Smoking Cessation With the Ottawa Model and SmartCard in Out-patient Respirology Clinic Setting

Study Overview
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Brief Summary
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Cigarette smoking is the most harmful and quitting smoking is very difficult. Despite quitting, it is very difficult to stay quit for long term. In Ottawa the investigators are very lucky to have designed and developed the Ottawa Model for Smoking Cessation (Ottawa Model). This project is an end result of pain staking research. The Ottawa Model has been implemented very successfully to the hospitalized patients and has shown very promising results of higher quitting rates. Our objective is to modify the Ottawa Model to suit the needs of patients attending out-patient respirology clinics. The investigators aim to apply the modified Ottawa Model along with the SmartCard to the adult smokers who attend the investigators out-patient Respirology clinic at the Ottawa Hospital. The investigators aim to train a nurse in clinical aspects and implementation of the protocols related to the Ottawa Model. The trained nurse will contact the smokers attending the clinic. Those subjects willing to participate in this study will be divided in to two groups. One group of subjects will get counseling and SmartCard on the day of the clinic and follow-up phone calls. The SmartCard is worth $110 toward the purchase of quit smoking medications (i.e. nicotine patch/gum, varenicline, or bupropion). The subjects can re-deem the card at the investigators hospital pharmacy. Those in the control group will be followed-up as the investigators are currently doing i.e. with standard smoking cessation counseling from the clinic physician and the nurse, +/- prescription for smoking cessation aids without access to the study nurse and the extra counseling or SmartCard. The investigators aim to find increased quitting rates in the group getting on-site access to the smoking cessation aids with the Smartcard and counseling. There are no studies implementing the Ottawa Model along with the SmartCard in out-patient respirology setting so far. The Ottawa Model has proven to be very successful in the in-patient subjects. Thus, the investigators believe, the investigators can modify the Ottawa Model and make it fit the out-patient Respirology setting and increase the quitting rates.

Detailed Description
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Design: Parallel group randomized control trial Method: All adult current smokers attending respirology clinic at the Ottawa General Hospital will be approached to participate. Concealed random allocation will be done if the subject is willing and signed the written informed consent. Experimental arm will receive counseling on site enrollment in the Ottawa Model of Smoking Cessation which includes IVR automated telephone follow-up and will receive a SmartCard worth $110 towards purchase of smoking cessation aids. Usual care arm will receive current usual care in our clinic i.e. strong physician advice, +/- prescription for smoking cessation aids if requested or willing. As a priori, a third arm was added to the parent study entitled, A PILOT IMPLEMENTATION OF BUDDHIST MINDFULNESS TRAINING COMBINED WITH THE OTTAWA MODEL FOR SMOKING CESSATION IN AN OUT-PATIENT RESPIROLOGY CLINIC SETTING. For this arm, research ethics board approval was sought and 10 participants were approached.

Official Title
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A Pilot Randomized Control Trial of Smoking Cessation Using The Ottawa Model With the SmartCard in Out-patient Respirology Clinic Setting

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Ottawa Model with SmartCard
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult >18 years of age attending Respirology Clinic at the Ottawa General hospital Current smokers (anyone who had smoked any form of tobacco in the 6 months prior to the clinic visit) Willing to set quit dates in next 30 days Exclusion Criteria: Subjects with less than 2 year life expectancy (end stage cancer, end stage lung or heart disease etc) and/or receiving palliative care Not willing to sign consent

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing | Behavioral: Usual care<br>* Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing<br>* Other names: Usual care as per current practice;|
| Experimental: Ottawa Model with SmartCard<br>On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids | Behavioral: Ottawa Model with SmartCard<br>* On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids<br>* Other names: Ottawa Model of Smoking Cessation and SmartCard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks. | The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be >10 ppm, the subject will be considered a smoker. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness Analysis | We will measure direct and indirect costs of the intervention and perform cost-effectiveness analysis of the intervention provided in the out-patient setting with a dedicated nurse available to deliver the intervention. | 6 months | 
| Rate of Recruitment and Retention | Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, respirology Out-patient setting, SmartCard