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
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 design | Single centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 11/10/2010 |
| Completion date | 10/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 1300; UK sample size: 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
- England
- United Kingdom
Study participating centre
Division of Epidemiology & Public Health
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
