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Randomized Controlled Trial
. 2019 Dec;25(12):948-958.
doi: 10.1016/j.cardfail.2019.06.011. Epub 2019 Jul 2.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial

Kathleen L Grady  1 , Adin-Cristian Andrei  2 , Tamara Shankel  3 , Richard Chinnock  3 , Shelley D Miyamoto  4 , Amrut V Ambardekar  5 , Allen Anderson  6 , Linda Addonizio  7 , Farhana Latif  7 , Debra Lefkowitz  8 , Lee R Goldberg  9 , Seth A Hollander  10 , Michael Pham  10 , Kathleen Van't Hof  11 , Jill Weissberg-Benchell  12 , Clyde Yancy  6 , Menghan Liu  2 , Nichole Melody  13 , Elfriede Pahl  11
Affiliations
Randomized Controlled Trial

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial

Kathleen L Grady et al. J Card Fail. 2019 Dec.

Abstract

Background: Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care.

Methods: Participants were randomized to the transition intervention (4 months long, focused on heart-transplant knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models.

Results: Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups.

Conclusions: The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.

Keywords: Heart transplantation; Transition program.

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Figure 1:
Figure 1:
TRANSIT Consort Flow Diagram – This figure demonstrates flow of patients through the study.
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