Integrating the "Ottawa Model" for Smoking Cessation Into Primary Care Practice (RCT-OMSC-PC)

This study is currently recruiting participants.
Verified October 2013 by University of Ottawa Heart Institute
Sponsor:
Information provided by (Responsible Party):
Sophia Papadakis, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01603524
First received: May 18, 2012
Last updated: October 21, 2013
Last verified: October 2013

May 18, 2012
October 21, 2013
March 2012
September 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]

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

  1. the delivery of evidence-based smoking cessation interventions within family doctors' offices,
  2. number of patient quit attempts, and
  3. patient bio-chemically verified 7-day point prevalence abstinence measured at 6-months compared to standard care control practices.
Same as current
Complete list of historical versions of study NCT01603524 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]

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

  1. provider delivery of evidence-based smoking cessation interventions,
  2. number of patient quit attempts, and
  3. 7-day point prevalence abstinence measured at 6-months in family doctors' offices compared to the OMSC alone and standard care control practices.
Same as current
Not Provided
Not Provided
 
Integrating the "Ottawa Model" for Smoking Cessation Into Primary Care Practice
Integrating the "Ottawa Model" for Smoking Cessation Into Routine Primary Care Practice: A Cluster Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Smoking Cessation
  • Other: Ottawa Model Intervention Group
    1. Coaching and Outreach Facilitation Visits: Each practice will receive on-site support to implement the intervention components.
    2. 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.
    3. Provider Training in Smoking Cessation Interventions: All clinic providers will be invited to a 3 hour training workshop on smoking cessation(CME).
    4. 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.
  • Behavioral: Ottawa Model+ Provider Performance Feedback Intervention Group
    The OMSC + Provider 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.
  • Ottawa Model Group
    Clinics will receive a facilitated intervention process that involves 3 components: 1) asking patients about smoking status at each clinic visit; 2) delivering clear, personalized advice to quit smoking to all patients who smoke; 3) offering cessation support by conducting a 10 to 20 minute quit plan consultation session with patients ready to quit in the next 30 days and referring patients to a telephone-based patient follow-up support program. Practices will be supported in implementing the OMSC using a multi-component intervention program which involves four components.
    Intervention: Other: Ottawa Model Intervention Group
  • Experimental: Ottawa Model+ Provider Performance Feedback Intervention Group
    The OMSC + Provider 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.
    Intervention: Behavioral: Ottawa Model+ Provider Performance Feedback Intervention Group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Roxane Assi, BS.c 613-798-5555 ext 17131 RAssi@ottawaheart.ca
Contact: Sophia Papadakis, Ph.D., MHA 613-761-5489 SPapadakis@ottawaheart.ca
Canada
 
NCT01603524
2011583-01H, NA 7193
No
Sophia Papadakis, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Not Provided
Principal Investigator: Sophia Papadakis, Ph.D., MHA University of Ottawa Heart Insitute
Principal Investigator: Andrew Pipe, MD University of Ottawa Heart Institute
University of Ottawa Heart Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP