Primary care-based integrated disease management for heart failure: a study protocol for a cluster randomised controlled trial

Abstract

Introduction: Heart failure (HF) is a common chronic disease that increases in prevalence with age. It is associated with high hospitalisation rates, poor quality of life and high mortality. Management is complex with most interactions occurring in primary care. Disease management programmes implemented during or after an HF hospitalisation have been shown to reduce hospitalisation and mortality rates. Evidence for integrated disease management (IDM) serving the primary care HF population has been investigated but is less conclusive. The aim of this study is to evaluate the efficacy of IDM, focused on, optimising medication, self-management and structured follow-up, in a high-risk primary care HF population.

Methods and analysis: 100 family physician clusters will be recruited in this Canadian primary care multicentre cluster randomised controlled trial. Physicians will be randomised to IDM or to care as usual. The IDM programme under evaluation will include case management, medication management, education, and skills training delivered collaboratively by the family physician and a trained HF educator. The primary outcome will measure the combined rate (events/patient-years) of all-cause hospitalisations, emergency department visits and mortality over a 12-month follow-up. Secondary outcomes include other health service utilisation, quality of life, knowledge assessments and acute HF episodes. Two to three HF patients will be recruited per physician cluster to give a total sample size of 280. The study has 90% power to detect a 35% reduction in the primary outcome. The difference in primary outcome between IDM and usual care will be modelled using a negative binomial regression model adjusted for baseline, clustering and for individuals experiencing multiple events.

Ethics and dissemination: The study has obtained approval from the Research Ethics Board at the University of Western Ontario, London, Canada (ID 114089). Findings will be disseminated through local reports, presentations and peer-reviewed publications.

Trial registration number: NCT04066907.

Keywords: Heart failure; PRIMARY CARE; Quality in health care.

Conflict of interest statement

Competing interests: CL has potential conflicts of interest unrelated to the submitted work: Western University Professor of Health System Innovation. Advisory Board member for GlaxoSmithKline, AstraZeneca, Teva, Sanofi Genzyme and Valeo Pharma. Research Grants from AstraZeneca. Honoraria or personal fees from AstraZeneca and GlaxoSmithKline. CL has potential conflicts of interest related to this current work: Novartis research grant to conduct the pilot testing preceding the submitted RCT. MFe has potential conflicts of interest unrelated to this study with honorarium from AstraZeneca. DS has potential conflicts of interest unrelated to this study with honoraria for Novartis, AstraZeneca, and Bayer. RSM has potential conflicts of interest unrelated to the submitted work: Advisory Board member for AstraZeneca, Novartis, Bayer, BI, Otsuka. Research Grants from AstraZeneca, Novartis, BI. Honoraria or personal fees from AstraZeneca, Bayer, BI, Novartis.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Study flow for cluster and patient recruitment, and cluster randomisation. FHO, Family Health organisation; FHT, Family Health Team; IDM, Integrated Disease Management; RA, research assitant.

Figure 2

Appointment timeline for intervention and control patient participants. Appointment conducted by telephone (all other appointments are to be conducted in-person at the patient's primary care provider clinic); 1Refer to table 2 for list of questionnaires; 2Acute HF episode is defined as a worsening of symptoms of HF leading to increase in medication (activation of action plan), an unscheduled physician visit, walk-in clinic, urgent care facility, emergency department or hospitalisation; ⬆Medication will be reviewed and optimized as per guidelines and/or as tolerated (frequent follow-up may be required during this period); ✫All data will be collected by telephone for the control group to minimise contact due to the COVID-19 pandemic. However, all data collected by telephone for the control group and in person for the intervention group will be checked using the patient's primary care electronic medical records. ED, emergency department; HFE, heart failure educator; HF, heart failure; IDM, Integrated Disease Management; NYHA, New York Heart Association; RA, research assistant.