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Trial registered on ANZCTR


Registration number
ACTRN12622001010785
Ethics application status
Approved
Date submitted
19/05/2022
Date registered
19/07/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
19/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can implementation strategies increase the routine provision of antenatal care addressing smoking for pregnant women?
Scientific title
The effect of implementation strategies on the routine provision of antenatal care addressing smoking in pregnant women: a stepped-wedge controlled trial.
Secondary ID [1] 307109 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking in pregnancy 326270 0
Condition category
Condition code
Public Health 323575 323575 0 0
Health service research
Public Health 323576 323576 0 0
Health promotion/education
Reproductive Health and Childbirth 323577 323577 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 4-month multi-component clinical practice change intervention will be implemented across Maternity Services in three health sectors. The practice change intervention will involve two components:
1. Best practice care pathway: Implementation support strategies will be used to support the routine implementation of the following best practice care pathway for smoking cessation during existing antenatal appointments for all pregnant women. Care will be delivered by the attending antenatal care provider (doctor, midwife or Aboriginal health worker) within existing time scheduled for antenatal appointments, with no additional time added, and the time taken on additional components will be monitored. The intervention will support the delivery of recommended antenatal care through the usual mode of providing antenatal care at each maternity service, and can include face-to-face, telephone and/or video conference consultations.
The best practice pathway is consistent with clinical guidelines (1) and is based on models of assessment, brief intervention and referral that have been shown to increase smoking cessation during pregnancy. (2)
i. Assess smoking status using a Carbon Monoxide (CO) breath monitor for all women at
the first/booking in appointment, and for all women who smoke at follow-up appointments;
ii. for women who smoke, Advise to quit and discuss risks of smoking and benefits of quitting;
iii. and, for women who have quit in the last 6 months, Advise on relapse prevention
iv. for women who smoke, and recent quitters, Arrange assistance, including;
a. referral to telephone-based Quitline, or culturally appropriate local service provider for Aboriginal women if available for behavioural counselling and
b. if clinically appropriate, Nicotine Replacement Therapy (oral formulation as first line pharmacotherapy, patch as second line)
It is estimated that for women who have recently quit or currently smoke, providing the full care pathway will take 5-10 minutes. For all other women it will take <1 minute.
2. Implementation support strategies: The following organisational and clinician-focused strategies will support clinician implementation of the above care pathway.
Leadership: Existing clinical networks and antenatal clinical leaders will be engaged prior to and during the intervention period to facilitate ongoing authorisation and endorsement of the initiative. This will include the presence of clinical leaders at staff training sessions and through their involvement in communication of performance and feedback. A clinical expert group will provide clinical guidance across all components of the intervention. Aboriginal Health staff will provide oversight on cultural appropriateness of the intervention.
Prompts and reminders: Physical point of care prompts will be designed specifically for the study and provided to clinicians to support care delivery, including stickers in the antenatal care record, and a clinic room flip chart, to prompt recommended care delivery.
Local guidelines and procedures: Will be developed to outline the care pathway elements, including guidelines for NRT provision, local service referral options and procedures for each maternity service site.
Service champion: A dedicated Clinical Midwife Educator (CME) will be allocated to each of the three health sectors for the four month intervention phase to facilitate the implementation of the practice change intervention in each service. They will train and advise staff, monitor performance and provide feedback to antenatal clinicians and service managers.
Clinician training and resources: Multi-mode (online and face-to-face) training will be provided to clinicians in each maternity service, facilitated by the CMEs. The initial focus will be on encouraging staff to complete the online training during the first 3 weeks of the intervention period. The online Smoking Cessation training module is estimated to take 40 minutes to complete. Following this staff will participate in at least 60 minutes of face-to-face training during the 4 month intervention period. Face-to-face training sessions will be rostered into the routine educational sessions, with the delivery of the training sessions (e.g. timing and number of repeat training sessions) decided by each maternity service as per local need. The training will focus on addressing identified barriers to care delivery and use evidence-based training elements including interactive components and case studies. Printed resources to support clinician delivery of recommended care will be designed specifically for the study and provided to each maternity service.
Care delivery monitoring and feedback (including academic detailing): Data on patient-reported receipt of care from telephone surveys and data from electronic medical records will be used to compile monthly reports of guideline recommended care delivery. Antenatal clinic managers will be supported to access, interpret and monitor performance measures. Services will be supported to set care delivery goals, monitor progress and develop action plans in response to feedback. Performance measures will be built into maternity services’ existing monitoring accountability frameworks, including operational plans and monthly accountability meetings.
The implementation support strategies will delivered to participating maternity services at the same time as they will commence delivering the ‘best practice care pathway’ - at the commencement of the 4 months intervention period in each maternity service.
All implementation support strategies have been co-developed and approved to be implemented at all participating maternity services by the executive leadership group. All strategies will be implemented in each maternity service, however the concentration of time and effort on individual strategies will be dependent on the results of formative staff surveys which will asked staff to rank their key barriers to providing recommended care. These key barriers will be mapped to Behaviour Change Techniques and implementation strategies to identify the priority strategies to support practice change at that site.
Launch of the implementation support strategies will commence on day 1 of the 4-month intervention period, starting with training sessions and a memo from operational management with staff encouraged to uptake the new best practice care pathway from that point onwards, with all implementation strategies provided across the 4 month intervention period. All strategies other than the dedicated Clinical Midwife Educator and specific academic detailing have the potential to continue on an ongoing basis to support care delivery.

