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

Sarah Duncan-Park, Claire Dunphy, Jacqueline Becker, Christine D’Urso, Rachel Annunziato, Joshua Blatter, Carol Conrad, Samuel B. Goldfarb, Don Hayes, 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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
JournalAmerican Journal of Transplantation
DOIs
StateAccepted/In press - 2021
Externally publishedYes

Bibliographical note

Funding Information:
This research was performed as a project of the Clinical Trials in Organ Transplantation in Children, a collaborative clinical research project headquartered at the National Institute of Allergy and Infectious Diseases. The work was supported by grant U01AI077810 “B Cell Targeted Induction to Improve Outcomes in Pediatric Lung Transplantation” (PI: Lara Danziger‐Isakov and Stuart Sweet) and UM2AI117870 (Rho) from the Division of Allergy, Immunology and Transplantation of the National Institutes of Health, NIDDK award R01DK080740 (PI: Eyal Shemesh), and NICHD award F31HD096946 (PI: Sarah Duncan‐Park).

Publisher Copyright:
© 2021 The American Society of Transplantation and the American Society of Transplant Surgeons

Keywords

  • clinical research/practice
  • compliance/adherence
  • immunosuppressant
  • pediatrics
  • social sciences

PubMed: MeSH publication types

  • Journal Article

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