Evaluating the effectiveness and cost-effectiveness of the Smoking Treatment Optimisation in Pharmacies (STOP) intervention: protocol for a cluster randomised controlled trial.

BACKGROUND: NHS community pharmacies provide effective smoking cessation services; however, there is scope for increasing throughput and improving quit rates. This trial examines whether the Smoking Treatment Optimisation in Pharmacies (STOP) intervention can improve smoker engagement to increase service throughput, retention and quitting. METHODS: This study is a pragmatic, cluster randomised controlled trial in 60 pharmacies in England and Wales. All workers in intervention pharmacies are offered STOP training while control pharmacies provide usual care. The STOP intervention, based on behavioural and organisational theories, comprises educational sessions for staff and environmental prompts in the pharmacy. Intervention fidelity is assessed by actors visiting pharmacies posing as smokers. The primary outcome is throughput, defined as the number of smokers who join the programme, set a firm quit date and undergo at least one stop smoking treatment session, and is measured using routinely collected data. Secondary outcomes include retention and quit rates at 4 weeks and continuous abstinence at 6 months verified by salivary cotinine. Cost-effectiveness is estimated using quality-adjusted life years and the probability that the intervention is effective at different levels of willingness to pay is calculated. DISCUSSION: The trial will generate evidence to inform the public health smoking cessation strategy in England and Wales, and may help to shape service commissioning decisions. The STOP intervention model may help inform the undertaking of a range of health behaviour change tasks in community pharmacies. TRIAL REGISTRATION: ClinicalTrials.gov, ISRCTN16351033. Retrospectively registered on 21 March 2017.

Evaluating NHS Stop Smoking Service engagement in community pharmacies using simulated smokers: fidelity assessment of a theory-based intervention.

OBJECTIVES: Smokers are more likely to quit if they use the National Health Service (NHS) Stop Smoking Service (SSS). However, community pharmacies experience low service uptake. The Smoking Treatment Optimisation in Pharmacies (STOP) programme aims to address this problem by enhancing staff training using a theory-based intervention. In this study, we evaluated intervention fidelity using simulated smokers (actors) to assess smoker engagement and enactment of key intervention components by STOP trained staff. DESIGN: An observational pilot study. SETTINGS: Five community pharmacies in North East London with an NHS SSS. METHODS: Six actors, representative of East London's population, were recruited and trained to complete intervention fidelity assessments. Consenting pharmacy staff from five participating pharmacies received STOP Intervention training. Four weeks after the staff training, the actors visited the participating pharmacies posing as smokers eligible for smoking cessation support. Engagement behaviour by pharmacy staff and enactment of intervention components was assessed using a scoring tool derived from the STOP logic model (scoring range of 0-36), and contemporaneous field notes taken by actors. RESULTS: 18 of 30 completed assessments were with STOP trained staff (10/18 were counter assistants). Mean score for smoker engagement was 24.4 (SD 9.0) points for trained and 16.9 (SD 7.8) for untrained staff, respectively. NHS SSS leaflets (27/30) were the most common smoking cessation materials seen on pharmacy visits. Most trained counter staff engaged with smokers using leaflets and a few proactively offered appointments with their cessation advisors. Appropriate use of body language was reported on 26/30 occasions alongside the use of key phrases from the STOP training session (n=8). Very few pharmacy staff wore STOP promotional badges (4/30). CONCLUSIONS: STOP training may change client engagement behaviour in pharmacy staff and could improve the uptake of the NHS SSS. A cluster randomised controlled trial is currently in progress to evaluate its effectiveness and cost-effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN16351033.

Depression in Visual Impairment Trial (DEPVIT): A Randomized Clinical Trial of Depression Treatments in People With Low Vision.

PURPOSE: The purpose of this study was to compare two interventions for depression, problem solving treatment (PST) and referral to the patient's physician, with a waiting-list control group in people with sight loss and depressive symptoms. METHODS: This was an assessor-masked, exploratory, multicenter, randomized clinical trial, with concurrent economic analysis. Of 1008 consecutive attendees at 14 low-vision rehabilitation centers in Britain, 43% (n = 430) screened positive for depressive symptoms on the Geriatric Depression Scale and 85 of these attendees participated in the trial. Eligible participants were randomized in the ratio 1:1:1 to PST, referral to their physician, or a waiting-list control arm. PST is a manualized talking intervention delivered by a trained therapist who teaches people over six to eight sessions to implement a seven-step method for solving their problems. Referral to the physician involved sending a referral letter to the person's physician, encouraging him or her to consider treatment according to the stepped care protocol recommended by the U.K.'s National Institute of Health and Care Excellence. The primary outcome was change in depressive symptoms (6 months after baseline) as determined by the Beck Depression Inventory. RESULTS: At 6 months, Beck Depression Inventory scores reduced by 1.05 (SD 8.85), 2.11 (SD 7.60), and 2.68 (SD 7.93) in the waiting-list control, referral, and PST arms, respectively. The cost per patient of the PST intervention was £1176 in Wales and £1296 in London. CONCLUSIONS: Depressive symptoms improved most in the PST group and least in the control group. However, the change was small and the uncertainty of the measurements relatively large.