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Trial registered on ANZCTR


Registration number
ACTRN12617001589370
Ethics application status
Approved
Date submitted
7/11/2017
Date registered
28/11/2017
Date last updated
11/02/2019
Date data sharing statement initially provided
11/02/2019
Date results information initially provided
11/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Do enhanced general practice services improve health outcomes and health service use? Flinders QUality Enhanced general practice Services Trial (Flinders - QUEST)
Scientific title
Do enhanced general practice services improve health outcomes and health service use? Flinders QUality Enhanced general practice Services Trial (Flinders - QUEST)
Secondary ID [1] 293224 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Flinders QUEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Health 305244 0
Condition category
Condition code
Public Health 304577 304577 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General practices (located in Adelaide, South Australia) in the intervention arm will deliver enhanced services to trial participants for a 12 month period. The enhanced services will be provided by the participant's usual general practice clinical team. Practices however will be supported (both financially and logistically) to deliver the enhanced services. The logistical support will include administrative assistance for participant recruitment and the provision of a Practice Facilitator who will support practices to incorporate the intervention elements into routine systems of care.

The enhanced general practice services to be provided are as follows:

(1) Enrollment with a preferred GP
Intervention arm practices will record the trial participant’s preferred GP in clinical (comments field) and appointment (notes field) practice systems. This will flag to practice staff (the clinical and administrative teams) that the patient is enrolled in the trial and has a preferred GP. Participants enrolled in the Intervention arm will be provided a folder comprising trial written materials (Care Plan, future appointments and referrals). Participants will be asked to inform practice staff of their participation in the trial (and preferred GP) when making appointments.

(2) Longer GP appointments
GP Medicare funded appointments are time based: Level A: “Brief consultations”; Level B: “Standard consultations” (<20 minutes); Level C “Long consultations” (>20 minutes) and Level D “Prolonged Consultations” (>40 minutes). Longer appointments will be defined as Level C and D consultations. A facilitator will assist practices to make changes to practice appointment systems to accommodate longer consultations for trial participants. Each practice will decide what changes will be necessary to allow this and the best manner in which to implement the changes.

(3) Follow-up after significant health events (Emergency Department presentation or hospital admission)
Intervention arm participants will be contacted by clinical practice staff for practice or home based review within seven days of the participant experiencing a significant health event, where this is clinically indicated.

(4) Same day appointments for children and young people experiencing acute conditions
The participation of children and young people in the Intervention arm of the trial will be recorded in the clinical (comments field) and appointment (notes field) practice systems. This will flag to all practice staff (the clinical and administrative teams) that the child or young people should receive priority access to same day appointments if they (or their parents) contact the practice seeking an appointment for an acute condition.
Intervention code [1] 299481 0
Treatment: Other
Comparator / control treatment
In this pragmatic trial participants in the control group will receive the care that is usually provided to them by their GPs.
Control group
Active

Outcomes
Primary outcome [1] 303780 0
Health status (EQ-5D-5L) Visual Analogue Scale (VAS)
Timepoint [1] 303780 0
At baseline, 6 months, 12 months (completion of intervention)
Secondary outcome [1] 340510 0
Number of ED presentations and hospital admissions measured from participant self-report and general practice records
Timepoint [1] 340510 0
At baseline (estimated from previous 12 months), 6 months (mid-point of intervention), 12 months (completion of intervention) and 24 month follow-up
Secondary outcome [2] 340511 0
Number of referrals to radiology, pathology and other medical specialists measured from general practice and Medicare (MBS) records
Timepoint [2] 340511 0
At baseline (estimated from previous 12 months), 6 months (mid-point of intervention), 12 months (completion of intervention) and 24 month follow-up
Secondary outcome [3] 340512 0
Number of prescription drugs supplied measured from general practice and Medicare (PBS) records
Timepoint [3] 340512 0
At baseline (estimated from previous 12 months), 6 months (mid-point of intervention), 12 months (completion of intervention) and 24 month follow-up
Secondary outcome [4] 340513 0
Health literacy will be assessed from scales from the Health Literacy Questionnaire. The scales used will be: Scale 1: “feeling understood and supported by healthcare providers”; Scale 2 “having sufficient information to manage their health”; Scale 6 “ability to actively engage with healthcare providers”; Scale 7 “navigating the healthcare system”; Scale 9 “understanding health information well enough to know what to do"
Timepoint [4] 340513 0
At baseline, 6 months (mid-point of intervention) and 12 months (completion of intervention)
Secondary outcome [5] 340515 0
A cost-effectiveness analysis will be performed based on the cost per QALYs gained. The QALYs will be estimated using responses to the EQ-5D-5L. Health service utilisation outcomes will be incorporated into the analysis allowing a secondary cost-effectiveness outcome to be cost per unit reduction in a composite measure of health service utilisation (primary and secondary care, referrals and prescriptions).
Timepoint [5] 340515 0
At 12 months (completion of intervention) and 24 month follow-up

