A study on implementing a smoking reduction programme through General Practices

ISRCTN	ISRCTN03732457
DOI	https://doi.org/10.1186/ISRCTN03732457
Protocol serial number	Version 1
Sponsor	University of Birmingham
Funder	Heart of Birmingham Teaching Primary Care Trust (UK) - (REF: 114000391)

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

Primary study design	Interventional
Study design	2-arm cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial testing the feasibility of nicotine assisted reduction to stop in General Practice
Study acronym	RedGP
Study objectives	1. 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) studied	Smoking reduction
Intervention	Participants 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 type	Other
Primary outcome measure(s)	1. 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
Key secondary outcome measure(s)	1. 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
Completion date	30/06/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. 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 criteria	Does 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 enrolment	01/12/2010
Date of final enrolment	30/06/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Primary Care Clinical Sciences

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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