Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000797673
Ethics application status
Approved
Date submitted
15/07/2014
Date registered
28/07/2014
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving ways of thinking and ways of doing (WoTWoD) Aboriginal and Cross Cultural Health in General Practice
Scientific title
A cluster randomised trial to examine the whether the “Ways of Thinking and Ways of Doing (WoTWoD)" Program and Toolkit improves cultural respect and delivery of culturally and clinically appropriate health care to Aboriginal patients in Australian general practice.
Secondary ID [1] 284985 0
Nil
Universal Trial Number (UTN)
Trial acronym
WoTWoD Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health inequities and culturally inappropriate health care in general practices for Aboriginal Australians. 292489 0
Condition category
Condition code
Public Health 292800 292800 0 0
Health service research
Public Health 292853 292853 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have developed a Toolkit and care partnership strategy – “Ways of Thinking and Ways of Doing” (WoTWoD)” to assist Australian general practices to provide culturally and clinically appropriate health care to Aboriginal people. Intervention practices will use WoTWoD for 12 months and we will then examine whether the WoTWoD improves cultural respect and delivery of culturally and clinically appropriate care to Aboriginal Australians.

In brief, the Toolkit is a whole-of-practice clinical re-design process to embed cultural respect in general practice. It includes ten case-scenarios describing management of Aboriginal patients at general practice setting and each scenario is followed by a narrative about whether the patient was managed in a culturally and clinically appropriate manner. It describes both aspects of the patient management – proper and improper – providing an explanation and guidance to the general practice staff how the patient could have provided high quality health care (both clinically and culturally). The Toolkit also includes a “Cultural Respect Framework” and also explains the importance of it. The other components of the Toolkit includes a “Self-Assessment” template for the practice staff to use to assess what are being done at the practices to accommodate the needs of the Aboriginal patients and an “Action Plan” template for practice staff to use to address their shortcomings (if any). The other two components of the “Toolkit” include a list of resources and recommended readings that practice staff can utilize.

For the intervention practice staff a 4-hour workshop will be organized to train them how the Toolkit should be used. The workshop will be face-to-face and presentation will be made by experts both Aboriginal and non-Aboriginal, but all expert in Aboriginal Health. After the workshop all the intervention practices will be visited by 1-2 trained Aboriginal Cultural Mentors who will assist practices to implement the Toolkit over the next 12 months.

At each Primary Health Network (PHN) area a Local Care Partnership (LCP) will be formed which will include representative from the Close the Gap staff from the PHN, representative from the local Aboriginal communities and also the Aboriginal Cultural Mentor(s). The LCP and members from the research will be in regular touch with the practices to monitor adherence to the intervention by the practices.
Intervention code [1] 289816 0
Early detection / Screening
Intervention code [2] 289817 0
Prevention
Intervention code [3] 289818 0
Lifestyle
Comparator / control treatment
General practices that will not implement WoTWoD Program and Toolkit
Control group
Active

Outcomes
Primary outcome [1] 292652 0
clinically appropriate Aboriginal health care will as assessed by the number of Aboriginal health assessments (MBS Item#715) done by GPs in each practice.

Timepoint [1] 292652 0
Baseline and at 12 months
Primary outcome [2] 292653 0
Cultural respect among practice staff will be measured using Cultural Quotient (CQ) instrument. CQ is a 20-item self-questionnaire will be filled in by the practice staff.
Timepoint [2] 292653 0
Baseline and 12 months
Secondary outcome [1] 309421 0
the number of Aboriginal patients shared with Aboriginal Community Controlled Health Services to ensure culturally appropriate care
Timepoint [1] 309421 0
Baseline and 12 months
Secondary outcome [2] 309422 0
Clinically appropriate health care as evident by an increased adherence to Aboriginal-specific clinical guidelines for common chronic conditions. This data will be part of the clinical audit of the practice database that we will conduct at baseline and 12 months. We will obtain the number of the Aboriginal patients who had their chronic disease risk factors measured (at least once) /recorded in the past 12 months. The risk factors that we will look at include BMI, blood lipids and sugar, blood pressure, smoking and alcohol intake etc.
Timepoint [2] 309422 0
Baseline and 12 months
Secondary outcome [3] 309423 0
culturally appropriate health care generally as assessed by patient satisfaction
Timepoint [3] 309423 0
at 12 months
Secondary outcome [4] 309424 0
Practice perceptions on the appropriateness of embedding WoTWoD into routine practice. This data will be collected through semi-structure interview of 1-2 staff from the intervention practices. The interview schedule has been prepared and approved by the ethics committees. Interviews will be conducted by an independent professional interviewer.
Timepoint [4] 309424 0
at 12 months
Secondary outcome [5] 309425 0
number of Aboriginal patients identified would also be collected via the audit for use as a denominator for the measure of the effectiveness of the WoTWoD
Timepoint [5] 309425 0
Baseline and 12 months

Eligibility
Key inclusion criteria
General practice staff (GPs, practice manager and nurses) working at the practices located in the 3 Primary Health Networks (PHNs) in Sydney (South Western Sydney, Central and Eastern Sydney and Western Sydney) and 2 PHNs (Eastern Melbourne and North Western Melbourne).

