Smoking Termination Opportunity for inPatients (STOP)

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

Official Title

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

Conditions

• Tobacco Use Disorder

Study Type

Interventional

Study Design

Prevention, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Smoking abstinence
  [ Time Frame: one year ]
  [ Designated as safety issue: Yes ]
• 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.

Secondary Outcome Measures:

• Reduced hospital bed utilisation
  [ Time Frame: one year ]
  [ Designated as safety issue: No ]
• 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 ]
  [ Designated as safety issue: Yes ]
  Defined as no cigarettes for the previous 7 days
• Reduction in health care costs
  [ Time Frame: one year ]
  [ Designated as safety issue: No ]
• 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 ]
  [ Designated as safety issue: No ]
• 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 ]
  [ Designated as safety issue: Yes ]
• Measured by self-report and observation by hospital and study staff prior to discharge.

Arms	Assigned Interventions
Champix plus counselling: Experimental 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 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)
Counselling alone: Active Comparator 5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period).	Drug: Champix 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)

 

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 Start

May 2008 – November 2011

Eligibility & Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Smoker of at least 10 cigarettes per day on average over the past 12 months
2. Inpatient with an anticipation admission of at least one day
3. Willingness to quit smoking
4. Aged between 20 and 75 years
5. A plan of discharge to go home
6. 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

Total Enrolment

392

Contact Details

Contact: Brian J Smith, MBBS;FRACP;PhD;Dip Clin Epid
08 8222 7966 ext 27966
brian.smith@health.sa.gov.au

Contact: Kristin V Carson, Dip Lab Sc; Cert III Lab Med
08 8222 8685 ext 28685
kristin.carson@health.sa.gov.au