peptidyl-Dipeptidase A
Pediatrics
Random Allocation
Equipment and Supplies
Heart Diseases
Institutional Practice
Foster Home Care
Practice Guidelines
Critical Illness
Placebos
Pharmaceutical Preparations
Population
Surveys and Questionnaires

Keywords

  • Clinical trials
  • Congenital heart disease
  • Functionally univentricular heart

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pediatrics, Perinatology, and Child Health

Cite this

Challenges and successes of recruitment in the angiotensin-converting enzyme inhibition in infants with single ventricle trial of the Pediatric Heart Network. / Pike, Nancy A.; Pemberton, Victoria; Allen, Kerstin; Jacobs, Jeffrey P.; Hsu, Daphne T.; Lewis, Alan B.; Ghanayem, Nancy; Lambert, Linda; Crawford, Kari; Atz, Teresa; Korsin, Rosalind; Xu, Mingfen; Ravishankar, Chitra; Cnota, James; Pearson, Gail D.

In: Cardiology in the Young, Vol. 23, No. 2, 01.2013, p. 248-257.

Research output: Contribution to journalArticle

Pike, NA, Pemberton, V, Allen, K, Jacobs, JP, Hsu, DT, Lewis, AB, Ghanayem, N, Lambert, L, Crawford, K, Atz, T, Korsin, R, Xu, M, Ravishankar, C, Cnota, J & Pearson, GD 2013, 'Challenges and successes of recruitment in the angiotensin-converting enzyme inhibition in infants with single ventricle trial of the Pediatric Heart Network', Cardiology in the Young, vol. 23, no. 2, pp. 248-257. https://doi.org/10.1017/S1047951112000832
Pike, Nancy A. ; Pemberton, Victoria ; Allen, Kerstin ; Jacobs, Jeffrey P. ; Hsu, Daphne T. ; Lewis, Alan B. ; Ghanayem, Nancy ; Lambert, Linda ; Crawford, Kari ; Atz, Teresa ; Korsin, Rosalind ; Xu, Mingfen ; Ravishankar, Chitra ; Cnota, James ; Pearson, Gail D. / Challenges and successes of recruitment in the angiotensin-converting enzyme inhibition in infants with single ventricle trial of the Pediatric Heart Network. In: Cardiology in the Young. 2013 ; Vol. 23, No. 2. pp. 248-257.
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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.",
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AU - Jacobs, Jeffrey P.

AU - Hsu, Daphne T.

AU - Lewis, Alan B.

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AU - Lambert, Linda

AU - Crawford, Kari

AU - Atz, Teresa

AU - Korsin, Rosalind

AU - Xu, Mingfen

AU - Ravishankar, Chitra

AU - Cnota, James

AU - Pearson, Gail D.

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N2 - 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.

AB - 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.

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