Integrating Smoking Cessation Into Routine Primary Care Practice
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|ClinicalTrials.gov Identifier: NCT00799279|
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : October 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Smoking cessation training, support, and telephone follow-up Behavioral: smoking cessation intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||835 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||January 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||September 2010|
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.
- smoking abstinence [ Time Frame: 16-weeks ]Self-report and biochemically validated point prevelence smoking abstinence
- cost-effectiveness [ Time Frame: 16-weeks ]
- Rate of provider delivery of evidence-based smoking treatments [ Time Frame: exit survey on day of clinic visits ]Rates of providers, asking, advising, assessing, assisting, and arranging were assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799279
|Principal Investigator:||Paul McDonald, PhD||University of Waterloo|