Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001219572
Ethics application status
Approved
Date submitted
24/07/2024
Date registered
4/10/2024
Date last updated
4/10/2024
Date data sharing statement initially provided
4/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
iSISTAQUIT Ngurrajili (implementing Supporting Indigenous Smokers to Assist Quitting) Scale-Up in Indigenous populations of Australia
Scientific title
Determine the optimal implementation strategy for iSISTAQUIT (implementing Supporting Indigenous Smokers to Assist Quitting) Scale-Up in Indigenous populations of Australia, and scale up to 50 to 100 services nationally.
Secondary ID [1] 312485 0
Nil known
Universal Trial Number (UTN)
Trial acronym
iSISTAQUIT Ngurrajili
Linked study record
This research is in its fifth phase. It builds on a multiphase research project that started as community and expert panel consultations (Phase I) followed by a pilot study (ICAN QUIT in pregnancy) during Phase II. Results of phase II informed the SISTAQUIT® (Supporting Indigenous Smokers to Assist Quitting) RCT (Phase III)-ACTRN12618000972224 and subsequently the iSISTAQUIT (iSQ) limited implementation project (Phase IV) which the present study (iSISTAQUIT scale-up) is scaling up.

Health condition
Health condition(s) or problem(s) studied:
Smoking/vaping in pregnancy 334813 0
Smoking/vaping cessation 334814 0
Nicotine Replacement Therapy use during pregnancy 334815 0
Babies birthweight small for gestational age 334817 0
Condition category
Condition code
Public Health 331007 331007 0 0
Health promotion/education
Reproductive Health and Childbirth 331008 331008 0 0
Other reproductive health and childbirth disorders
Public Health 331374 331374 0 0
Health service research
Reproductive Health and Childbirth 331375 331375 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are scaling up iSISTAQUIT which was the implementation phase of SISTAQUIT research implemented in around 40 health services. The full iSISTAQUIT intervention for scale up consists of 15 eLearning modules that take approximately four hours to complete. The training is internet-enabled, self-paced and includes videos, text, and interactive elements, The iSISTAQUIT online modules are 1. Getting started, 2. Acknowledgement of country, 3. About SISTAQUIT, 4. Supporting Indigenous smokers to assist quitting, 5. ABCD approach, 6. A: Ask and assess, 7. B: Brief, 8. C: Cessation aids, 9. BCT, 10. Nicotine Replacement Therapy (NRT), 11. D: Discuss family, social and cultural contexts, 12. Vaping in pregnancy, 13. Practice Session: making a quit plan, 14. Follow up, 15. Telling a new story.

There are also resources to aid smoking cessation care including a Treatment Manual, a Patient Flipchart for use during consultations, a patient (My Journey) booklet that includes augmented reality videos, and strategies for quitting smoking and vaping, Nicotine Replacement Therapy posters, Vaping posters, and an ABCD (A—ask; B—brief advice; C—cessation; D—discuss the psychosocial context of smoking) mousepad for use within the health service, These resources were developed for SISTAQUIT and updated with vaping content for this scale-up study.

We have also developed medical practice software templates based on the ABCD (A—ask; B—brief advice; C—cessation; D—discuss the psychosocial context of smoking) approach. The ABCD digital decision-making tool guides consultations and collects data. It can be implemented into health services and medical practices that have PenCS compatible clinical/medical practice software such as Medical Director, Best Practice or ZedMed OR Communicare clinical/medical practice software.

The project also supplies CO breath monitors (smokerlyzers), After attaching a new breath sampling piece to the smokerlyzer, the patient inhales deeply and holds their breath for 15 seconds while the device counts down. Then the patient blows slowly into the mouthpiece, aiming to empty lungs completely. The smokerlyzer provides a CO ppm score, and the woman's %COHb and the baby's corresponding %FCOHb will show. A CO level over 6ppm is indicative of smoking.

Services are given the option to choose from four implementation packages which vary in the amount of health service participation. This approach was adopted to maximise the reach of iSISTAQUIT training to time-poor health services. iSISTAQUIT scale-up aims at doing a comprehensive scalability assessment of the iSISTAQUIT intervention with the intention of scale up in around 50-100 health services Australia-wide.

