Home > Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial.

Tappin, David and Sinclair, Lesley and Kee, Frank and McFadden, Margaret and Robinson-Smith, Lyn and Mitchell, Alex and Keding, Ada and Watson, Judith and Watson, Sinead and Dick, Alison and Torgerson, David and Hewitt, Catherine and McKell, Jennifer and Hoddinott, Pat and Harris, Fiona M and Boyd, Kathleen A and McMeekin, Nicola and Ussher, Michael and Bauld, Linda (2022) Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial. BMJ, 379, e071522. https://doi.org/10.1136/bmj-2022-071522.

External website: https://www.bmj.com/content/379/bmj-2022-071522

OBJECTIVE
To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services.

DESIGN

Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)).

SETTING
Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England.

PARTICIPANTS
944 pregnant women (age ≥16 years) who self-reported as being smokers (at least one cigarette in the past week) when asked at first maternity visit, less than 24 weeks' gestation, and notified to the trial team by routine stop smoking services.

INTERVENTIONS
Participants in the control group were offered the standard stop smoking services, which includes the offer of counselling by specially trained workers using withdrawal orientated therapy and the offer of free nicotine replacement therapy. The intervention was the offer of usual support from the stop smoking services and the addition of up to £400 ($440; €455) of LoveToShop financial voucher incentives for engaging with current stop smoking services or to stop smoking, or both, during pregnancy.

MAIN OUTCOME MEASURES
Self-reported smoking cessation in late pregnancy (between 34 and 38 weeks' gestation) corroborated by saliva cotinine (and anabasine if using nicotine replacement products). Results were adjusted for age, smoking years, index of multiple deprivation, Fagerström score, before or after covid, and recruitment site. Secondary outcomes included point and continuous abstinence six months after expected date of delivery, engagement with stop smoking services, biochemically validated abstinence from smoking at four weeks after stop smoking date, birth weight of baby, cost effectiveness, generalisability documenting formats of stop smoking services, and acceptability to pregnant women and their carers.

RESULTS
From 9 January 2018 to 4 April 2020, of 4032 women screened by stop smoking services, 944 people were randomly assigned to the intervention group (n=471) or the control group (n=470). Three people asked for their data to be removed. 126 (27%) of 471 participants stopped smoking from the intervention group and 58 (12%) of 470 from the control group (adjusted odds ratio 2.78 (1.94 to 3.97) P<0.001). Serious adverse events were miscarriages and other expected pregnancy events requiring hospital admission; all serious adverse events were unrelated to the intervention. Most people who stopped smoking from both groups relapsed after their baby was born.

CONCLUSIONS
The offer of up to £400 of financial voucher incentives to stop smoking during pregnancy as an addition to current UK stop smoking services is highly effective. This bolt-on intervention supports new guidance from the UK National Institute for Health and Care Excellence, which includes the addition of financial incentives to support pregnant women to stop smoking. Continuing incentives to 12 months after birth is being examined to prevent relapse.

TRIAL REGISTRATION

ISRCTN Registry ISRCTN15236311.


Item Type
Article
Publication Type
International, Open Access, Article
Drug Type
Tobacco / Nicotine
Intervention Type
Treatment method, Prevention, Harm reduction
Date
19 October 2022
Identification #
https://doi.org/10.1136/bmj-2022-071522
Publisher
BMJ Publishing Group Ltd
Volume
379
EndNote

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