Pediatric Heart Transplantation: Transitioning to Adult Care TRANSIT: 1008

Purpose: Medically complex patients who transition from pediatric to adult care are at high risk for poor outcomes such as repeated hospitalizations and death. Our randomized, controlled, multicenter pilot trial tests an intervention focused on enhancing adherence to improve outcomes for heart transplant (HT) patients (pts) who transfer to adult care. We report baseline findings. Method(s): We aim to enroll 100 pts-{50 intervention (INT), 50 usual care (UC)} from six paired pediatric/adult U.S. sites over 3 years with 6 months post transfer follow-up. Our intervention uses computer-based education modules followed by individualized discussion with HT coordinators, and is delivered through 3 months post transfer. Outcomes are: (1) immunosuppression levels, (2) adherence, (3) rejection episodes, (4) use of healthcare resources (ER Visits/Admits). The intervention focuses on enhancing HT knowledge, self-care, self-advocacy and support. Assessments at baseline, 3 months and 6 months post transition include: 1. HT knowledge questionnaire, 2. Transition readiness assessment questionnaire, 3. Social support index and 4. Patient assessment of problems with the HT regimen. Groups were compared via t-tests and chi square. Result(s): To date, 77/126 screened pts (61%) are enrolled and randomized (38= INT and 39= UC). Baseline demographics were similar in both study arms: INT vs UC: mean age= 21.5+3.3 yrs vs, 21.8+3.5 yrs; female= 42% vs 46%; Caucasian= 82% vs 72%; > high school education= 55% vs 70%. Most pts in both groups were on tacrolimus based immunosuppression (68 vs 64%). There were no differences between groups at baseline: mean tacrolimus levels INT vs US (6.6+2.4 vs 5.9+3.1); overall self-report of adherence (3.6 vs 3.5 [1= hardly ever to 4= all of the time]); rejection episodes (1 vs 0); hospital re-admissions (7 vs 2; p= 11); and no differences regarding HT knowledge, self-care, self-advocacy, and social support. Potential for improvement was similar in both groups. Conclusion(s): Our pilot trial randomization scheme was effective. There were no significant differences between INT and UC groups for demographics, medical or psychosocial outcomes. Future analyses will inform whether our intervention improves outcomes early after transfer to adult care.