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Trial registered on ANZCTR


Registration number
ACTRN12623000231640
Ethics application status
Approved
Date submitted
24/01/2023
Date registered
3/03/2023
Date last updated
3/03/2023
Date data sharing statement initially provided
3/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Good Way Yarning for Better Health: Implementing Clinical Yarning in Western Australia's Midwest - Phase 1
Scientific title
Good Way Yarning for Better Health: Implementing Clinical Yarning for health professionals across Western Australia's Midwest - Phase 1
Secondary ID [1] 308815 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical Communication 328773 0
Health Literacy 328857 0
Condition category
Condition code
Public Health 325781 325781 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The overall project is a mixed-method implementation study conducted over four phases. The ethics approval and this register is for phase one, a context analysis that includes understanding Aboriginal patients experience of communication (objective 1 – mixed method design using a patient survey and qualitative data collection); developing a system to collate existing health care information known to be associated with patient-practitioner communication (objective 2 – system development and retrospective audit of data from patient health care databases); and investigating barriers and enablers to implementing Clinical Yarning in Midwest (objective 3 – qualitative interviews with health care staff). The overall project has subsequent phases (develop implementation plan (Phase 2), roll out the implementation of Clinical Yarning (Phase 3) and Phase 4, measure change and understand implementation process which will be registered at a later date.

Objectives:
(Phase 1)
1. To understand Aboriginal patients experiences of communication in the Midwest. This will involve interviewing Aboriginal adult inpatients and outpatients from six Midwest health sites. The sampling frame for inpatients are all Aboriginal patients about to be discharged in a specified one-week period. The sampling frame for outpatients is a computer-generated random sample of all Aboriginal patients discharged within the previous 2 weeks. The overall sample size is 90 patients. The data collection will occur three times across the three-year project. Interviews can last up to 30 minutes. Interviews are to gather base line data of Aboriginal patient experiences prior to further project phases. Interviews will be repeated at 12 months (after Clinical Yarning training with Midwest staff) and at 24 months post initial data collection.

2. Develop a system to collate and analyse existing health care data that is associated with communication. This will involve collecting a range of data associated with patient communication experiences currently collected by local authorities over the past year and disaggregated into 6-month intervals, in order to provide a ‘snapshot’ of Aboriginal patients’ experiences. A search strategy and curated dataset will be developed to extract data from a range of data management systems to provide a baseline and enable ongoing monitoring and will include such things as take own leave (TOL), did not wait (DNW) in the emergency department, abscond or go missing, self-discharge, leave at their own risk (LOR), are away without leave (AWOL) or discharge against medical advice (DAMA). In addition,
• Consumer feedback about the health service.
• Patient re-admission and re-presentation rate within 30 days for the same health care problem. These data will be described in terms of overall incidence, number of re-admissions/re-presentations for Aboriginal/non-Aboriginal patients per 1000 health service separations, as a whole health region and disaggregated by site and clinical area within the Midwest. A curated dataset and search process will be developed in the initial phases of the project. These data are being collected from Midwest/state health databases, including consumer feedback.

3. To ascertain barriers and enablers to implementing Clinical Yarning training across the Midwest region at the individual, health service, and system-level. This will involve participants from five staff groups (Aboriginal staff, medical, nursing, allied health, managerial staff) working in, or visiting, each of the six sites in the Midwest. The sample size is approximately 20-30 or until thematic saturation has been reached. Purposive sampling using a maximum variation approach will be used to include the groups and sites. Focus groups of up to four participants and/or individual semi-structured interviews either face to face or via digital means. Research team members will conduct the interviews, which will be audio recorded and then transcribed.

Intervention code [1] 325415 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333630 0
Barriers and enablers to implementing Clinical Yarning in the Midwest region of Western Australia will be known from theoretical domains framework analysis of collected data. The data set will comprise of Aboriginal patient experience data collected in semi-structured interviews with members of the research team, interview data from health workforce collected by research team members. .
Timepoint [1] 333630 0
7 months post implementation of the context analysis phase
Secondary outcome [1] 417811 0
Cultural Safety assessed using Cultural Safety Survey Scale tool
Timepoint [1] 417811 0
12 and 24 months post-commencement of the context analysis phase

Eligibility
Key inclusion criteria
1: Inclusion criteria are Aboriginal adult inpatients and outpatients, aged 18 years or older, who have either been discharged within the previous two weeks (outpatient or emergency patient) or about to be discharged (inpatient), are able to complete the survey (Cultural Safety Survey Scale - CSSS), and provide consent to participate.

2: Inclusion criteria is all Aboriginal and Torres Strait Islander patients who have attended the six WACHS-Midwest sites within the past year.