1. Australian Government, Department of Health. Clinical Practice Guidelines: Pregnancy Care - 2020 Edition. Canberra, ACT, Australia.2020.
2. Bar-Zeev Y, Bonevski B, Lim LL, Twyman L, Skelton E, Gruppetta M, Palazzi K, Oldmeadow C, Gould GS. Improving health providers smoking cessation care in pregnancy: A systematic review and meta-analysis. Addict Behav. 2019 Jun;93:29-38. doi: 10.1016/j.addbeh.2019.01.002. Epub 2019 Jan 10. PMID: 30684819.
Intervention code [1] 323563 0
Prevention
Intervention code [2] 323564 0
Behaviour
Comparator / control treatment
During the pre-intervention (control) phase for each participating service, usual antenatal care for addressing smoking (i.e. standard care) will be provided to patients according to existing care pathways, including any quality improvement strategies being implemented according to local practice. Data collected during the baseline periods for each of the three sectors will measure usual antenatal care (i.e. standard care) for addressing smoking in pregnancy and will serve as the control for the intervention periods, with each health sector serving as its own control. Baseline data will be collected for 16 months at which point the 4 month intervention period for sector one will commence. The second and third sectors will commence their intervention periods after a further 4 months and 8 months respectively. Pragmatic elements will decide the order in which the sectors implement the intervention.
Control group
Active

Outcomes
Primary outcome [1] 331331 0
The proportion of women attending a first/booking in antenatal appointment that report receiving a CO breath analysis using a CO monitor.

Self-reported data will be collected through telephone or online surveys with a random sample of pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of data collection methods, Aboriginal women and/or women receiving antenatal care from an AMIHS (Aboriginal Maternal and Infant Health Service) will be offered the choice of doing the survey via computer-assisted telephone interview (CATI) or online.
Timepoint [1] 331331 0
Continuous cross-sectional data collection on a weekly basis for 35 months for first/booking in appointment. Baseline data will be gathered for all three health sectors from 16 months prior to the intervention in the first health sector and data collection will continue until 7 months post intervention completion in the third health sector.
Primary outcome [2] 331335 0
The proportion of women who were currently smoking or had recently quit smoking at their booking in visit that report receiving quit/relapse advice and discussion of the risks of smoking and benefits of quitting/staying a non-smoker.

Self-reported data will be collected through telephone or online surveys with a random sample of pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of data collection methods, Aboriginal women and/or women receiving antenatal care from an AMIHS (Aboriginal Maternal and Infant Health Service) will be offered the choice of doing the survey via computer-assisted telephone interview (CATI) or online.
Timepoint [2] 331335 0
Continuous cross-sectional data collection on a weekly basis for 35 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 16 months prior to the intervention in the first health sector and data collection will continue until 7 months post intervention completion in the third health sector.
Primary outcome [3] 331336 0
The proportion of women who were currently smoking at their booking in visit that report offer of help to quit smoking. Composite measure: referral to the Quitline Service or culturally appropriate referral services (for Aboriginal women) or offer of Nicotine Replacement Therapy.
Self-reported data will be collected through telephone or online surveys with a random sample of pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of data collection methods, Aboriginal women and/or women receiving antenatal care from an AMIHS (Aboriginal Maternal and Infant Health Service) will be offered the choice of doing the survey via computer-assisted telephone interview (CATI) or online.
Timepoint [3] 331336 0
Continuous cross-sectional data collection on a weekly basis for 35 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 16 months prior to the intervention in the first health sector and data collection will continue until 7 months post intervention completion in the third health sector.
Secondary outcome [1] 409541 0
The proportion of women who were currently smoking at their first/booking in appointment that report being offered CO breath monitoring at follow up appointments.

