Smoking Cessation
Conditions
Keywords
Smoking Cessation, respirology Out-patient setting, SmartCard
Brief summary
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
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.
Interventions
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
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
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks. | 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. |
| Self-reported Smoking Status | 52 weeks | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recruitment and Retention | 52 weeks | Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 23 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Ottawa Model With SmartCard | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 26 Participants | 49 Participants |
| Age, Continuous | 48.3 years STANDARD_DEVIATION 12.6 | 50.9 years STANDARD_DEVIATION 10.4 | 49.8 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Canada | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 1 / 23 |
| other Total, other adverse events | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 23 |
Outcome results
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.
Time frame: 26 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks. | 26 Participants |
| Ottawa Model With SmartCard | Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks. | 23 Participants |
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?
Time frame: 52 weeks
Population: \[Not Specified\]
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Self-reported Smoking Status | Self-reported non-smoker status | 2 Participants |
| Usual Care | Self-reported Smoking Status | did not report report non-smoker status | 24 Participants |
| Ottawa Model With SmartCard | Self-reported Smoking Status | Self-reported non-smoker status | 4 Participants |
| Ottawa Model With SmartCard | Self-reported Smoking Status | did not report report non-smoker status | 19 Participants |
Rate of Recruitment and Retention
Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial
Time frame: 52 weeks
Population: \[not specified\]
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Rate of Recruitment and Retention | Complete self-reported smoking status data | 16 Participants |
| Usual Care | Rate of Recruitment and Retention | Did not complete self-reported smoking status data | 10 Participants |
| Ottawa Model With SmartCard | Rate of Recruitment and Retention | Complete self-reported smoking status data | 16 Participants |
| Ottawa Model With SmartCard | Rate of Recruitment and Retention | Did not complete self-reported smoking status data | 7 Participants |