None listed
Conditions
Brief summary
Pregnant tobacco smokers with substance use problems are a highly vulnerable and priority population with an over-representation of Aboriginal women. To date, smoking cessation rates are negligible in this target group with few existing effective interventions to support them to quit smoking. This study aims to assess the feasibility and acceptability of the addition of current evidence-based smoking cessation care to routine prenatal care of women attending a substance use in pregnancy clinic. The package of care consists of financial incentives contingent on validated smoking reduction and abstinence; counselling for tobacco use in pregnancy and nicotine replacement therapy (short and long acting), tailored to individual needs. The intervention is single armed, using pre-post comparisons. A group of 100 women recruited from two NSW Health Substance Use in Pregnancy and Parenting Service (SUPPS) antenatal clinics will be provided the intervention. Comparison data will come from the electronic medical records of a historical control group comprising of women attending SUPPS antenatal services for one year prior to the commencement of the study. The study’s primary objectives are to: I. Assess the feasibility of addressing tobacco smoking amongst this population II. Evaluate the acceptability of addressing tobacco smoking and the intervention components among participants and staff of a substance use in pregnancy service. Its secondary objectives are to: I. Calculate the cost effectiveness of implementing the intervention into antenatal healthcare of women attending a substance use in pregnancy service II. Measure changes in tobacco smoking behaviours of study participants III. Examine the pregnancy and postpartum outcomes of study participants in comparison to those of a historical control group IV. Examine neonatal outcomes of infants born to study participants in comparison to those of a historical control group
Interventions
This study will assess the impact of the addition of a smoking treatment to the routine antenatal care offered to pregnant women who smoke tobacco and attend high risk antenatal clinics targeting substance use in pregnancy, at two NSW principle referral hospitals.
The treatment will offer a combination of evidence-based methods to cease smoking during pregnancy, consisting of:
1. Financial incentives (in the form of retail e-vouchers) to be earnt for every instance of biochemically verified a
This study will assess the impact of the addition of a smoking treatment to the routine antenatal care offered to pregnant women who smoke tobacco and attend high risk antenatal clinics targeting substance use in pregnancy, at two NSW principle referral hospitals. The treatment will offer a combination of evidence-based methods to cease smoking during pregnancy, consisting of: 1. Financial incentives (in the form of retail e-vouchers) to be earnt for every instance of biochemically verified abstinence. The first negative sample will earn $3:00 and increase by $0.10 for each negative sample thereafter. Participants will be required to self-monitor breath carbon monoxide (CO) levels according to a set monitoring schedule, starting at twice per day and gradually reducing to every other day. Video evidence of the test and result will be required for verification purposes. 2. Tobacco-related psychosocial counselling delivered by qualified drug and alcohol counsellors. Four x 30 minute antenatal sessions and two postpartum sessions will be offered. Timing of sessions is flexible and will depend on length of time on study, Additional sessions will be available if required. 3. Nicotine replacement therapy, both short- and long-acting, delivered as required as per RACGP guidelines for pregnant women All three components of the intervention will be available for consenting women aged 16 years and over from study enrolment (any time prior to 33 weeks gestation) until birth. Following delivery, women will be offered counselling and nicotine replacement therapy until 12-weeks postpartum. The intervention will be offered to all clients and delivered by staff of a NSW health-based drug and alcohol clinical research team. Participation in weekly research data collection interviews is required. With the exception of referral and recruitment, all aspects of the intervention will be delivered to individuals using internet based teleconference facilities (telehealth), telephone and postage services as required. The feasibility and acceptability of the intervention in this client population will be assessed, along with its cost-effectiveness. Changes in smoking behaviours, pregnancy and birth outcomes of study participants, as well as neonatal outcomes of their infants will be compared to those of a historical control group.
Sponsors
Hunter New England Health Drug and Alcohol Clinical Services
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be: 1) Pregnant women attending substance use in pregnancy services up to and including 32 weeks gestation 2) Aged >=16 years of age and willing and able to provide written informed consent 3) Current verified daily tobacco smokers interested in reducing smoking during pregnancy with a positive breath carbon monoxide (CO) level greater than 3 p.p.m. 4) Willing and able to comply with requirements of the study
Exclusion criteria
Clients will be unable to participate if they will not be available for follow-up
Outcome results
None listed