Implementing the ASSIST smoking prevention programme following a successful RCT. Rona Campbell
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1 Implementing the ASSIST smoking prevention programme following a successful RCT Rona Campbell
2 DECIPHer Development and Evaluation of Complex Interventions for Public Health Improvement
3 Aim Review issues that arise when implementing evidence-based health promotion interventions in a school setting Use the Assist smoking prevention intervention as an example Reflect on time taken to produce evidence Reflections on whether current guidance on implementation of evidence-based interventions sufficient
4 Phases of developing randomised controlled trials of complex interventions (Campbell et al, 2000, p. 696)
5
6 Time line for the development of the ASSIST smoking prevention programme 1993/4: Phase 0: Seminar, discussion, networking 1995: Phase 1: Development, piloting, feasibility testing 1998/99: Phase 2: Publication, planning and fund-seeking 2001: Phase 3: Full-scale randomised trial ( 1.5M) 2001 Further piloting School recruitment 2002 Baseline measures, intervention year follow-up year follow-up 2006-: Phase 4: Implementation & Dissemination
7 ASSIST intervention Year 8 (aged 12-13) Not a typical school-based peer-led intervention Not teacher-led or classroom-based Influential students nominated by their year group Trained to be peer supporters to diffuse norms of non- smoking behaviour through their social networks Adapted from Kelly s (1997) sexual health approach with gay men in America
8 Training objectives.. Enhance knowledge of harmful effects of smoking and the benefits of remaining smoke-free
9 Enhance communication skills needed to promote the smoke-free message among peers
10 Increase confidence to intervene in everyday situations to encourage peers not to smoke
11 Have fun
12 ASSIST (A Stop Smoking in Schools Trial) Cluster randomised trial involving 59 schools in south Wales and Bristol area Comparing effectiveness of an informal, peer-led intervention in preventing smoking uptake in students aged 12 to 13 in addition usual smoking education, with usual smoking education Interventions involved influential Year 8 students, identified by their peers, being trained to diffuse smokefree message Weekly smoking was assessed at baseline, immediately post-intervention and at one and two years.
13 Smoking prevalence at each follow-up point Control Prevalence of weekly smoking at 1 year follow-up Control Prevalence of weekly smoking at 2 year follow-up Control Prevalence of weekly smoking immediately postintervention Intervention Intervention Intervention All students 8.48% 403/ % 334/ % 736/ % 630/ % 1022/ % 941/4966 High-risk group 9.80% 168/ % 157/ % 389/ % 338/ % 549/ % 536/1717
14 Odds ratios from multi-level model for overall intervention effect & according to time of follow-up, baseline smoking status, gender, peer supporter status, free school meal entitlement and school location Odds ratio (95% Confidence Interval) Main model of intervention effect using data from all three follow-ups 0.78 ( 0.64, 0.96) Subgroup: Time Immediately post intervention 0.76 ( 0.58, 1.00) One-year follow-up 0.73 ( 0.58, 0.93) Two-year follow-up 0.83 ( 0.66, 1.04) Subgroup: Baseline smoking Never smoked 0.81 ( 0.62, 1.06) Experimented 0.77 ( 0.62, 0.97) Smoker 0.76 ( 0.50, 1.15) Subgroup: Gender Boys 0.84 ( 0.66, 1.07) Girls 0.76 ( 0.61, 0.96) Subgroup: Peer supporter Not selected 0.80 ( 0.64, 0.99) Selected 0.73 ( 0.54, 0.99) Subgroup: Free school meal entitlement Low 0.79 ( 0.60, 1.03) High 0.78 ( 0.57, 1.07) Subgroup: School Town or city 0.89 ( 0.71, 1.11) South Wales valley 0.52 ( 0.34, 0.78) OR Favours treatment Favours control
15 Conclusions from the trial Possible to recruit range of influential students to informally promote healthy behaviour amongst their peers ASSIST intervention is effective in reducing adolescent smoking Findings generalisable to range of schools If implemented on a UK-wide basis could prevent 43, year olds taking up smoking
16 Reporting Questions to ask yourself include: Have you reported your evaluation appropriately, and have you updated your systematic review? It is important to provide a detailed account of the intervention, as well as a standard report of the evaluation methods and findings, to enable replication studies, or wider scale implementation. The results should ideally be presented in the context of an updated systematic review of similar interventions
17 Dissemination of the evidence Main trial results 1. Campbell R, Starkey F, Holliday J, Audrey S, Bloor M, Parry-Langdon N, Hughes R, Moore L. An informal school-based peer-led intervention for smoking prevention in adolescence (ASSIST): a cluster randomised trial Lancet 2008; 371: Description of the intervention 2. Audrey S, Cordall K, Moore L, Cohen D, Campbell R on behalf of ASSIST (A Stop Smoking In Schools Trial). The development and implementation of a peer-led intervention to prevent smoking among secondary school students using their established social networks. Health Education Journal (3) Trial protocol 3. Starkey F, Moore L, Campbell R, Sidaway M, Bloor M. and ASSIST (A Stop Smoking in Schools Trial) Rationale, design and conduct of a comprehensive evaluation of a school-based peer-led anti-smoking intervention in the UK: the ASSIST cluster randomised trial [ISRCTN ]. BMC Public Health 2005, 5:43 doi: / Fidelity of implementation 4. Holliday J, Audrey S, Moore L, Parry-Langdon N, Campbell R. High fidelity? How should we consider variations in the delivery of school-based health promotion interventions? Health Education Journal 2009;68:44-62
18 Dissemination of the evidence Acceptability of the intervention 5. Audrey S, Holliday J, Campbell R. Commitment and compatibility: Teacher perspectives on the implementation of a school-based, peer-led smoking intervention. Health Education Journal 2008: 67: Audrey, S. Holliday J. Campbell R. It's good to talk: Adolescent perspectives of an informal, peer-led intervention to reduce smoking. Social Science & Medicine 2006:63: Evaluation of method used to select peer supporters 7. Starkey F, Holliday J, Audrey S, Moore L, Campbell R, Identifying influential young people to undertake effective peer-led health promotion: the example of A Stop Smoking In Schools Trial (ASSIST) Health Ed Res 2009 doi: /her/cyp045 Process evaluation 8. Audrey S, Holliday J, Parry Langdon N, Campbell R. Meeting the challenges of implementing process evaluation within randomised controlled trials: the example of ASSIST (A Stop Smoking In Schools Trial) Health Educ. Res ;3: Cost effectiveness 9. Hollingworth W, Cohen D, Hawkins J, Hughes R, Moore L, Holliday J, Audrey S, Starkey F, Campbell R. Reducing smoking in adolescents: cost-effectiveness results from the cluster randomised ASSIST (A Stop Smoking In Schools Trial). Nicotine and Tobacco Research (in press)
