- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01004276
Increasing Smoking Cessation Counselling in Primary Care Using a Chronic Disease Management System
October 28, 2009 updated by: McMaster University
A Cluster Randomized Controlled Pilot Trial of the Effect of a New, Improved Smoking Cessation Management Module, Compared With Use of the Standard Version of Such a Management Module, on Smoking Counselling Initiation and Continuation Rates in Primary Care Practices Currently Using P-PROMPT Chronic Disease Management System in Ontario
This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system.
The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
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
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physician subscribers to P-PROMPT CDMS
Exclusion Criteria:
- Paper users
- Physicians expected to retire during the course of the study
- Physicians whose billing files are not set-up with DataSynch
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Improved module
|
The intervention that will be tested is an improved smoking cessation management module in an existing chronic disease management system, P-PROMPT CDMS.
This module includes the following components: a) the Patient Care Status and Update Form, b) the smoking registry and c) patient prompts.
|
No Intervention: Standard module
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Smoker Identifying Cards
Time Frame: 3 months post-intervention
|
3 months post-intervention
|
Chronic disease management system's activity log
Time Frame: monthly post-intervention
|
monthly post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Smoking cessation counselling billing codes from physician's remittance advice files
Time Frame: monthly post-intervention
|
monthly post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Selby, MD, Centre for Addiction and Mental Health
- Principal Investigator: Natalie T. MacLeod, M.Sc. Candidate, McMaster University
- Principal Investigator: Rolf J. Sebaldt, MD, McMaster University
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
November 1, 2009
Primary Completion (Anticipated)
April 1, 2010
Study Completion (Anticipated)
April 1, 2010
Study Registration Dates
First Submitted
October 28, 2009
First Submitted That Met QC Criteria
October 28, 2009
First Posted (Estimate)
October 29, 2009
Study Record Updates
Last Update Posted (Estimate)
October 29, 2009
Last Update Submitted That Met QC Criteria
October 28, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-341
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.
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