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Smoking CessationRCT-OMSC-PCNCT01603524

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

A study testing OMSC Group and OMSC + Performance Feedback Group in people with Smoking Cessation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
OMSC Group and OMSC + Performance Feedback Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
Mar 2012to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
OMSC Group, OMSC + Performance Feedback Group
Keywords
Ottawa Model for Smoking Cessation, Primary Care
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 + Performance Feedback GroupBehavioural

    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.

Study groups in NCT01603524
Study groupRoleWhat they receive
OMSC GroupActive comparatorThe 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.
Receives: Other: OMSC Group; Behavioral: OMSC + Performance Feedback Group
OMSC + Performance Feedback GroupExperimentalThe 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.
Receives: Behavioral: OMSC + Performance Feedback Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. 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:

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01603524
Sponsor's protocol ID
2011583-01H
Other IDs
NA 7193
Acronym
RCT-OMSC-PC
Status last verified
Jun 2015
First submitted
18 May 2012
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19903737

  • 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.

    PubMed 20600264

  • 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.

    PubMed 19707607

  • 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.

    PubMed 26348788

Questions about this trial

What is this clinical trial studying?

A study testing OMSC Group and OMSC + Performance Feedback Group in people with Smoking Cessation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603524, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

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