scholarly journals A digital behaviour change intervention to increase booking and attendance at Stop Smoking Services: the MyWay feasibility RCT

2021 ◽  
Vol 9 (5) ◽  
pp. 1-62
Author(s):  
Emily A Fulton ◽  
Katie Newby ◽  
Kayleigh Kwah ◽  
Lauren Schumacher ◽  
Kajal Gokal ◽  
...  
Keyword(s):  
Social Media ◽  
Randomised Controlled Trial ◽  
Health Research ◽  
Controlled Trial ◽  
Age Groups ◽  
Data Access ◽  
Stop Smoking ◽  
Stop Smoking Services ◽  
Randomised Controlled

Background Smoking remains a leading cause of illness and preventable death. NHS Stop Smoking Services increase quitting, but, as access is in decline, cost-effective interventions are needed that promote these services. StopApp™ (Coventry University, Coventry, UK) is designed to increase booking and attendance at Stop Smoking Services. Design A two-arm feasibility randomised controlled trial of StopApp (intervention) compared with standard promotion and referral to Stop Smoking Services (control) was conducted to assess recruitment, attrition and health equity of the design, alongside health economic and qualitative process evaluations. Setting Smokers recruited via general practitioners, community settings and social media. Participants Smokers aged ≥ 16 years were recruited in one local authority. Participants had to live or work within the local authority area, and there was a recruitment target of 120 participants. Interventions StopApp to increase booking and attendance at Stop Smoking Services. Main outcome measures Participants completed baseline measures and follow-up at 2 months post randomisation entirely online. Objective data on the use of Stop Smoking Services were collected from participating Stop Smoking Services, and age groups, sex, ethnicity and socioeconomic status in baseline recruits and follow-up completers/non-completers were assessed for equity. Results Eligible participants (n = 123) were recruited over 116 days, with good representation of lower socioeconomic status groups; black, Asian and minority ethnic groups; and all age groups. Demographic profiles of follow-up completers and non-completers were broadly similar. The attrition rate was 51.2%, with loss to follow-up lowest in the social media setting (n = 24/61; 39.3%) and highest in the general practitioner setting (n = 21/26; 80.8%). Most measures had < 5% missing data. Social media represented the most effective and cost-efficient recruitment method. In a future, definitive, multisite trial with recruitment driven by social media, our data suggest that recruiting ≥ 1500 smokers over 12 months is feasible. Service data showed that five bookings for the Stop Smoking Services were scheduled using StopApp, of which two did not attend. Challenges with data access were identified. A further five participants in the intervention arm self-reported booking and accessing Stop Smoking Services outside StopApp compared with two control arm participants. Event rate calculations for the intervention were 8% (Stop Smoking Services data), 17% (including self-reports) and 3.5% from control arm self-reports. A conservative effect size of 6% is estimated for a definitive full trial. A sample size of 840 participants would be required to detect an effect for the primary outcome measure of booking a Stop Smoking Services appointment in a full randomised controlled trial. The process evaluation found that participants were satisfied with the research team contact, study methods and provision of e-vouchers. Staff interviews revealed positive and negative experiences of the trial and suggestions for improvements, including encouraging smokers to take part. Conclusion This feasibility randomised controlled trial found that, with recruitment driven wholly or mainly by social media, it is possible to recruit and retain sufficient smokers to assess the effectiveness and cost-effectiveness of StopApp. The study methods and measures were found to be acceptable and equitable, but accessing Stop Smoking Services data about booking, attendance and quit dates was a challenge. A full trial may be feasible if service data are accessible. This will require careful planning with data controllers and a targeted social media campaign for recruitment. Changes to some study measures are needed to avoid missing data, including implementation of a more intensive follow-up data collection process. Future work We plan a full, definitive randomised controlled trial if the concerns around data access can be resolved, with adaptations to the recruitment and retention strategy. Limitations Our trial had high attrition and problems with collecting Stop Smoking Services data, which resulted in a reliance on self-reporting. Trial registration Research Registry: 3995. The trial was registered on 18 April 2018. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 5. See the NIHR Journals Library website for further project information.

