Premium
Remote intervention engagement and outcomes in the Clinical Trials in Organ Transplantation in Children consortium multisite trial
Author(s) -
DuncanPark Sarah,
Dunphy Claire,
Becker Jacqueline,
D’Urso Christine,
Annunziato Rachel,
Blatter Joshua,
Conrad Carol,
Goldfarb Samuel B.,
Hayes Don,
Melicoff Ernestina,
Schecter Marc,
Visner Gary,
Armstrong Brian,
Chin Hyunsook,
Kesler Karen,
Williams Nikki M.,
Odim Jonah N.,
Sweet Stuart C.,
DanzigerIsakov Lara,
Shemesh Eyal
Publication year - 2021
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.16567
Subject(s) - medicine , psychological intervention , intervention (counseling) , clinical trial , randomized controlled trial , transplantation , physical therapy , psychiatry
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.