Remote intervention engagement and outcomes in the Clinical Trials in Organ Transplantation in Children consortium multisite trial

Autor: Christine D’Urso, Samuel B. Goldfarb, Don Hayes, Hyunsook Chin, Rachel A. Annunziato, Carol Conrad, E. Melicoff-Portillo, Jacqueline H. Becker, Eyal Shemesh, Jonah Odim, Karen Kesler, Sarah Duncan-Park, Lara Danziger-Isakov, Stuart C. Sweet, Gary A. Visner, Brian Armstrong, Joshua Blatter, Claire Dunphy, N. Williams, Marc G. Schecter
Rok vydání: 2021
Předmět:
Zdroj: Am J Transplant
ISSN: 1600-6135
DOI: 10.1111/ajt.16567
Popis: Remote interventions are increasingly utilized 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 3 weekly phone calls and regular follow-up calls. A comparison group included patients who met enrollment criteria after the sub-protocol 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 post-enrollment 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 post-enrollment (2.9 ± 1.29) compared to pre-enrollment (4.6 ± 2.10), p=0.02. At 180 days, MLVI decreased by 1.6 points in the intervention group, but increased by 0.6 in the comparison group (p=0.054). Participants successfully engaged in a long-term remote intervention, and their medication blood levels stabilized. NCT02266888.
Databáze: OpenAIRE