Integrating Smoking Cessation Into Routine Primary Care Practice

Sponsor

University of Waterloo (Other)

Overall Status

Completed

CT.gov ID

NCT00799279

Collaborator

Ottawa Heart Institute Research Corporation (Other), Canadian Tobacco Control Research Initiative (Other)

835

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Smoking cessation training, support, and telephone follow-up Behavioral: smoking cessation intervention	N/A

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:

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.
Increases smoking abstinence as measured three months after the estimated target quit date (i.e.16 weeks) compared to providing only practice supports.
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 Design

Study Type:

Interventional

Actual Enrollment :

835 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

smoking abstinence [16-weeks]
Self-report and biochemically validated point prevelence smoking abstinence

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Practice is a family health team (FHT), family health group (FHG); or family health network (FHN);
All physicians within the practice are willing to participate in the study;
Practice will see an average of 50 patients per day and 10% of patients are smokers;
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:

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