Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000600347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/04/2026
Date registered
Help: Date registered
13/05/2026
Date last updated
Help: Date last updated
13/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Mapping men's health systems use in Australian general practice: a study of engagement and drop out from primary care
Scientific title
Mapping men's health systems use – engagement and drop out from primary care: a secondary analysis of MedicineInsight national general practice data
Additional trial identifiers [1] 316963 0
Protocol Number: MedicineInsight-2025-008
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
men's health and wellbeing 341411 0
cardiovascular disease 341416 0
cancer 341417 0
respiratory diseases 341418 0
mental health 341419 0
sexual and reproductive health 341423 0
urological conditions 341546 0
Condition category
Condition code
Public Health 337474 337474 0 0
Health service research
Mental Health 337475 337475 0 0
Other mental health disorders
Cardiovascular 337476 337476 0 0
Coronary heart disease
Respiratory 337616 337616 0 0
Other respiratory disorders / diseases
Mental Health 337617 337617 0 0
Depression
Cancer 337618 337618 0 0
Any cancer
Cancer 337619 337619 0 0
Prostate
Metabolic and Endocrine 337620 337620 0 0
Metabolic disorders
Renal and Urogenital 337621 337621 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This is a secondary analysis of MedicineInsight, a national general practice dataset of de-identified patient-level data managed by the Australian Commission on Safety and Quality in Health Care (ACSQHC). MedicineInsight captures whole-of-practice electronic health record data from consenting general practices across all Australian states and Territories. The exposure of interest is engagement with Australian general practice, defined as one or more clinical encounters (consultation provided by a doctor, nurse, or nurse practitioner; administrative visit types excluded) recorded in MedicineInsight between 2015 and 2025. Eligible patients: aged 16 years or older with at least one recorded clinical encounter between 2015 and 2025 and a minimum of 12 months since last recorded encounter date. Observation period: up to 10 years (2015–2025) using longitudinal linked patient-level data.
Intervention code [1] 333694 0
Not applicable
Description of the comparator or control
Gender-disaggregated analyses will compare outcomes between men and women within the MedicineInsight dataset
Control group
Active

Outcomes
Primary outcome [1] 344983 0
Return to general practice care within 12 months of a flagged index encounter (as estimate of drop out of care)
Timepoint [1] 344983 0
Up to 12 months after index encounter
Primary outcome [2] 344984 0
Time to return to general practice after an index clinical encounter (continuity of care) determined from the MedicineInsight dataset
Timepoint [2] 344984 0
Time since index encounter (across available data period)
Secondary outcome [1] 460041 0
Reasons for general practice encounter
Timepoint [1] 460041 0
Across available data period.
Secondary outcome [2] 460042 0
Treatment pathways following index encounter (clinical observations) by main reason for encounter type
Timepoint [2] 460042 0
During encounter. For encounters over the available data period.
Secondary outcome [3] 460525 0
Treatment pathways following index encounter (diagnostic tests) by main reason for encounter type
Timepoint [3] 460525 0
During encounter For encounters over the available data period..
Secondary outcome [4] 460526 0
Treatment pathways following index encounter (mental health specialist/allied health referrals) by main reason for encounter type
Timepoint [4] 460526 0
During encounter. For encounters over the available data period.
Secondary outcome [5] 460529 0
Treatment pathways following index encounter (medicines prescribed) by main reason for encounter type
Timepoint [5] 460529 0
During encounter. For encounters over the available data period.
Secondary outcome [6] 460968 0
Annual frequency of GP encounters
Timepoint [6] 460968 0
Annual over the available data period
Secondary outcome [7] 460969 0
Proportion of eligible regular patients who have received a MBS billable 45-49 preventative health check
Timepoint [7] 460969 0
Age specific time points per patient across available data period
Secondary outcome [8] 460970 0
Proportion of eligible regular patients who have received a MBS billable 75+ preventative health check
Timepoint [8] 460970 0
Age specific time points per patient across available data period
Secondary outcome [9] 460971 0
Return to general practice care within 6 months of a flagged index encounter (as estimate of drop out of care)
Timepoint [9] 460971 0
Assessed at 6 months after index encounter
Secondary outcome [10] 460972 0
Return to general practice care within 3 months of a flagged index encounter (as estimate of drop out of care)
Timepoint [10] 460972 0
Assessed at 3 months after index encounter

Eligibility
Key inclusion criteria
1. Patient record held within a consenting MedicineInsight general practice 2. Aged 16 years or older at time of index encounter 3. At least one recorded clinical encounter (consultation by doctor, nurse, or nurse practitioner; not administrative) in MedicineInsight between 2015 and 2025 4. Minimum of 12 months elapsed since last recorded encounter date (to allow drop-out assessment)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Patients under 16 years of age at time of index encounter 2. Patients who have opted out of MedicineInsight data collection at the practice level 3. Administrative encounter records only (e.g. non-visit, practice admin, email) with no clinical encounter 4. Records with insufficient data quality to support time-to-event analyses (to be determined by the Statistician upon data access)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
indicative sample of 200,000 men with a minimum drop-out incidence of 10%, the study will have a greater than 99% power to detect a small but significant risk increase (hazard ratio of 1.10, Cox model). Analytic approach: All analyses will be conducted in R or Stata within a Secure Unified Research Environment (SURE) workspace (Sax Institute). Methods include: • Descriptive statistics (demographic and clinical characteristics, encounter frequency, diagnoses, prescribed medicines) • Cox proportional hazards models to estimate time to return after index encounter • Drop-out prevalence: proportion of patients with no return within defined periods (1, 3, 6, 12 months) • Multivariate regression to assess covariates associated with time to return and drop out • Cumulative effect plots comparing return probabilities across population subgroups • Marginal effect estimation for individual risk factor impact • Gender-disaggregated segmentation analyses • Simulated individualised modelled profiles for key subgroups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/05/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
200000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321558 0
Charities/Societies/Foundations
Name [1] 321558 0
Movember Foundation
Country [1] 321558 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Movember Foundation
Address
Country
Australia
Secondary sponsor category [1] 324346 0
None
Name [1] 324346 0
Address [1] 324346 0
Country [1] 324346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320094 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 320094 0
Ethics committee country [1] 320094 0
Australia
Date submitted for ethics approval [1] 320094 0
03/12/2025
Approval date [1] 320094 0
19/01/2026
Ethics approval number [1] 320094 0
2025-11-1991

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

Contacts
Principal investigator
Name 149406 0
A/Prof Zac Seidler
Address 149406 0
Movember (Australia), Level 4/21-31 Goodwood St, Richmond VIC 3121
Country 149406 0
Australia
Phone 149406 0
+61432 438 254
Fax 149406 0
Email 149406 0
[email protected]
Contact person for public queries
Name 149407 0
Marg McGee
Address 149407 0
Movember (Australia), Level 4/21-31 Goodwood St, Richmond VIC 3121
Country 149407 0
Australia
Phone 149407 0
+61420958403
Fax 149407 0
Email 149407 0
[email protected]
Contact person for scientific queries
Name 149408 0
Marg McGee
Address 149408 0
Movember (Australia), Level 4/21-31 Goodwood St, Richmond VIC 3121
Country 149408 0
Australia
Phone 149408 0
+61420958403
Fax 149408 0
Email 149408 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.