Package 1 is the standard package which includes online training with CDP points, and hardcopy resources, Package 2 is the standard package which includes online training with CDP points, hardcopy resources, iSISTAQUIT mobile phone app, smokerlyzer, access to Social Media, Community of Practice membership, and the ABCD medical software template. Package 3 is the standard package plus a Boost of Adaption of Posters & Social Media tiles to local context - ie the Health Service is able to provide local pictures to go in their posters and social media tiles. Package 4 is the Standard Package plus a Boost of Hybrid Training model. This may be, for example: online train the trainer or online group-training allowing small group discussion and role play facilitated by iSISTAQUIT. Thus, the iSISTAQUIT training is online only unless the health services picks the option 4 package in which case iSISTAQUIT will facilitate the training either online or in person - depending on the location of the health service.

Adherence to the intervention will be assessed through completion of the on-line post-training survey, the 1,3 and 6 month implementation surveys and qualitative end of study interviews.
Intervention code [1] 329021 0
Prevention
Intervention code [2] 329367 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338812 0
Implementation
Timepoint [1] 338812 0
1, 3, and 6 months after completing the training.
Primary outcome [2] 338813 0
Implementation Reach
Timepoint [2] 338813 0
End of study
Primary outcome [3] 338814 0
Implementation adoption (the participation rate of services and health professionals in the study AND completion of training by health professionals with respect to different implementation strategies.)
Timepoint [3] 338814 0
6 monthly intervals from start of recruitment including once at the end of the project.
Secondary outcome [1] 437555 0
Impact assessment
Timepoint [1] 437555 0
End of study (6 months post commencement of the last service to join the study)
Secondary outcome [2] 437557 0
The confidence of health professionals, pre- and post- completing the iSISTAQUIT training
Timepoint [2] 437557 0
Baseline survey prior to commencing the iSISTAQUIT online training and immediate post-training survey
Secondary outcome [3] 437563 0
The skills of health professionals, pre- and post- completing the iSISTAQUIT training
Timepoint [3] 437563 0
Baseline survey prior to commencing the iSISTAQUIT online training and immediate post-training survey
Secondary outcome [4] 437564 0
The knowledge of health professionals, pre- and post- completing the iSISTAQUIT training
Timepoint [4] 437564 0
Baseline survey prior to commencing the iSISTAQUIT online training and immediate post-training survey
Secondary outcome [5] 439124 0
The optimism of health professionals, pre- and post- completing the iSISTAQUIT training
Timepoint [5] 439124 0
Baseline survey prior to commencing the iSISTAQUIT online training and immediate post-training survey
Secondary outcome [6] 440150 0
ABCD software usage
Timepoint [6] 440150 0
End of study
Secondary outcome [7] 440151 0
Smoking/vaping cessation rate
Timepoint [7] 440151 0
Commencement and End of study
Secondary outcome [8] 440152 0
Change in birthweights
Timepoint [8] 440152 0
Commencement and End of study
Secondary outcome [9] 440153 0
Change in Nicotine Replacement Therapy scripts
Timepoint [9] 440153 0
Commencement and End of study

