A study on implementing a smoking reduction programme through General Practices

ISRCTN ISRCTN03732457
DOI https://doi.org/10.1186/ISRCTN03732457
Secondary identifying numbers Version 1
Submission date
29/09/2010
Registration date
19/10/2010
Last edited
25/05/2018
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Taina Taskila
Scientific

Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Study information

Study design2-arm cluster randomised controlled 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 contact details below to request a patient information sheet
Scientific titleA randomised controlled trial testing the feasibility of nicotine assisted reduction to stop in General Practice
Study acronymRedGP
Study objectives1. General Practices can successfully implement smoking reduction programme as part of their stop smoking service
2. Reducing smoking gradually will help people with chronic conditions to stop smoking
Ethics approval(s)West Midlands REC Centre, ref: 10/H1208/67
Health condition(s) or problem(s) studiedSmoking reduction
InterventionParticipants will be randomised into either an intervention group receiving a smoking reduction service or a control group receiving the standard NHS care.

Participants in the intervention group will be encouraged to use both a nicotine patch and a short acting form of NRT. Patients who agree to behavioural support, will be in the trial for a minimum of 2 weeks and maximum of 20 weeks.

The programme will be evaluated using qualitative methods. Semi structured interviews with a sample of GPs and their medical staff as well as trial participants.
Intervention typeOther
Primary outcome measure1. Number of people within the populations of interest that are offered smoking reduction programmes
2. Number that take up the offer
3. Number of behavioural support visits made
4. Amount of NRT used
5. Number that complete reduction programmes
6. All episodes where a GP records that a patient stopped NRT due to adverse events
Secondary outcome measures1. Number of people within the population of interest that try to quit smoking
2. Number that succeed in quitting: Success defined as a self-report of at least four weeks of complete cessation verified by at least one CO reading of <10ppm, which is in line with the NHS standard
3. Proportion of people that meet the GCP criteria for serious adverse events and the occurrence of any events of interest e.g. hospitalisation for acute coronary syndrome in those with ischaemic heart disease. These are events where smoking cessation might be expected to reduce the incidence.
4. All hospitalisations and visits to the GP, classifying the latter as scheduled for chronic care and incidental events
5. Number of people that reduce their smoking: Smoking reduction defined as smoking <50% of baseline cigarettes per day accompanied by a fall of at least 1ppm in exhaled carbon monoxide
Overall study start date01/12/2010
Completion date30/06/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants400
Key inclusion criteria1. Males and females 18 years or older
2. People with one or more of the following chronic conditions:
2.1. Ischaemic heart disease
2.2. Hypertension
2.3. Diabetes mellitus
2.4. Stroke
2.5. Asthma
2.6. Chronic Obstructive Pulmonary Disease (COPD)
2.7. Chronic kidney disease
2.8. Schizophrenia
2.9. Bipolar disorder
3. For the intervention arms only: Daily smokers with either a carbon monoxide (CO) of at least 10 parts per million (ppm) at least 15 minutes after last smoking or smoke at least 10 cigarettes or 8g of loose tobacco as roll your own cigarettes daily
4. As the programme will be offered as a part of normal follow-up care, consent will not be required.
Key exclusion criteriaDoes not match inclusion criteria.
All smokers, regardless of interest are included in the denominator population. Some smokers might not be offered NRT if, in the judgement of their GP, it would be unsafe to do so. The situations where this might occur include:
1. Has had severe reactions to NRT previously
2. Unstable angina pectoris, myocardial infarction, acute coronary syndrome, or cerebrovascular accident during the last 3 weeks
3. Severe cardiac arrhythmia
4. Currently uncontrolled hyperthyroidism
5. Active phaeocromocytoma
6. Pregnancy or lactation
Date of first enrolment01/12/2010
Date of final enrolment30/06/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham
University/education

c/o Dr Brendan Laverty
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Hospital/treatment centre

Heart of Birmingham Teaching Primary Care Trust (UK) - (REF: 114000391)

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

Editorial Notes

25/05/2018: Confirmed that the study was terminated because the member of staff left post (and couldn't be replaced) and the general practices were not keen to pursue it.
02/05/2018: Informed that the study was abandoned due to a variety of reasons, with no data and no outcome.
27/03/2018: No publications found, verifying study status with principal investigator.
05/02/2016: No publications found, verifying study status with principal investigator