Integrating Smoking Cessation Into Routine Primary Care Practice
Comparative Evaluation of the Efficacy and Cost-effectiveness of Two Interventions for Integrating Smoking Cessation Into Routine Primary Care Practice: A Cluster-randomized Trial
3 other identifiers
interventional
835
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 27, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 6, 2010
October 1, 2010
1.2 years
November 17, 2008
October 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
smoking abstinence
Self-report and biochemically validated point prevelence smoking abstinence
16-weeks
Secondary Outcomes (2)
cost-effectiveness
16-weeks
Rate of provider delivery of evidence-based smoking treatments
exit survey on day of clinic visits
Study Arms (2)
Follow-up Counseling Arm
EXPERIMENTALsmoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers
Practice Support Arm
ACTIVE COMPARATORsmoking cessation training for providers,practice tools for providers, patient quit plan for smokers.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who do not have the mental capacity to provide informed consent and complete study protocols will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Waterloolead
- Ottawa Heart Institute Research Corporationcollaborator
- Canadian Tobacco Control Research Initiativecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul McDonald, PhD
University of Waterloo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 27, 2008
Study Start
January 1, 2009
Primary Completion
April 1, 2010
Study Completion
September 1, 2010
Last Updated
October 6, 2010
Record last verified: 2010-10