Smoking CessationNCT00799279
Integrating Smoking Cessation Into Routine Primary Care Practice
A study testing Smoking cessation training, support, and telephone follow-up and smoking cessation intervention in people with Smoking Cessation, run by University of Waterloo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking cessation training, support, and telephone follow-up and smoking cessation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 835 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- Patients who do not have the mental capacity to provide informed consent and complete study protocols will be excluded.
About this 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
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation training, support, and telephone follow-up, smoking cessation intervention
- Keywords
- smoking, cessation, family medicine, evidence-based, knowledge translation, smoking cessation, primary care
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation training, support, and telephone follow-upBehavioural
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.
smoking cessation interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up Counseling Arm | Experimental | smoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers Receives: Behavioral: Smoking cessation training, support, and telephone follow-up |
| Practice Support Arm | Active comparator | smoking cessation training for providers,practice tools for providers, patient quit plan for smokers. Receives: Behavioral: smoking cessation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking abstinence
Self-report and biochemically validated point prevelence smoking abstinence
Measured: 16-weeks
Secondary outcomes (2)
cost-effectiveness
Measured: 16-weeks
Rate of provider delivery of evidence-based smoking treatments
Rates of providers, asking, advising, assessing, assisting, and arranging were assessed
Measured: exit survey on day of clinic visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation, Canadian Tobacco Control Research Initiative
- Investigators
- Paul McDonald, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799279
- Sponsor's protocol ID
- 15053
- Other IDs
- CTCRI 019826, CTCRI 19813
- Status last verified
- Oct 2010
- First submitted
- 17 Nov 2008
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00799279
- Acronym / sponsor ID
- 15053
- Conditions
- Smoking Cessation
- Keywords
- smoking, cessation, family medicine, evidence-based, knowledge translation, smoking cessation, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation, Canadian Tobacco Control Research Initiative
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up Counseling Arm | Experimental | Behavioral: Smoking cessation training, support, and telephone follow-upsmoking cessation training for providers,practice tools for providers, patient quit plan, and follow-up telephone counselling for smokers |
| Practice Support Arm | Active comparator | Behavioral: smoking cessation interventionsmoking cessation training for providers,practice tools for providers, patient quit plan for smokers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Practices will be eligible for participation in the present study if they meet the following criteria:
- Patients will be eligible to participate in the study if they meet the following criteria:
Key exclusion criteria (1 listed)
- Patients who do not have the mental capacity to provide informed consent and complete study protocols will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation training, support, and telephone follow-upThe 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. | Behavioural | Follow-up Counseling Arm |
| smoking cessation interventionIntervention 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. | Behavioural | Practice Support Arm |
Primary outcome
smoking abstinence
Time frame: 16-weeks
Self-report and biochemically validated point prevelence smoking abstinence
2 secondary outcomes
cost-effectiveness
Time frame: 16-weeks
Rate of provider delivery of evidence-based smoking treatments
Time frame: exit survey on day of clinic visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul McDonald, PhD principal investigator
University of Waterloo
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation training, support, and telephone follow-up and smoking cessation intervention in people with Smoking Cessation, run by University of Waterloo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking abstinence (time frame: 16-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2010.