scholarly journals Quit attempts and tobacco abstinence in primary care patients: long-term follow-up of a pragmatic, two-arm cluster randomised controlled trial on brief stop-smoking advice (ABC versus 5As method)

2021 ◽  
Author(s):  
Sabrina Kastaun ◽  
Wolfgang Viechtbauer ◽  
Verena Leve ◽  
Jaqueline Hildebrandt ◽  
Christian Funke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Outcome Data ◽  
Cluster Randomised ◽  
Stop Smoking ◽  
Patient Reported ◽  
Quit Attempts ◽  
Randomised Controlled

We developed a 3.5-h-training for general practitioners (GPs) in delivering brief stop-smoking advice according to different methods (ABC, 5As). In a pragmatic, cluster randomised controlled trial our training proved effective in increasing GP-delivered rates of such advice. In this follow-up analysis we examined the effect of ABC and 5As on patient-reported quit attempts and point prevalence abstinence at weeks 4, 12, and 26 following GP consultation. Follow-up data were collected by questionnaires delivered to 1,937 smoking patients recruited before or after the training in which 69 GPs participated. At week 26, ~70% of the patients were lost to follow-up. All 1,937 smoking patients were included in an intention-to-treat analysis. Multiple imputation was used to impute missing outcome data of each follow-up and few missing data of potential confounders. While the receipt of brief GP advice compared to no advice was associated with a two-fold increase in patients' attempts to quit at each follow-up and abstinence at week 26, quit attempts and abstinence rates did not differ significantly from pre- to post-training or between patients from the ABC versus the 5As group. We previously reported that our training increases patient-reported rates of GP-delivered stop-smoking advice. The present follow-up analysis did not show that patients more often attempted or achieved to quit when they received advice from a trained vs. untrained GP. Future training studies should take contextual factors into account - such as access to free evidence-based cessation treatment - which might hamper the transfer of GPs' effective advice into patients' behaviour change.

scholarly journals A school intervention for 13- to 15-year-olds to prevent dating and relationship violence: the Project Respect pilot cluster RCT

2020 ◽  
Vol 8 (5) ◽  
pp. 1-338
Author(s):  
Rebecca Meiksin ◽  
Jo Crichton ◽  
Matthew Dodd ◽  
Gemma S Morgan ◽  
Pippa Williams ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health Research ◽  
Controlled Trial ◽  
Response Rates ◽  
Phase Iii ◽  
Relationship Violence ◽  
Dating Relationships ◽  
Adolescent Dating ◽  
Randomised Controlled

