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Trial registered on ANZCTR


Registration number
ACTRN12618001970235
Ethics application status
Approved
Date submitted
3/12/2018
Date registered
5/12/2018
Date last updated
14/11/2019
Date data sharing statement initially provided
5/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The OPTIMISE project: Collaborative improvement of primary health care delivery to the Australian refugee community
Scientific title
The OPTIMISE project: Collaborative improvement of primary health care delivery to the Australian refugee community
Secondary ID [1] 296729 0
None
Universal Trial Number (UTN)
Not applicable
Trial acronym
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Refugee health 310595 0
Primary health care 310596 0
Condition category
Condition code
Public Health 309310 309310 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Procedures: a primary care practice based quality improvement intervention built on the principles of outreach practice facilitation where an experienced, external change agent visits the practice to provide support in change management that targets improvements in the delivery of evidence based care to patients.
Who: a refugee health fellow or refugee health nurse with extensive experience in refugee health matters
Mode of delivery: face to face and phone/email
Intervention: each practice will receive a minimum of 6 contacts with the practice facilitator. This includes 3x 1 hour face to face visits and 3 phone calls over the 6 month intervention period. Visits will be in months 1, 3 and 5; phone calls will be made in months 2, 4 and 6.
Location: Primary care practice
Materials: Evidence based guidelines for refugee health (Victorian Refugee Health Network, Australasian Society for Infectious Diseases and others) with a focus on refugee identification, interpreter use, conduct of comprehensive health assessments and referral.
Intervention code [1] 313040 0
Other interventions
Comparator / control treatment
All practices will receive the intervention (see above).
Recruited practices will undergo blinded, stratified random allocation into either the early or late intervention group using a minimization procedure.
Early group practices will start receiving the intervention immediately after recruitment. Late group practices will start the intervention 6-months after the date of completing the initial baseline data collection i.e. once the early group practices have completed the intervention.
Each group will serve as a control for the other.
Control group
Active

Outcomes
Primary outcome [1] 308272 0
Change in the documented rate of completion of a health assessment within the past 12 months.
This outcome will be measured using the electronic chart audit data to determine the proportion of eligible (within 12 months of arrival in Australia) refugee background patients whose records indicate billing for MBS items 701, 703, 705 or 707).
Timepoint [1] 308272 0
Pre intervention, post intervention, 6 month follow up
Secondary outcome [1] 354490 0
Change in the proportion of refugee patients with records with recorded refugee status (country of birth, ethnicity)

This outcome will be measured using the electronic chart audit data to determine the proportion of patients with at least one visit to the practice in the preceding two years who have either a country of birth or ethnicity and year of arrival corresponding to a recent humanitarian source country (as defined by the Department of Immigration and Border Protection Settlement Reporting Facility) OR have the term refugee or asylum seeker noted in their record.
Timepoint [1] 354490 0
Pre intervention, post intervention, 6 month follow up
Secondary outcome [2] 354492 0
Change in proportion of refugee patient consultations with documented use of credentialed interpreter, where one was required
Timepoint [2] 354492 0
Pre intervention, post intervention, 6 month follow up
Secondary outcome [3] 354494 0
Change in practice staff knowledge, attitudes and behaviours towards referring refugee patients to external health and welfare services for which their refugee patients are eligible.

This is a composite secondary outcome and will be determined using practice staff responses to survey questions on (i) use of established referral pathways, (ii) knowledge of bulk billing and/or bilingual secondary health services and (iii) difficulty identifying suitable services for clients with complex health or social welfare needs,

Surveys were designed specifically for the study.
Timepoint [3] 354494 0
Pre intervention, post intervention

Eligibility
Key inclusion criteria
To be eligible, primary care practices will:
• Be located in the identified priority catchment areas;
• Provide general primary care services including private (solo, group or corporate practices) or public community health centres;
• Plan to be in operation for at least the next two years without substantial change to governance or management;
• Be using electronic medical records and billing software compatible with PENCS CAT4™ de-identified data extraction software, namely Best Practice and Medical Director;
• Be willing to see patients of refugee background;
• Have at least 50% of GPs willing to participate in a practice facilitation intervention;
• Have no objection from other staff at the practice to the practice facilitation intervention or a de-identified medical record audit;

To be eligible, primary care practice staff will be: aged over 18 years, fluent in English and willing to see patients from a refugee background.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Have participated in an intensive practice facilitation intervention to improve refugee primary care in the last 12 months.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed through central randomisation by the project bio-statistician (see below for details)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following recruitment into the study practices will undergo blinded, stratified random
allocation into either the early or late intervention group using a minimization procedure.
To ensure that study groups are similar, practices will be stratified based on Region (1, 2, 3)
and Practice size (less than 5 full-time equivalent general practitioners or more than 5 full-time equivalent general practitioners). Minimisation was chosen as the allocation of a recruited practice can be determined shortly after recruitment, and it has the advantage of making small groups closely similar in terms of characteristics at all stages of the study.

A research team member who was not in contact with practices for recruitment or data
collection and blind to the identity of the practices will use minim software in a dos emulator to randomise by the method of minimisation. Wherever possible, batches (of two or more practices), will randomised at the same time.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Practices were allocated to either the immediate start group or late start group. Groups act as controls for each other.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes in practice performance relating to primary outcome measures will be assessed between early and late intervention practice groups using multilevel mixed effects models. Changes in provider and practice scores between early and late intervention groups will be assessed for clustering, and if not significant will be further explored through uni-level multivariate methods (e.g. logistic regression to investigate factors affecting the proportion of consultations with interpreter use). However, if practice-level clustering is indicated, then the mixed models will include a cluster-specific random effect to deal with clustering at the practice level. The independent variables will be intervention (1=early, 0=late) and time (0=baseline, 1=6 months, 2=12 months, 3=18 months). Provider and practice level covariates thought to influence outcomes will be included to adjust for baseline differences between the two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/09/2017
Date of last participant enrolment
Anticipated
Actual
5/02/2018
Date of last data collection
Anticipated
1/08/2019
Actual
25/09/2019
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 301323 0
Government body
Name [1] 301323 0
National Health and Medical Research Council
Country [1] 301323 0
Australia
Primary sponsor type
University
Name
Southern Academic Primary Care Research Unit, Department of General Practice, Monash University
Address
Level 1, Building 1, 270 Ferntree Gully Road, Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 301014 0
University
Name [1] 301014 0
Centre for Primary Health Care and Equity, The University of New South Wales
Address [1] 301014 0
Level 3, AGSM Building
University of New South Wales Australia
Sydney NSW 2052
Country [1] 301014 0
Australia
Secondary sponsor category [2] 301015 0
University
Name [2] 301015 0
Australian Institute for Primary Care & Ageing , La Trobe University
Address [2] 301015 0
Level 1
Health Sciences Building 1
La Trobe University
Melbourne Campus (Bundoora)
Victoria 3086 Australia
Country [2] 301015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302006 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 302006 0
Ethics committee country [1] 302006 0
Australia
Date submitted for ethics approval [1] 302006 0
12/07/2017
Approval date [1] 302006 0
18/08/2017
Ethics approval number [1] 302006 0
2017-10086
Ethics committee name [2] 302051 0
Monash Health Human Research Ethics Committee
Ethics committee address [2] 302051 0
Ethics committee country [2] 302051 0
Australia
Date submitted for ethics approval [2] 302051 0
24/08/2017
Approval date [2] 302051 0
27/09/2017
Ethics approval number [2] 302051 0
LNR/17/MonH/411
Ethics committee name [3] 302052 0
South West Sydney Local Hospital District Human Research Ethics Committee
Ethics committee address [3] 302052 0
Ethics committee country [3] 302052 0
Australia
Date submitted for ethics approval [3] 302052 0
15/09/2017
Approval date [3] 302052 0
03/10/2017
Ethics approval number [3] 302052 0
LNR/17/Lpool/391
Ethics committee name [4] 302053 0
La Trobe University Human Research Ethics Committee
Ethics committee address [4] 302053 0
Ethics committee country [4] 302053 0
Australia
Date submitted for ethics approval [4] 302053 0
27/07/2017
Approval date [4] 302053 0
18/08/2017
Ethics approval number [4] 302053 0
S17-138

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

Contacts
Principal investigator
Name 88830 0
Prof Grant Russell
Address 88830 0
Southern Academic Primary Care Research Unit,
Department of General Practice,
Monash University
Building 1, 270 Ferntree Gully Rd
Notting Hill VIC 3168
Country 88830 0
Australia
Phone 88830 0
+61 3 9902 4509
Fax 88830 0
Email 88830 0
grant.russell@monash.edu
Contact person for public queries
Name 88831 0
Grant Russell
Address 88831 0
Southern Academic Primary Care Research Unit,
Department of General Practice,
Monash University
Building 1, 270 Ferntree Gully Rd
Notting Hill VIC 3168
Country 88831 0
Australia
Phone 88831 0
+61 3 9902 4509
Fax 88831 0
Email 88831 0
grant.russell@monash.edu
Contact person for scientific queries
Name 88832 0
Grant Russell
Address 88832 0
Southern Academic Primary Care Research Unit,
Department of General Practice,
Monash University
Building 1, 270 Ferntree Gully Rd
Notting Hill VIC 3168
Country 88832 0
Australia
Phone 88832 0
+61 3 9902 4509
Fax 88832 0
Email 88832 0
grant.russell@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval not obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5684Study protocolRussell, G., Gunatillaka, N., Lewis, V. et al. The OPTIMISE project: protocol for a mixed methods, pragmatic, quasi-experimental trial to improve primary care delivery to refugees in Australia. BMC Health Serv Res 19, 396 (2019) doi:10.1186/s12913-019-4235-6https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-019-4235-6 


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.