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Trial registered on ANZCTR
Registration number
ACTRN12613000969763
Ethics application status
Not yet submitted
Date submitted
28/08/2013
Date registered
30/08/2013
Date last updated
30/08/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does free primary health care access reduce secondary care use in a vulnerable patient group?
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Scientific title
The effect of free primary health care access on health services utilisation by a socioeconomically disadvantaged patient population: A controlled before-and-after study.
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Secondary ID [1]
283098
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nil
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Universal Trial Number (UTN)
U1111-1147-2871
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Trial acronym
None
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental illness
289935
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Substance abuse
289936
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Social problems
289937
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Condition category
Condition code
Public Health
290310
290310
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0
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Health service research
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Mental Health
290331
290331
0
0
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Other mental health disorders
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Mental Health
290332
290332
0
0
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Addiction
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
Years
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Description of intervention(s) / exposure
Free primary health care access at Dunedin's free clinic (Servants Health Centre). The free clinic opened in January 2010, so the intervention period is January 2010 to December 2012. This "after" phase will be compared with the "before" phase, in which patients were receiving primary health care at other clinics from January 2007 to December 2012.
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Intervention code [1]
287815
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Not applicable
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Comparator / control treatment
Access to fee-for-service primary health care at other Dunedin clinics serving low income neighbourhoods ("treatment as usual"). The total study period is January 2007 to December 2012.
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Control group
Active
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Outcomes
Primary outcome [1]
290347
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Secondary care utilisation rates. Data on emergency department presentations and hospital admissions will be obtained from the National Non-Admitted Patient Collection and the National Minimum Dataset respectively. Primary care consultation data will be joined by record linkage (using a one-off key-coded identifier in lieu of the encrypted National Health Index) by the New Zealand Health Information Service to these secondary care datasets. The prevalence of "unfilled prescriptions" will be used a proxy for the extent of unmet health need, and will be inferred from the gap between prescriptions generated at the free clinic, as determined from the primary care consultation data above, and prescription items subsequently dispensed, as determined from the Pharmaceutical Collection.
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Assessment method [1]
290347
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Timepoint [1]
290347
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January 2007 to December 2012.
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Secondary outcome [1]
304337
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Health care expenditure. Basic costing methods will be used given the constraints of the proposed project (to be achieved within the timeframe of PhD study). Expenditure will be estimated using Diagnosis Related Groups (DRG) codes added by the Ministry of Health to the datasets mentioned above.
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Assessment method [1]
304337
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Timepoint [1]
304337
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January 2007 to December 2012.
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Eligibility
Key inclusion criteria
Enrolment at Dunedin's free clinic. A gatekeeping role is performed by the practice manager: criteria for enrolment include possession of a current Community Services Card (CSC, which is means-tested), and a variety of social vulnerability characteristics such as having a mental illness, substance abuse, an imprisonment record, prior child abuse. There is a degree of discretion with regards to the latter. Therefore, enrolment at the free clinic is implicitly associated with both socioeconomic deprivation and social vulnerability.
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Minimum age
0
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Not being resident in Dunedin prior to enrolment at the free clinic. Since there is almost certainly no fully appropriate comparator group, even among patients at Dunedin clinics serving low income catchment neighbourhoods, the primary outcome (secondary care usage) is being compared for free clinic patients pre- and post-enrolment (constituting in essence a before-and-after study). For this reason, study participants need to be resident in Dunedin during the pre-enrolment phase of the study period.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2007
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Actual
1/01/2007
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Date of last participant enrolment
Anticipated
31/12/2012
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Actual
31/12/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5344
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New Zealand
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State/province [1]
5344
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Otago
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Funding & Sponsors
Funding source category [1]
287852
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University
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Name [1]
287852
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University of Otago
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Address [1]
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Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
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Country [1]
287852
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
286581
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Address [1]
286581
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Country [1]
286581
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Other collaborator category [1]
277592
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Charities/Societies/Foundations
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Name [1]
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South Link Health
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Address [1]
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Level 9, Burns House
10 George Street, Dunedin 9016
PO Box 6032, Dunedin 9059
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Country [1]
277592
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
289793
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
289793
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Ethics Committees
Ministry of Health
PO Box 5013
Wellington 6145
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Ethics committee country [1]
289793
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New Zealand
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Date submitted for ethics approval [1]
289793
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02/09/2013
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Approval date [1]
289793
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Ethics approval number [1]
289793
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Summary
Brief summary
This study aims to assess whether access to free primary health care reduces secondary care use in vulnerable patient groups. Primary care and secondary care datasets will be joined using record linkage. Secondary care use for patients at Dunedin's free clinic will be compared before and after enrolment at the clinic. Secondary care use by patients at local clinics serving low income areas will also be studied to take into account the effect of temporal trends and external factors such as changes in hospital policy. A mixed methods study is being proposed, in which patient interviews in a qualitative phase are used to explain and interpret findings from the earlier quantitative phase. Factors associated with high usage of secondary care, other than the cost barrier to primary care, will be explored during these interviews.
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Trial website
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Trial related presentations / publications
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Public notes
The study uses routinely collected data during the first (quantitative) phase, so no participants are actually physically recruited, and the inclusion of participants' health data into the study appears to commence before ethics approval is obtained. Only in the second, qualitative phase is recruitment carried out, when 15-20 free clinic patients are selected for interviews on the basis of their health services usage patterns, in order to elucidate the reasons explaining these patterns.
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Contacts
Principal investigator
Name
42474
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Dr Lik Loh
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Address
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Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
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Country
42474
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New Zealand
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Phone
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+64-21-650126
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Fax
42474
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+64 3 4797431
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Email
42474
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[email protected]
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Contact person for public queries
Name
42475
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Prof Susan Dovey
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Address
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Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
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Country
42475
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New Zealand
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Phone
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+64 3 4794135
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Fax
42475
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+64 3 4797431
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Email
42475
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[email protected]
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Contact person for scientific queries
Name
42476
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Prof Peter Crampton
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Address
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Faculty of Medicine
University of Otago
PO Box 913
Dunedin 9050
New Zealand
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Country
42476
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New Zealand
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Phone
42476
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+64 3 4797454
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Fax
42476
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+64 3 479-5459
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Email
42476
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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