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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Smoking Cessation
Other: Ottawa Model Intervention Group
Behavioral: Ottawa Model+ Provider Performance Feedback Intervention Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Integrating the "Ottawa Model" for Smoking Cessation Into Routine Primary Care Practice: A Cluster Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603524

Contacts
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

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Marion Fraser, BA    613-761-5000    MFraser@ottawaheart.ca   
Sub-Investigator: Robert Reid, Ph.D., MBA         
Sub-Investigator: Heather Tulloch, Ph.D.         
Sub-Investigator: George Wells, Ph.D.         
Sub-Investigator: Debbie Aitken, RN, BScN         
Sub-Investigator: Kerri-Anne Mullen, M.Sc.         
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
Principal Investigator: Sophia Papadakis, Ph.D., MHA University of Ottawa Heart Insitute
Principal Investigator: Andrew Pipe, MD University of Ottawa Heart Institute
  More Information

Publications:
Responsible Party: Sophia Papadakis, Program Director, Primary Care Smoking Cessation Program, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01603524     History of Changes
Other Study ID Numbers: 2011583-01H, NA 7193
Study First Received: May 18, 2012
Last Updated: May 29, 2014
Health Authority: Canada: Health Canada
United States: Institutional Review Board

Keywords provided by University of Ottawa Heart Institute:
Ottawa Model for Smoking Cessation
Primary Care

ClinicalTrials.gov processed this record on September 18, 2014