19 Dissemination PhD Thesis 35 + Conference presentations Numerous presentations to various groups of NHS staff and NHS organisations at national, regional and local level
20 Systematic review to support NICE Guidance on smoking prevention interventions for use in schools Qualitative review generally highlights ASSIST as a particularly promising approach The effect size for ASSIST included in the initial quantitative review was a subgroup of the multilevel model for those who had never smoked at baseline that found an odds ratio of 0.81 (0.62, 1.06). Explanation - focus of the review on smoking prevention Ignored all those who were not smoking regularly but at high risk of smoking uptake (ex occasional smokers and those experimenting with smoking). Provided a reanalysis of the trial data with regular smoker excluded 0.79 (95% CI: 0.64, 0.98) Final published version does not now present any results from our primary analysis and asserts that 7 schools withdrew after randomisation which is not the case. It does though accurately report the odds ratios at each of the three follow up points.
21 Implementation Questions to ask yourself include: Are your results accessible to decision-makers, and have you presented them in a persuasive way? Are your recommendations detailed and explicit? Strategies to encourage implementation of evaluation findings should be based on a scientific understanding of the behaviours that need to change, the relevant decision-making processes, and the barriers and facilitators of change. If the intervention is translated into routine practice, monitoring should be undertaken to detect adverse events or long term outcomes that could not be observed directly in the original evaluation,
22 Implementation of ASSIST Documentation Training the Trainers guide ASSIST programme manual Monitoring process of initial roll out Wales Tower Hamlets PCT Bristol PCT completed a detailed evaluation funded by the PCT
23 Lessons learnt Implementation is possible beyond a research context Contact teacher(s) key role within school to champion implementation (timetable, rooms) Recruiting training team health promotion specialists and youth workers male trainers? importance of fidelity v flexibility Costs of implementation vary considerably economies of scale and greater control if ASSIST trainers are employed by PCT/LA (not freelance)
24 What we wanted to do Scale up the roll out of ASSIST Have a staffed office to grant licences for the delivery of ASSIST to support and monitor implementation to undertake quality assurance to ensure fidelity of implementation to provide initial training of ASSIST organisers organise regional meetings to encourage best practice provide regular updates of materials
25 Barriers to implementation Initially university development offices / lacked understanding of our product therefore unable to provide helpful advice Told initially we didn t qualify for translational funding No obvious workforce to deliver this public health intervention in the school setting
26 Solution for us To set up a Community Interest Company Not for profit Any surplus to be reinvested Edge of campus organisation under the auspices of DECIPHer Write a business plan Find people who could help
27
28 2020 Aspirations Stopping the inflow of young people recruited as smokers: aspiring to reduce the year-old smoking rate to 1% of less and the rate among yearolds to 8% by 2020
29 Recommendation 3 Head teachers, school governors, teachers and support staff in secondary schools...should...con sider offering evidence-based, peer-led interventions aimed at preventing the uptake of smoking such as the ASSIST programme
30 Decipher-Impact.com Company limited by guarantee formed in March 2010 Wholly owned by the two Universities Board five directors (two from each University and an independent Chair) General Manager in post for 21 months who had previously been in charge of roll out in Wales Issued 20 licences to PCTs and LA for use of Decipher- Assist Held our first annual conference for all those currently delivering ASSIST in Bristol in February 2012
31
32 Lessons Setting up and running a spinout company is extremely hard work and very time consuming Running a business requires some very different skills from those required to be a successful academic Universities want to be supportive but their structures are bureaucratic and not always helpful Find an existing company to work with Decipher-Impact is broadly constituted to support the delivery of interventions and services that improve public health
33 Questions Are current guidelines on the evaluation of complex interventions sufficient when it comes to implementation? Was setting up a community interest company a good solution? With public health moving into LA in England will they want to continue resourcing school-based interventions like this particularly when increasing numbers of state schools are becoming independent from LAs? Can schools themselves be left to decide which health promotion interventions should or should not be implemented? How do we know ASSIST is working outside the trial setting?
34 Further trials of ASSIST In discussions with researchers at the University of Texas who are going to make an application to NIH in USA for funding for a replication trial Also in contact with the Public Health Foundation of India and Centre of Excellence for Youth Engagement in Canada about the possibility of them using ASSIST
35 Acknowledgements ASSIST Professor Laurence Moore, Dr Jo Holliday, Dr Suzanne Audrey Decipher Impact Fellow directors: Sue Sundstom, Dr Eryl Cox, Dr Mark Hughes, Prof Laurence Moore General Manager: Sally Good
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