Background ‘Dating and relationship violence’ is intimate partner violence during adolescence. Among dating adolescents in England, 66–75% of girls and 32–50% of boys report victimisation. Multicomponent school-based interventions might reduce dating and relationship violence. We optimised and piloted Project Respect, a new intervention in secondary schools in England, and study methods, to assess the value of a Phase III randomised controlled trial. Objectives To optimise Project Respect and to then conduct a pilot randomised controlled trial in southern England, addressing whether or not progression to a Phase III trial is justified in terms of prespecified criteria. To assess which of two dating and relationship violence scales is optimal, to assess response rates and to consider any necessary refinements. Design Optimisation activities aimed at intervention development and a pilot randomised controlled trial. Setting Optimisation in four secondary schools across southern England, varying by region and local deprivation. A pilot cluster randomised controlled trial in six other such schools (four intervention schools and two control schools), varying by region, attainment and local deprivation. Participants School students in years 8–10 at baseline and staff. Interventions Schools were randomised to the intervention or control arm in a 2 : 1 ratio; intervention comprised staff training, mapping ‘hotspots’ in school for dating and relationship violence, modifying staff patrols, school policy review, informing parents and carers, an application supporting student help-seeking, and a classroom curriculum for students in years 9 and 10 (including student-led campaigns). Main outcome measures Prespecified criteria for progression to Phase III of the trial, concerning acceptability, feasibility, fidelity and response rates. Primary health outcomes were assessed using the Safe Dates and short Conflicts in Adolescent Dating Relationships Inventory measures collected and analysed by individuals who were masked to allocation. Feasibility of economic analysis was assessed. Data sources Baseline and follow-up student and staff surveys, interviews, observations and logbooks. Results The intervention was optimised and approved by the Study Steering Committee. The student response rates in intervention and control groups were 1057 (84.8%) and 369 (76.6%) at baseline, and 1177 (76.8%) and 352 (83.4%) at follow-up, respectively. Safe Dates and the short Conflicts in Adolescent Dating Relationships Inventory had high levels of completion and reliability. At follow-up, prevalence of past-year dating and relationship violence victimisation was around 35% (Safe Dates scale and short Conflicts in Adolescent Dating Relationships Inventory). Staff response rates were very low. Training occurred in all four schools, with suboptimal fidelity. The curriculum was delivered with optimal fidelity in three schools. Other components were delivered inconsistently. Dating and relationship violence was addressed in control schools via violence prevention and responses, but not systematically. Intervention acceptability among students and staff was mixed. An economic evaluation would be feasible. Limitations One school did not undertake baseline surveys. Staff survey response rates were low and completion of the logbook was patchy. Conclusions Our findings suggest that progression to a Phase III trial of this intervention is not indicated because of limited fidelity and acceptability. Future work High prevalence of dating and relationship violence highlights the ongoing need for effective intervention. Potential intervention refinements would include more external support for schools and enhanced curriculum materials. Any future randomised controlled trials could consider having a longer lead-in from randomisation to intervention commencement, using the short Conflicts in Adolescent Dating Relationships Inventory as the primary outcome and not relying on staff surveys. Trial registration Current Controlled Trials ISRCTN65324176. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 5. See the NIHR Journals Library website for further project information.

scholarly journals Quit attempts and tobacco abstinence in primary care patients: follow-up of a pragmatic, two-arm cluster randomised controlled trial on brief stop-smoking advice (ABC versus 5As)

2021 ◽  
pp. 00224-2021
Author(s):  
Sabrina Kastaun ◽  
Wolfgang Viechtbauer ◽  
Verena Leve ◽  
Jaqueline Hildebrandt ◽  
Christian Funke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Outcome Data ◽  
Cluster Randomised ◽  
Stop Smoking ◽  
Patient Reported ◽  
Quit Attempts ◽  
Randomised Controlled

We developed a 3.5 h-training for general practitioners (GPs) in delivering brief stop-smoking advice according to different methods (ABC, 5As). In a pragmatic, cluster randomised controlled trial our training proved effective in increasing GP-delivered rates of such advice (from 13% to 33%). In this follow-up analysis we examined the effect of the training and compared ABC versus 5As on patient-reported quit attempts and point prevalence abstinence at weeks 4, 12, and 26 following GP consultation.Follow-up data were collected in 1937 smoking patients – independently of the receipt of GP advice – recruited before or after the training of 69 GPs. At week 26, ∼70% of the patients were lost to follow-up. All 1937 patients were included in an intention-to-treat analysis; missing outcome data were imputed.Quit attempts and abstinence rates did not differ significantly from pre- to post-training or between patients from the ABC versus the 5As group. However, ancillary analyses showed that patients who received GP advice compared to those who did not, had two times higher odds of reporting a quit attempt at all follow-ups and abstinence at week 26.We reported that our training increases GP-delivered rates of stop-smoking advice, and the present analysis confirms that advice is associated with increased quit attempts and abstinence rates in patients. However, our training did not further improve these rates, which might be related to patients’ loss to follow-up or to contextual factors – e.g., access to free evidence-based cessation treatment – which can hamper the transfer of GPs’ advice into patients’ behaviour change.

