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Trial registered on ANZCTR

Registration number

ACTRN12625000490471p

Ethics application status

Submitted, not yet approved

Date submitted

28/04/2025

Date registered

20/05/2025

Date last updated

20/05/2025

Date data sharing statement initially provided

20/05/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Talking Scrubs: Supporting the first-person communication between clinicians and patients with communication disability.

Scientific title

Talking Scrubs: A study of the use of key communication icons on scrubs (and vest) to support communication between clinicians and patients with communication disability - a Phase 4 feasibility and efficacy trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

communication disability

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study involves both patients and their health professionals of the participating health services to consent to be part of the study. For clinicians participating in the research, it will involve 2 hours of preliminary training in the use of the adapted scrubs and scrub vest. This involves the clinician becoming familiar with the protocols of using the scrubs. It will also require the participating clinician to practice their use of the scrubs with members of the research team who have communication disability. Once the clinician feels confident in how to use the scrubs and scrubs vest, they will be asked to use them with patient participants with communication disability. Before using the scrubs and vest both health professionals and their patients will be interviewed. Clinician and patient participant (dyads) will be interviewed by a researcher and invited to complete a survey before using the scrubs. This survey is used to measure how confident the participants are in communicating with each other. It will form a baseline of communication self-efficacy. The clinician and patient (dyads) will be interviewed using a combination of structured, semi structured, and open questions. The interviews will be video recorded. Participants with communication disability are welcome to include a trusted support or communication assistant to help them get their messages out, if required. The interviewer(s) are trained in augmentative and alternative communication (AAC) and are experienced in interviewing people with diverse and complex forms of disability.
The participant dyads will then be invited to use the scrubs in their health appointments which can be once only or over several sessions (over a period of up to 4 months). Participants can decide to provide feedback on one session of using the scrubs or over multiple sessions. When the participant dyad is ready to give feedback, they will be re-interviewed which will involve answering the same survey that was answered before the use of the scrubs. We anticipate a period of four to six months will be required for clinicians to wear and use the scrubs/vest but this can be extended up to a maximum of eight months should participants wish to continue. At the end of this timeframe the scrubs/vest will be withdrawn, however, replica communication boards will be provided to assist clinicians continue using AAC in their communication with patients. We anticipate patient participant time of involvement in the study will vary. It is possible that a patient participant involvement may only be a single appointment with a GP, where diagnosis and treatment is discussed without need for diagnostic screening or a follow up appointment. It is also possible that a patient may require several appointments before diagnosis can be completed and thus be involved in the study over a longer period. Clinician and ongoing patient participants will be invited to keep a journal/scrap book centred on the interviewer questions such as what it felt like to use the scrubs/vest to communicate. Journal recordings are optional. What worked well or did not work well. Ideas for improving the scrubs/vest. Patient participants who are not ongoing (i.e., their involvement in the study does not extend beyond one appointment) will not be invited to keep a journal but will be interviewed instead.
Please - see example of icons in attached document.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group or similar.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of the scrubs/vest intervention for use across the diagnostic process.

Timepoint [1]

For patient participants the timepoint is a brief interview with a researcher at baseline (prior to intervention) and upon completion of the diagnostic process which may conclude with one or more sessions and may involve onsite diagnostic screening such as blood tests with participant clinicians. For clinician participants the timepoint is a single interview at baseline (prior to intervention with any patients) but with journalled self-recorded responses to broad feasibility questions upon completion of the diagnostic process with individual patient participants with a final brief interview with clinician participants at the conclusion of the study

Secondary outcome [1]

Efficacy of the scrubs/vest intervention for use across the diagnostic process.

Timepoint [1]

The questionnaires are used at baseline and upon completion of the diagnostic process for patient participants. The questionnaires are used at baseline and upon completion of the diagnostic process for clinician participants.

Secondary outcome [2]

Efficacy of the individual SE:CD22 instrument will be analyzed as an extension of the validation process.

Timepoint [2]

Dual points - at baseline and after final interview.

Secondary outcome [3]

Efficacy of the individual SE:CH18 instrument will be analyzed as an extension of the validation process.

Timepoint [3]

Dual points - at baseline and after final interview.

Eligibility

Key inclusion criteria

• GPs providing diagnosis for patients with communication disability (people with a disability who cannot easily be understood using speech)
• Patients of the GPs who have communication disability receiving a diagnosis
• Flow-on, on-site, clinician colleagues of the GPs who will perform diagnostic screening services for the patient as requested by the GP e.g., participating onsite nurses or phlebotomists.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion criteria
• Patients where this is no diagnostic involvement/requirement.
• Flow-on diagnostic screening clinicians external to the site agency.
• Patients without communication disability such as those who can speak but not in English.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Baseline and completion questionnaire analysis - SPSS:29

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

4/08/2025

Actual

Date of last participant enrolment

Anticipated

6/04/2026

Actual

Date of last data collection

Anticipated

3/08/2026

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

University of South Australia

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Due to gaps in first-person communication with their clinicians, people with communication disability can experience poor health outcomes, lengthier hospital admissions and adverse events including preventable deaths. Despite numerous attempts to integrate augmentative and alternative communication (AAC) into health settings, patient input is often deferred to others, such as parents or carers, or is subject to the ‘best guess’ by healthcare professionals. The Talking Scrubs project aims to form a bridge to AAC by locating key communication icons on scrubs (and scrubs vest) to be used with patients (in and of themselves) and/or to prompt the use of patient individualised communication methods.
Our study is propelled by the following hypothesis. A patients health improves, and adverse risk reduces, when the patient’s communication agency is understood and used (reflected back) by clinicians; when s/he has the first-person voice in their own health care; when s/he is no longer ‘spoken for’ but instead indicates their health concerns, feelings and consent.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Betty-Jean Dee-Price

Address

University of South Australia 61-68 North Terrace Adelaide 5000 South Australia

Country

Australia

Phone

+61 0434192392

Fax

[email protected]

Contact person for public queries

Name

Betty-Jean Dee-Price

Address

University of South Australia - 61-68 North Terrace Adelaide 5000 South Australia

Country

Australia

Phone

+61 0434192392

Fax

[email protected]

Contact person for scientific queries

Name

Betty-Jean Dee-Price

Address

university of South Australia 61-68 North Terrace Adelaide 5000 South Australia

Country

Australia

Phone

+61 0434192392

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee

What individual participant data might be shared?

• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• UniSA sponsored website contact (website is in initial stages of development). Please see our early-stage website. https://unisa.portals.in-part.com/686f4e87-d5de-460e-9a10-7847e7f8360f?utm_source=technologies&utm_medium=portal&utm_term=latest

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24728	Other					Icon examples.pdf

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.

Trial Review

Documents added manually

Documents added automatically