Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol

Abstract

IntroductionNon-adherence after kidney transplantation contributes to increased rejections, hospitalisations and healthcare expenditures. Although effective adherence interventions are sorely needed, increasing education and support to transplant recipients demands greater use of care providers’ time and resources in a healthcare system that is stretched. The objective of this clinical trial is to determine the effectiveness of an electronically delivered video series and adherence behaviour contract on improving medication adherence to immunosuppressant medications.Methods and analysisA multicentre, parallel arm, randomised controlled trial will be conducted with four sites across North America (Saskatoon, Calgary, Halifax, Chicago). Adult patients will be randomised (1:1) to either the intervention (ie, home-based video education +behaviour contract plus usual care) or usual care alone. De novo transplant recipients will be enrolled prior to their hospital discharge and will be provided with electronic access to the video intervention (immediately) and adherence contract (1 month post-transplant). Follow-up electronic surveys will be provided at 3 and 12 months postenrolment. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report Basel Assessment of Adherence to Immunosuppressive medications and immunosuppressant levels. Secondary outcomes include the difference in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalised Self-efficacy Scale), Beliefs of Medicine Questionnaire (BMQ), quality of life (Short Form-12), patient satisfaction and cost utilisation. The study aims to recruit at least 200 participants across participating sites.Ethics and disseminationEthical approval was obtained from the University of Saskatchewan Behavioural Ethics Committee (Beh 18–63), and all patients provide informed consent prior to participating. This educational intervention aims to improve information retention and self-efficacy, leading to improved medication adherence after kidney transplantation, at low cost, with little impact to existing healthcare personnel. If proven beneficial, delivery can be easily implemented into standard of care.Trial registration numberNCT03540121; Pre-results.

Pragmatic solutions to enhance self-management skills in solid organ transplant patients: systematic review and thematic analysis

“…Two studies created educational animation programs to improve self-management behaviors in kidney transplant patients in two different formats [48,49]. Video-based programs were developed in two studies to improve medication adherence and symptom management in renal transplantation [50,51]. In the other three studies, face-to-face educational sessions, telephone-based consultations, and educational booklets were used to educate transplant patients and improve patient knowledge regarding organ transplantation [52][53][54].…”

Pretransplant Patient Education in Solid-organ Transplant: A Narrative Review

“…Transplant education may improve access to transplant and adherence to antirejection medication. 9,[23][24][25][26][27][28] Transplant programs routinely offer education during the evaluation phase. This may consist of some combination of printed and online text, videos, group sessions, and the opportunity to speak one-on-one with an educator but the format, content, and amount of education varies substantially.…”

“…Transplant pharmacists are involved in evaluating transplant recipient candidates. 7,28,121,122 A retrospective observational study found that including pharmacists as transplant educators reduced the average length of hospital stay after transplant for KT recipients and improved medication reconciliation. 123 Currently, pharmacists are mainly involved during the posttransplant phase.…”

From Nonadherence to Adherence

“…Recent years have seen an ultrafast growth of smart technology in medicine including remote monitoring of health indicators, wearables, interactive educational and assistance platforms, video consulting, interactive voice response system (IVRS) and mobile health (mHealth) devices. [49][50][51][52] Recent studies in kidney and lung transplantation have accomplished variable success rates. [53][54][55] It is important to evaluate these novel technological applications not on a level of hardware performance (which is an implicated prerequisite), but firstly on their value for improving: medication adherence and adherence in general, a healthy life style and support of patients to achieve better self-management and self-care agency.…”