NCT01603524

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3.2 years

First QC Date

May 18, 2012

Last Update Submit

June 1, 2015

Conditions

Smoking Cessation

Keywords

Ottawa Model for Smoking CessationPrimary Care

Outcome Measures

Primary Outcomes (1)

  • 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: 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.

    Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.

Secondary Outcomes (1)

  • Examining the incremental impact of audit and feedback within family doctors' offices compared to the OMSC alone group and standard control practices.

    Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.

Study Arms (2)

OMSC Group

ACTIVE COMPARATOR

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.

Other: OMSC GroupBehavioral: OMSC + Performance Feedback Group

OMSC + Performance Feedback Group

EXPERIMENTAL

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: OMSC + Performance Feedback Group

Interventions

OMSC GroupOTHER

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 Group
OMSC + Performance Feedback GroupBEHAVIORAL

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 GroupOMSC Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Current smoker (\>5 cigarette per day on most days of the week);
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (4)

  • 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.

    PMID: 19903737BACKGROUND

  • 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.

    PMID: 20600264BACKGROUND

  • 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.

    PMID: 19707607BACKGROUND

  • 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.

    PMID: 26348788DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Sophia Papadakis, Ph.D., MHA

    University of Ottawa Heart Insitute

    PRINCIPAL INVESTIGATOR

  • Andrew Pipe, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Primary Care Smoking Cessation Program

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 23, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

CA(1)