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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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?
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.
Secondary ID [1] 283098 0
nil
Universal Trial Number (UTN)
U1111-1147-2871
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 289935 0
Substance abuse 289936 0
Social problems 289937 0
Condition category
Condition code
Public Health 290310 290310 0 0
Health service research
Mental Health 290331 290331 0 0
Other mental health disorders
Mental Health 290332 290332 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Years
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.
Intervention code [1] 287815 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 290347 0
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.
Timepoint [1] 290347 0
January 2007 to December 2012.
Secondary outcome [1] 304337 0
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.
Timepoint [1] 304337 0
January 2007 to December 2012.

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.
Minimum age
0 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 5344 0
New Zealand
State/province [1] 5344 0
Otago

Funding & Sponsors
Funding source category [1] 287852 0
University
Name [1] 287852 0
University of Otago
Address [1] 287852 0
Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country [1] 287852 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 286581 0
None
Name [1] 286581 0
Address [1] 286581 0
Country [1] 286581 0
Other collaborator category [1] 277592 0
Charities/Societies/Foundations
Name [1] 277592 0
South Link Health
Address [1] 277592 0
Level 9, Burns House
10 George Street, Dunedin 9016
PO Box 6032, Dunedin 9059
Country [1] 277592 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289793 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 289793 0
Ethics Committees
Ministry of Health
PO Box 5013
Wellington 6145
Ethics committee country [1] 289793 0
New Zealand
Date submitted for ethics approval [1] 289793 0
02/09/2013
Approval date [1] 289793 0
Ethics approval number [1] 289793 0

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.
Trial website
Trial related presentations / publications
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.

Contacts
Principal investigator
Name 42474 0
Dr Lik Loh
Address 42474 0
Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 42474 0
New Zealand
Phone 42474 0
+64-21-650126
Fax 42474 0
+64 3 4797431
Email 42474 0
lik_wei@mac.com
Contact person for public queries
Name 42475 0
Prof Susan Dovey
Address 42475 0
Department of General Practice & Rural Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 42475 0
New Zealand
Phone 42475 0
+64 3 4794135
Fax 42475 0
+64 3 4797431
Email 42475 0
susan.dovey@otago.ac.nz
Contact person for scientific queries
Name 42476 0
Prof Peter Crampton
Address 42476 0
Faculty of Medicine
University of Otago
PO Box 913
Dunedin 9050
New Zealand
Country 42476 0
New Zealand
Phone 42476 0
+64 3 4797454
Fax 42476 0
+64 3 479-5459
Email 42476 0
peter.crampton@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary