A Multifaceted Intervention to Improve Medication Adherence in Kidney Transplant Recipients: An Exploratory Analysis of the Fidelity of the TAKE IT Trial

Esther S Yoon, Scott Hur, Laura M Curtis, Aiden H Wynia, Pauline Zheng, Sumi S Nair, Stacy C Bailey, Marina Serper, Peter P Reese, Daniela P Ladner, Michael S Wolf, Esther S Yoon, Scott Hur, Laura M Curtis, Aiden H Wynia, Pauline Zheng, Sumi S Nair, Stacy C Bailey, Marina Serper, Peter P Reese, Daniela P Ladner, Michael S Wolf

Abstract

Background: Inadequate adherence to prescribed immunosuppressive medication regimens among kidney transplant recipients is common, yet interventions are needed to support patients in sustaining adequate adherence to prescribed regimens and achieving optimal transplant outcomes.

Objective: We examined the preliminary fidelity of a transplant center-based, multifaceted adherence monitoring strategy known as TAKE IT.

Methods: The TAKE IT strategy includes: (1) routine, online, monthly patient self-report adherence assessments; (2) care alerts directed to nurses; (3) quarterly reports monitoring tacrolimus values and adherence trends; (4) support tools tailored to specific adherence concerns. A 2-arm, patient-randomized trial is underway at two large transplant centers (N=449). To evaluate the initial fidelity of TAKE IT, we investigated patient uptake of monthly adherence assessments during the course of a 3-month period, whether any disparities emerged, and the nature of any reported adherence concerns.

Results: Among 202 patients randomized and exposed to TAKE IT for 3-months or more, 81% (164/202) completed an adherence assessment, 73% (148/202) completed at least two, and 57% (116/202) completed all monthly assessments. Overall, 50% (82/164) of kidney transplant recipients reported at least one adherence concern over the 3-month assessment period. The most common barriers were classified as regimen-related (eg, regimen complexity), cognitive (eg, forgetfulness), and medical (eg, side effects). Higher-income participants were more likely to complete all surveys compared to lower-income participants (P=.01).

Conclusions: TAKE IT demonstrated 81% (164/202) completion of an adherence assessment, 73% (148/202) completion of at least two, and 57% (116/202) completion of all monthly assessments during this brief, initial observation period. Among those that did respond to the online assessments, the majority demonstrated sustained engagement. Additional monitoring modalities could also be offered to meet patient preferences to ensure all patients' medication use can be properly monitored.

Trial registration: ClinicalTrials.gov NCT03104868; https://ichgcp.net/clinical-trials-registry/NCT03104868.

Keywords: digital health; fidelity; kidney transplantation; medication adherence; patient portal.

Conflict of interest statement

Conflicts of Interest: SCB reports grants from the National Institutes of Health (NIH), Merck, RRF Foundation for Aging, Pfizer, Gordon, and Betty Moore Foundation, Lundbeck, and Eli Lilly and personal fees from Sanofi, Pfizer, University of Westminster, Lundbeck, and Luto UK outside the submitted work. MSW reports grants from the NIH (National Institute on Aging [NIA], National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK], National Institute of Nursing Research [NINR], National Heart, Lung, and Blood Institute [NHLBI], National Institute of Neurological Disorders and Stroke [NINDS]), Gordon and Betty Moore Foundation, and Eli Lilly, and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster, and Lundbeck. PPR receives investigator-initiated and collaborative grants from Merck, AbbVie, and Gilead to the University of Pennsylvania to support research on transplantation of HCV-infected organs into uninfected recipients, followed by antiviral treatment. PPR is also an Associate Editor for the American Journal of Kidney Diseases, consults for VALHealth (management of patients with chronic kidney disease), and provides unpaid consultation to eGenesis, a company developing xenotransplantation technology.

©Esther S Yoon, Scott Hur, Laura M Curtis, Aiden H Wynia, Pauline Zheng, Sumi S Nair, Stacy C Bailey, Marina Serper, Peter P Reese, Daniela P Ladner, Michael S Wolf. Originally published in JMIR Formative Research (https://formative.jmir.org), 05.05.2022.

Figures

Figure 1
Figure 1
Flowchart of TAKE IT adherence assessment.
Figure 2
Figure 2
Flowchart of participant completion of TAKE IT adherence assessment.

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