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| Name | Class |
|---|---|
| Ottawa Heart Institute Research Corporation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | 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 |
|
| Ottawa Model with SmartCard | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ottawa Model with SmartCard | Behavioral | 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 |
| 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. | 26 weeks |
| Self-reported Smoking Status | Self-reported smoking status was the primary indicator of effectiveness and was obtained at 26-52 weeks. Participants were asked to respond "yes" or "no" to the question "Do you still smoke?" | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Recruitment and Retention | Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smita Pakhale, MD, FRCPC | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital, General Campus | Ottawa | Ontario | K1H8L6 | Canada |
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We enrolled and randomized 49 (54.4%) of 90 respirology patients identified as smokers at their routine respirology clinic appointments between November 2011 and December 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | 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 Usual care: 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 |
| FG001 | Ottawa Model With SmartCard | 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 Ottawa Model with SmartCard: 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | 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 Usual care: 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 26 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | 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 Usual care: 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 |
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Small sample size is not sufficient for a statistically significant intervention effect to be detected.
Control participants were contacted monthly by the research team and were asked to set a quit date; it may be argued that this represents an enhanced version of standard care.
Financial limitations: might resulted in shorter NRT treatment than the standard of care.
Recruitment bias - we recruited low educational and income levels and the study was limited to a single site
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Smita Pakhale | Ottawa Hospital Research Institute | 613-737-8899 | 79428 | spakhale@ohri.ca |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Usual care | Behavioral | 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 |
|
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| Lost to Follow-up |
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| BG001 | Ottawa Model With SmartCard | 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 Ottawa Model with SmartCard: 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Ottawa Model With SmartCard | 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 Ottawa Model with SmartCard: 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 |
|
|
| Primary | Self-reported Smoking Status | Self-reported smoking status was the primary indicator of effectiveness and was obtained at 26-52 weeks. Participants were asked to respond "yes" or "no" to the question "Do you still smoke?" | [Not Specified] | Posted | Count of Participants | Participants | 52 weeks |
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| Secondary | Rate of Recruitment and Retention | Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial | [not specified] | Posted | Count of Participants | Participants | 52 weeks |
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Ottawa Model With SmartCard | 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 Ottawa Model with SmartCard: 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 | 1 | 23 | 0 | 23 | 0 | 23 |
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