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Completed

NCT Number: NCT01603524

Integrating the "Ottawa Model" for Smoking Cessation Into Primary Care Practice

This proposal outlines the design of a cluster randomized controlled trial to compare the effectiveness of a new approach to integrating smoking cessation services into routine interactions with patients in the primary care setting using an adaptation of the Ottawa Model for Smoking Cessation (OMSC). The OMSC aims to systematically identify the smoking status of all patients, provide brief cessation advice, and offer evidence-based cessation support to those interested in embarking on a quit attempt. This study will provide important new evidence to assist with the development of a more comprehensive cessation system in the province of Ontario and across Canada.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

About this study

A multi-component intervention has been designed to facilitate the uptake of the OMSC using best evidence regarding the integration of smoking cessation intervention into primary care practice. The secondary objective of the study is to examine the incremental value of providing tailored performance feedback to primary care practitioners when delivered as part of the OMSC intervention program.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Practice Inclusion Criteria:

  • Is a primary care practice (family health team, family health group, family health network, community health centre);
  • Has a minimum of five full time physicians on staff or sees an average of 50 patients per day;
  • All physicians within the practice are willing to participate in the study.

Practice Exclusion Criteria:

  • Primary care practices with less than 5 family physicians in a shared clinic space will be excluded.
  • Clinics who have already implemented the OMSC will also be excluded.

Patient Inclusion Criteria:

  • Current smoker (>5 cigarette per day on most days of the week);
  • 18 years of age or older;
  • Scheduled for an annual exam or non-urgent medical appointment with a physician or nurse practitioner;
  • Able to read and understand English or French;
  • Has a home or mobile telephone which can be used to receive follow-up telephone counselling calls;
  • Has the mental capacity to provide informed consent and complete study protocols.

Patient Exclusion Criteria:

  • Unable to read and understand English or French;
  • Do not have a home or mobile telephone which can be used to receive follow-up calls;
  • Do not have the mental capacity to provide informed consent and complete study protocols.

Treatment and study plan

OMSC Group

Other

The OMSC Group will receive a multi-component intervention which includes:

  • Coaching and Outreach Facilitation Visits: Each practice will receive on-site support to implement the intervention components.
  • Practice tools and real time prompts: Practices will be provided with 4 tools to support the integration of evidence-based cessation practices into brief clinical encounters as part of a practice-level strategy.
  • Provider Training in Smoking Cessation Interventions: All clinic providers will be invited to a 3 hour training workshop on smoking cessation(CME).
  • Telephone follow-up support program: Clinics will be able to refer smokers embarking upon a quit attempt to the smoker's telephone follow-up counseling program.

OMSC + Performance Feedback Group

Behavioral

The OMSC + Performance Feedback Group will receive the same intervention program as the OMSC group. In addition, clinicians will complete a one-hour audit and feedback session prior to the implementation of the OMSC program at their clinic. The goal of the audit and feedback is to increase provider self-efficacy in the delivery of smoking cessation interventions, raise awareness of the current delivery of evidence-based cessation practices, identify areas for improvement, and motivate providers to deliver evidence-based treatments.

Primary outcomes

  1. Effect of the Ottawa Model for Smoking Cessation within family doctors' offices compared to control practices.

    Time frame: Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.

    The primary objectives of this study are to determine whether the Ottawa Model for Smoking Cessation (OMSC) increases:

    • the delivery of evidence-based smoking cessation interventions within family doctors' offices,
    • number of patient quit attempts, and
    • patient bio-chemically verified 7-day point prevalence abstinence measured at 6-months compared to standard care control practices.

Secondary outcomes

  1. Examining the incremental impact of audit and feedback within family doctors' offices compared to the OMSC alone group and standard control practices.

    Time frame: Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.

    The secondary objectives of this study are to examine the incremental impact of audit and feedback on:

    • provider delivery of evidence-based smoking cessation interventions,
    • number of patient quit attempts, and
    • 7-day point prevalence abstinence measured at 6-months in family doctors' offices compared to the OMSC alone and standard care control practices.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Integrating the "Ottawa Model" for Smoking Cessation Into Routine Primary Care Practice: A Cluster Randomized Controlled Trial

Acronym: RCT-OMSC-PC

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 23, 2012
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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