Aboriginal patients attending participating general practices .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years

For patients
1) Not Australian Aboriginal or Torres Strait Islander
2) Has cognitive impairment and not able to provide a 10-15 mins telephone interview

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)
Randomisation will be conducted at practice level. The practices that will be randomized into the intervention group will attend a cultural respect workshop followed by an Aboriginal cultural mentor visit who will assist them to implement WoTWoD Program Toolkit. "STATA statistical package will be used to generate the randomisation sequence. Practices will be stratified by size and whether they take 1st year or 2nd year GP registrar and randomised in blocks. Stratified random allocation will be conducted to obtain an equal distribution of these 2 attributes. Randomisation will be carried out using a computer-generated randomization program with a minimisation algorithm to ensure a balance of practice characteristics that could potentially affect practice’s ability to implement the WoTWoD Program and Toolkit. Allocation will be concealed and the method that will be used is contacting the holder of the allocation schedule who is “off-site” (a senior research staff from the Sydney University).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
STATA statistical package will be used to generate the randomisation sequence. Practices will be stratified by size and whether they take 1st year or 2nd year GP registrar and randomised in blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Nationally, 81,093 MBS item#715 were claimed in 2011; using the ABS 2011 census figures of 548,368 Aboriginal people as the denominator, the proportion of uptake is 14.8%. The Marumali Brokerage Service in SW Sydney claimed 330 MBS item#715 in the first quarter of 2011. Using the approximately 11,000 Aboriginal people in its catchment, the projected proportion of uptake for 2011 is estimated at 13.6%. Uptake in our pilot was about 20%. We estimate that the baseline uptake of MBS item#715 is between 10-15% of the estimated Aboriginal population. We aim to achieve a change from 15% to 40% in the amount of MBS item#715 claimed. This is reasonable because the intervention is quite intensive. The sample size can be calculated based on whether we use the patient or the practice as the unit of analysis:
1) Patients as unit of analysis: If we assume a difference of 30% in the proportion of patients in the intervention group (45%) and control group (15%) receiving a health check, for a beta of 0.8, a of 0.05 and a 2-sided test to detect a change, we need to recruit 36 people in each arm of the study. Conservatively assuming a design effect of 4 due to clustering of this outcome by practice the required sample size is 144. We estimate that we will recruit 5 patients per practice. Thus we will need 29 practices in each arm or 58 practices in total in Sydney and Melbourne combined.
2) Practice and practice staff as unit of analysis: The above sample size is adequate to detect an increase in the Cultural Quotient score from a mean of 80 (50%) to 114 (70%) or 130 (80%).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
1/04/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
30/06/2017
Date of last data collection
Anticipated
30/06/2017
Actual
30/06/2017
Sample size
Target
58
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 289609 0
Government body
Name [1] 289609 0
National Health and Medical Research Council (NHMRC)
Country [1] 289609 0
Australia
Primary sponsor type
University
Name
UNSW Australia
Address
UNSW Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 288293 0
University
Name [1] 288293 0
The University of Melbourne
Address [1] 288293 0
The University of Melbourne
Victoria 3010
Country [1] 288293 0
Australia
Other collaborator category [1] 278056 0
Other
Name [1] 278056 0
GP Synergy
Address [1] 278056 0
PO Box 3398
Liverpool Westfield
NSW 2170
Country [1] 278056 0
Australia
Other collaborator category [2] 278057 0
Other
Name [2] 278057 0
Gandangara Local Aboriginal Land Council
Address [2] 278057 0
PO Box 1038
Liverpool BC 1871
Country [2] 278057 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291346 0
UNSW Australia - Human Research Ethics Committee
Ethics committee address [1] 291346 0
Ethics committee country [1] 291346 0
Australia
Date submitted for ethics approval [1] 291346 0
Approval date [1] 291346 0
12/03/2014
Ethics approval number [1] 291346 0
14036
Ethics committee name [2] 291347 0
The University of Melbourne - Human Research Ethics Committee
Ethics committee address [2] 291347 0
Ethics committee country [2] 291347 0
Australia
Date submitted for ethics approval [2] 291347 0
Approval date [2] 291347 0
02/04/2014
Ethics approval number [2] 291347 0
1441978
Ethics committee name [3] 291348 0
The Royal Australian College of General Practitioners (RACGP) - National Research and Evaluation Ethics Committee (NREEC)
Ethics committee address [3] 291348 0
Ethics committee country [3] 291348 0
Australia
Date submitted for ethics approval [3] 291348 0
Approval date [3] 291348 0
08/07/2014
Ethics approval number [3] 291348 0
NREEC 14-009
Ethics committee name [4] 295424 0
Aboriginal Health and Medical Research Council -HREC
Ethics committee address [4] 295424 0
Ethics committee country [4] 295424 0
Australia
Date submitted for ethics approval [4] 295424 0
20/03/2014
Approval date [4] 295424 0
01/03/2015
Ethics approval number [4] 295424 0
1005/14

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

Contacts
Principal investigator
Name 48198 0
Prof Siaw-Teng Liaw
Address 48198 0
General Practice Unit (Research)
Level 3, Ingham Institute for Applied Medical Research
1, Campbell Street, Liverpool, NSW 2170
Country 48198 0
Australia
Phone 48198 0
+61 2 87389347
Fax 48198 0
Email 48198 0
[email protected]
Contact person for public queries
Name 48199 0
Iqbal Hasan
Address 48199 0
General Practice Unit (Research)
Level 3, Ingham Institute for Applied Medical Research
1, Campbell Street, Liverpool, NSW 2170
Country 48199 0
Australia
Phone 48199 0
+61 2 87389330
Fax 48199 0
Email 48199 0
[email protected]
Contact person for scientific queries
Name 48200 0
Iqbal Hasan
Address 48200 0
General Practice Unit (Research)
Level 3, Ingham Institute for Applied Medical Research
1, Campbell Street, Liverpool, NSW 2170
Country 48200 0
Australia
Phone 48200 0
+61 2 87389330
Fax 48200 0
Email 48200 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseCultural respect in general practice: a cluster randomised controlled trial.2019https://dx.doi.org/10.5694/mja2.50031
N.B. These documents automatically identified may not have been verified by the study sponsor.