Self-reported data will be collected through telephone or online surveys with a random sample of pregnant women receiving antenatal care from the maternity services within the three health sectors involved in the trial. The survey instrument was designed specifically for the study. To enhance cultural safety and appropriateness of data collection methods, Aboriginal women and/or women receiving antenatal care from an AMIHS (Aboriginal Maternal and Infant Health Service) will be offered the choice of doing the survey via computer-assisted telephone interview (CATI) or online.
Timepoint [1] 409541 0
Continuous cross-sectional data collection on a weekly basis for 35 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Baseline data will be gathered for all three health sectors from 16 months prior to the intervention in the first health sector and data collection will continue until 7 months post intervention completion in the third health sector.
Secondary outcome [2] 409542 0
Participant reported acceptability of each of the elements of the best practice care pathway will be assessed through telephone surveys/online surveys with a random sample of pregnant women at each time point. The telephone/online surveys were designed specifically for this study.
Timepoint [2] 409542 0
Continuous cross-sectional data collection on a weekly basis for 35 months for three antenatal appointment time-points: first/booking in appointment, 28 week gestation appointment and 36 week gestation appointment. Data will be gathered for all three health sectors from 16 months prior to the intervention in the first health sector and data collection will continue until 7 months post intervention completion in the third health sector.
Secondary outcome [3] 409543 0
An assessment of clinician barriers and facilitators (using the theoretical domains framework) to provision of care will be undertaken through pre and post implementation surveys at each maternity service to determine theoretical mediators of intervention effect. The surveys were designed specifically for this study, using the theoretical domains framework as a basis.
Timepoint [3] 409543 0
Cross-sectional data collection 2 months pre intervention implementation and 4 months post intervention completion at each maternity service.
Secondary outcome [4] 409544 0
Cost effectiveness and budget impact: The incremental costs and outcomes of the practice change intervention will be presented as a cost effectiveness analysis. The analysis will adhere to cost and economic analysis guidelines. Budget impact assessment will be conducted to inform affordability of the intervention from the perspective of the public health service.

Delivery of the intervention strategies and data regarding resources expended on materials, labour and other expenses incurred in developing and executing the intervention will be recorded in project management logs, as has occurred in previous trials conducted by the research team. Labour costs for training, quality assurance processes, managerial oversight and activities undertaken by the midwife educators will be recorded prospectively. Research and data collection and analysis costs will be excluded.
Timepoint [4] 409544 0
Data will be entered into project management logs on a fortnightly basis from 4 months prior to intervention implementation and during the intervention implementation phase at each site.

Eligibility
Key inclusion criteria
The best practice care pathways will be implemented as routine care for all women attending antenatal clinics within the participating sectors. All health professionals providing antenatal care will participate in the implementation intervention as part of routine service improvement and all will be offered to opportunity to participate in clinician surveys pre and post intervention.

All pregnant women who have had attended at least one face-to-face antenatal appointment with an obstetrics focus for a first/booking in appointment, 28 week appointment, or 36 week appointment within three health sectors of the Hunter New England Local Health District (HNELHD) of New South Wales, Australia who meet the following inclusion criteria will be eligible for participation in study surveys:
- Had an antenatal care appointment with an HNELHD maternity service in Greater Newcastle, Peel or Lower Mid North Coast Sector.
- Aged 18 years or older.
- More than 12 weeks and less than 37 weeks’ gestation at time of the appointment.
- English proficient to complete a survey.
- Mentally and physically capable of completing a survey.
- Attended the appointment of interest in the previous week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women will be excluded if they are determined by clinical discretion to be inappropriate to contact for the telephone/online survey (e.g. medical or social issues).

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped-wedge controlled trial. Data will be gathered across all three health sectors from 16 months prior to the commencement of the intervention in the first sector to the start of the intervention in each sector, and continued until 7 months post intervention in the third sector.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous trials conducted by the research team in maternity services, it is expected that 60% of invited clients, or 15 clients (5 per service), will consent to participate in surveys each week for each of the 3 gestation periods (‘~12-18’, ‘27-29’ or ’35-37’ weeks) total 45 clients. This will yield 6560 data points during a data collection period of 35 months sufficient to detect (80% power, Bonferroni adjusted alpha 0.0167) i) 7.2% absolute increase in receipt of recommended assessment for smoking (baseline:2%); ii) 12.3% absolute increase in CO monitor being offered to smokers in follow up appointments (baseline: 1%); iii) 17.6% absolute increase for advice for quitting smoking/preventing relapse (baseline:48%); and iv) 21.8% absolute increase for arranging referral for smoking support/NRT for current smokers (baseline:40%).

Pre and post intervention primary outcome data will be analysed using mixed effects logistic regression models to detect change in reported receipt of the three recommended elements of smoking cessation care for all three services combined. Separate models will be fitted for each outcome.

The main predictor of interest will be a before/after intervention indicator variable as well as a fixed effect for time, and a random intercept for client group. The intervention will be declared effective if the coefficient for the intervention period variable is below the threshold of 0.0167 for any of the outcomes. Time-series analysis will be performed over the post intervention periods to determine if slope changes occur, as an indicator of sustainability.

The cost analysis and practice change cost effectiveness results will be incorporated into an economic model to project the expected costs and outcomes that would be associated with broader scale-up of the practice change intervention to antenatal services across NSW.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/07/2022
Actual
25/07/2022
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
6760
Accrual to date
6961
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22344 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 22345 0
Belmont Hospital - Belmont
Recruitment hospital [3] 22346 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [4] 22347 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [5] 22348 0
Gunnedah District Hospital - Gunnedah
Recruitment hospital [6] 22349 0
Quirindi Community Hospital - Quirindi
Recruitment postcode(s) [1] 37506 0
2280 - Belmont
Recruitment postcode(s) [2] 37505 0
2305 - New Lambton
Recruitment postcode(s) [3] 37508 0
2340 - Tamworth
Recruitment postcode(s) [4] 37510 0
2343 - Quirindi
Recruitment postcode(s) [5] 37509 0
2380 - Gunnedah
Recruitment postcode(s) [6] 37507 0
2430 - Taree

Funding & Sponsors
Funding source category [1] 311472 0
Government body
Name [1] 311472 0
Hunter New England Local Health District – Clinical Services, Nursing and Midwifery
Country [1] 311472 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10 Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 312870 0
None
Name [1] 312870 0
Address [1] 312870 0
Country [1] 312870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310894 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 310894 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 310894 0
Australia
Date submitted for ethics approval [1] 310894 0
14/07/2020
Approval date [1] 310894 0
16/07/2020
Ethics approval number [1] 310894 0
16/11/16/4.07
Ethics committee name [2] 310897 0
Aboriginal Health and Medical Research Council
Ethics committee address [2] 310897 0
35 Harvey Street, Little Bay, NSW, 2036
Ethics committee country [2] 310897 0
Australia
Date submitted for ethics approval [2] 310897 0
21/07/2020
Approval date [2] 310897 0
31/07/2020
Ethics approval number [2] 310897 0
1236/16
Ethics committee name [3] 310898 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [3] 310898 0
University Drive, Callaghan, NSW, 2308
Ethics committee country [3] 310898 0
Australia
Date submitted for ethics approval [3] 310898 0
05/08/2020
Approval date [3] 310898 0
03/09/2020
Ethics approval number [3] 310898 0
H-2017-0032

Summary
Brief summary
This study aims to determine the effectiveness of a practice change intervention in increasing the provision of recommended smoking cessation care by antenatal services. Relative to usual antenatal appointments, it is hypothesised that the intervention will achieve increases in the proportion of post intervention appointments in which smoking cessation care is consistent with guideline recommendations: assessment using CO monitors (predicted 7.2% increase); brief advice (predicted 17.6% increase); referral (predicted 21.8% increase). The study will be conducted as a stepped-wedge controlled trial, with staggered implementation of the intervention across maternity services in three health sectors within Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based, locally tailored practice change strategies including guidelines and procedures, prompts and reminders, leadership support, training, and audit and feedback. The prevalence of woman-reported assessment, advice and referral for smoking will be the primary outcomes of interest. Cross-sectional measurement of outcomes will occur via telephone interviews with a random sample of women who attend the services each week. An intervention effect will be determined by an increase in recommended care delivery across the sites. Economic analyses will be undertaken to assess the cost, cost effectiveness and budget impact of the practice change intervention. Acceptability of the intervention to women will also be measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119262 0
Dr Justine Daly
Address 119262 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 119262 0
Australia
Phone 119262 0
+61 2 49246390
Fax 119262 0
Email 119262 0
Justine.daly@health.nsw.gov.au
Contact person for public queries
Name 119263 0
Dr Justine Daly
Address 119263 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 119263 0
Australia
Phone 119263 0
+61 2 49246390
Fax 119263 0
Email 119263 0
Justine.daly@health.nsw.gov.au
Contact person for scientific queries
Name 119264 0
Dr Justine Daly
Address 119264 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 119264 0
Australia
Phone 119264 0
+61 2 49246390
Fax 119264 0
Email 119264 0
Justine.daly@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no ethical approval to share individual participant data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16121Informed consent form    384051-(Uploaded-19-05-2022-08-28-16)-Study-related document.pdf



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