Eligibility
Key inclusion criteria
Health Professionals who work at Aboriginal and Torres Strait Islander Health Services or Mainstream health services that care for pregnant Indigenous women.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
Other
Other design features
All participating services will implement the iSISTAQUIT training package using implementation strategies that are most suitable to them
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
If we are able to gather sufficient National Key Performance Indicator data (pre and post intervention) from Health Services on smoking in pregnancy and babies birthweights, they will be quantitatively analysed, as will survey data pre and post online training, and implementation questions. We are aiming for 50-100 health services with approximately 3 health professionals at each site undertaking the survey - 150-300 health professionals. End of study interviews will be qualitatively analysed, using inductive and deductive thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/06/2024
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
150
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 316905 0
Government body
Name [1] 316905 0
National Health and Medical Research Council (NHMRC)
Country [1] 316905 0
Australia
Funding source category [2] 316997 0
Charities/Societies/Foundations
Name [2] 316997 0
Global Alliance for Chronic Disease
Country [2] 316997 0
United Kingdom
Primary sponsor type
University
Name
Southern Cross University
Address
Country
Australia
Secondary sponsor category [1] 319243 0
None
Name [1] 319243 0
Address [1] 319243 0
Country [1] 319243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315663 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 315663 0
Ethics committee country [1] 315663 0
Australia
Date submitted for ethics approval [1] 315663 0
26/09/2022
Approval date [1] 315663 0
07/03/2023
Ethics approval number [1] 315663 0
2029/22
Ethics committee name [2] 315750 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [2] 315750 0
Ethics committee country [2] 315750 0
Australia
Date submitted for ethics approval [2] 315750 0
Approval date [2] 315750 0
30/04/2023
Ethics approval number [2] 315750 0
2023/057
Ethics committee name [3] 315752 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [3] 315752 0
Ethics committee country [3] 315752 0
Australia
Date submitted for ethics approval [3] 315752 0
Approval date [3] 315752 0
02/04/2024
Ethics approval number [3] 315752 0
HREC/2023/QCH/101501
Ethics committee name [4] 315753 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [4] 315753 0
Ethics committee country [4] 315753 0
Australia
Date submitted for ethics approval [4] 315753 0
Approval date [4] 315753 0
10/10/2023
Ethics approval number [4] 315753 0
HREC/2023/QTDD/101376
Ethics committee name [5] 315754 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [5] 315754 0
Ethics committee country [5] 315754 0
Australia
Date submitted for ethics approval [5] 315754 0
Approval date [5] 315754 0
09/02/2024
Ethics approval number [5] 315754 0
HREC1286
Ethics committee name [6] 315755 0
Aboriginal Health Research Ethics Committee
Ethics committee address [6] 315755 0
Ethics committee country [6] 315755 0
Australia
Date submitted for ethics approval [6] 315755 0
Approval date [6] 315755 0
22/02/2024
Ethics approval number [6] 315755 0
04-23-1080
Ethics committee name [7] 315756 0
NT HREC (NT Health and Menzies School of Health Research)
Ethics committee address [7] 315756 0
Ethics committee country [7] 315756 0
Australia
Date submitted for ethics approval [7] 315756 0
Approval date [7] 315756 0
26/02/2024
Ethics approval number [7] 315756 0
HREC-2023-4701

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

Contacts
Principal investigator
Name 135422 0
Prof Gillian Gould
Address 135422 0
Southern Cross University, Gold Coast Airport, Terminal Dr, Bilinga QLD 4225
Country 135422 0
Australia
Phone 135422 0
+61 0403615563
Fax 135422 0
Email 135422 0
[email protected]
Contact person for public queries
Name 135423 0
Nicole Ryan
Address 135423 0
Southern Cross University, Hogbin Drive, Coffs Harbour, NSW 2450
Country 135423 0
Australia
Phone 135423 0
+61 0421746202
Fax 135423 0
Email 135423 0
[email protected]
Contact person for scientific queries
Name 135424 0
Nicole Ryan
Address 135424 0
Southern Cross University, Hogbin Drive, Coffs Harbour, NSW 2450
Country 135424 0
Australia
Phone 135424 0
+61 0421746202
Fax 135424 0
Email 135424 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24023Study protocol    388091-(Uploaded-19-07-2024-12-04-02)-Protocol-V3-iSQ Scale-Up-27Nov23-clean.docx
24024Ethical approval    388091-(Uploaded-19-07-2024-12-04-57)-02.22 1747 Approved letter signed-FNQ HREC.pdf
24025Ethical approval    388091-(Uploaded-23-07-2024-14-34-02)-AHMRC_Approval_070323.pdf
24026Ethical approval    388091-(Uploaded-23-07-2024-14-35-03)-NT HREC Approval 26Feb24.pdf
24027Ethical approval    388091-(Uploaded-23-07-2024-14-35-49)-DDHHS HREC Approval 101023.pdf
24028Ethical approval    388091-(Uploaded-24-07-2024-14-37-30)-SA AHREC Approval 22Feb24.pdf
24029Ethical approval    388091-(Uploaded-24-07-2024-14-38-19)-WA AHEC Approval 9Feb24.pdf
24030Ethical approval    388091-(Uploaded-24-07-2024-14-38-42)-Min of Duplication Approval 30Apr23.pdf
24137Informed consent form    388091-(Uploaded-24-07-2024-14-53-15)-FNQ-HP-CF-V3-iSQ-Scale-Up-21Nov23-clean.doc



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.