TAKE IT
Title:
Transplant regimen Adherence in Kidney recipients by Engaging Information Technologies: The TAKE IT Trial
Dates:
April 2017 - March 2021
Funding Source:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Grant Number:
R01DK110172
Background:
Poor adherence to prescribed medication costs the U.S. healthcare system an estimated $300 billion annually due to increased health services use resulting from less effective treatment or adverse events. In the context of kidney transplantation, this problem affects 1 in 3 kidney recipients, jeopardizing their transplant and overall health. Interventions are urgently needed to help kidney transplant recipients adhere to complex medication regimens, while aiding health systems in routinely monitoring these patients to respond earlier to potential problems.
Abstract:
We will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant (KT) recipients demonstrating inadequate adherence. Medication non-adherence is a leading root cause of graft failure, and KT recipients have the highest reported rate of poor adherence (~35%) among all organ transplant recipients. Despite many attempts, there have been few successful interventions evaluated to date that have significantly improved KT recipients' regimen adherence and subsequent health outcomes over time. Using evidence from our research team's extensive previous studies in other chronic disease contexts, we will implement and comprehensively test a low cost, `low touch', thus highly scalable intervention: the Transplant regimen Adherence for Kidney recipients by Engaging Information Technologies (TAKE IT) strategy. The TAKE IT strategy leverages a transplant center's electronic health record a web-based patient portal, and mobile technology to: 1) educate patients on their prescribed Rx regimens, 2) help them organize their daily regimen schedule in the most efficient manner, 3) remind them via SMS text when to take their medicine, 4) routinely monitor regimen use, and 5) provide care alerts to engage appropriate transplant center clinical staff (e.g. pharmacist, social worker, nurse care coordinator) when medication concerns are detected. All components of the TAKE IT strategy have been developed with prior NIH support, refined with `user' input (patient, family, clinic staff), and their efficacy tested in non-transplant settings. Our primary aim is to: 1) test the effectiveness of the TAKE IT strategy, compared to usual care, to improve KT recipients' treatment knowledge, medication use, transplant-specific and chronic disease outcomes. Our secondary aims are to: 2) examine the persistence of any effects of the TAKE IT strategy on outcomes over 2 years among new and established KT recipients, 3) evaluate the fidelity of each component of the TAKE IT strategy over time, and investigate any patient, provider, or transplant center barriers to implementation, and 4) determine the costs of delivering the TAKE IT strategy from a transplant center perspective. We will conduct a 2-arm, patient- randomized controlled trial at two large, diverse transplant centers (Northwestern University; Mayo Clinic). 300 KT recipients within 3 months of transplant (`de novo') and 400 `established' patients between 18 and 36 months post-KT will be recruited and followed for 2 years. In-person interviews will be conducted at baseline, 6, 12, 18 and 24 months. Electronic health and pharmacy records will be ascertained to capture medication adherence and clinical outcomes. Additionally, our team will closely evaluate the implementation of all components of the TAKE IT strategy from launch through 2 years follow-up. We will further inform future dissemination efforts by estimating the incremental costs of implementing and sustaining the TAKE IT strategy from the perspective of two transplant centers.
ClinicalTrials.gov identifier:
Contact:
• Principal Investigators: Michael S. Wolf, PhD MPH; Daniela Ladner, MD MPH
• Project Lead: Pauline Zheng