P rimary care A dherence T o H eart F ailure guidelines IN D iagnosis, E valuation and R outine management (PATHFINDER): a randomised controlled trial protocol

Liying Dai; Tashi Dorje; Jan Gootjes; Amit Shah; Lawrence Dembo; Jamie Rankin; Graham Hillis; Suzanne Robinson; John J Atherton; Angela Jacques; Christopher M Reid; Andrew Maiorana

doi:10.1136/bmjopen-2022-063656

P rimary care A dherence T o H eart F ailure guidelines IN D iagnosis, E valuation and R outine management (PATHFINDER): a randomised controlled trial protocol

BMJ Open. 2023 Mar 27;13(3):e063656. doi: 10.1136/bmjopen-2022-063656.

Authors

Liying Dai¹, Tashi Dorje^{2

3

4}, Jan Gootjes⁵, Amit Shah⁶, Lawrence Dembo⁶, Jamie Rankin⁶, Graham Hillis^{3

7}, Suzanne Robinson^{8

9}, John J Atherton^{10

11}, Angela Jacques^{1

12}, Christopher M Reid^{8

13}, Andrew Maiorana^{14

15}

Affiliations

¹ Curtin School of Allied Health, Curtin University, Perth, Western Australia, Australia.
² Department of Cardiology, Mount Hospital, Perth, Western Australia, Australia.
³ Department of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia.
⁴ Department of Cardiology, Joondalup Health Campus, Joondalup, Western Australia, Australia.
⁵ WA Cardiology, Perth, Western Australia, Australia.
⁶ Department of Cardiology and Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
⁷ Medical School, The University of Western Australia, Perth, Western Australia, Australia.
⁸ Curtin School of Population Health, Curtin University, Perth, Western Australia, Australia.
⁹ Deakin Health Economics, Deakin University, Melbourne, Western Australia, Australia.
¹⁰ Department of Cardiology, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.
¹¹ Faculty of Medicine, The University of Queensland, Saint Lucia, Queensland, Australia.
¹² Institute for Health Research, The University of Notre Dame, Fremantle, Western Australia, Australia.
¹³ School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
¹⁴ Curtin School of Allied Health, Curtin University, Perth, Western Australia, Australia A.Maiorana@curtin.edu.au.
¹⁵ Department of Allied Health, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.

Abstract

Introduction: General practitioners (GPs) routinely provide care for patients with heart failure (HF); however, adherence to management guidelines, including titrating medication to optimal dose, can be challenging in this setting. This study will evaluate the effectiveness of a multifaceted intervention to support adherence to HF management guidelines in primary care.

Methods and analysis: We will undertake a multicentre, parallel-group, randomised controlled trial of 200 participants with HF with reduced ejection fraction. Participants will be recruited during a hospital admission due to HF. Following hospital discharge, the intervention group will have follow-up with their GP scheduled at 1 week, 4 weeks and 3 months with the provision of a medication titration plan approved by a specialist HF cardiologist. The control group will receive usual care. The primary endpoint, assessed at 6 months, will be the difference between groups in the proportion of participants being prescribed five guideline-recommended treatments; (1) ACE inhibitor/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitor at least 50% of target dose, (2) beta-blocker at least 50% of target dose, (3) mineralocorticoid receptor antagonist at any dose, (4) anticoagulation for patients diagnosed with atrial fibrillation, (5) referral to cardiac rehabilitation. Secondary outcomes will include functional capacity (6-minute walk test); quality of life (Kansas City Cardiomyopathy Questionnaire); depressive symptoms (Patient Health Questionnaire-2); self-care behaviour (Self-Care of Heart Failure Index). Resource utilisation will also be assessed.

Ethics and dissemination: Ethical approval was granted by the South Metropolitan Health Service Ethics Committee (RGS3531), with reciprocal approval at Curtin University (HRE2020-0322). Results will be disseminated via peer-reviewed publications and conferences.

Trial registration number: ACTRN12620001069943.

Keywords: Clinical trials; Heart failure; PRIMARY CARE.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cardiac Rehabilitation*
Heart Failure* / diagnosis
Heart Failure* / drug therapy
Humans
Multicenter Studies as Topic
Primary Health Care
Quality of Life
Randomized Controlled Trials as Topic
Self Care / methods