Building research initiative group: chronic illness management and adherence in transplantation (BRIGHT) study: study protocol

Abstract

Aim: This article describes the rationale, design and methodology of the Building research initiative group: chronic illness management and adherence in transplantation (BRIGHT) study. This study of heart transplant patients will: (1) describe practice patterns relating to chronic illness management; (2) assess prevalence and variability of non-adherence to the treatment regimen; (3) determine the multi-level factors related to immunosuppressive medication non-adherence.

Background: The unaltered long-term prognosis after heart transplantation underscores an urgent need to identify and improve factors related to survival outcomes. The healthcare system (e.g. level of chronic illness management implemented) and patient self-management are major drivers of outcome improvement.

Design: The study uses a survey design in 40 heart transplant centres covering 11 countries in four continents.

Methods: Theoretical frameworks informed variable selection, which are measured by established and investigator-developed instruments. Heart transplant recipients, outpatient clinicians and programme's directors complete a survey. A staged convenience sampling strategy is implemented in heart transplant centres, countries and continents. Depending on the centre's size, a random sample of 25-60 patients is selected (N estimated 1680 heart transplant recipients). Five randomly selected clinicians and the medical director from each centre will be invited to participate.

Conclusion: This is the first multi-centre, multi-continental study examining healthcare system and heart transplant centres chronic illness management practice patterns and potential correlates of immunosuppressive medication non-adherence. The knowledge gained will inform clinicians, researchers and healthcare policy makers at which level(s) interventions need to be implemented to improve long-term outcomes for transplant recipients.

Keywords: chronic illness; health behaviour; healthcare system; medication adherence; nursing; organ transplantation; patient compliance.