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The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial
BACKGROUND: Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3482147/ https://www.ncbi.nlm.nih.gov/pubmed/22818493 http://dx.doi.org/10.1186/1745-6215-13-113 |
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author | Tappin, David M Bauld, Linda Tannahill, Carol de Caestecker, Linda Radley, Andrew McConnachie, Alex Boyd, Kathleen Briggs, Andrew Grant, Liz Cameron, Alan MacAskill, Susan Sinclair, Lesley Friel, Brenda Coleman, Tim |
author_facet | Tappin, David M Bauld, Linda Tannahill, Carol de Caestecker, Linda Radley, Andrew McConnachie, Alex Boyd, Kathleen Briggs, Andrew Grant, Liz Cameron, Alan MacAskill, Susan Sinclair, Lesley Friel, Brenda Coleman, Tim |
author_sort | Tappin, David M |
collection | PubMed |
description | BACKGROUND: Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? DESIGN AND METHODS: This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable? DISCUSSION: This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit. TRIAL REGISTRATION: Current Controlled Trials ISRCTN87508788 |
format | Online Article Text |
id | pubmed-3482147 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-34821472012-10-27 The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial Tappin, David M Bauld, Linda Tannahill, Carol de Caestecker, Linda Radley, Andrew McConnachie, Alex Boyd, Kathleen Briggs, Andrew Grant, Liz Cameron, Alan MacAskill, Susan Sinclair, Lesley Friel, Brenda Coleman, Tim Trials Study Protocol BACKGROUND: Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? DESIGN AND METHODS: This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable? DISCUSSION: This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit. TRIAL REGISTRATION: Current Controlled Trials ISRCTN87508788 BioMed Central 2012-07-20 /pmc/articles/PMC3482147/ /pubmed/22818493 http://dx.doi.org/10.1186/1745-6215-13-113 Text en Copyright ©2012 Tappin et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Tappin, David M Bauld, Linda Tannahill, Carol de Caestecker, Linda Radley, Andrew McConnachie, Alex Boyd, Kathleen Briggs, Andrew Grant, Liz Cameron, Alan MacAskill, Susan Sinclair, Lesley Friel, Brenda Coleman, Tim The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial |
title | The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial |
title_full | The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial |
title_fullStr | The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial |
title_full_unstemmed | The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial |
title_short | The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial |
title_sort | cessation in pregnancy incentives trial (cpit): study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3482147/ https://www.ncbi.nlm.nih.gov/pubmed/22818493 http://dx.doi.org/10.1186/1745-6215-13-113 |
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