Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients.

Marina Serper, Daniela P Ladner, Laura M Curtis, Sumi S Nair, Scott I Hur, Mary J Kwasny, Bing Ho, John Friedewald, Peter P Reese, Michael M I Abecassis, Michael S Wolf

Journal: Contemporary clinical trials 2021;103():106294

PMID: 33515781

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Abstract

BACKGROUND

Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence.

METHODS

The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined.

CONCLUSION

The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.

Address: Division of Gastroenterology, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: [email protected].; Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Department of Surgery, Northwestern Medicine, Chicago, IL, United States of America.; Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.; Mayo Clinic Arizona Transplant Center, Mayo Clinic, Phoenix, AZ, United States of America.; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America.; Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Division of Nephrology/Hypertension Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America; Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Renal-Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America.; Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.

DOI: 10.1016/j.cct.2021.106294

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MeSH Terms: Humans, Information Technology, Kidney, Kidney Transplantation, Medication Adherence, Randomized Controlled Trials as Topic, Research Design, Transplant Recipients