A Phase III Randomised Controlled Trial (2017-2020)
Lifelong smokers lose 10 years of life. Smoking cessation by age 40 leads to a near normal lifespan. Eighty percent of women have a baby, most by age 40, making pregnancy an opportunity to help women quit before their health is irreversibly compromised. Few of the UK's current 130,000 pregnant smokers quit despite free counselling and Nicotine Replacement Therapy. Offering financial incentives for smoking cessation has worked in local single site trials including in Glasgow where the pilot study for this trial took place. NICE have asked for evidence from a multi-centre trial.
To conduct a pivotal phase III randomised controlled multi-centre trial to examine the effectiveness and cost effectiveness of offering financial incentives in the form of shopping vouchers to pregnant smokers to engage with smoking cessation services, quit smoking during pregnancy and stay quit after pregnancy.
This 39 month trial will recruit 940 smokers over 18-24 months in 2-4 UK centres and follow them until 6 months after birth. The extra cost and long-term benefits will be used to calculate the cost per Quality Adjusted Life Year gained. Pregnant smokers attending their first maternity booking appointment will be invited to participate. All participants will be offered usual smoking cessation services. In addition, the intervention group will be offered up to £400 of shopping vouchers, £50 if they attend counselling and set a quit date, £50 if proven quit 4-weeks later, £100 if quit after 12 weeks, and £200 if quit near the end of pregnancy. Self-report in late pregnancy and 6 months after birth will be verified by saliva cotinine, a nicotine metabolite.
1) To understand the mechanisms of identification and referral of pregnant women to smoking cessation services in each geographical area.
2) To understand the varied contexts in which smoking cessation services operate so that facilitators and barriers to implementation in a range of contexts, including diverse populations can be identified.
Prof David M Tappin leads the CPIT III trial group, performing evaluation of specialist smoking cessation services for pregnant women throughout Scotland. This group looks at accuracy of self reporting by pregnant smokers, seeking to improve treatment of smoking during pregnancy in Scotland by establishing methods to identify all smokers, improving methods of referral and engagement and treatment including access to nicotine replacement therapy.
Margaret is a Senior Research Nurse at NHS Glasgow Clinical Research Facility. She has extensive experience in a variety of clinical areas and was Lead Trial Nurse for the CPIT (Cessation in Pregnancy Incentives Trial) Pilot Study from 2012 - 2014. Following the completion of her MSc, she has worked as lead nurse in complex CTIMPs (Clinical Trials of Investigational Medicinal Products) Phase 1 - IV, and is relishing the opportunity to re-join the CPIT team for this multicentre trial.
Lesley Sinclair is the CPIT III trial manager, whose expertise is in conducting health services research including randomised controlled trials. From 2012-2014, Lesley was the trial manager for the first CPIT (Cessation in Pregnancy Incentives Trial), the world's largest trial to date of financial incentives for smoking cessation.
Gemma Manning has newly joined the CPIT III research trial group. Gemma is a qualified music therapist, and has previously worked in educational and care facilities, providing music therapy to clients with a wide range of additional support needs. Gemma has extensive administrative experience, and will be working closely with David, Lesley and Margaret, to provide administrative support for the CPIT III trial research group.
Cancer Research UK
Chief Scientist Office Scottish Government
Health and Social Care Services Northern Ireland
Chest Heart and Stroke Northern Ireland
Scottish Cot Death Trust
Start date: September 2017
End date: November 2020
Professor David Tappin, University of Glasgow
Professor Linda Bauld, University of Stirling
Lesley Sinclair, University of Stirling
Frank Kee, Queen's University, Belfast
Michael Ussher, St George's University, London
Pat Hoddinott, University of Stirling
Fiona Harris, University of Stirling
Jennifer McKell, University of Stirling
Tim Coleman, University of Nottingham
Sue Cooper, University of Nottingham
Stephen Higgins, University of Vermont
Shirley Mitchell, NHS Lanarkshire
David Torgerson, University of York
Catherine Hewitt, University of York
Jude Watson, University of York
Ada Keding, University of York
Matthew Bailey, University of York
Helen Tilbrook, University of York