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Trial registered on ANZCTR


Registration number
ACTRN12616001603404
Ethics application status
Approved
Date submitted
11/11/2016
Date registered
21/11/2016
Date last updated
21/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can we improve how health providers support smoking cessation in Aboriginal and Torres Strait Islander pregnant women? - a pilot study
Scientific title
The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Step-Wedge Pilot Study: feasibility of training health providers in evidence based smoking cessation care for Australian Indigenous pregnant smokers.
Secondary ID [1] 290467 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ICAN QUIT in Pregnancy - pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of smoking during pregnancy in Aboriginal and Torres Strait Islander women 300833 0
Condition category
Condition code
Public Health 300659 300659 0 0
Health service research
Reproductive Health and Childbirth 300660 300660 0 0
Antenatal care
Mental Health 300760 300760 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include webinar training, an educational resources package, provision of Oral Nicotine Replacement Therapy, implementation support, and audit and feedback. The duration of the total intervention will be 9 months in all sites.
1. Webinar training:
Three 60 minutes (total 180 minutes) training sessions will be provided to all health providers in participating sites. In cases of staff turnover webinar training is repeated as required. Sessions will be delivered by 2 physicians, one a general practitioner and the other a public health physician, both tobacco treatment specialists.
Attendance of staff members in all of the webinar sessions will be monitored through a specific form.
Training Sessions:
Session 1: Background on smoking in pregnancy and relevance to vulnerable subgroups including the Indigenous context – health risks/psychosocial/environmental/cultural. Non-confrontational history taking. Engagement of vulnerable pregnant smokers. Assessment of smoking in Indigenous and vulnerable women - nicotine dependence and motivation. Assessing socio-cultural aspects and environmental smoking. Culturally competent care - importance and content. Non-didactic counselling styles. Concept and benefit of ‘teachable moments’.
Session 2: ABCD approach – Ask-Brief advice-Cessation medications-Discuss psychosocial context. Behaviour change techniques (BCTs) successful in pregnancy, e.g. goal setting, setting a quit date, problems solving, and boosting self-efficacy. How to tailor advice to the client. Interventions of differing intensity - brief to intensive. Involving the family in smoking management and smoke-free environments. Supportive counselling and follow up. Psychosocial support. Use of optimised resources. Referral mechanisms. Ancillary resources available: Quitline, on-line and mobile phone apps.
Session 3: Using NRT in pregnancy, initiating NRT, and how to advise about NRT - NRT algorithm for pregnancy – step-wise titration. Dosage management, side-effects, indications/contra-indications, promoting adherence, recording outcomes. Use of the CO meter as a motivational tool, and for monitoring and validating abstinence. Advising re cannabis and e-cigarettes.

2. Educational package resources:
Services will receive targeted educational resources including a provider training manual, provider desktop guide, a flipchart and patient booklet to guide patient education. These resources are based on a published pragmatic guide for the management of smoking in Indigenous pregnant women, and were developed collaboratively with two Aboriginal Medical Services and a Stakeholder and Consumer Aboriginal Advisory Panel. They were also put through a stringent 4 step evaluation process that included an expert panel and focus groups with health providers and community female members from three additional Aboriginal Medical Services in three states (NSW, SA, QLD).

3. Provision of free Oral NRT:
Oral forms of NRT are not currently subsidised on Australian Government Schemes, so will be supplied as part of this study.. An oral NRT voucher system will be arranged, redeemable by arrangement at a local pharmacy or through the participating service, thus enabling an open-label free supply of oral NRT.
The provision of Oral NRT will be monitored through a voucher system.

4. Implementation support comprised of three site visits and weekly telephone calls from the research team.

5. Audit and feedback - We will analyse the data acquired after 1 month and each service will receive information comparing its work to the other de-identified services in the study. This will be done in line with guidance from the research team on ways to improved provider practices.

Intervention code [1] 296319 0
Behaviour
Intervention code [2] 296390 0
Treatment: Other
Comparator / control treatment
We will be collecting data on a service level, and from recruited pregnant women, and from the health providers that will be used as the control data. Recruitment of women receiving usual care will be performed for 2 months prior to the service receiving the intervention. The data collected from these women during this time will serve as control. Furthermore, the service will provide us with aggregated de-identified data regarding # of NRT scripts that were provided to pregnant women who smoke for up to 4 months prior to receiving the intervention. In additional all health providers will be completing a survey prior to receiving the intervention that will serve as the control data.
Control group
Active

Outcomes
Primary outcome [1] 300080 0
Rate of NRT prescription to expectant mothers, assessed by number of Oral NRT vouchers and number of NRT Patch prescription that were given to pregnant women who smoke. This will be collected through a monthly computerized report of aggregated de-identified data from the service, and through data collected from the registration of NRT vouchers given to women.
Timepoint [1] 300080 0
Monthly intervals from site recruitment (0, 4, 8, 12, 16, 20, 24, 28, 32 , 36 weeks)
Primary outcome [2] 300081 0
Feasibility of performing the intervention and research study including recruitment rates, percent complete follow-up for participating women, and percent of health providers performing the training
Timepoint [2] 300081 0
Monthly intervals from site recruitment (0, 4, 8, 12, 16, 20, 24, 28, 32 , 36 weeks)
Secondary outcome [1] 328974 0
Mean scores on patient checklists. Checklist comprise of 11 items that are scored to form a composite score representing quality of smoking cessation care. This was designed specifically for this study, after consulting with experts in the field.
Timepoint [1] 328974 0
At the exit of each visit to the medical service, from recruitment to the study up till 12 weeks post recruitment.
Secondary outcome [2] 328977 0
Self-reported adherence to NRT using a question in a survey designed specifically for this study
Timepoint [2] 328977 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [3] 328978 0
Behaviour Change Techniques (BCT) used by providers . These will be assessed through audio-recording of consultations (in regard to smoking), transcribing and coding them for behavior change techniques based on the BCT taxonomy that was previously published.
Timepoint [3] 328978 0
Pre and post training intervention
Secondary outcome [4] 328980 0
Self-reported Growth and Empowerment Measure
Timepoint [4] 328980 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [5] 328981 0
Evaluation of cultural responsiveness using a Critical Success Measure
Timepoint [5] 328981 0
12 weeks post recruitment
Secondary outcome [6] 329401 0
Home smoking ban/rules using a question in a survey designed specifically for this study
Timepoint [6] 329401 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [7] 329402 0
Car smoking rules/ban using a question in a survey designed specifically for this study
Timepoint [7] 329402 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [8] 329403 0
Heaviness of smoking index - this is validated index formed of 2 questions that will be included in the survey designed for the study
Timepoint [8] 329403 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [9] 329404 0
Severity of Urges to Smoke (SUTS) score - a validated question that will be included in the survey designed specifically for the study
Timepoint [9] 329404 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [10] 329405 0
Frequency of Urges to Smoking (FUTS) score - a validated question that will be included in the survey designed specifically for this study
