Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000958381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/07/2026
Date registered
Help: Date registered
4/08/2026
Date last updated
Help: Date last updated
4/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Early Interventions for Healthy Ageing for Older People in Primary Care
Scientific title
Assessing the impact of a bundled intervention program on quality of life in Older People accessing Primary Care
Additional trial identifiers [1] 317920 0
Nil
Universal Trial Number (UTN)
Trial acronym
EIP3
Related trial records

Health condition
Health condition(s) studied:
healthy ageing 342864 0
Quality of life 342866 0
Social wellbeing 342867 0
Condition category
Condition code
Public Health 338984 338984 0 0
Health service research
Mental Health 339080 339080 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Project Design:
This research will include a pre-post study with mixed-methods approach underpinned by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation frameworks.

Intervention and activities:
The project involves implementation of a bundled intervention involving the following components: pre-assessment checklist completed by patients, nurse-coordination of health assessments, GP care planning, discussions and recommendations about advanced care directives (ACD) planning, and discussions and recommendations for social prescribing. The intervention will be delivered in 12 general practices across Adelaide metropolitan region.
Implementation Phase:
Implementation of bundled intervention involving nurse-coordination of health assessments, care planning, advanced care directives (ACD) planning, and social prescribing will be completed by general practice team members (practice nurses, GPs, practice managers) from the 12 participating general practices. To support implementation, external facilitation from Quality Improvement Performance (QIP) Consulting will occur from July 2026 - April 2027. During the initial 3 months of the project, practices will be required to identify and recruit patients that fit eligibility criteria, then provide the bundled intervention within exiting Medicare (MBS) billable consultations i.e chronic condition management planning/review appointments, practice nurse health assessments and/or 75+ health assessments (for those over 75 years). During this 9-month implementation phase Quality Improvement Performance (QIP) Consulting will support each practice in quality improvement processes and undertake communities of practice to facilitate implementation.

Pre-assessment checklist:
General practices will provide their patients with a pre-assessment checklist designed for this study, Healthy Home (home-check), Planning Ahead and Staying Social. The checklist is accessible via QR code to an online questionnaire. The pre-assessment will take up to 20 minutes. The pre-assessment will include information about their home environment, home safety hazards (steps, stairs, rugs, lighting etc), readiness for information about advanced care directive planning, level of social interactions per week and readiness for information about social activities.
The pre-assessment checklist will be provided to patients at recruitment, Patients will be requested to complete the pre-assessment prior to their next clinic consultation.

Health Assessments and GP care planning:
GPs and practice nurses will encourage uptake of routinely used general practice health assessments and chronic condition management care planning with their recruited patients. The health assessments and chronic condition care planning are MBS funded items that GPs and practice nurses can implement with eligible patients for long-term management and proactive and preventative approaches to health and wellbeing. Health assessments and care planning appointments will be conducted with patients at the GP clinic by a GP and practice nurse Health assessments and chronic condition care planning items vary between practices, but commonly include height, weight, blood pressure, cardiovascular risk, vaccination status, smoking status, alcohol intake, risk of depression or anxiety, risk of social isolation or loneliness, risk of cognitive changes, risk of frailty, falls or mobility issues, risk or nutrition concerns, home and safety concerns. Health assessments and chronic condition care planning can also be tailored to address patient's specific concerns that arise and health goals, with referrals to allied health professionals and specialists, health education, follow up tests and scans based on individual patient's concerns or health issues. During these appointments, general practice clinicians will discuss and recommend options for advanced care planning and social prescribing. Health assessments and chronic condition care planning appointments generally take up to 1 hour with the nurse and GP.
Practice teams will be encouraged to complete a the following components of health assessments and care planning: 1) initial health assessment and education - up to 1 hour, 2.) GP led chronic condition management plan within next 3 months (or as eligible depending of MBS criteria) - up to 1 hour, 3.) Health review by practice nurse 6-weeks later - up to 20 minutes, 4) Review of chronic condition management plan 3 months later - up to 1 hour. These assessments, care planning and reviews will be completed with GP and nurse with patients in the GP clinic.

