Implementing the ASSIST smoking

prevention programme following a

successful RCT

Rona Campbell

DECIPHer

Development and Evaluation of

Complex Interventions for Public

Health Improvement

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

Phases of developing randomised controlled trials of

complex interventions’ (Campbell et al, 2000, p. 696)

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

2003 1-year follow-up

2004 2-year follow-up

2006-: Phase 4: Implementation & Dissemination

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

Enhance

knowledge of

harmful effects

of smoking and

the benefits of

remaining

‘smoke-free’

Training objectives…..

Enhance

communication

skills needed to

promote the

smoke-free

message among

peers

Increase

confidence

to intervene

in everyday

situations to

encourage

peers not to

smoke

Have

fun

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 ‘smoke-free’ message

• Weekly smoking was assessed at baseline, immediately post-intervention and at one and two years.

Smoking prevalence at each follow-up

pointPrevalence of

weekly smoking

immediately post-

intervention

Prevalence of

weekly smoking at

1 year follow-up

Prevalence of

weekly smoking at

2 year follow-up

Control Inter-

vention

Control Inter-

vention

Control Inter-

vention

All

students

8.48%

403/4753

6.60%

334/5058

15.13%

736/4865

12.49%

630/5044

21.74%

1022/4701

18.95%

941/4966

High-risk

group

9.80%

168/1715

8.50%

157/1846

23.03%

389/1689

18.84%

338/1794

34.81%

549/1577

31.22%

536/1717

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

OR

Favours treatment Favours control

.342082 1 2.92327

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)

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 43,289 14-15 year olds taking up smoking

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

Dissemination of the evidenceMain 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: 1595–1602

Description of the intervention

2. AudreyS, 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 2004. 63(3) 266-284.

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 [ISRCTN55572965]. BMC Public Health 2005, 5:43 doi:10.1186/1471-2458-5-43.

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

Dissemination of the evidenceAcceptability 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: 74–90.

6. 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 2006:63:320-334.

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:10.1093/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. 2006 21;3:366-377

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)

Dissemination

• PhD Thesis

• 35 + Conference presentations

• Numerous presentations to various groups

of NHS staff and NHS organisations at

national, regional and local level

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.

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,

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

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)

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

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

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

2020 Aspirations

Stopping the inflow

of young people

recruited as

smokers: aspiring

to reduce the 11-

15-year-old

smoking rate to 1%

of less and the rate

among 16-17 year-

olds to 8% by 2020

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

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

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

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?

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

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