Implementation of an Evidence Based Smoking Cessation Strategy (SMOCC) for Patients With COPD in Primary Care
September 22, 2010 updated by: Radboud University Medical Center
A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates.
The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective.
Therefore the present study investigates a large scale implementation strategy in a 2-armed community intervention trial.
The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
COPD is an increasing cause of death and morbidity and smoking is its primary cause.
Professional smoking cessation treatment is very cost-effective and therefore recommended by national guidelines.
A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates.
The incremental cost-effectiveness ratio (ICER) was Euro 1012 showing that the protocol was cost-effective.
The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective.
Therefore the present study investigates an implementation strategy in a 2-armed community intervention trial.
General practices (N=150, 2700 smoking patients with COPD) will be randomly allocated to the intervention or control condition.
In the control condition the usual dissemination strategy of distributing guidelines and subsequent products through the professional channels (journals, postgraduate education) will take place.
In the intervention condition a multifaceted implementation strategy wil be executed aimed at support of the general practice team (outreach education by a facilitator, support for detecting smoking patients with COPD, provision of patient education materials, help desk/website, telephone and e-mail reminders).
The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures.
Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months.
Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients.
A process analysis and evaluations by patients and professionals are an integral part of the study.
A cost-effectiveness analysis taking a health care sector perspective will be performed and will show the expected costs per practice and an incremental cost-effectiveness ratio (ICER).
The study will last 34 months, the intervention period will take 18 months per practice.
Study Type
Interventional
Enrollment (Anticipated)
2700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
6500 Hb
-
117 KWAZO, Postbus 9101, 6500 Hb, Netherlands, Nijmegen
- Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research (WOK)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COPD
- Smoking
- Age 40 years or over
Exclusion Criteria:
- Under control of lung specialist
- Not Dutch-speaking
- Serious physical of psychiatric comorbidity
- Under 40 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: R. Grol, PhD, Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion (Anticipated)
June 1, 2008
Study Registration Dates
First Submitted
February 21, 2006
First Submitted That Met QC Criteria
February 21, 2006
First Posted (Estimate)
February 22, 2006
Study Record Updates
Last Update Posted (Estimate)
September 23, 2010
Last Update Submitted That Met QC Criteria
September 22, 2010
Last Verified
February 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- 945-16-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.