Advance care directive planning:
During the health assessment and chronic condition care planning appointments outlined above, GPs and practice nurses will provide information and education about advanced care directives. Clinicians will provide patients with a range of routinely available education resources about advanced care directives, including a kit to complete advanced care directives. These resources are Advance Care Directive Kits available from Government of South Australia (2023), and information sheets and brochures about how to complete an advance care directive available from Advance Care Planning Australia (not dated). Throughout the program, practice teams will promote the uptake of advanced care planning and uploading completed directives to My Health Record.

Social prescribing:
During the health assessment and chronic condition planning appointments outline above, GPs and practice nurses will provide information and education about social activities and the importance of social connections on health. Clinicians will provide patients with information about community and council led services available in their local area including social groups, community centres and libraries, seniors activity programs, volunteer agencies, transport assistance, strength and balance programs, walking groups, falls prevention classes, carer services, My Aged Care referral for long-term home support. At subsequent clinic appointments throughout the program, practice nurses will ask patients about their level of engagement with recommended social activities provided.

Quality improvement approach to facilitate implementation:
QIP consulting will provide external facilitation and supervision to the general practices to support implementation through quality improvement processes. Quality improvement (QI) processes include QI planning through an audit practice teams will complete on their practice software to identify patients aged 65+ years eligible for health assessments and chronic condition care planning. QI Planning will inform gaps in care and inform QI plan to address gaps, set goals, and complete small tests of change using Plan, Do, Study, Act (PDSA) process. Practices will monitor adherence to the QI plans using a PDSA template designed specifically for this study.
QIP consulting will meet with each practice on a monthly basis for 1 hour throughout the project implementation phase to focus on supporting recruited patients through the health assessment and care planning pathway, review progress against QI plans, provide support of general practice workflows, share learnings. QIP consulting will host 3x two hour face to face community of practice workshops. Communities of practice will involve: 1) practice sharing of what they have implemented, what has changed, what they are seeing; 2) consumer stories - sharing their patient's experience of ageing, care received, advance care planning and social supports; 3) connections with allied health and medical pathways for referral pathways, services, access criteria and connection points with external services.
Practices will be provided with a "2026-2027 Early Interventions for Healthy Ageing in Primary Care Practice Toolkit" designed specifically for this study by QIP Consulting and Adelaide Primary Health Network.
General practices will report adherence for each of the components of the bundled intervention (number and MBS items of health assessments, care planning appointments, outcomes of advance care planning and social prescribing discussions), in addition to clinical characteristics of patients in a spreadsheet database, specifically designed for this project.
Intervention code [1] 334764 0
Treatment: Other
Description of the comparator or control
Pre-implementation data collected with be compared with post-implementation data to measure comparison of outcomes.
Pre-implementation phase will be July-September 2026. During this phase the practices will: 1) complete general practice team survey of knowledge, confidence, perceived barriers; and 2) a subset of practices will complete the Mobilising Integrated Promoting Action on Research
Implementation in Health Services (Mi-PARIHS) Tool.. During pre-implementation phase, practices will identify and recruit patients. Patients will complete baseline measures for quality of life and social wellbeing outcomes.
Control group
Active

