Condition category
Not Applicable
Date applied
28/10/2010
Date assigned
28/10/2010
Last edited
15/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.nottingham.ac.uk/

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

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23836616

Publication citations

  1. 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.

Additional files

Editorial Notes