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Remote intervention engagement and outcomes in the Clinical Trials in Organ Transplantation in Children consortium multisite trial |
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| Authors: | Sarah Duncan-Park Claire Dunphy Jacqueline Becker Christine D’Urso Rachel Annunziato Joshua Blatter Carol Conrad Samuel B Goldfarb Don Hayes Jr Ernestina Melicoff Marc Schecter Gary Visner Brian Armstrong Hyunsook Chin Karen Kesler Nikki M Williams Jonah N Odim Stuart C Sweet Lara Danziger-Isakov Eyal Shemesh |
| Institution: | 1. Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children’s Hospital, New York, New York, USA;2. Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children’s Hospital, New York, New York, USA
Department of Psychology, Fordham University, Bronx, New York, USA;3. Washington University in St. Louis, St. Louis, Missouri, USA;4. Lucille Packard Children’s Hospital, Palo Alto, California, USA;5. Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA;6. Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA;7. Texas Children's Hospital, Houston, Texas, USA;8. Boston Children's Hospital, Boston, Massachusetts, USA;9. Rho Inc, Durham, North Carolina, USA;10. National Institutes of Health, NIAID, Bethesda, Maryland, USA |
| Abstract: | Remote interventions are increasingly used in transplant medicine but have rarely been rigorously evaluated. We investigated a remote intervention targeting immunosuppressant management in pediatric lung transplant recipients. Patients were recruited from a larger multisite trial if they had a Medication Level Variability Index (MLVI) ≥2.0, indicating worrisome tacrolimus level fluctuation. The manualized intervention included three weekly phone calls and regular follow-up calls. A comparison group included patients who met enrollment criteria after the subprotocol ended. Outcomes were defined before the intent-to-treat analysis. Feasibility was defined as ≥50% of participants completing the weekly calls. MLVI was compared pre- and 180 days postenrollment and between intervention and comparison groups. Of 18 eligible patients, 15 enrolled. Seven additional patients served as the comparison. Seventy-five percent of participants completed ≥3 weekly calls; average time on protocol was 257.7 days. Average intervention group MLVI was significantly lower (indicating improved blood level stability) at 180 days postenrollment (2.9 ± 1.29) compared with pre-enrollment (4.6 ± 2.10), p = .02. At 180 days, MLVI decreased by 1.6 points in the intervention group but increased by 0.6 in the comparison group (p = .054). Participants successfully engaged in a long-term remote intervention, and their medication blood levels stabilized. NCT02266888. |
| Keywords: | clinical research/practice compliance/adherence immunosuppressant pediatrics social sciences |