3: Inclusion criteria are WACHS-Midwest staff from five groups (Aboriginal staff, medical, nursing, allied health, managerial staff) who provide consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if the inclusion criteria is not met.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis


Data Management and Analysis: Information from the Cultural Safety Survey Scale (CSSS) (1) will be entered/imported into SPSS. Descriptive statistics will be calculated summarising demographic information, overall CSSS score and sub scores for the domains related to communication. In order to check if the sample is similar to the usual population of Aboriginal patients, we will compare age and sex to assess whether they are within reasonable bounds; a mean age within 5 years and sex proportion within 10%. Variations will be reported in the analysis and acknowledged in the limitations. Audio-recorded patient stories will be transcribed using a secure, online artificial intelligence transcribing application. Written stories will be typed or imported into a word document. Qualitative data will be managed using Nvivo (QSR International), qualitative data management software. Analysis will be informed by interpretative description. Interpretive description is an inductive analysis approach that draws on a number of epistemological positions and aims to understand phenomena in a way that is applicable to clinical situations. Following this approach, we will develop a conceptual description of patients’ health care communication experiences. We also will triangulate qualitative patient experiences to results of the CSSS, in order to check congruence between the quantitative and qualitative results.
Objective 2 Data Management and Analysis: Initially manual searches will be completed in each dataset. A curated dataset and search process will be developed in the first 6 months of the project. Raw data and descriptive analysis as outlined above will be undertaken using health information data management interfaces and summarised. Key data will be displayed visually using decomposition trees as a way to visually depict the health service journey related to communication. Key data will be imported into SPSS in order to analyse changes over time in future phases.
Objective 3 Data Management and Analysis: Focus groups will be recorded and transcribed verbatim using a secure, online artificial intelligence transcribing application and imported into NViVo (QSR International). Framework analysis using the Theoretical Domains Framework (TDF) as the theoretical framework will be undertaken. Transcriptions will be read in detail by researchers. Two researchers will independently undertake a preliminary analysis of one transcription using the TDF as the initial thematic framework. Researchers will then compare their analyses, discussing any differences, returning to the data to clarify discrepancies, and developing a common analysis framework via consensus. This will be the basis of ongoing analysis with all researchers acting as ‘critical friends’ in order to prompt re-examination and interpretation of data. Based on these steps a final summary will be developed of the multidimensional barriers and enablers for clinicians to utilise Clinical Yarning and for the Midwest regional health service to deliver regular, sustainable Clinical Yarning training and support.

Based on previous results of the CSSS, in order to detect a meaningful change in the CSSS of 7.38 over time, at an alpha of 0.05 and power of .8, an estimated minimum sample of 63 individuals overall, is required to allow us to compare the CSSS at different study phases.

1) Elvidge, E., et al., Cultural safety in hospitals: validating an empirical measurement tool to capture the Aboriginal patient experience. Australian Health Review, 2020. 44(2): p. 205-211.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2023
Actual
Date of last participant enrolment
Anticipated
13/03/2025
Actual
Date of last data collection
Anticipated
11/04/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 39334 0
6531 - Geraldton
Recruitment postcode(s) [2] 39335 0
6642 - Meekatharra
Recruitment postcode(s) [3] 39336 0
6701 - Carnarvon
Recruitment postcode(s) [4] 39337 0
6630 - Mullewa
Recruitment postcode(s) [5] 39339 0
6638 - Mount Magnet

Funding & Sponsors
Funding source category [1] 313035 0
Government body
Name [1] 313035 0
Government of Western Australia, Department of Health
Country [1] 313035 0
Australia
Funding source category [2] 313047 0
University
Name [2] 313047 0
The University of Western Australia
Country [2] 313047 0
Australia
Primary sponsor type
Government body
Name
Government of Western Australia Department of Health
Address
Research and Innovation Office
Department of Health
PO Box 8172
Perth Business Centre
PERTH WA 6849
Country
Australia
Secondary sponsor category [1] 314734 0
None
Name [1] 314734 0
Address [1] 314734 0
Country [1] 314734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312292 0
WA Country Health Service Human Research Ethics Committee
Ethics committee address [1] 312292 0
Ethics committee country [1] 312292 0
Australia
Date submitted for ethics approval [1] 312292 0
09/12/2022
Approval date [1] 312292 0
24/01/2023
Ethics approval number [1] 312292 0
RGS0000005764
Ethics committee name [2] 312300 0
Aboriginal Health Council of WA Ethics
Ethics committee address [2] 312300 0
Ethics committee country [2] 312300 0
Australia
Date submitted for ethics approval [2] 312300 0
27/10/2022
Approval date [2] 312300 0
Ethics approval number [2] 312300 0

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

Contacts
Principal investigator
Name 124134 0
Dr Ivan Lin
Address 124134 0
Western Australian Centre for Rural Health (WACRH)
167 Fitzgerald St, Geraldton WA 6530 PO Box 109, Geraldton WA 6531
Country 124134 0
Australia
Phone 124134 0
+61 8 99560219
Fax 124134 0
Email 124134 0
ivan.lin@uwa.edu.au
Contact person for public queries
Name 124135 0
Deborah Balmer
Address 124135 0
Western Australian Centre for Rural Health (WACRH)
167 Fitzgerald St, Geraldton WA 6530 PO Box 109, Geraldton WA 6531
Country 124135 0
Australia
Phone 124135 0
+61 8 99560227
Fax 124135 0
Email 124135 0
deborah.balmer@uwa.edu.au
Contact person for scientific queries
Name 124136 0
Ivan Lin
Address 124136 0
Western Australian Centre for Rural Health (WACRH)
167 Fitzgerald St, Geraldton WA 6530 PO Box 109, Geraldton WA 6531
Country 124136 0
Australia
Phone 124136 0
+61 8 99560219
Fax 124136 0
Email 124136 0
ivan.lin@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.