Evaluating the effectiveness and cost-effectiveness of the Smoking Treatment Optimisation in Pharmacies (STOP) intervention: protocol for a cluster randomised controlled trial.
Behaviour change
Cluster randomised controlled trial
Community pharmacy
Quit rate
Recruitment
Retention
Smoking cessation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
10 Jun 2019
10 Jun 2019
Historique:
received:
08
10
2018
accepted:
15
04
2019
entrez:
12
6
2019
pubmed:
12
6
2019
medline:
28
12
2019
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov, ISRCTN16351033. Retrospectively registered on 21 March 2017.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov, ISRCTN16351033. Retrospectively registered on 21 March 2017.
Identifiants
pubmed: 31182134
doi: 10.1186/s13063-019-3368-6
pii: 10.1186/s13063-019-3368-6
pmc: PMC6558670
doi:
Types de publication
Clinical Trial Protocol
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
337Subventions
Organisme : Department of Health
ID : RP-PG-0609-10181
Pays : United Kingdom
Organisme : Programme Grants for Applied Research
ID : RP-PG-0609-10181
Références
Am Psychol. 2000 Jan;55(1):68-78
pubmed: 11392867
Milbank Q. 2004;82(4):581-629
pubmed: 15595944
Addiction. 2005 Mar;100(3):299-303
pubmed: 15733243
Implement Sci. 2011 Apr 23;6:42
pubmed: 21513547
Addiction. 2011 Oct;106(10):1819-26
pubmed: 21561499
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
BMJ. 2013 May 09;346:f2838
pubmed: 23661113
BMJ Open. 2014 Feb 04;4(2):e003821
pubmed: 24496696
Syst Rev. 2014 Aug 22;3:93
pubmed: 25145710
BMJ. 2015 May 08;350:h2147
pubmed: 25956159
BMJ Open. 2016 Jul 07;6(7):e010921
pubmed: 27388355
BMC Med. 2016 Dec 16;14(1):209
pubmed: 27978837
Pilot Feasibility Stud. 2017 Jan 10;3:1
pubmed: 28097016
J Clin Epidemiol. 2017 Oct;90:119-126
pubmed: 28629699
BMJ Open. 2017 Aug 11;7(8):e015637
pubmed: 28801403
BMJ Open. 2017 Oct 27;7(10):e015664
pubmed: 29079601
BMJ Open. 2019 May 19;9(5):e026841
pubmed: 31110097
Psychol Rev. 1977 Mar;84(2):191-215
pubmed: 847061