Timepoint [10] 329405 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [11] 329406 0
Fagerstrom score - a validated composite score from 6 questions including in the survey designed specifically for this study
Timepoint [11] 329406 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [12] 329407 0
Number of Quit Attempts that lasted over 24hrs using a question in a survey designed specifically for this study
Timepoint [12] 329407 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [13] 329408 0
Nicotine Replacement Therapy use measured using a question in a survey designed specifically for this study
Timepoint [13] 329408 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [14] 329411 0
Intentions to Quit - Composite Scale of sum of 5 Likert Scales (4-point) - mean value
Timepoint [14] 329411 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [15] 329412 0
Risk Behavior Diagnosis (RBD) Scales - a composite score using a validated survey
Timepoint [15] 329412 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [16] 329413 0
Self reported continuous abstinence using a validated question in a survey designed specifically for this study
Timepoint [16] 329413 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [17] 329414 0
Biochemically verified continuous abstinence using a validated question in a survey designed specifically for this study, and a CO measurement under or equal to 6 ppm.
Timepoint [17] 329414 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [18] 329415 0
Self reported 7 days point prevalence using a validated question in a survey designed specifically for this study
Timepoint [18] 329415 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [19] 329416 0
Biochemically verified 7 days point prevalence using a validated question in a survey designed specifically for this study, and a CO measurement under or equal to 6 ppm
Timepoint [19] 329416 0
at recruitment (baseline), 4 weeks and 12 weeks post recruitment
Secondary outcome [20] 329445 0
Self-reported provision of SCC - this is a composite score using 12 different items measured with 5-point Likert scales
Timepoint [20] 329445 0
pre and post training and at the end of study (6 months post training)
Secondary outcome [21] 329446 0
Self reported prescription of NRT using a 5-point Likert scale in a survey designed for this study
Timepoint [21] 329446 0
pre and post training and at the end of the study (6 months post training)
Secondary outcome [22] 329447 0
Self reported provision of smoking cessation care according to the ABCD guidelines - this is a composite score using 4 items measured with 5-point Likert scales
Timepoint [22] 329447 0
pre and post training and at the end of the study (6 months post training)
Secondary outcome [23] 329448 0
Self reported provision of smoking cessation care according to the 5A's guidelines - this is a composite score using 5 items measured with 5-point Likert scales
Timepoint [23] 329448 0
pre and post training and at the end of the study (6 months post training)
Secondary outcome [24] 329449 0
Self reported provision of smoking cessation care according to the AAR guidelines - this is a composite score using 3items measured with 5-point Likert scales
Timepoint [24] 329449 0
pre and post training and at the end of the study (6 months post training)
Secondary outcome [25] 329450 0
Knowledge on smoking cessation care in pregnancy - this will be measured with 24 True/False statements regarding smoking cessation in pregnancy. These statements will be computed to form a composite knowledge score.
Timepoint [25] 329450 0
pre and post training and at the end of the study (6 months post training)
Secondary outcome [26] 329451 0
Attitudes to providing smoking cessation care - these will be measured using a composite score from 22 items measured with 5-point Likert scales
Timepoint [26] 329451 0
pre and post training and at the end of the study (6 months post training)

Eligibility
Key inclusion criteria
For participating woman:
1. Pregnant woman equal or under 28 weeks gestation
2. Aboriginal and/or Torres Strait Islander (as defined by the health service they are attending) or expectant mothers of Aboriginal and/or Torres Strait Islander babies
3. Aged equal or over 16 years old
4. Smoke Tobacco (any level of consumption)

For Health professionals:
1. Be employed by the participating medical service
2. Consult a pregnant women for any reason
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no additional exclusion criteria for either women or health providers

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
This study is a step-wedge design. Some participants are recruited before the service receive the training intervention, and some are recruited after.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We estimate recruiting approximately 50-80 women at up to 6 ACCHS/AMS. As this is a feasibility pilot study, the aim is not to be able to produce statistically significant results but to get qualitative feedback and process measures, and to determine trends, means and standard deviations, in order to inform the design of a future clustered randomized controlled study.
Analysis: An NRT prescription or voucher accepted by patient, checked at each follow up visit, will qualify as a success. We will compare the proportion of successful audits between baseline (audit of grouped de-identified client records pre intervention - number of NRT scripts given to number of patients) to the number of successful audits at 4 weeks and 12 weeks post intervention. iii) Changes in health providers knowledge and attitudes relating to smoking cessation in pregnancy will compare baseline to post-training and end of study using McNemar/ Bowkers test for categorical variables and paired T-tests/ Wilcoxon sign-rank tests for continuous variables. Patient characteristics (e.g. dependence levels, smoking status, home smoking) will be compared between time periods using chi-square tests for categorical variables and t-tests for continuous variables; factors found to be different between time periods will be included in the regression as covariates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 294878 0
Government body
Name [1] 294878 0
NSW Health
Address [1] 294878 0
Level 3, 73 Miller St North Sydney NSW 2060
Country [1] 294878 0
Australia
Funding source category [2] 294879 0
Other Collaborative groups
Name [2] 294879 0
Hunter Cancer Research Alliance
Address [2] 294879 0
Calvary Mater Newcastle, Locked Bag 7, Hunter Region Mail Centre NSW 2310
Country [2] 294879 0
Australia
Funding source category [3] 294950 0
Government body
Name [3] 294950 0
National Health and Medical Research Council
Address [3] 294950 0
Level 4
414 LaTrobe Street
Melbourne
VIC 3000
Country [3] 294950 0
Australia
Funding source category [4] 294951 0
Government body
Name [4] 294951 0
Cancer Institute New South Wales
Address [4] 294951 0
Level 9, 8 Central Avenue, Eveleigh,
NSW 2015
Country [4] 294951 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 293717 0
None
Name [1] 293717 0
Address [1] 293717 0
Country [1] 293717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296255 0
University of Newcastle HREC
Ethics committee address [1] 296255 0
Research Services
Research Integrity Unit
The Chancellery
The University of Newcastle
University drive, Callaghan NSW 2308
Ethics committee country [1] 296255 0
Australia
Date submitted for ethics approval [1] 296255 0
09/12/2015
Approval date [1] 296255 0
19/02/2016
Ethics approval number [1] 296255 0
H-2015-0438
Ethics committee name [2] 296256 0
AH&MRC
Ethics committee address [2] 296256 0
3/66 Wentworth Ave
Surry Hills NSW 2010
Ethics committee country [2] 296256 0
Australia
Date submitted for ethics approval [2] 296256 0
16/11/2015
Approval date [2] 296256 0
05/02/2016
Ethics approval number [2] 296256 0
1140/15
Ethics committee name [3] 296257 0
AHREC
Ethics committee address [3] 296257 0
GPO Box 719, Adelaide SA 5001
Ethics committee country [3] 296257 0
Australia
Date submitted for ethics approval [3] 296257 0
15/02/2016
Approval date [3] 296257 0
10/03/2016
Ethics approval number [3] 296257 0
04-16-652
Ethics committee name [4] 296258 0
Far North QLD HREC
Ethics committee address [4] 296258 0
William McCormack Place
Level 7 East, 5B Sheridan Street
Cairns QLD 4870
PO Box 902 CAIRNS
Queensland 4870
Ethics committee country [4] 296258 0
Date submitted for ethics approval [4] 296258 0
16/03/2016
Approval date [4] 296258 0
25/08/2016
Ethics approval number [4] 296258 0
HREC/16/QCH/34 – 1040

Summary
Brief summary
The overall aim is to improve health professional’s management of smoking in Aboriginal and/or Torres Strait Islander pregnant woman in a culturally tailored approach. The study will include 6 Aboriginal Medical Services in 3 states (NSW, SA, and QLD). Each service will receive webinar training to all the staff, audit and feedback, an educational resources package and free oral Nicotine Replacement Therapy for participating pregnant women.
This study is a pilot study aimed to assess how the intervention is likely to be feasible in a full clinical study and foresee any implementation challenges we will need to overcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70170 0
Dr Gillian S Gould
Address 70170 0
Centre for Brain & Mental Health Research
The University of Newcastle
PO Box 833 Newcastle, 2300
NSW

Country 70170 0
Australia
Phone 70170 0
+61403615563
Fax 70170 0
Email 70170 0
gillian.gould@newcastle.edu.au
Contact person for public queries
Name 70171 0
Dr Gillian S Gould
Address 70171 0
Centre for Brain & Mental Health Research
The University of Newcastle
PO Box 833 Newcastle, 2300
NSW
Country 70171 0
Australia
Phone 70171 0
+61403615563
Fax 70171 0
Email 70171 0
gillian.gould@newcastle.edu.au
Contact person for scientific queries
Name 70172 0
Dr Gillian S Gould
Address 70172 0
Centre for Brain & Mental Health Research
The University of Newcastle
PO Box 833 Newcastle, 2300
NSW
Country 70172 0
Australia
Phone 70172 0
+61403615563
Fax 70172 0
Email 70172 0
gillian.gould@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results