Outcomes
Primary outcome [1] 346219 0
Quality of life
Timepoint [1] 346219 0
Baseline - pre-implementation phase, and 9-months post baseline assessment
Primary outcome [2] 346220 0
Quality of Life
Timepoint [2] 346220 0
Baseline (pre-implementation) and 9-months post baseline assessment
Secondary outcome [1] 465051 0
Social Connectedness
Timepoint [1] 465051 0
Baseline (pre-implementation), and 9-months post baseline assessment
Secondary outcome [2] 465052 0
Satisfaction of the healthy ageing program
Timepoint [2] 465052 0
Post-implementation phase - 9-months post baseline assessments completed
Secondary outcome [3] 465053 0
Levels of knowledge of health assessments, advanced care planning, social prescribing from general practice team members. This will be assessed as a composite outcome
Timepoint [3] 465053 0
Baseline (pre-implementation) and 9-months post baseline assessment
Secondary outcome [4] 465054 0
Barriers to implementation
Timepoint [4] 465054 0
Post-implementation between 9-12 months post baseline
Secondary outcome [5] 465055 0
Implementation factors for facilitation of implementation of general practices
Timepoint [5] 465055 0
Baseline (pre-implementation) and 9-months post baseline assessment (post-implementation)
Secondary outcome [6] 465056 0
Sustainability
Timepoint [6] 465056 0
Post-implementation phase at 9-months post-baseline assessments completed
Secondary outcome [7] 465416 0
Confidence in health assessments, advanced care planning, social prescribing from general practice teams. This will be assessed as a composite outcome
Timepoint [7] 465416 0
Baseline (pre-implementation) and 9-months post baseline assessment
Secondary outcome [8] 465417 0
Perceived barriers to implementing health assessments, advanced care planning, social prescribing from general practice teams. This will be assessed as a composite outcome
Timepoint [8] 465417 0
Baseline (pre-implementation phase) and 9-months post baseline assessment.
Secondary outcome [9] 465418 0
Enablers to implementation
Timepoint [9] 465418 0
Post-implementation between 9-12 months post-baseline assessments completed
Secondary outcome [10] 465419 0
Patient perspectives of the program
Timepoint [10] 465419 0
Post-implementation - 9 months post baseline assessments were completed
Secondary outcome [11] 465436 0
Reach
Timepoint [11] 465436 0
Post-implementation phase (April-June) 2027
Secondary outcome [12] 465437 0
Effectiveness
Timepoint [12] 465437 0
Pre-implementation phase for baseline assessment and 9-months later for post-implementation assessments.
Secondary outcome [13] 465438 0
Adoption
Timepoint [13] 465438 0
Post-implementation phase (April-June 2027), 9 months post baseline measures were completed

Eligibility
Key inclusion criteria
Patient Inclusion Criteria:
Patients are eligible to participate to receive the bundled intervention and participate in the research evaluation if they
are:
- aged 65 years or older
- Have one or more chronic condition (previously diagnosed and recorded by the general practice). Chronic conditions may include and are not exclusive to cardiovascular diseases, diabetes, asthma, arthritis, anxiety, depression, musculoskeletal conditions, dementia, chronic obstructive pulmonary disease.
- Are an active patient at the participating general practice (defined as having 3 or more clinical consultations at the general practice in the past 24 months).
- Are able to provide informed consent to participate
- Able to participate in regular consultations with their general practice and undertake the research activities
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- older people who do not consent to participation
- Older people with cognitive, behavioural, acute medical concerns that may impact on participating in the healthy ageing bundle of intervention (as identified by general practice health professional)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Implementation design.
All practices will commence the pre-implementation phase in parallel from July-September 2026. Implementation of the intervention will commence across all participating practices in parallel for 9 months. post-implementation data collection will occur from April-July 2027.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Each general practice will recruit n=40 patients that meet inclusion criteria who may benefit from receiving the bundled intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2026
Actual
Date of last participant enrolment
Anticipated
30/04/2027
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 322456 0
Government body
Name [1] 322456 0
Adelaide Primary Health Network
Country [1] 322456 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 325384 0
Government body
Name [1] 325384 0
Adelaide Primary Health Network
Address [1] 325384 0
Country [1] 325384 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320947 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 320947 0
Ethics committee country [1] 320947 0
Australia
Date submitted for ethics approval [1] 320947 0
20/04/2026
Approval date [1] 320947 0
29/05/2026
Ethics approval number [1] 320947 0
9831

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

Contacts
Principal investigator
Name 152170 0
Dr Heather Block
Address 152170 0
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 152170 0
Australia
Phone 152170 0
+61 08 82013911
Fax 152170 0
Email 152170 0
[email protected]
Contact person for public queries
Name 152171 0
Heather Block
Address 152171 0
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 152171 0
Australia
Phone 152171 0
+61 08 82013911
Fax 152171 0
Email 152171 0
[email protected]
Contact person for scientific queries
Name 152172 0
Heather Block
Address 152172 0
Flinders University, Sturt Road, Bedford Park, South Australia, 5042
Country 152172 0
Australia
Phone 152172 0
+61 08 82013911
Fax 152172 0
Email 152172 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.