Julie Redfern1,2,3, Nashid Hafiz4, Karice Hyun4, Andrew Knight5,6, Charlotte Hespe7, Clara K Chow4,8, Tom Briffa9, Robyn Gallagher10, Christopher Reid11, David L Hare12, Nicholas Zwar13, Mark Woodward6,14, Stephen Jan15, Emily R Atkins15, Tracey-Lea Laba16, Elizabeth Halcomb17, Laurent Billot15, Tracey Johnson18, Timothy Usherwood15,19. 1. Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, PO Box 154 Westmead, Sydney, NSW, 2154, Australia. julie.redfern@sydney.edu.au. 2. Western Sydney Local Health District, Sydney, Australia. julie.redfern@sydney.edu.au. 3. The George Institute for Global Health, Sydney, Australia. julie.redfern@sydney.edu.au. 4. Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, PO Box 154 Westmead, Sydney, NSW, 2154, Australia. 5. Primary ageind Integrated Care Unit, South Western Sydney Local Health District, Sydney, Australia. 6. University of New South Wales, Sydney, Australia. 7. School of Medicine Sydney, The University of Notre Dame Australia, Sydney, Australia. 8. Western Sydney Local Health District, Sydney, Australia. 9. School of Population and Global Health, Faculty of Health and Medical Sciences, The University of Western Australia, Sydney, Australia. 10. Sydney Nursing School, Faculty of Medcine and Health, University of Sydney, Sydney, Australia. 11. School of Public Health, Curtin University and School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. 12. Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Austin Health, Heidelberg, Australia. 13. Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Australia. 14. The George Institute for Global Health, University of Oxford, Oxford, UK. 15. The George Institute for Global Health, Sydney, Australia. 16. Centre for Health Economics Research and Evaluation, University of Technology, Sydney, Australia. 17. School of Nursing, University of Wollongong, Wollongong, Australia. 18. Inala Primary Care, Brisbane, Queensland, Australia. 19. Department of General Practice and Westmead Applied Research Centre, Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
Abstract
BACKGROUND:Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months. METHODS: Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using log-binomial regression or robust Poisson regression, if necessary. DISCUSSION: Despite extensive research with surrogate outcomes, to the authors' knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).
RCT Entities:
BACKGROUND:Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months. METHODS: Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using log-binomial regression or robust Poisson regression, if necessary. DISCUSSION: Despite extensive research with surrogate outcomes, to the authors' knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).
Entities:
Keywords:
Cardiovascular disease; Coronary heart disease; Data; Data linkage; Health services; Primary care; Quality improvement; Secondary prevention
Authors: Nashid Hafiz; Karice Hyun; Qiang Tu; Andrew Knight; Charlotte Hespe; Clara K Chow; Tom Briffa; Robyn Gallagher; Christopher M Reid; David L Hare; Nicholas Zwar; Mark Woodward; Stephen Jan; Emily R Atkins; Tracey-Lea Laba; Elizabeth Halcomb; Tracey Johnson; Timothy Usherwood; Julie Redfern Journal: Contemp Clin Trials Date: 2022-05-17 Impact factor: 2.261
Authors: Qiang Tu; Karice Hyun; Nashid Hafiz; Andrew Knight; Charlotte Hespe; Clara K Chow; Tom Briffa; Robyn Gallagher; Christopher M Reid; David L Hare; Nicholas Zwar; Mark Woodward; Stephen Jan; Emily R Atkins; Tracey-Lea Laba; Elizabeth Halcomb; Tim Usherwood; Laurent Billot; Julie Redfern Journal: Int J Environ Res Public Health Date: 2022-08-29 Impact factor: 4.614