Smoking Termination Opportunity for inPatients (STOP)
|ClinicalTrials.gov Identifier: NCT01141855|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : August 8, 2012
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
- sustained smoking abstinence
- reduced hospital bed and health service utilisation
- reduced inpatient smoking and craving prior to discharge
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Drug: Champix Behavioral: Counselling alone||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||392 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Champix plus counselling
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
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)
Active Comparator: counselling alone
5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period).
Behavioral: Counselling alone
Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
Other Name: Quitline counselling service
- Smoking abstinence [ Time Frame: one year ]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.
- Reduced hospital bed utilisation [ Time Frame: one year ]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.
- 7-day point prevalence [ Time Frame: from 2 weeks to 3 months post enrollment ]Defined as no cigarettes for the previous 7 days
- Reduction in health care costs [ Time Frame: one year ]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.
- Inpatient craving levels [ Time Frame: baseline to end of inpatient stay ]Craving scales will be used to assess levels during inpatient stay (pre and post intervention delivery)
- Prevalence of inpatient smoking [ Time Frame: From baseline to end of inpatient stay ]Measured by self-report and observation by hospital and study staff prior to discharge.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141855
|Australia, South Australia|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|The Queen Elizabeth Hospital|
|Adelaide, South Australia, Australia, 5011|
|Lyell McEwin Health Service|
|Adelaide, South Australia, Australia, 5112|
|Principal Investigator:||Brian J Smith, MBBS; FRACP;PhD;Dip Clin Epid||The Queen Elizabeth Hospital|