Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001790134
Ethics application status
Approved
Date submitted
10/12/2019
Date registered
20/12/2019
Date last updated
20/12/2019
Date data sharing statement initially provided
20/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with coronary heart disease (QUEL)
Scientific title
QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with coronary heart disease (QUEL): A 24 month cluster randomised controlled trial in primary care
Secondary ID [1] 300048 0
Nil
Universal Trial Number (UTN)
U1111-1245-1420
Trial acronym
QUEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 315551 0
Condition category
Condition code
Cardiovascular 313840 313840 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 month collaborative quality improvement program via (i) Learning workshops where practices participate in three online (1 hour each) and two face-to-face learning workshops (6 hours each based in Sydney, Australia); (ii) Activity periods where practices use their own electronically extracted data test and implement improvements through cycles of small step-wise changes (implemented strategies within the practice in order to achieve cardiovascular risk factor targets, see below for an example); (iii) Data reporting and feedback where practices submit monthly data and PDSA cycles on which they are provided objective feedback (telephone and in-person visits) on their outcomes and progress and; (iv) Sustainability where Primary Health Networks spread knowledge and success. To spread knowledge and success PHNs will foster a supportive environment where practices share their progress towards achieving goals such that successful strategies can be trialled by other practices and in other areas of health beyond CVD.
Training workshops will be standardised across all practices and will provide support and education that support practices to use their practice data to monitor cardiovascular risk factors (cholesterol, blood pressure, smoking status), medication prescription rate, influenza vaccination rates and provision of chronic disease management plans. The mode of training is a combination of short videos, presentations by experts, discussion groups and practical workshops. The two face-to-face workshops will be held at 6 monthly intervals (2 in total) and virtual workshops will be held approximately every four months (3 in total) during the 12 month intervention period. A minimum of two representatives from each practice will attend the learning workshops – ideally this will be one GP and one other practice staff member (ideally a practice nurse or practice manager). The concept being that these staff collaborate with other team members within their practice between workshops.
Only personnel who have undergone training in delivery of collaborative quality improvement will deliver the practice support. All practices will have access to an online Sharepoint website for regular communication and support. Practice will be expected to enter detail into sharepoint monthly but engage in practice level improvement on a weekly basis. Intervention fidelity will be monitored by attendance at workshops, engagement with monthly reporting and completion of PDSA cycles and surveys after workshops to examine satisfaction and utility. The step-wise changes will be based on practice setting monthly achievable goals for their practice that supports improve electronic recording and use of data relating to CVD management for patients attending their practice. For example, at baseline a practice will be supported to use their data to see that 70% (for example) of their patients with CHD have a prescription for statin medication and set themselves a goal to increase this to 80% within 3 months. The practice could then implement training of their staff to improve the rate of prescriptions and reassess their performance monthly to monitor their progress towards their goal. The intervention will take place in addition to usual care.
Intervention code [1] 316317 0
Prevention
Comparator / control treatment
Usual care without access to the quality improvement intervention for coronary heart disease during the study period. Usual care is defined as ongoing management of patients with CHD in each participating practice according to their standard and ongoing procedures where each patient is managed by their GP in the method by which they have been doing prior to commencement of the QUEL study.
Control group
Active

Outcomes
Primary outcome [1] 322233 0
Rate of unplanned CVD hospitalisations according linkage with state-based administrative data for hospitalisations.
Timepoint [1] 322233 0
24 months post baseline data extraction
Secondary outcome [1] 377810 0
Major adverse cardiac and cerebrovascular events (MACE, fatal and non-fatal) that includes CHD (angina or MI), stroke or CVD death. Data will be collected by linkage with state-based administrative data for hospitalisations that includes the date and reason for admission.
Timepoint [1] 377810 0
24 months post baseline data extraction
Secondary outcome [2] 377811 0
Proportion of patients who received prescriptions for guideline-recommended medicines based on data recorded in GP electronic records for prescriptions.
Timepoint [2] 377811 0
24 months post baseline data extraction
Secondary outcome [3] 377812 0
Proportion of patients with a chronic disease management plan or review (Australian Medicare Item numbers 721 or 732 respectively) based on MBS claims data recorded in GP electronic records.
Timepoint [3] 377812 0
24 months post baseline extraction
Secondary outcome [4] 377813 0
Proportion of patients achieving national targets for low density lipoprotein (LDL) cholesterol (<2.0 mmol/L) based data recorded by GP at point of care in GP electronic records .
Timepoint [4] 377813 0
24 months post baseline data extraction
Secondary outcome [5] 377814 0
Proportion of patients achieving national target for blood pressure (less than or equal to 130/80) based data recorded by GP at point of care in GP electronic records.
Timepoint [5] 377814 0
24 months post baseline data extraction
Secondary outcome [6] 377815 0
Proportion of patients not smoking tobacco based data recorded by GP at point of care in GP electronic records .
Timepoint [6] 377815 0
24 months post baseline extraction
Secondary outcome [7] 377816 0
Proportion of patients who have an influenza vaccination recorded within the previous 12 months based data recorded by GP at point of care in GP electronic records .
Timepoint [7] 377816 0
24 months post baseline data extraction

Eligibility
Key inclusion criteria
Practices will be eligible to participate if they have:
i. greater than or equal to 100 patients year with CHD and
ii. use practice software that is compliant with Improvement Foundation systems (eg. Medical Director, Best Practice, Communicare, Monet and Clarity which account for the majority of practice management market-share in Australia).

The patient cohort for the QUEL will comprise a dataset of individuals made up of all eligible patients presenting to participating practices. Data will be electronically extracted into a central secure database. Patient data will be included for people who are:
i. greater than or equal to 18 years with a documented diagnosis of CHD in the primary care record of a participating practice and,
ii. have visited their GP at least once in the previous 12 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Practices will be excluded if they are:
i. unable to provide written agreement to participate in the quality improvement program or
ii. the primary care practice is already participating in a formal quality improvement project targeting CVD.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
It was not possible to conceal the group allocation from the practices themselves or the research team delivering the intervention. However, the statistician generating the randomisation sequence will be blinded to practice name. The statistician conducting analysis will also be blinded to practice allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Practices will be randomized 1:1 to intervention (collaborative quality improvement program) or control groups using using a computer-generated sequence generated with SAS 9.4 (Proc Surveyselect). Randomisation will be stratified according to two subgroups - rural versus urban location and size of the practice (less than or equal to 2 GPs versus greater than 2 GPs in a practice). The statistician who performed the randomisation was blinded to practice names and details and was only exposed to the two practice characteristics to enable stratification. Once allocation was completed, a research team member was provided the allocation list to enable communication with practices and commence arrangements for their respective requirements.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster randomisation at the level of primary care practice. To evaluate the Quality Improvement program, practice staff from the intervention group involved in quality improvement work will be asked to complete learning workshop evaluation surveys.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted at the individual level while accounting for clustering of patients within practices. Intention-to-treat principle will be followed with patients analysed according to their randomisation group. 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 in case of convergence issues. Clustering will be accounted for by modelling the correlation among patients from the same cluster using generalised estimating equations with an exchangeable correlation structure. Sensitivity analyses will include analyses of yearly rates using Poisson regression and/or time-to-event analyses via Cox models. Adjusted analyses will also be performed to account for baseline imbalances in cluster and patient characteristics with statistical significance set at P <0.05. Pre-specified sub-analyses will be used to determine the impact of the intervention on different patient groups (male v female; low SES v high SES, different CVD subgroups, influenza vaccination or not) and practice types (e.g., large v small and urban v rural).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
50
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 304498 0
Government body
Name [1] 304498 0
National Health and Medical Research Council
Country [1] 304498 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 304768 0
None
Name [1] 304768 0
Address [1] 304768 0
Country [1] 304768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304932 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [1] 304932 0
Ethics committee country [1] 304932 0
Australia
Date submitted for ethics approval [1] 304932 0
07/09/2018
Approval date [1] 304932 0
01/11/2018
Ethics approval number [1] 304932 0
HREC/18/CIPHS/44

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98678 0
Prof Julie Redfern
Address 98678 0
Department of General Practice, Acacia House, Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country 98678 0
Australia
Phone 98678 0
+61 2 8890 8181
Fax 98678 0
Email 98678 0
[email protected]
Contact person for public queries
Name 98679 0
Nashid Hafiz
Address 98679 0
Department of General Practice, Acacia House, Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country 98679 0
Australia
Phone 98679 0
+61 2 8890 8181
Fax 98679 0
Email 98679 0
[email protected]
Contact person for scientific queries
Name 98680 0
Julie Redfern
Address 98680 0
Department of General Practice, Acacia House, Westmead Hospital, PO Box 154, Westmead, NSW, 2145
Country 98680 0
Australia
Phone 98680 0
+61 2 8890 8181
Fax 98680 0
Email 98680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This cRCT has strict conditions on "waiver of consent" and only deidentifiable aggregate data can be removed from SURE.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseQUality 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.2020https://dx.doi.org/10.1186/s12875-020-01105-0
EmbaseData-driven quality improvement program to prevent hospitalisation and improve care of people living with coronary heart disease: Protocol for a process evaluation.2022https://dx.doi.org/10.1016/j.cct.2022.106794
N.B. These documents automatically identified may not have been verified by the study sponsor.