Integrating Smoking Cessation Into Routine Primary Care Practice

Comparative Evaluation of the Efficacy and Cost-effectiveness of Two Interventions for Integrating Smoking Cessation Into Routine Primary Care Practice: A Cluster-randomized Trial

The aim of this study is to determine if providing smokers identified in family doctors offices with follow-up counselling enhances their success with quitting and the number of health professionals helping patients with quitting. Six to eight family medicine clinics will be involved in the study. We will compare the frequency of addressing smoking with patients and the proportion of smokers who are successful with quitting 16-weeks following the clinic appointment between practices. It is hypothesized that the addition of follow-up counseling to a multi-component smoking cessation intervention will improve smoking outcomes.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Smoking cessation training, support, and telephone follow-up; Behavioral: smoking cessation intervention

Detailed Description

A family doctor's advice to quit has been shown to increase a smoker's motivation to quit. Despite the evidence supporting the importance of smoking cessation, there is a well-documented practice gap in the rates at which smoking cessation is being addressed by practitioners. The primary objectives of this research study are to determine whether adjunct telephone-based smoking cessation follow-up counselling when delivered as part of a multi-component intervention:

1. Increases the rate at which evidence-based smoking cessation interventions are delivered to smokers identified in family doctors offices, compared to providing only practice supports.
2. Increases smoking abstinence as measured three months after the estimated target quit date (i.e.16 weeks) compared to providing only practice supports.
3. Is more cost-effective (cost/quit) than providing only practice supports to family doctors offices.

A two-arm before-after matched-pair cluster randomized trial, will test the effectiveness of two strategies for integrating smoking cessation treatments into primary care practice routines and enhancing cessation. Six to eight family doctors offices will be randomized to either a practice support (PS) group, or a follow-up counseling (FC) group. From each of the intervention practices a cross-sectional sample of 50 eligible smokers will be recruited pre- and post-intervention to assess 5A's delivery and smoking abstinence.

• Study Type: Interventional
• Enrollment (Actual): 835
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Practices will be eligible for participation in the present study if they meet the following criteria:

  1. Practice is a family health team (FHT), family health group (FHG); or family health network (FHN);
  2. All physicians within the practice are willing to participate in the study;
  3. Practice will see an average of 50 patients per day and 10% of patients are smokers;
  4. Practice is willing to provide consent to contact patients in waiting rooms and survey patients during office hours and by telephone.

• Patients will be eligible to participate in the study if they meet the following criteria:

  1. Patient is seen in clinic for annual exam or non-urgent visit;
  2. Patient is a current smoker (>1 cigarette per day on most days of the week);
  3. Patient is 18 years of age or older;
  4. Patient is able to read and understand English or French;
  5. Patient has a home or mobile telephone which can be used to receive follow-up telephone counselling calls

Exclusion Criteria:

• Patients who do not have the mental capacity to provide informed consent and complete study protocols will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Follow-up Counseling Arm; smoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers	Behavioral: Smoking cessation training, support, and telephone follow-up; The CF group will receive the same smoking cessation training and practice support tools delivered to the PS group. In addition, patients in the FC group who are smokers and are willing to set a quit date within the next 30 days and who have set a quit date will be enrolled in an interactive voice response (IVR)-mediated telephone follow-up and counselling system. The IVR system will automatically contact patients via telephone 7 days before their TQD, and 5, 14, 30, and 60 days after their TQD to check the patients' smoking status, potential concerns, and their risk of relapse.
Active Comparator: Practice Support Arm; smoking cessation training for providers,practice tools for providers, patient quit plan for smokers.	Behavioral: smoking cessation intervention; Intervention practices will be provided with training in smoking cessation, and will be supported with integrating a waiting room screener for smoking and smoking consult form and patient quit plan into their practice routines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
smoking abstinence	Self-report and biochemically validated point prevelence smoking abstinence	16-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cost-effectiveness		16-weeks
Rate of provider delivery of evidence-based smoking treatments	Rates of providers, asking, advising, assessing, assisting, and arranging were assessed	exit survey on day of clinic visits

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Ottawa Heart Institute Research Corporation; Canadian Tobacco Control Research Initiative
• Investigators: Principal Investigator: Paul McDonald, PhD, University of Waterloo

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 26, 2008
• First Posted (Estimate): November 27, 2008

Study Record Updates

• Last Update Posted (Estimate): October 6, 2010
• Last Update Submitted That Met QC Criteria: October 5, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: smoking; knowledge translation; cessation; family medicine; evidence-based; smoking cessation, primary care
• Other Study ID Numbers: 15053; CTCRI 019826 (Other Grant/Funding Number: Canadian Tobacco Control Research Initiative); CTCRI 19813 (Other Grant/Funding Number: Canadian Tobacco Control Research Initiative)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No