scholarly journals All-Wales Licensed Premises Intervention (AWLPI): a randomised controlled trial of an intervention to reduce alcohol-related violence

2015 ◽  
Vol 3 (10) ◽  
pp. 1-152 ◽  
Author(s):  
Simon C Moore ◽  
Mohammed Fasihul Alam ◽  
David Cohen ◽  
Kerenza Hood ◽  
Chao Huang ◽  
...  
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Research ◽  
Controlled Trial ◽  
Public Health Research ◽  
Licensed Premises ◽  
Randomised Controlled ◽  
And Control

BackgroundViolence in and around premises licensed for the on-site sale and consumption of alcohol continues to burden the NHS with assault-related injuries.Trial designA randomised controlled trial with licensed premises as the unit of allocation, with additional process and cost-effectiveness evaluations.MethodsPremises were eligible (n = 837) if they were licensed for on-site sale and consumption of alcohol, were within 1 of the 22 local authorities (LAs) in Wales and had previously experienced violence. Data were analysed using Andersen–Gill recurrent event models in an intention-to-treat analysis. An embedded process evaluation examined intervention implementation, reach, fidelity, dose and receipt. An economic evaluation compared costs of the intervention with benefits.InterventionPremises were randomised to receive a violence-reduction intervention, Safety Management in Licensed Environments (SMILE), which was delivered by an environmental health practitioner (EHP; the agent). SMILE consisted of an initial risk audit to identify known risks of violence, a follow-up audit scheduled to enforce change for premises in which serious risks had been identified, structured advice from EHPs on how risks could be addressed in premises and online materials that provided educational videos and related material.ObjectiveTo develop intervention materials that are acceptable and consistent with EHPs’ statutory remit; to determine the effectiveness of the SMILE intervention in reducing violence; to determine reach, fidelity, dose and receipt of the intervention; and to consider intervention cost-effectiveness.OutcomeDifference in police-recorded violence between intervention and control premises over a 455-day follow-up period.RandomisationA minimum sample size of 274 licensed premises per arm was required, rounded up to 300 and randomly selected from the eligible population. Licensed premises were randomly assigned by computer to intervention and control arms in a 1 : 1 ratio. Optimal allocation was used, stratified by LA. Premises opening hours, volume of previous violence and LA EHP capacity were used to balance the randomisation. Premises were dropped from the study if they were closed at the time of audit.ResultsSMILE was delivered with high levels of reach and fidelity but similar levels of dose to all premises, regardless of risk level. Intervention premises (n = 208) showed an increase in police-recorded violence compared with control premises (n = 245), although results are underpowered. An initial risk audit was less effective than normal practice (hazard ratio = 1.34, 95% confidence interval 1.20 to 1.51) and not cost-effective. Almost all eligible intervention premises (98.6%) received the initial risk audit; nearly 40% of intervention practices should have received follow-up visits but fewer than 10% received one. The intervention was acceptable to EHPs and to some premises staff, but less so for smaller independent premises.ConclusionsSMILE was associated with an increase in police-recorded violence in intervention premises, compared with control premises. A lack of follow-up enforcement visits suggests implementation failure for what was seen as a key mechanism of action. There are also concerns as to the robustness of police data for targeting and assessing outcome effectiveness, while intervention premises may have received greater attention from statutory agencies and, therefore, the identification of more violence than control premises. Although SMILE had high reach and was feasible and acceptable to EHPs, it was found to be ineffective and associated with increased levels of violence, compared with normal practice and it requires additional work to promote the implementation of follow-up enforcement visits. Future work will aim to better understand the role of intervention dose on outcomes and seek more objective measures of violence for use in similar trials.Trial registrationCurrent Controlled Trials ISRCTN78924818.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 10. See the NIHR Journals Library website for further project information.

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