Integrating the "Ottawa Model" for Smoking Cessation Into Primary Care Practice (RCT-OMSC-PC)
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.
|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|
- 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:
- 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.
- 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:
- 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.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control Group
All clinicians in control group clinics will receive an information leaflet on smoking cessation best practices. No other intervention support will be provided.
Experimental: Ottawa Model Intervention 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
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.
|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|
|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.|
|Principal Investigator:||Sophia Papadakis, Ph.D., MHA||University of Ottawa Heart Insitute|
|Principal Investigator:||Andrew Pipe, MD||University of Ottawa Heart Institute|