Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000108516
Ethics application status
Approved
Date submitted
19/12/2014
Date registered
6/02/2015
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing Cardiovascular disease (CVD): Translating an evidence based quality improvement tool into ‘real-world’ general practice
Scientific title
Central and Eastern Sydney General Practice (GP) Quality Improvement (QI) Network: building a sustainable model of QI to achieve reduced cardiovascular disease in the primary care setting compared to the usual standard of care.
Secondary ID [1] 285880 0
None
Universal Trial Number (UTN)
U1111-1163-7995
Trial acronym
Q Pulse
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 293455 0
Condition category
Condition code
Cardiovascular 293736 293736 0 0
Coronary heart disease
Public Health 294341 294341 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To embed within a Primary Health Network (PHN) a multi-faceted quality improvement intervention for cardiovascular disease (CVD) prevention and to assess its impact on the identification and prevention of CVD risk factors in general practice
1. To improve General Practitioner (GP) identification of CVD risk using absolute risk tools
2. To improve prescribing according to evidence-based practice guidelines
3. To inform dissemination and delivery of strategic support for GP quality improvement activities through local GP organisation
80 General Practices will be recruited for the study from within the Central and Eastern Sydney Primary Health Network (CESPHN). At enrolment each practice will;
1. Access Pen Computer Systems Clinical Audit Tool (Trademark), PrimaryCare TopBar (Trademark) and HealthTracker.
The Clinical Audit Tool is a population health reporting tool for General Practice. Its suite of tools provide a population view of the practice data. It allows the practice population to be viewed from the perspective of Preventative care, disease register management, improving data quality, optimising financial opportunities. It is compatible with the leading GP Clinical Desktop Systems in Australian General Practice. Interoperating with the clinical desktop system, the PrimaryCare TopBar can deliver web-based resources directly into patient consultations and provides access to:
a. Electronic clinical decision support tools such as HealthTracker (an evidence-based innovative point-of-care electronic decision support tool that improves the identification of patients at high risk of heart disease)
b. Cleansing App- Can be used to i)Update Patient’s missing Demographics and Accreditation items while the patient is at consultation; ii)Identify undiagnosed patients who have indicated to have Diabetes, Mental Health, Chronic Kidney Disease or Chronic Obstructive Pulmonary Disease during consultation
c. Medicare Benefit Schedule (MBS) App– Quickly identify what MBS items the patient is eligible for.
d. Waiting Room App – Provides information to i) Notify Receptionists of missing Patient’s Demographics while the Patient is in the Waiting Room; ii) Identify Patient’s missing Clinical/Accreditation items prior to consultation.
Each practice will be provided with 30minutes of training and ongoing support by the Primary Care Network (PHN) Project Officer (PO), in the use of this suite of tools for all administrative and clinical staff. The GP’s will be specifically trained in the use of HealthTracker.
2. Provide a baseline report of the Practice profile using the Clinical Audit Tool and then 5 monthly dataset downloads (identification of patients with high risk of CVD; prescribing of recommended medications: aspirin, statins and ACE to high risk patients; regular measurement of clinical BP, weight, waist, LDL cholesterol, HDL cholesterol, ACR in high risk patients) prior to the commencement of the actual intervention.
3. Complete a Clinical Microsystem Analysis tool. This tool will be used for qualitative analysis of the clinical microsystem features of General Practices that assists them in adopting Quality Improvement recommendations and achieving sustainable change.(Johnson & Barach, 2008)
4. Attend a One day face to face Workshop where the Quality Improvement Collaboration (QIC) model and the specific aims and data targets of this project will be introduced by expert and peer presenters. The QIC methodology utilises a series of learning workshops where the General Practice participants exchange ideas, share experiences and learn from experts about the topic for Improvement. There are 5 essential change principles for the topic:
1) Build a Practice Team,
2) Establish a system for updating a register of people with the disease or condition (such as CVD),
3) Be systematic and proactive in managing care,
4) Involve patients in delivering and developing care,
5) Develop effective links with key local partners.
Participants learn how to make and test changes using the “Model for Improvement” that consists of 3 Fundamental questions-
a) What are we trying to accomplish? (Goal),
b) How will we know that a change is an improvement? (Measure),
c) What Changes can we make that will result in an improvement? (Idea).
