Abstract
BackgroundThe 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.MethodsThe 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.DiscussionMany 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 registrationClinicalTrials.gov ID NCT01723332
Highlights
The population of adolescents and young adults with congenital heart disease (CHD) is growing exponentially
The rapidly growing population of adolescent and young adult survivors of CHD is at risk of late cardiac and non-cardiac morbidity and premature mortality
Few pediatric cardiology programs facilitate the transition of adolescents in their care [30], and many adolescents and young adults experience a gap in care [7, 8, 31] predisposing them to late cardiac complications [9]
Summary
Study design The CHAPTER 2 Study is a two-center cluster randomized controlled trial of a nurse-led transition intervention versus usual care (see “usual care” section below). With multiple pediatric cardiologists and clinic nurses at each site, clinician-led education is likely variable and constrained by limited clinic time At both sites, pertinent medical records are sent to ACHD providers at the time of transfer. Group allocation Participants will be randomized by clusters defined by week of attendance in the pediatric cardiology clinic. Clinical outcomes will be adjudicated by observers who are blind to group allocation (see Secondary outcomes #4 below) Participants in both groups will be unaware of the primary outcome (excess time to attendance at first ACHD appointment) and this outcome cannot be consciously influenced, though participants will be aware that the study will track information from the cardiology chart, including the first ACHD clinic visit. The “recommended time” interval will be the interval suggested by the cardiologist
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