Exploring ways to help hospital patients stop smoking

ISRCTN ISRCTN25441641
DOI https://doi.org/10.1186/ISRCTN25441641
Secondary identifying numbers 8974
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

k.nilan@nottingham.ac.uk

Study information

Study designSingle centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of the impact of systematic delivery of cessation interventions on delivery of smoking cessation in secondary care
Study objectivesTo 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) studiedTopic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Public Health Research
InterventionFor 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 typeOther
Primary outcome measureNumber of smokers with validated cessation, measured at one month post-discharge
Secondary outcome measures1. 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 study start date11/10/2010
Completion date10/03/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexAll
Target number of participantsPlanned sample size: 1300; UK sample size: 1300
Key inclusion criteria1. 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 criteria1. 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 enrolment11/10/2010
Date of final enrolment10/03/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of Epidemiology & Public Health
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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