The Practice team then use PDSA (Plan, Do, Study, Act) cycles arising from the “Idea” until the “Goal” has been achieved.
The participants will be acquainted with how to make use of PDSA’s to assist the GPs in achieving improvements based on their data results.
5. Receive ongoing support from the PHN PO in the use of PrimaryCareTopBar, Clinical Audit Tool and HealthTracker to assist change of practice. Monthly administrative support and reminders to download the data and submit one PDSA (Plan, Do, Study, Act) statement that documents the “idea” which has been addressed each month.
6. Obtain individualised monthly graphical feedback and a de-identified overall summary for the entire cohort.
7. Be offered membership in a local “GP QI Network”. Practices will be encouraged to share their solutions as well as the difficulties encountered via weekly group email discussion forums, bimonthly webinars (45 minutes at lunchtime or evenings) and/ or 3 monthly face to face meetings (1 hour breakfast meetings in locally accessible locations). This GP QI Network will act as both a method of collaboration and joint problem solving. The GP QI Network will be coordinated and facilitated by the PHN PO.
Webinars and face to face meetings will be scheduled to occur over the first 12 months of the project. It is anticipated that the PHN will then continue to support the network after this time if the GP QI Network has achieved a regular membership of participating practices.
The active QI intervention will last 6 months.
Intervention code [1] 290564 0
Behaviour
Comparator / control treatment
This will be an Interrupted time series study where the Practice baseline data over 6 months will be used as the comparator to the QI intervention for each practice. Each Practice will provide “baseline” data on enrollment and then a further 5 monthly downloads before commencement of the active intervention (QIC). Each Practice will then continue to submit monthly data for a further 6 months.
Control group
Active

Outcomes
Primary outcome [1] 293537 0
Identification of patients with high risk of CVD who routinely attend General Practitioners through data obtained using Pen Computer Systems Clinical Audit Tool (Trademark)
Timepoint [1] 293537 0
At baseline and then monthly for 12 months
Primary outcome [2] 293538 0
Prescription of recommended medications to patients identified as high risk of cardiovascular disease: aspirin, statins and ACE. Data of prescriptions will be obtained using Pen Computer Systems Clinical Audit Tool (Trademark)
Timepoint [2] 293538 0
At baseline and then monthly for 12 months
Primary outcome [3] 293539 0
Measurement of BP, weight, waist, LDL cholesterol, HDL cholesterol, ACR of patients with high risk of CVD who routinely attend General Practitioners through data obtained using Pen Computer Systems Clinical Audit Tool (Trademark)
Timepoint [3] 293539 0
At baseline and then monthly for 12 months
Secondary outcome [1] 311290 0
Participation in the project by 80 General Practices
Timepoint [1] 311290 0
calculated from commencement of baseline data measurement to completion at 12 months
Secondary outcome [2] 311291 0
Monthly PDSA submission from each Practice
Timepoint [2] 311291 0
Measured at monthly intervals over the 12 months
Secondary outcome [3] 311292 0
Interviews with all key stakeholders in the intervention process
Timepoint [3] 311292 0
12 months

Eligibility
Key inclusion criteria
80 General Practices will be recruited for the study from within the Central and Eastern Sydney. The region is characterised by high population growth and cultural diversity. There are around 1.5million residents living in the catchment, with the number of people aged over 65 expected to increase by more than fifty percent by 2025. Approximately half (46.1%) of the residents in Central and Eastern Sydney identify a language other than English as the primary language spoken at home. There are approximately 600 General Practices located in the region which comprise a mixture of solo, group and corporate style. The recruited practices will be required to use software for their clinical record keeping that is compatible with the use of Pen Clinical Audit Tool (Trademark), a data extraction tool (such as Medical Director or Best Practice software).
Each “General Practice” is seen as the “participant” in the study but in reality this will be made up of the members of each general practice team – General practitioners (GP), Practice Nurses (PN), Practice Managers (PM), reception staff (RS). For some practices there will also be Allied health practitioners (AHP).
