Clinical trial NCT01603524: Integrating the "Ottawa Model" for Smoking Cessation Into Primary Care Practice
Official title: Integrating the "Ottawa Model" for Smoking Cessation Into Routine Primary Care Practice: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Ottawa Model for Smoking Cessation
Primary Care
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of the Ottawa Model for Smoking Cessation within family doctors' offices compared to control practices.
timeFrame: Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.
Secondary outcomes:
measure: Examining the incremental impact of audit and feedback within family doctors' offices compared to the OMSC alone group and standard control practices.
timeFrame: Patient bio-chemically verified 7-day point prevalence abstinence is measured at 6 months post-enrollement.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Heart Insitute
name: Sophia Papadakis, Ph.D., MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Andrew Pipe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.