Exploring ways to help hospital patients stop smoking

ISRCTN	ISRCTN25441641
DOI	https://doi.org/10.1186/ISRCTN25441641
Protocol serial number	8974
Sponsor	University of Nottingham (UK)
Funder	National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

Submission date: 28/10/2010
Registration date: 28/10/2010
Last edited: 15/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Kapka Nilan
Scientific

Division of Epidemiology & Public Health
Clinical Sciences Building B125
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Email	k.nilan@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of the impact of systematic delivery of cessation interventions on delivery of smoking cessation in secondary care
Study objectives	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(s)	Nottingham Research Ethics Committee 1 approved on the 30th April 2010 (ref: 10/H0403/34)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Number of smokers with validated cessation, measured at one month post-discharge
Key secondary outcome measure(s)	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
Completion date	10/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	1300
Key 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
Key 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.
Date of first enrolment	11/10/2010
Date of final enrolment	10/03/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Division of Epidemiology & Public Health

Nottingham
NG5 1PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes