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Trial registered on ANZCTR


Registration number
ACTRN12623000939695
Ethics application status
Approved
Date submitted
24/07/2023
Date registered
31/08/2023
Date last updated
31/08/2023
Date data sharing statement initially provided
31/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of early intervention for healthy ageing in primary care
Scientific title
Evaluation of early intervention initiatives in primary care on primary care service utilisation for patients aged 40 to 70 years presenting with chronic conditions
Secondary ID [1] 310155 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic disease 330730 0
dementia 330731 0
frailty 330732 0
Condition category
Condition code
Public Health 327578 327578 0 0
Health service research
Neurological 327798 327798 0 0
Dementias
Musculoskeletal 327799 327799 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves development and implementation of an evidence-based Healthy Ageing quality improvement (QI) toolkit. The intervention is targeted to general practice professionals, including general practitioners and practice nurses. The healthy ageing QI toolkit contains best practice processes to identify patients, recommended assessments, treatments and management plans with resources to support best use of Medicare MBS items for patients with chronic disease, dementia, and frailty in general practices.
The intervention is targeted to 10 general practices within Adelaide Primary Health Network, and involves education, facilitated quality improvement, development and use of a tool kit for identification and management of chronic conditions for patients.
This program involves three 3-4 month sprints involving a range of facilitated activities to support patients to be appropriately assessed, treated and supported in primary care to live well. Each sprint was targeted for education and facilitation to support care to a specific patient cohort: patients with 1) chronic disease; 2) frailty; and 3) early dementia. The activities within each of the 3 sprints include:
• Participation in 2-3 hour education session (face to face group training) facilitated by practice consultants on development opportunities to support healthy ageing for each sprint relevant to the patient cohort. The timing of the education sessions will be within the first 1-2 months of each sprint, depending on availability of the practice consultants providing the education.
• Weekly virtual huddles with general practices and practice consultants to facilitate and develop continuous improvement action plans targeted to implement early interventions (such as care plans and team care arrangements) for the patient cohort.
• Use of QI processes over 10 weeks for each general practice to:
- Understand the needs of the practice population
- Identify patients at risk of or who have chronic diseases including frailty, early dementia
- Identity patients who will benefit from chronic disease management, frailty prevention and management and early dementia management plans
- Understand and implement treatment management plans, health assessments, team care arrangements for each patient cohort.
• Development and application of a Healthy Ageing Toolkit into routine general practice to identify and support the patient cohort with chronic conditions. The toolkit includes resources for assessments, management plans, MBS items, patient identification and recall reminders, QI cycle templates, referral pathways. Assessments can include 40-49 year old health assessments, healthy heart assessments, cognitive assessments, FRAIL scales. Treatments plans can include GP management plans, indications for practice nurse consultations, primary care multi-disciplinary case conferencing, HealthPathways to guide referrals. Supported uptake of use of MBS items relevant to chronic disease management, such as chronic disease management plans, health assessments, medication reviews, team care arrangements, and case conferencing. Through facilitation and education of use of the implemented toolkit, general practice professionals will provide care to patients with chronic conditions utilising the toolkit resources for a proactive early intervention for healthy ageing for patients aged 40-70 years. The toolkit will be used by general practice professionals providing care to a range of patients with chronic conditions, including frailty and early dementia.
Therefore, the frequency of the intervention will be continuous throughout the project duration and throughout the three sprints. It is anticipated that during the education, facilitation and implementation of the Healthy Ageing Toolkit, general practice professionals will provide care to patients with chronic conditions using the implemented toolkit and resources. No set frequency/duration of patient consultations will be measured. The uptake of the implemented Healthy Ageing Toolkit will be measured by pre- post- MBS item utilisation collected from the existing de-identified database at Adelaide Primary Health Network.
Education, facilitation and support will be provided to general practice professionals through various modes. Weekly online virtual huddles with each general practice will occur to facilitate and support uptake of the toolkit resources. An education session will occur face to face in a group setting during each sprint. The general practices will also be supported with online communication (Teams pages, emails) and occasional visits to each practice on sporadic, needs basis. During the implementation phase, general practice professionals will provide care to patients with chronic diseases utilising the Healthy Ageing toolkit and resources during their patient consultations (online, in person and in case conferencing with multi-disciplinary team members).
• Map local medical neighbourhood services for primary care referrals of services and team care arrangements.
Intervention code [1] 326553 0
Diagnosis / Prognosis
Intervention code [2] 326667 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335439 0
primary care service utilisation
Measured using regional primary care database collecting frequency of MBS items utilised.
Timepoint [1] 335439 0
pre- and post-12 month implementation phase
Primary outcome [2] 335440 0
Health related quality of life for adults with chronic conditions, measured using three quality of life instruments: QOL-ACC, SF-12 and EQ-5D-5L. This will be assessed as a composite outcome.
Timepoint [2] 335440 0
Measured at baseline, one-month, and three-months during the 12 month implementation phase
Primary outcome [3] 335643 0
Loneliness of patients with chronic disease. Measured using the UCLA loneliness scale
Timepoint [3] 335643 0
Baseline, one-month, three-months during the 12 month implementation phase
Secondary outcome [1] 424525 0
Effectiveness of training primary care professionals of early interventions for chronic diseases. Measured using evaluation surveys consisting of Likert scales and free text responses.
Timepoint [1] 424525 0
post 12 month implementation phase
Secondary outcome [2] 425040 0
Implementation outcomes assessed as a composite outcome: Barriers and enablers to implementing early interventions for chronic disease in primary care.
Implementation outcomes will be measured using semi-structured interviews with patients and primary care professionals.
Timepoint [2] 425040 0
Throughout 12 month implementation phase

Eligibility
Key inclusion criteria
- patients (or carers of patients) aged 40-70 years from included general practices with one or more chronic conditions, who provide informed consent
- primary care professionals (GPs, practice nurses, allied health professionals) who provide services to patients with chronic conditions
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- healthy people without chronic conditions
- people who are unable to provide informed consent due to cognitive or communication impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Implementation evaluation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics for quantitative pre- post- data
Thematic analysis for qualitative data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2023
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314316 0
Commercial sector/Industry
Name [1] 314316 0
Adelaide Primary Health Network
Country [1] 314316 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road,
Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 316268 0
None
Name [1] 316268 0
Address [1] 316268 0
Country [1] 316268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313425 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 313425 0
Ethics committee country [1] 313425 0
Australia
Date submitted for ethics approval [1] 313425 0
08/06/2023
Approval date [1] 313425 0
27/06/2023
Ethics approval number [1] 313425 0
6132

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

Contacts
Principal investigator
Name 128118 0
Prof Stacey George
Address 128118 0
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
Country 128118 0
Australia
Phone 128118 0
+61 872218287
Fax 128118 0
Email 128118 0
stacey.george@flinders.edu.au
Contact person for public queries
Name 128119 0
Heather Block
Address 128119 0
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
Country 128119 0
Australia
Phone 128119 0
+61 473845999
Fax 128119 0
Email 128119 0
heather.block@flinders.edu.au
Contact person for scientific queries
Name 128120 0
Stacey George
Address 128120 0
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
Country 128120 0
Australia
Phone 128120 0
+61 872218287
Fax 128120 0
Email 128120 0
stacey.george@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect patient confidentiality in line with ethics approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19892Ethical approval  heather.block@flinders.edu.au



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.