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

NCT01495689 | Completed Results

• 1 other identifier: OHRI
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; respirology Out-patient setting; SmartCard

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Rate of Recruitment and Retention

  52 weeks

Study Arms (2)

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

Behavioral: Usual care

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

Behavioral: Ottawa Model with SmartCard

Interventions

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

Also known as: Ottawa Model of Smoking Cessation and SmartCard

Ottawa Model with SmartCard

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

Also known as: Usual care as per current practice

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Ottawa Heart Institute Research Corporation: collaborator

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

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

Results Point of Contact

• Title: Smita Pakhale
• Organization: Ottawa Hospital Research Institute

spakhale@ohri.ca

613-737-8899

Study Officials

• Smita Pakhale, MD, FRCPC

  OHRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist and Assistant Professor

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 20, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 19, 2024
• Results First Posted: May 5, 2017

Record last verified: 2023-05

Locations

CA (1)