Eligibility
Key inclusion criteria
Participants will have been assessed by their GPs as having high health care needs and possibly likely to benefit from enhanced services. Participants will be drawn from three cohorts: (1) Children and young people (under 18 years of age), (2) Elderly (65 years of age or over) people or (3) Adults (18 to 64 years of age) with two or more chronic diseases.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A clinically dominant disease likely to shorten life expectancy
Unable to comprehend English
Suffer from significant cognitive impairment
Severe mental illness
Not community dwelling
Enrolled in another health intervention study
Enrolled in a chronic disease management program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by staff not directly associated with the research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
General practices will be randomised by a covariate-constrained technique accounting for practice size, socio-economic (practice area) and bulk billing status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be based on the intent to treat principle. Linear regression and Poisson regression models will include the baseline value of the dependent variable, the group (intervention versus control), time as a categorical variable and an intervention*time interaction. A cost-effectiveness analysis will be based on the primary outcome (from EQ-5D-5L) of cost per quality of life years (QALYs) gained. Pre-specified participant level sub-groups will include: gender, age, chronic disease severity and trial cohort (children/young people; adults (18-64 years); older people (65 years+). At the General Practice level sub-groups will include: practice size, SEIFA index and whether the practice is a bulk billing practice.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297856 0
Charities/Societies/Foundations
Name [1] 297856 0
Royal Australian College of General Practitioners
Address [1] 297856 0
100 Wellington Parade, East Melbourne VIC 3002
Country [1] 297856 0
Australia
Primary sponsor type
University
Name
Flinders University of South Australia
Address
GPO Box 2100, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 296892 0
None
Name [1] 296892 0
Address [1] 296892 0
Country [1] 296892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298902 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 298902 0
Flinders Medical Centre
Flinders Drive
Bedford Park Adelaide 5042
Ethics committee country [1] 298902 0
Australia
Date submitted for ethics approval [1] 298902 0
28/11/2017
Approval date [1] 298902 0
23/02/2018
Ethics approval number [1] 298902 0
313.17

Summary
Brief summary
The Australian health care system is facing many challenges as a result of an ageing population, rising rates of chronic and complex disease and a strong demand from consumers for more and higher quality health care services. A high performing and adequately resourced primary health care sector is needed to address these challenges and produce better population health outcomes and sustainable health care funding into the future. Flinders QUEST will test whether Australian general practices that are assisted (logistically and financially) to deliver enhanced services can produce better patient health outcomes and improved health service use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78602 0
Prof Richard Reed
Address 78602 0
Discipline of General Practice, Level 3 Health Sciences Building, Flinders University, Registry Road, Bedford Park SA 5042
Country 78602 0
Australia
Phone 78602 0
+61 8 7221 8530
Fax 78602 0
Email 78602 0
richard.reed@flinders.edu.au
Contact person for public queries
Name 78603 0
Dr Leigh Roeger
Address 78603 0
Discipline of General Practice, Level 3 Health Sciences Building, Flinders University, Registry Road, Bedford Park SA 5042
Country 78603 0
Australia
Phone 78603 0
+61 8 7221 8532
Fax 78603 0
Email 78603 0
leigh.roeger@flinders.edu.au
Contact person for scientific queries
Name 78604 0
Dr Leigh Roeger
Address 78604 0
Discipline of General Practice, Level 3 Health Sciences Building, Flinders University, Registry Road, Bedford Park SA 5042
Country 78604 0
Australia
Phone 78604 0
+61 8 7221 8532
Fax 78604 0
Email 78604 0
leigh.roeger@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results presented in this article after de-identification.
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication.
Available to whom?
Investigators whose proposed use of the data is supported by approval from an independent review committee and who provide a methodologically sound proposal to the Primary Investigator.
Available for what types of analyses?
To achieve the aims in the approved proposal.
By what mechanism will data be made available?
Proposals should be directed to Professor Richard Reed by email: richard.reed@flinders.edu.au.
What supporting documents are/will be available?
Study protocol
Ethical approval
Attachments/websites
Type [1] 1303 0
Ethical approval
URL/details/comments [1] 1303 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary