A cluster randomized trial of a transition intervention for adolescents with congenital heart disease

Rationale and design of the CHAPTER 2 study

Andrew S. Mackie, Gwen R. Rempel, Adrienne Kovacs, Miriam Kaufman, Kathryn N. Rankin, Ahlexxi Jelen, Cedric Manlhiot, Samantha J. Anthony, Joyce Magill-Evans, David Nicholas, Renee Sananes, Erwin Oechslin, Dimi Dragieva, Sonila Mustafa, Elina Williams, Michelle Schuh, Brian W. McCrindle

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background: The population of adolescents and young adults with congenital heart disease (CHD) is growing exponentially. These survivors are at risk of late cardiac complications and require lifelong cardiology care. However, there is a paucity of data on how to prepare adolescents to assume responsibility for their health and function within the adult health care system. Evidence-based transition strategies are required. Methods: The Congenital Heart Adolescents Participating in Transition Evaluation Research (CHAPTER 2) Study is a two-site cluster randomized clinical trial designed to evaluate the efficacy of a nurse-led transition intervention for 16-17 year olds with moderate or complex CHD. The primary endpoint is excess time to adult CHD care, defined as the time interval between the final pediatric cardiology appointment and the first adult CHD appointment, minus the recommended time interval between these appointments. Secondary endpoints include the MyHeart score (CHD knowledge), Transition Readiness Assessment Questionnaire score, and need for catheter or surgical re-intervention. Participants are enrolled in clusters based on week of attendance in the pediatric cardiology clinic. The intervention consists of two one-hour individualized sessions between a cardiology nurse and study participant. Session One focuses on knowledge of the participant's CHD, review of their cardiac anatomy and prior interventions, and potential late cardiac complications. Session Two focuses on self-management and communication skills through review and discussion of videos and role-play. The study will recruit 120 participants. Discussion: Many adolescents and young adults experience a gap in care predisposing them to late cardiac complications. The CHAPTER 2 Study will investigate the impact of a nurse-led transition intervention among adolescents with CHD. Fidelity of the intervention is a major focus and priority. This study will build on our experience by (i) enrolling at two tertiary care programs, (ii) including a self-management intervention component, and (iii) evaluating the impact of the intervention on time to ACHD care, a clinically relevant outcome. The results of this study will inform pediatric cardiology programs, patients and policy makers in judging whether a structured intervention program provides clinically meaningful outcomes for adolescents and young adults living with CHD. Trial registration: ClinicalTrials.gov ID NCT01723332.

Original languageEnglish (US)
Article number127
JournalBMC Cardiovascular Disorders
Volume16
Issue number1
DOIs
StatePublished - Jan 1 2016
Externally publishedYes

Fingerprint

Heart Diseases
Cardiology
Young Adult
Appointments and Schedules
Nurses
Pediatrics
Self Care
Tertiary Healthcare
Administrative Personnel
Anatomy
Catheters
Randomized Controlled Trials
Communication
Delivery of Health Care
Health
Population

Keywords

  • Adolescents
  • Clinical trial
  • Congenital heart disease
  • Continuity of care
  • Education
  • Transition

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

A cluster randomized trial of a transition intervention for adolescents with congenital heart disease : Rationale and design of the CHAPTER 2 study. / Mackie, Andrew S.; Rempel, Gwen R.; Kovacs, Adrienne; Kaufman, Miriam; Rankin, Kathryn N.; Jelen, Ahlexxi; Manlhiot, Cedric; Anthony, Samantha J.; Magill-Evans, Joyce; Nicholas, David; Sananes, Renee; Oechslin, Erwin; Dragieva, Dimi; Mustafa, Sonila; Williams, Elina; Schuh, Michelle; McCrindle, Brian W.

In: BMC Cardiovascular Disorders, Vol. 16, No. 1, 127, 01.01.2016.

Research output: Contribution to journalArticle

Mackie, AS, Rempel, GR, Kovacs, A, Kaufman, M, Rankin, KN, Jelen, A, Manlhiot, C, Anthony, SJ, Magill-Evans, J, Nicholas, D, Sananes, R, Oechslin, E, Dragieva, D, Mustafa, S, Williams, E, Schuh, M & McCrindle, BW 2016, 'A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: Rationale and design of the CHAPTER 2 study', BMC Cardiovascular Disorders, vol. 16, no. 1, 127. https://doi.org/10.1186/s12872-016-0307-2
Mackie, Andrew S. ; Rempel, Gwen R. ; Kovacs, Adrienne ; Kaufman, Miriam ; Rankin, Kathryn N. ; Jelen, Ahlexxi ; Manlhiot, Cedric ; Anthony, Samantha J. ; Magill-Evans, Joyce ; Nicholas, David ; Sananes, Renee ; Oechslin, Erwin ; Dragieva, Dimi ; Mustafa, Sonila ; Williams, Elina ; Schuh, Michelle ; McCrindle, Brian W. / A cluster randomized trial of a transition intervention for adolescents with congenital heart disease : Rationale and design of the CHAPTER 2 study. In: BMC Cardiovascular Disorders. 2016 ; Vol. 16, No. 1.
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