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

Smoking Cessation Clinical Trial

— RCT-OMSC-PC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603524
• Other study ID #: 2011583-01H
• Secondary ID: NA 7193
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: June 1, 2015
• Start date: March 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• OMSC Group
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.

Behavioral:
• OMSC + Performance Feedback Group
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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (3)

McIvor A, Kayser J, Assaad JM, Brosky G, Demarest P, Desmarais P, Hampson C, Khara M, Pathammavong R, Weinberg R. Best practices for smoking cessation interventions in primary care. Can Respir J. 2009 Jul-Aug;16(4):129-34. Review. — View Citation

Papadakis S, McDonald P, Mullen KA, Reid R, Skulsky K, Pipe A. Strategies to increase the delivery of smoking cessation treatments in primary care settings: a systematic review and meta-analysis. Prev Med. 2010 Sep-Oct;51(3-4):199-213. doi: 10.1016/j.ypmed.2010.06.007. Epub 2010 Jun 17. Review. — View Citation

Reid RD, Mullen KA, Slovinec D'Angelo ME, Aitken DA, Papadakis S, Haley PM, McLaughlin CA, Pipe AL. Smoking cessation for hospitalized smokers: an evaluation of the "Ottawa Model". Nicotine Tob Res. 2010 Jan;12(1):11-8. doi: 10.1093/ntr/ntp165. Epub 2009 Nov 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of the Ottawa Model for Smoking Cessation within family doctors' offices compared to control practices.	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.	Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.	No
Secondary	Examining the incremental impact of audit and feedback within family doctors' offices compared to the OMSC alone group and standard control practices.	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.	Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.	No