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Trial registered on ANZCTR


Registration number
ACTRN12624001483549
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
19/12/2024
Date last updated
19/12/2024
Date data sharing statement initially provided
19/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Newborn Project: investigating the feasibility and impact of a targeted Antenatal Point of Care Ultrasound (ApoCUS) training to Aboriginal Healthcare workers (AHWs) and practitioners (AHPs) on antenatal care attendance of pregnant Aboriginal women.
Scientific title
The Healthy Newborn Project: Development and delivery of targeted Antenatal Point of Care Ultrasound (APoCUS) training to Aboriginal Healthcare workers (AHWs) and practitioners (AHPs), investigating the initiative’s feasibility and impact on antenatal care attendance of pregnant Aboriginal women and satisfaction of AHWs and AHPs
Secondary ID [1] 312846 0
Nil
Universal Trial Number (UTN)
Trial acronym
HNP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 334981 0
Health of Aboriginal women 334982 0
Condition category
Condition code
Reproductive Health and Childbirth 331498 331498 0 0
Childbirth and postnatal care
Public Health 332535 332535 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to:
Phase 1 - iteratively co-design a culturally safe, 1-day training package for Aboriginal Health Workers (AHW)/Practitioners (AHP) on how to provide Antenatal Point of Care Ultrasound (APoCUS) scans for pregnant Aboriginal and Torres Strait Islander women
Phase 2 - assess the feasibility and effectiveness of the above training module

Phase 1: one-on-one interviews/yarns will be conducted in person or online by experienced interviewers (some of whom are of Aboriginal and/or Torres Strait Islander descent) via Teams/Zoom with 18-24 participants using semi-structured moderator guides. Three rounds of interviews will be conducted (with 6-8 participants in each) to enable the iterative co-design of the culturally tailored APoCUS training module. After the first round of interviews/yarns has been completed, feedback from participants will be used to revise existing APoCUS training materials, with these revised materials then used as the demonstration resources for the second round of participants. This process will be undertaken a third time for the final 6-8 participant interviews/yarns, whereby their feedback will be incorporated to produce a finished co-design APoCUS training package to be considered for use in a future feasibility study. It is not necessary that the participants from round 1 will also be interviewed for each iteration of the materials in rounds 2 and 3. We intend to recruit different participants from each cohort in each round of interviews/yarns to enhance representatives and have variety of perspective from as many participants as possible.

Phase 2 will involve training of AHWs/AHPs to use the equipment in a safe and appropriate manner to identify intrauterine pregnancy and heartbeat in the pregnancy. The trainees will be taught basic principles of ultrasound, turning on and off the ultrasound machine, and the use of knobs on the machine. The basics of ultrasound appearance of a normal intrauterine pregnancy including detecting the fetal heartbeat will be explained and demonstrated with the use of presentations, ultrasound simulators, and human pregnant volunteers. The training model (APoCUS module first-trimester identification of fetal heartbeat) is a scaled back version from this particular POCUS module from ASUM: https://www.asum.com.au/files/public/Education/CAHPU/CAHPUSyllabi/CAHPU-Basic-Early-Pregnancy-Assessment-Syllabus.pdf .

Ultrasound training will be conducted face to face at the University of South Australia, City East Campus as a 1-day workshop, by a team of experienced ultrasound educators in a small group workshop, with a trainer to trainee ratio of 1:4. The participants will have an opportunity at the end of the training module to practice their skills on a pregnant volunteer (note that the only role Aboriginal pregnant women play in Phase 2 is to assist AHW/Ps with practicing ultrasound skills at the end of the 1-day training workshop).

The learning objective for this workshop is to enable participants to feel confident using a portable ultrasound machine to identify and show pregnant women their baby on ultrasound. Learning materials will be provided before and after the workshop. The material for the workshops and follow up mentoring sessions will be developed through the co-design process, as well as the evaluation surveys for the trainees.
The training model (APoCUS module first-trimester identification of fetal heartbeat) will be delivered to AHWs and AHPs with the provision of online mentoring/teaching and remote supervision for 6 months following training. This will involve group Zoom sessions by an experienced sonographer within the research team.
Intervention code [1] 329392 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340052 0
Use of APoCUS since training
Timepoint [1] 340052 0
6-months post-training
Secondary outcome [1] 439316 0
Barriers and enablers to implementation and scalability of this training assessed as a composite outcome
Timepoint [1] 439316 0
At time of one-off interview during co-design of training module (Phase 1)
Secondary outcome [2] 439320 0
AHW/AHP knowledge, skills, confidence to perform APoCUS, assessed via a Likert-scale questionnaire. This will be assessed as a composite outcome
Timepoint [2] 439320 0
3-month follow-up, 6-month follow-up post-training
Secondary outcome [3] 439324 0
Implementation feasibility - Reach
Timepoint [3] 439324 0
End of phase 1
Secondary outcome [4] 439326 0
Implementation feasibility - Adoption
Timepoint [4] 439326 0
6-month follow-up post-training
Secondary outcome [5] 439327 0
Implementation feasibility - Implementation
Timepoint [5] 439327 0
6-month follow-up post-training
Secondary outcome [6] 439328 0
Implementation feasibility - Maintenance
Timepoint [6] 439328 0
6-month follow-up post-training
Secondary outcome [7] 442478 0
Implementation feasibility - Implementation
Timepoint [7] 442478 0
6-months post-training

