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

NCT ID: NCT01603524

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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OMSC Group

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

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.

Group Type ACTIVE_COMPARATOR

OMSC Group

Intervention Type OTHER

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

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.

OMSC + Performance Feedback Group

Intervention Type 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.

OMSC + Performance Feedback 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.

Group Type EXPERIMENTAL

OMSC + Performance Feedback Group

Intervention Type 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.

Interventions

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OMSC Group

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

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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


* 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.

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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Sophia Papadakis

Program Director, Primary Care Smoking Cessation Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sophia Papadakis, Ph.D., MHA

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa Heart Insitute

Andrew Pipe, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 19903737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20600264 (View on PubMed)

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. doi: 10.1155/2009/412385.

Reference Type BACKGROUND
PMID: 19707607 (View on PubMed)

Papadakis S, Pipe AL, Reid RD, Tulloch H, Mullen KA, Assi R, Cole AG, Wells G. Effectiveness of performance coaching for enhancing rates of smoking cessation treatment delivery by primary care providers: Study protocol for a cluster randomized controlled trial. Contemp Clin Trials. 2015 Nov;45(Pt B):184-190. doi: 10.1016/j.cct.2015.08.013. Epub 2015 Sep 5.

Reference Type DERIVED
PMID: 26348788 (View on PubMed)

Other Identifiers

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NA 7193

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011583-01H

Identifier Type: -

Identifier Source: org_study_id

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