EMPoWARed: Edmonton pediatric warfarin self-management study

Abstract Background Patient self-management (PSM) in adults is safer and more cost effective than conventional management. Warfarin is a narrow therapeutic index drug with individual patient response to changes and frequently a long-term therapy. Children and their families are proposed to be able to effectively manage their child's warfarin therapy. Increased health related quality of life is highly associated with effective therapy in patients with chronic conditions. Objectives The aim of this study is to evaluate the safety and efficacy of PSM over time including HRQOL and variables that may influence PFU success at PSM. Patients/methods Children and their family units (PFUs) current performing patient self-testing/monitoring for ≥ 3 months were enrolled in this cohort study. PFUs participated in comprehensive education on warfarin testing and management followed by an apprenticeship. Socio-demographic, clinical, and laboratory data were collected to evaluate safety and efficacy and health related quality of life. Outcomes were compared between the first 6 months on PSM (phase 1) and the last 6 months data collected on PSM (phase 2). Results Forty-two patients performed PSM for a median of 2.7 years (range: 1.1–6.2 years). Time in therapeutic range was 90% and 92.9% (p = 0.30) in phases 1 and 2 respectively. All measures were strongly associated with improved heath related quality of life. PFUs socio-demographic status did not influence success at PSM. All PFUs maintained warfarin knowledge and INR testing competency. Warfarin dosing decision errors median 0 (range: 0–5, p = 0.73) and a median 0 (range 0–4, p = 0.55) per patient in phases 1 and 2 respectively. There were no adverse hemorrhagic or thrombotic events. Conclusions Empowering PFUs to self-manage warfarin results in increased knowledge and understanding of their health condition, improved commitment to their health care and adherence to medication regimens and is demonstrated to be sustainable over time.