Smoking Termination Opportunity for inPatients

Study Overview
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Brief Summary
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The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of: the new medication Champix with best practice counselling initiated in an inpatient setting to achieve: sustained smoking abstinence reduced hospital bed and health service utilisation reduced inpatient smoking and craving prior to discharge

Detailed Description
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A national standard in public hospitals for the management of smoking in patients admitted with smoking related acute illnesses is lacking. Where such patients have continued to smoke up until the time of admission, it can be assumed that primary prevention has failed. Once admitted, there is a vastly under-utilised opportunity, by use of a structured and systematic approach, to intervene with a secondary prevention attempt. This takes advantage of the synergy of: the smoker is a captive audience and may be receptive to considering lifestyle factors that have lead to the admission, and best practice medication and counselling can be initiated prior to discharge. If proven to be cost-effective in our analysis, a systematic roll-out of this secondary prevention initiative would be advocated. ie translation of research into practice.

Official Title
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Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Champix
* Behavioral: Counselling alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoker of at least 10 cigarettes per day on average over the past 12 months Inpatient with an anticipation admission of at least one day Willingness to quit smoking Aged between 20 and 75 years A plan of discharge to go home Acute hospital admission with cardiovascular, cerebrovascular, peripheral vascular diseases or airways (asthma and/or Chronic Obstructive Pulmonary disease Exclusion Criteria: Subject preference to use an alternative pharmacotherapy for smoking cessation Respiratory patient being considered for home oxygen Pregnancy Breast feeding Acute or pre-existing severe psychiatric illnesses Past history of psychosis or suicidal ideation Renal impairment with creatinine clearance <30ml/min

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Champix plus counselling<br>varenicline tartrate will be initiated whilst subjects are inpatients with the standard MIMS dosing schedule (including period of titration). In combination with Quit SA (5A) telephone counselling service | Drug: Champix<br>* Standard MIMS dosage (including period of titration) will be used. 0.5mg daily for 3 days 0.5mg b.d. for 4 days 1mb b.d. for 70 days (full course 3 months)<br>* Other names: Chantix;|
| Active Comparator: counselling alone<br>5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period). | Behavioral: Counselling alone<br>* Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period<br>* Other names: Quitline counselling service;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence | Continued smoking abstinence is defined as: less than or equal to no more than 5 cigarettes smoked during the period of 2 weeks to 12 months post enrollment. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced hospital bed utilisation | Hospital casemix/DRG data will be collected for the 5 years prior to enrollment and one year post enrollment. This will be supplemented by SA Department of Health data and PBS/MBS data sets of study completion, to monitor admissions at other hospitals and GP visits. | one year | 
| 7-day point prevalence | Defined as no cigarettes for the previous 7 days | from 2 weeks to 3 months post enrollment | 
| Reduction in health care costs | Reduced health care costs with greater economic value will be relative to other health interventions. Four seperate economic models will be built for vascular diseases: cardiovascular, cerebrovascular and peripheral vascular diseases and airways diseases: asthma and/or chronic obstructive pulmonary disease. Each model will compare outcomes and costs for varenicline and counselling compared to counselling alone, and will incorporate epidemiological data on natural disease progression of smokers and previous smokers from the four disease profiles split by gender if indicated. | one year | 
| Inpatient craving levels | Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery) | baseline to end of inpatient stay | 
| Prevalence of inpatient smoking | Measured by self-report and observation by hospital and study staff prior to discharge. | From baseline to end of inpatient stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases, Peripheral Vascular Diseases, Cerebrovascular Stroke, Lung Diseases, Obstructive, Asthma, Tobacco Use Disorder, Smoking, Smoking Cessation