Contact information
Type
Scientific
Primary contact
Mrs Kapka Nilan
ORCID ID
Contact details
Division of Epidemiology & Public Health
Clinical Sciences Building B125
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
k.nilan@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8974
Study information
Scientific title
Evaluation of the impact of systematic delivery of cessation interventions on delivery of smoking cessation in secondary care
Acronym
Study hypothesis
To develop and test the effectiveness and cost-effectiveness of a systematic smoking intervention service that offers treatment to all smokers admitted to the medical wards of an acute NHS Trust who want to quit smoking.
A service is currently offered to relevant patients and we now wish to test the delivery of a new service by randomising certain wards to receive the new service. The study is therefore not a service evaluation and should be categorised as research.
Ethics approval
Nottingham Research Ethics Committee 1 approved on the 30th April 2010 (ref: 10/H0403/34)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Public Health Research
Intervention
For participants in the active intervention group, a cessation practitioner will deliver a brief cessation intervention and offer Nicotine Replacement Therapy and further 1:1 counselling. If accepted and not contraindicated, NRT will be prescribed according to service protocol and where appropriate. Participants who decline NRT will be offered varenicline or bupropion, and if accepted, their clinician requested to confirm that no contra-indications apply and to prescribe the treatment. Carbon monoxide validation will be performed at one and six months post discharge on participants from both groups to ascertain smoking status. Behavioural support will continue to be given by the counsellor on repeated occasions as appropriate and as acceptable to the patient during admission. Follow-up behavioural support after discharge will be arranged with the appropriate local Stop Smoking Service (SSS).
Follow up length: 6 months
Study entry: registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of smokers with validated cessation, measured at one month post-discharge
Secondary outcome measures
1. Smokers abstinent from smoking at discharge (CO validated), measured at discharge
2. Smokers abstinent from smoking, with CO validation, at 6 months post-discharge
3. Smokers discharged on cessation therapy and have post-discharge support arranged, measured at discharge
4. Smokers offered cessation counselling and pharmacotherapy as an inpatient, measured up to one month
5. Smokers who accept cessation counselling and pharmacotherapy as an inpatient, measured up to one month
6. Smokers who leave hospital with an active prescription for a smoking cessation therapy, measured at discharge
7. Smokers who receive post-discharge support from Stop Smoking Services (e.g. New Leaf), measured at 1 and 6 months following discharge
Overall trial start date
11/10/2010
Overall trial end date
10/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients 16 years and older, either sex
2. Admitted to one of eighteen medical wards at the Nottingham City Hospital for a medical condition or illness
3. Current smokers, or have smoked regularly within 28 days of admission or the onset of the illness causing admission
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 1300; UK sample size: 1300
Participant exclusion criteria
1. Do not consent to participate
2. Too ill to understand the information and consent forms
All other smokers will be eligible for inclusion. Decisions to prescribe nicotine replacement therapy will be made in discussion with supervising clinicians. The default will however be to prescribe NRT if it seems otherwise more likely than not that the patient will smoke.
Recruitment start date
11/10/2010
Recruitment end date
10/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Epidemiology & Public Health
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23836616
Publication citations
-
Results
Murray RL, Leonardi-Bee J, Marsh J, Jayes L, Li J, Parrott S, Britton J, Systematic identification and treatment of smokers by hospital based cessation practitioners in a secondary care setting: cluster randomised controlled trial., BMJ, 2013, 347, f4004.