A primary care study of tailored advice for stopping smoking

ISRCTN	ISRCTN05385712
DOI	https://doi.org/10.1186/ISRCTN05385712
Protocol serial number	BRD/06/022
Sponsor	University College London (UCL) (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C16265)

Submission date: 04/01/2008
Registration date: 14/02/2008
Last edited: 06/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hazel Gilbert
Scientific

Department of Primary Care and Population Sciences
University College London (UCL)
Hamstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Phone	+44 (0)20 7317 7548
Email	hazel.gilbert@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised single centre controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of computer tailored Smoking Cessation Advice in Primary carE: a randomised trial
Study acronym	ESCAPE
Study objectives	Personally tailored feedback reports, based on an assessment of individual needs and tailored to levels of reading ability, sent to smokers identified from general practitioner (GP) lists with varying levels of motivation and readiness to quit, will increase quit rates and quitting activity over and above that found with standard self help and usual care received from the practice. The study objectives are: 1. To compare the effectiveness of sending personalised computer tailored feedback reports to smokers with sending standard self-help materials 2. To explore the effectiveness of tailored feedback reports by socio-economic status to determine their effect in more deprived groups 3. To determine the characteristics of smokers who are prompted to change their behaviour after receiving tailored feedback reports Please note that the pilot study to this randomised trial was assigned an ISRCTN in 2004. This was assigned to ISRCTN34254423: Pilot trial to assess the feasibility and response rates for an RCT evaluating the effectiveness of a computer tailored intervention for smoking cessation in general practice (see http://www.controlled-trials.com/ISRCTN34254423). As of 15/07/2009 this record was updated to include an extended anticipated end date; the initial end date at the time of registration was 31/12/2008.
Ethics approval(s)	Northern and Yorkshire Multicentre Research Ethics Committee (MREC) approved on the 19th April 2006 (ref: 06/MRE03/10).
Health condition(s) or problem(s) studied	Smoking cessation
Intervention	The control group will receive the usual care plus standard information. Participants will be assessed at baseline and sent standard non-tailored information (NHS Smokefree booklet), as well as receiving the usual care offered by their general practice. The control group receive only one mailing on receipt of their completed baseline questionnaire. The intervention group will receive usual care plus standard information plus computer-tailored feedback reports based on the information obtained at baseline. The intervention group receives an additional assessment and personal report one month after the baseline. The follow up is 6 months after baseline.
Intervention type	Other
Primary outcome measure(s)	Prolonged abstinence for 1 month and for 3 months at the 6-month follow-up. Outcomes will be measured by postal questionnaire. Non-respondents to questionnaires will receive one postal reminder. Non-respondents to the reminder will be contacted by telephone. In order to estimate the accuracy of self-reports, a random sample of 20% of the participants who report abstinence will have their status validated by salivary cotinine sample, obtained by post.
Key secondary outcome measure(s)	1. 24 hour and 7 day point-prevalence abstinence 2. Quit attempts 3. Changes in motivation and intention to quit 4. Cognitions measured at baseline 5. Use of Nicotene Replacement Therapy (NRT) or Zyban 6. Any contact with advice services or health professionals (group, clinic, telephone, or face-to-face) 7. Use of NHS resources and other smoking cessation aids for economic analysis Process measures: 1. Adherence to advice 2. Perceptions of the feedback reports 3. Perceived personal relevance of the feedback reports Information from General Practices: Performance against target figures set by PCTs before and after the intervention as indicators of activity
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	7250
Key inclusion criteria	All current cigarette smokers aged 18 to 65, either sex, able to read English will be eligible for inclusion in the study.
Key exclusion criteria	Exclusion criteria are minimal because the aim is to recruit all smokers. However, any patients selected who are considered by the GP to be unsuitable for the project, e.g., people with severe mental impairment or severely or terminally ill, will be excluded.
Date of first enrolment	01/07/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Primary Care and Population Sciences

London
NW3 2PF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012		Yes	No
Results article	results	01/04/2013		Yes	No