Eligibility
Key inclusion criteria
Phase 1: Cohort A - Aboriginal Health Workers/Practitioners, Cohort B - Aboriginal pregnant women and community representatives, Cohort C - Key policy/industry stakeholders

Phase 2:
Trainees: Adult professionals, rural and remote healthcare workers and practitioners, working with pregnant women, Aboriginal and Torres Strait Island background, must be employed by a clinical site in a rural or remote area.

Pregnant volunteers: low risk pregnancy, had one normal ultrasound scan, 3-7 months pregnant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to provide informed consent.

Study design
Purpose of the study
Educational / counselling / training
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
Statistical methods / analysis
Phase 1: The in-depth interviews/yarns with stakeholders in phase one of the project will be conducted using an open-ended semi-structured guide. The time required for each in-depth interview/yarn will be between 20-30 minutes. The interviews will be conducted face-to-face or online via zoom. The interviews will be audio-recorded and transcribed verbatim. Qualitative deductive thematic analysis of interviews will be done, and the transcripts will be coded according to constructs of the COM-B (Capability, Opportunity, Motivation and Behaviors) model , by two experienced coders to build a model of consensus.

Phase 2: All surveys will be created with SurveyMonkey using prepared survey questionnaires. The survey will be face to face at the end of the training or it can be online and will take approximately 15-20 minutes. Collected data will be analyzed using appropriate software (Microsoft excel, SPSS) with consultation from a UniSA statistician.
Collected data will be synthesized according to constructs of the RE-AIM framework for implementation analysis and scale-up, with presentation of data and write-up of relevant results according to this framework. This will include manuscript-style presentation of data with presentation of participant characteristics and relevant quantitative and qualitative data in table/figure format, and narrative synthesis of results, with dot points for discussion, and full outline of applied methodology. Results of the analysis will be written in publication format, along with a detailed methodology, and dot points for discussion. Relevant participant characteristics data and additional coding tables will be presented as an appendix as required. A report will be created outlining end user recommendations for educational program development for (objectives, workshop schedule, pre-course materials, lecture slides and pre-/post-training knowledge tests) to aid in the design of the educational training module for the AHWs and AHPs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317287 0
Charities/Societies/Foundations
Name [1] 317287 0
The Hospital Research Foundation Group
Country [1] 317287 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 319702 0
None
Name [1] 319702 0
Address [1] 319702 0
Country [1] 319702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316024 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 316024 0
Ethics committee country [1] 316024 0
Australia
Date submitted for ethics approval [1] 316024 0
21/05/2023
Approval date [1] 316024 0
21/01/2024
Ethics approval number [1] 316024 0
Ethics committee name [2] 316139 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [2] 316139 0
Ethics committee country [2] 316139 0
Australia
Date submitted for ethics approval [2] 316139 0
13/08/2024
Approval date [2] 316139 0
12/09/2024
Ethics approval number [2] 316139 0
2023/HRE00260
Ethics committee name [3] 316140 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [3] 316140 0
Ethics committee country [3] 316140 0
Australia
Date submitted for ethics approval [3] 316140 0
14/10/2024
Approval date [3] 316140 0
Ethics approval number [3] 316140 0

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

Contacts
Principal investigator
Name 136542 0
A/Prof Nayana Parange
Address 136542 0
Allied Health & Human Performance, University of South Australia, City East Campus, Corner of North Terrace and Frome Road, Adelaide South Australia, 5001.
Country 136542 0
Australia
Phone 136542 0
+61088302 2585
Fax 136542 0
Email 136542 0
Nayana.Parange@unisa.edu.au
Contact person for public queries
Name 136543 0
Dr Shagufta Perveen
Address 136543 0
Houd Research Group, 13 Rossall St, Somerton Park, 5044, SA
Country 136543 0
Australia
Phone 136543 0
+610424192209
Fax 136543 0
Email 136543 0
Shagufta@houdresearch.com.au
Contact person for scientific queries
Name 136544 0
Dr Shagufta Perveen
Address 136544 0
Houd Research Group, 13 Rossall St, Somerton Park, 5044, SA
Country 136544 0
Australia
Phone 136544 0
+610424192209
Fax 136544 0
Email 136544 0
Shagufta@houdresearch.com.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.