CESPHN will invite eligible General Practices to join a local Quality Improvement program and GP QI Network with the target project being Cardiovascular Disease prevention and reduction.
Recruitment will be via a number of different pathways:
1. Individual invitation (targeting Practices who are already familiar with the QIC methodology as “Lead” practices)
2. Oral invitation at group functions (Professional Development meetings, local network meetings)
3. Written invitation via specific email, newsletter and weekly fax communication systems.
All interested General practices will be eligible to enrol if they are use the appropriate medical software (> 90% General Practices in this region are currently eligible to enrol).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Practices that do not use computer software for clinical purposes that can interact with the Pen Clinical Audit Tool will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All General Practices in CESPHN will be invited to participate in the study. They will need to use GP computer software compatible with Pen Computer Systems Clinical Audit Tool (Trademark), PrimaryCare TopBar (Trademark) and HealthTracker (90% of General Practices in CESPHN currently use compatible software). They will then submit baseline data and 5 x monthly data before participating in the QIC. All practices will receive the same intervention and support.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This will be an Interrupted time series study where the Practice baseline data over 6 months will be used as the comparator to the QI intervention for each practice. Each Practice will provide “baseline” data on enrollment and then a further 5 monthly downloads before commencement of the active intervention (QIC). Each Practice will then continue to submit monthly data for a further 6 months.
All of the Practices will be part of the intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2015
Actual
4/05/2015
Date of last participant enrolment
Anticipated
31/03/2017
Actual
7/11/2016
Date of last data collection
Anticipated
30/03/2018
Actual
30/11/2017
Sample size
Target
80
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290203 0
Charities/Societies/Foundations
Name [1] 290203 0
Bupa Health Foundation
Country [1] 290203 0
Australia
Primary sponsor type
University
Name
University of Notre Dame, Australia
Address
School of Medicine, Sydney
160 Oxford St,
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 289164 0
University
Name [1] 289164 0
George Institute
University of Sydney
Address [1] 289164 0
Level 13, 321 Kent Street
Sydney NSW 2000 Australia
Country [1] 289164 0
Australia
Other collaborator category [1] 278231 0
Charities/Societies/Foundations
Name [1] 278231 0
Improvement Foundation
Address [1] 278231 0
Level 5,
19 Grenfell Street,
Adelaide SA 5000
Postal Address: PO Box 3645, Rundle Mall SA 5000
Country [1] 278231 0
Australia
Other collaborator category [2] 278232 0
Other Collaborative groups
Name [2] 278232 0
Central and Eastern Sydney PHN (CESPHN)
Address [2] 278232 0
Lev 1, 158 Liverpool Rd
Ashfield
NSW 2131
Country [2] 278232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291914 0
University of Notre Dame, Australia Human Research Ethics committee
Ethics committee address [1] 291914 0
Ethics committee country [1] 291914 0
Australia
Date submitted for ethics approval [1] 291914 0
Approval date [1] 291914 0
11/08/2014
Ethics approval number [1] 291914 0
014105S

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

Contacts
Principal investigator
Name 52562 0
A/Prof Charlotte Hespe
Address 52562 0
University of Notre Dame Australia,
School of Medicine Sydney
160 Oxford St,
Darlinghurst,
NSW 2010
Country 52562 0
Australia
Phone 52562 0
+61414855322
Fax 52562 0
+61293577680
Email 52562 0
charlotte.hespe@nd.edu.au
Contact person for public queries
Name 52563 0
Charlotte Hespe
Address 52563 0
University of Notre Dame Australia,
School of Medicine Sydney
160 Oxford St,
Darlinghurst,
NSW 2010
Country 52563 0
Australia
Phone 52563 0
+61414855322
Fax 52563 0
+61293577680
Email 52563 0
charlotte.hespe@nd.edu.au
Contact person for scientific queries
Name 52564 0
David Peiris
Address 52564 0
George Institute
Level 10, King George V Building, Royal Prince Alfred Hospital, Missenden Rd
Camperdown NSW 2050
Country 52564 0
Australia
Phone 52564 0
+61 2 9993 4500
Fax 52564 0
Email 52564 0
dpeiris@georgeinstitute.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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