Integrating Smoking Cessation Into Routine Primary Care Practice - Full Text View

Sponsors and Collaborators:	University of Waterloo University of Ottawa Heart Institute Canadian Tobacco Control Research Initiative
Information provided by:	University of Waterloo
ClinicalTrials.gov Identifier:	NCT00799279

Purpose

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	Intervention
Smoking Cessation	Behavioral: Smoking cessation training, support, and telephone follow-up Behavioral: smoking cessation intervention

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by University of Waterloo:

Primary Outcome Measures:

smoking abstinence [ Time Frame: 16-weeks ] [ Designated as safety issue: No ]
Rates of provider delivery of smoking treatments [ Time Frame: clinic visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cost-effectiveness [ Time Frame: 16-weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Follow-up Counseling Arm: Experimental 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.
Practice Support Arm: Active Comparator 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.

Arms

Assigned Interventions

Follow-up Counseling Arm: Experimental

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.

Practice Support Arm: Active Comparator

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799279

Sponsors and Collaborators

University of Waterloo

University of Ottawa Heart Institute

Canadian Tobacco Control Research Initiative

Investigators

Principal Investigator:

Paul McDonald, PhD

University of Waterloo

More Information

No publications provided

Responsible Party:	University of Waterloo ( Paul McDonald )
Study ID Numbers:	15053, CTCRI 019826, CTCRI 19813
Study First Received:	November 17, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00799279 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Waterloo:

smoking
cessation
family medicine

evidence-based
knowledge translation
smoking cessation, primary care

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on September 10, 2009