“Stop Smoking in its Tracks”: a single arm intervention study of a smoking cessation program for women receiving maternity care through the Birthing in Our Community program. A sub-study of the Indigenous Birthing in an Urban Setting (IBUS) study

1. Assessment of all women: In accordance with the Queensland Clinical Practice Guideline for Smoking Cessation in Pregnancy, all BiOC-enrolled women will be assessed at their first antenatal visit for smoking status, smoking history and nicotine dependence using a motivational approach. 2. Initial counselling by the midwife to motivate a quit attempt: The midwife will attempt to motivate women to make a quit attempt using brief advice, provision of written materials and offers of significant support through the SST program. The benefits of quitting smoking will be briefly discussed and women will be strongly advised to quit smoking as soon as possible in the interests of both their baby’s and their own health. A brochure on reasons for quitting will be used as a prompt for discussions. Women who smoke will be offered the opportunity to enrol in the SST program. Those not interested in participating or who are ineligible will receive usual care through BiOC. 3. First follow-up by Indigenous workers in the SST team: Following recruitment and consent, the SST staff will provide additional support to motivate a quit attempt: counselling, written materials, measurement of expired CO using the smokerlyzer and offers of significant support. Participants will again be counselled on the benefits of quitting smoking and will be strongly advised to quit smoking as soon as possible in the interests of both their baby’s and their own health. The brochure on reasons for quitting will again be used as a prompt for discussions. Women will be encouraged to identify and articulate their own views on the benefits of quitting. Additionally women will be asked to blow in a smokerlyzer which measures expired CO. The smokerlyzers used in this study provide immediate readings of the woman’s expired CO, her estimated carboxyhaemoglobin (COHb) and estimated foetal carboxyhaemoglobin (FCOHb). These readings will be used as a motivational tool to encourage the woman to quit. The staff member will emphasise her belief in the woman’s ability to quit and her willingness to support the woman to do so. They will then ask the woman to make a commitment to make a quit attempt. 4. Committing to try to quit: Women who are willing to make a commitment to try to quit will be asked to complete a Commitment Contract stating the reasons she wants to quit and that she is willing to try. The contract will also be signed by the SST staff member, to commit to supporting the woman’s quit attempt. The staff member will assist women to identify potential barriers, strategies to overcome these barriers and other sources of support for her quit attempt. A brochure providing advice on cessation strategies will be given to each woman attempting to quit. 5. Follow-up support to women trying to quit: SST staff will undertake follow-up visits with women wanting to try to quit. At each of these visits, progress will be assessed, positive feedback given, and ongoing support and advice provided. These will occur: a) Twice a week for two weeks; b) then weekly for four weeks; c) then fortnightly until the baby is born. Frequent visits are required early in a quit attempt as this is the period when relapse is common. The visits will mostly be home visits, although they may be undertaken at the clinic if the woman is attending the clinic for other reasons. For example, most fortnightly visits for women in their third trimester could be scheduled on the same day as their fortnightly antenatal visit. These visits will last approximately 30 to 60 minutes, as necessary. 6. Free Nicotine Replacement Therapy (NRT): Intermittent forms of NRT (inhalers, gum, lozenges etc) will be offered to women who are unable to quit after two attempts without NRT, or earlier if the woman requests it. There will be no cost to the woman for this NRT. Women will be instructed by the SST staff on the best way to use these products safely and effectively. Free NRT will also be made available to household members making a quit attempt if they have no contraindications to its use. Training will be provided to all SST staff in the appropriate use of NRT, and a standard list of contraindications will be used. 7. Household members: Other members of the woman’s household will be opportunistically targeted, either through contact during a home visit, while accompanying the woman for an antenatal visit, or through the woman herself, as appropriate. Household members will be asked to help the pregnant woman by creating a smoke free car and home, not smoking near her, and by providing encouragement and support. A specific brochure related to this will be provided. Where possible household members will also be encouraged to quit smoking themselves, and if interested will be supported to do so through brief intervention counselling and referral to other local smoking cessation services, including those provided through the ATSICHS and IUIH, with provision of free NRT if appropriate. 