Kathleen L Grady1, Adin-Cristian Andrei2, Tamara Shankel3, Richard Chinnock3, Shelley D Miyamoto4, Amrut V Ambardekar5, Allen Anderson6, Linda Addonizio7, Farhana Latif7, Debra Lefkowitz8, Lee R Goldberg9, Seth A Hollander10, Michael Pham10, Kathleen Van't Hof11, Jill Weissberg-Benchell12, Clyde Yancy6, Menghan Liu2, Nichole Melody13, Elfriede Pahl11. 1. Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: kgrady@nm.org. 2. Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL. 3. Department of Medicine, Loma Linda University Children's Hospital, Loma Linda, CA. 4. Department of Medicine, Children's Hospital Colorado, Aurora, CO. 5. Department of Medicine, University of Colorado, Aurora, CO. 6. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL. 7. Department of Medicine, Columbia University Medical Center, New York, NY. 8. Department of Psychiatry, The Children's Hospital of Philadelphia, Philadelphia, PA. 9. Department of Medicine, University of Pennsylvania, Philadelphia, PA. 10. Department of Medicine, Stanford University, Palo Alto, CA. 11. Department of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL. 12. Department of Psychiatry, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL. 13. Pharmacy Department, Northwestern Memorial Hospital, Chicago, IL.
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.
RCT Entities:
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.
Authors: Mary E McBride; Margaret T Foushee; Robert N Brown; Gregory A Ewald; Charles E Canter Journal: J Heart Lung Transplant Date: 2010-07-08 Impact factor: 10.247