Clinical trial NCT00799279: Integrating Smoking Cessation Into Routine Primary Care Practice
Official title: Comparative Evaluation of the Efficacy and Cost-effectiveness of Two Interventions for Integrating Smoking Cessation Into Routine Primary Care Practice: A Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking
cessation
family medicine
evidence-based
knowledge translation
smoking cessation, primary care
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Ottawa Heart Institute Research Corporation
name: Canadian Tobacco Control Research Initiative
First posted: 2008-11-27
Enrollment: 835
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: smoking abstinence
timeFrame: 16-weeks
Secondary outcomes:
measure: cost-effectiveness
timeFrame: 16-weeks
measure: Rate of provider delivery of evidence-based smoking treatments
timeFrame: exit survey on day of clinic visits
Other outcomes:
Locations:
Study officials:
affiliation: University of Waterloo
name: Paul McDonald, PhD
role: PRINCIPAL_INVESTIGATOR
References: