Integrating Smoking Cessation Into Routine Primary Care Practice

NCT ID: NCT00799279

Last Updated: 2010-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 835 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-09-30

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Follow-up Counseling Arm

smoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers

Group Type: EXPERIMENTAL

Smoking cessation training, support, and telephone follow-up

Intervention Type: BEHAVIORAL

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.

Practice Support Arm

smoking cessation training for providers,practice tools for providers, patient quit plan for smokers.

Group Type: ACTIVE_COMPARATOR

smoking cessation intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: collaborator

Canadian Tobacco Control Research Initiative

OTHER

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

University of Waterloo

Principal Investigators

Paul McDonald, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Other Identifiers

CTCRI 019826

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CTCRI 19813

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15053

Identifier Type: -

Identifier Source: org_study_id