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Exploring ways to help hospital patients stop smoking
ISRCTN ISRCTN25441641
DOI 10.1186/ISRCTN25441641
ClinicalTrials.gov identifier
EudraCT number
Public title Exploring ways to help hospital patients stop smoking
Scientific title Evaluation of the impact of systematic delivery of cessation interventions on delivery of smoking cessation in secondary care
Acronym N/A
Serial number at source 8974
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.
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Public Health Research
Participants - 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
Participants - 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.
Anticipated start date 11/10/2010
Anticipated end date 10/03/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned sample size: 1300; UK sample size: 1300
Interventions 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
Primary outcome measure(s) Number of smokers with validated cessation, measured at one month post-discharge
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
Sources of funding National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23836616
Contact name Mrs  Kapka  Nilan
  Address Division of Epidemiology & Public Health
Clinical Sciences Building B125
City Hospital Campus
Hucknall Road
  City/town Nottingham
  Zip/Postcode NG5 1PB
  Country United Kingdom
  Email k.nilan@nottingham.ac.uk
Sponsor University of Nottingham (UK)
  Address Research Innovation Services
Kings Meadow Campus
Lenton Lane
  City/town Nottingham
  Zip/Postcode NG7 2NR
  Country United Kingdom
  Sponsor website: http://www.nottingham.ac.uk/
Date applied 28/10/2010
Last edited 15/07/2013
Date ISRCTN assigned 28/10/2010
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