8. Post-partum support: For women who quit smoking during their pregnancy and are not smoking at the end of their pregnancy, supportive counselling and follow-up will be provided until 6 months post-partum. Approximately 70% of women who quit smoking during pregnancy experience relapse after the baby is born; support during this period may help prevent this. Visits will be weekly for the first four weeks, then fortnightly until six months postpartum. A brochure focusing on the postpartum period will be given to women in late pregnancy, in order to raise the issues early, as relapse early in the post-partum period is common. This brochure will also be used to guide discussions in the post-partum period. 9. Resources: Four brochures will be used and will emphasise the benefits of quitting, with a focus on short term/immediate gains and benefits to the woman, the baby and the family. These brochures will cover harms from smoking, benefits from quitting, strategies to assist with quitting and to avoid relapse including in social situations, and alternative activities to replace smoking and the benefits from smoking. 10. Contingency-based financial rewards (CBFR): (N.B. We use the term ‘rewards’ rather than ‘incentives’ to recognise and acknowledge the effort women make in quitting smoking). Rewards will be provided for validated abstinence at each visit, according to the following: a) Validation by expired carbon monoxide (CO). Monitoring using expired CO will take place at each scheduled program visit (twice weekly for two weeks, weekly for four weeks, then fortnightly until the birth) if the woman reports quitting, using MICRO-smokerlyzers (Bedfont Scientific Ltd, Kent UK) and a cut-off CO less than or equal to 6ppm indicating abstinence. b) Immediate provision of CBFR. Women testing negative for smoking (expired CO equal to or less than 6ppm) will be provided with a reward within, or as close as possible to within, a 48 hour period after the result confirming abstinence. This is consistent with the principle of providing rewards as soon as possible after confirmation of abstinence. The reward will be provided as one of two options: 1) vouchers in the form of Coles Myer gift cards, (cannot be used for purchase of tobacco or alcohol) provided to the woman immediately; or 2) having the value of the reward deposited directly into a pre-nominated bank account. c. CBFR value. The rewards will be given in conjunction with the follow-up visits described in section 4 above. They will start at $10 and increase by $2 for each consecutive CO-negative test (i.e. confirmed non-smoking) to a maximum of $30. If women test CO-positive (i.e. smoking) the frequency of monitoring and value of the reward voucher will be reset to the beginning and they will not be given a voucher until they again test CO-negative (i.e. non-smoking). If they then test CO-negative for 3 consecutive tests, the frequency and value of the reward voucher will be reinstated to the previous level. These amounts were considered appropriate by the Community Reference Group involved in developing the initial pilot program and the structure is consistent with the principles of setting the value at a level sufficiently high to be attractive and of progressive increase to reinforce abstinence with resetting of rewards following relapse. As an indication of the amount women can receive, the amount for a woman quitting at 12 weeks gestation, and continuing without smoking until 6 months post-partum would total $970. Women booking later than 12 weeks, but still quitting and remaining abstinent, will receive a total which is proportionately lower. d. Post-partum CBFR. Following the birth of the baby, provision of CBFR will continue until 6 months post-partum, in conjunction with the post-partum support visits, with frequency of visits and rewards initially increasing to weekly to reinforce post-partum abstinence, then gradually becoming less frequent. Training: A two day training workshop will be delivered to all SST staff (midwives, health and support workers) to enhance their knowledge and skills in the provision of smoking cessation to pregnant women, and the specific procedures for this program. The training will be provided by CI Passey and AIs Turnbull who have extensive experience in smoking cessation training, the use of motivational interviewing and other psychological strategies for managing smoking cessation. Training will include sessions on smoking and pregnancy, addiction, smoking cessation during pregnancy, social and emotional wellbeing, counselling skills, and the use of the resources and procedures involved in delivering the SST program. Training on the use of the Smokerlyzers and cotinine testing will be included. Following the initial training, ongoing supervision and support will be provided through regular meetings, with identification of challenges and gaps in skills. Additional training will be provided as required. The duration of the program from first booking in visit until 6 months post-partum, should the woman stay in the program for its full duration.