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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01495689
Acronym
Quit&Win
Enrollment
49
Registered
2011-12-20
Start date
2011-11-30
Completion date
2013-11-30
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

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

BEHAVIORALOttawa 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

BEHAVIORALUsual 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

Sponsors

Ottawa Heart Institute Research Corporation
CollaboratorOTHER
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.26 weeksThe 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 Status52 weeksSelf-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

MeasureTime frameDescription
Rate of Recruitment and Retention52 weeksRate 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

ArmCount
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
Total49

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath01
Overall StudyLost to Follow-up76
Overall StudyWithdrawal by Subject30

Baseline characteristics

CharacteristicOttawa Model With SmartCardUsual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
23 Participants26 Participants49 Participants
Age, Continuous48.3 years
STANDARD_DEVIATION 12.6
50.9 years
STANDARD_DEVIATION 10.4
49.8 years
STANDARD_DEVIATION 11.3
Region of Enrollment
Canada
23 Participants26 Participants49 Participants
Sex: Female, Male
Female
12 Participants13 Participants25 Participants
Sex: Female, Male
Male
11 Participants13 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 261 / 23
other
Total, other adverse events
0 / 260 / 23
serious
Total, serious adverse events
0 / 260 / 23

Outcome results

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.

Time frame: 26 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareBiochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.26 Participants
Ottawa Model With SmartCardBiochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.23 Participants
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?

Time frame: 52 weeks

Population: \[Not Specified\]

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareSelf-reported Smoking StatusSelf-reported non-smoker status2 Participants
Usual CareSelf-reported Smoking Statusdid not report report non-smoker status24 Participants
Ottawa Model With SmartCardSelf-reported Smoking StatusSelf-reported non-smoker status4 Participants
Ottawa Model With SmartCardSelf-reported Smoking Statusdid not report report non-smoker status19 Participants
Secondary

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: \[not specified\]

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Usual CareRate of Recruitment and RetentionComplete self-reported smoking status data16 Participants
Usual CareRate of Recruitment and RetentionDid not complete self-reported smoking status data10 Participants
Ottawa Model With SmartCardRate of Recruitment and RetentionComplete self-reported smoking status data16 Participants
Ottawa Model With SmartCardRate of Recruitment and RetentionDid not complete self-reported smoking status data7 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026