Dataset Information

PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol.

ABSTRACT: BACKGROUND:Smoking is the primary preventable risk factor for disease and premature mortality. It is highly addictive and cessation attempts are often unsuccessful. Incentive-based programmes may be an effective method to reach sustained abstinence. Individualisation of incentives based on personal characteristics yields potential to further increase the effectiveness of incentive-based programmes. METHOD:A randomised controlled trial among healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme. The intervention under study is the provision of personalised incentives on validated smoking cessation at several time points after the smoking cessation programme. A total of 220 participants are required. Participants are randomised 1:1 into intervention (personalised incentives) or control (no incentives). All participants join the group-based programme. Incentives are provided on validated abstinence directly after the smoking cessation programme and after 3, 6 and 12 months.Incentives are provided according to four schemes:(1) Standard: total reward size €350, pay-out scheme: €50 (t=0), €50 (t=3 months), €50 (t=6 months) and €200 (t=12 months), (2) descending: total reward size €300, pay-out scheme: €150, €100, €50 and €0, (3) ascending: total reward size: €400, pay-out scheme: €0, €0, €50 and €350 and (4) deposit: total reward size €450, pay-out scheme: €50, €50, €150, €200; participants pay a €100 deposit, returned conditional on abstinence after 6 months.Advice on which incentive scheme suits participants best is based on willingness to provide a deposit, readiness to quit, nicotine dependency and long-term or short-term reward preference. Participants are free to deviate from this advice. Abstinence is validated at each time point, with 15 months of total follow-up. The primary end point is validated abstinence at 12 months. Effectiveness will be determined by intention-to-treat analysis. ETHICS AND DISSEMINATION:The Erasmus MC Medical Ethics Committee decided that according to the Dutch Human Research Law (WMO), the protocol required no formal ethical approval. The results will be published in a peer-reviewed scientific journal and communicated to the participants. TRIAL REGISTRATION NUMBER:Netherlands Trial Register NL7711.

SUBMITTER: Boderie NW

PROVIDER: S-EPMC7482494 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol.

Boderie Nienke W NW van Kippersluis Johannes Lw JL Ó Ceallaigh Diarmaid T DT Radó Márta K MK Burdorf Alex A van Lenthe Frank J FJ Been Jasper V JV

BMJ open 20200909 9

<h4>Background</h4>Smoking is the primary preventable risk factor for disease and premature mortality. It is highly addictive and cessation attempts are often unsuccessful. Incentive-based programmes may be an effective method to reach sustained abstinence. Individualisation of incentives based on personal characteristics yields potential to further increase the effectiveness of incentive-based programmes.<h4>Method</h4>A randomised controlled trial among healthcare workers recruited through the ...[more]

PMID: 32912952

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Project description:BackgroundEighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit?MethodsThe Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n?=?940) are pregnant smokers (age?>?16 years, <?24?weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6?months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6?months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK?DiscussionThis phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women.Trial registrationCurrent Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

Project description:ObjectiveTo evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers.DesignSingle blind, randomised controlled trial.SettingFinancial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France.Participants460 pregnant smokers aged at least 18 years who smoked ≤5 cigarettes/day or ≤3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229).InterventionsParticipants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits.Main outcome measuresThe main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome-a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death.ResultsMean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=-1.81, 95% confidence interval -3.55 to -0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution.ConclusionsFinancial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.Trial registrationClinicalTrials.gov NCT02606227.

Project description:Recurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue damage, potentially leading to osteoarthritis. Recurrent patellar dislocation can be managed with physiotherapy or surgery. However, it is not known which treatment is most effective. Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) is a pragmatic, multicentre, two-arm, superiority, randomised controlled trial. It will compare the clinical and cost-effectiveness of an initial management strategy of personalised, phased and progressive rehabilitation, termed personalised knee therapy versus surgery for recurrent patellar dislocation.The trial's target sample size is 276 participants who will be recruited from approximately 20 sites across the UK. Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system. Treatment allocation will be in a 1:1 ratio, stratified by age, presence of patella alta and recruitment site.The primary outcome is participant-reported function using the Knee injury and Osteoarthritis Outcome 4-domain score at 18 months post randomisation. Health economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including patellar instability, health utility, work/education status, satisfaction with social roles and treatment, health resource use and adverse events will be collected at 6, 12, 18 and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. The trial was approved by the East Midlands-Nottingham 2 Research Ethics Committee on 30 March 2023.Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries, and using the REPPORT website and social media channels. ISRCTN17972668.

Project description:IntroductionCombined efforts to encompass different aspects of tobacco control have been in place for some time. Despite the recognition of the need to offer support to tobacco users to quit tobacco use, such support remains highly inadequate in India. However, little is known about the practice of oral health professionals (OHP) and the experiences and expectations of dental patients in the context of tobacco cessation (TC) services. In this article, we describe the protocol of a doctoral research project that explores OHPs and their patients in an Indian city. The aims are (A) to understand the functioning of the oral healthcare system towards TC and what changes to it will be needed to benefit TC and (B) to capture the views of dental patients on TC services provided by OHPs.Methods and analysisA cross-sectional qualitative study based on individual interviews with OHPs and dental patients will be carried out in the city of Ahmedabad, Gujarat, India. The OHP will be purposively selected from two major organisation types: (1) single-doctor dental clinics and (2) dental hospital attached to teaching institutions. The sample population will be divided into two subgroups: general OHP (dentists practising general dentistry irrespective of their qualification) and prosthodontists (dentists with a specialisation in prosthodontics). We will sample dental patients through convenient sampling from a public teaching hospital and select private dental care facilities. The sampling of OHPs and dental patients will continue until we reach data saturation. Interviews will be audio recorded, transcribed verbatim and coded by hand. The interview transcript will subsequently be analysed using thematic content analysis.Ethics and disseminationThe study received ethical approval from the Institutional Ethical Committee of the Government Dental College and Hospital, Ahmedabad. The findings will be disseminated through conference presentations, peer-reviewed publications and to the study participants.

Dataset Information

PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol.

Publications

PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol.

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