The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding (REASON-II)
August 25, 2011 updated by: Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
The Dissemination of Consensus Recommendations on the Management of Canadian Patients With Non Variceal Upper Gastrointestinal Bleeding: A National Cluster Randomized Trial of a Multifaceted Tailored Implementation Strategy
The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved with implementation of a national, tailored multifaceted intervention.
Outcomes include adherence rates to two key endoscopic and pharmacological therapy guidelines together (primary), or adherence to these individually as well as to other recommendations (secondary).
Patient outcomes and economic data are also assessed (tertiary).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Clusters are randomized to receive a published algorithm and guidelines (control group), or a multifaceted, tailored educational intervention (see details in protocol - intervention group).
The charts of treated patients with non variceal upper GI bleeding are reviewed and adherence to selected guidelines recorded.
Study Type
Interventional
Enrollment (Actual)
3157
Phase
- Phase 4
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or over.
- Treated during the study duration
- Primary or secondary discharge diagnoses of NVUGIB (per charted ICD-10 code). Additional confirmation of NVUGIB using endoscopic findings or patient symptoms done as previous.
Exclusion Criteria:
- Patients initially assessed at another institution for the present episode of NVUGIB and subsequently transferred to the participating site with unavailable initial data.
- Endoscopy noted no gastro-duodenal ulcer bleeding, to ensure patient homogeneity.
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational intervention
see protocol
|
As per detailed protocol.
Other Names:
|
|
No Intervention: Standard care
distribution of guidelines and a published algorithm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adherence to guidelines G10 or G17 alone, G5b, G6, G7a, G7b , G7c, G18 of the 2003 International Consensus Conference on nonvariceal upper GI bleeding.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alan Barkun, MD, McGill University Health Centre/Research Institute of the McGill University Health 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.
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
September 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 9, 2009
First Posted (Estimate)
February 10, 2009
Study Record Updates
Last Update Posted (Estimate)
August 26, 2011
Last Update Submitted That Met QC Criteria
August 25, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCT-88113
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.