QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with coronary heart disease (QUEL): protocol for a 24-month cluster randomised controlled trial in primary care.
Angiotensin Receptor Antagonists
/ therapeutic use
Angiotensin-Converting Enzyme Inhibitors
/ therapeutic use
Australia
Blood Pressure
Blood Pressure Determination
Cholesterol, LDL
/ blood
Coronary Disease
/ blood
Disease Management
Guideline Adherence
/ statistics & numerical data
Hospitalization
/ statistics & numerical data
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
/ therapeutic use
Platelet Aggregation Inhibitors
/ therapeutic use
Practice Guidelines as Topic
Primary Health Care
Quality Improvement
Quality Indicators, Health Care
Randomized Controlled Trials as Topic
Secondary Prevention
Smoking
/ epidemiology
Cardiovascular disease
Coronary heart disease
Data
Data linkage
Health services
Primary care
Quality improvement
Secondary prevention
Journal
BMC family practice
ISSN: 1471-2296
Titre abrégé: BMC Fam Pract
Pays: England
ID NLM: 100967792
Informations de publication
Date de publication:
14 02 2020
14 02 2020
Historique:
received:
06
01
2020
accepted:
05
02
2020
entrez:
16
2
2020
pubmed:
16
2
2020
medline:
1
12
2020
Statut:
epublish
Résumé
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. 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. 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. Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).
Sections du résumé
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).
Identifiants
pubmed: 32059641
doi: 10.1186/s12875-020-01105-0
pii: 10.1186/s12875-020-01105-0
pmc: PMC7020350
doi:
Substances chimiques
Angiotensin Receptor Antagonists
0
Angiotensin-Converting Enzyme Inhibitors
0
Cholesterol, LDL
0
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Platelet Aggregation Inhibitors
0
Banques de données
ANZCTR
['ACTRN12619001790134']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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