A study on implementing a smoking reduction programme through General Practices

Not Applicable

Completed

• Conditions: Smoking reduction; Mental and Behavioural Disorders; Persons encountering health services for other counselling and medical advice, not elsewhere classified

• Registration Number: ISRCTN03732457
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-19
• Study Completion: 2013-06-30
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of people within the populations of interest that are offered smoking reduction programmes<br>2. Number that take up the offer<br>3. Number of behavioural support visits made<br>4. Amount of NRT used<br>5. Number that complete reduction programmes<br>6. All episodes where a GP records that a patient stopped NRT due to adverse events

Secondary Outcome Measures

Name	Time	Method
1. Number of people within the population of interest that try to quit smoking<br>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<br>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. <br>4. All hospitalisations and visits to the GP, classifying the latter as scheduled for chronic care and incidental events<br>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