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The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding (REASON-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00840008
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : August 26, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Other: Educational intervention Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : September 2008
Primary Completion Date : December 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Educational intervention
see protocol
Other: Educational intervention
As per detailed protocol.
Other Name: Multifacetted tailored educational intervention
No Intervention: Standard care
distribution of guidelines and a published algorithm

Outcome Measures

Primary Outcome Measures :
  1. Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840008

Sponsors and Collaborators
McGill University Health Center
Horizon Health Network
QEII Health Sciences Centre
St-Johns Health Sciences Centre
Centre hospitalier de l'Université de Montréal (CHUM)
Jewish General Hospital
Montreal General Hospital
Royal Victoria Hospital, Canada
Maisonneuve-Rosemont Hospital
St Mary's Hospital, London
Centre Hospitalier Pierre Boucher
Cité de la Santé Hospital
Centre Hospitalier Anna Laberge
Hotel Dieu Hospital
CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus
Hôtel-Dieu de Lévis
Hamilton Health Sciences Corporation
St. Joseph Hospital Health Center
Sunnybrook Health Sciences Centre
Toronto General Hospital
York Central Hospital, Ontario
Lakeridge Health Corporation
Guelph General Hospital
London Health Sciences Centre
The Ottawa Hospital
Kingston General Hospital
Scarborough General Hospital
Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital
Vancouver General Hospital
Peter Lougheed Centre/The Calgary General Hospital
Foothills Medical Centre
Rockyview General Hospital
Grey Nuns Hospital
University of Alberta
Royal Alexandra Hospital
Royal University Hospital Foundation
Regina General Hospital
University of Manitoba
Principal Investigator: Alan Barkun, MD McGill University Health Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan Barkun, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00840008     History of Changes
Other Study ID Numbers: MCT-88113
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Alan Barkun, McGill University Health Center:
peptic ulcer bleeding
upper GI hemorrhage
adherence to guidelines
knowledge transfer

Additional relevant MeSH terms:
Peptic Ulcer
Gastrointestinal Hemorrhage
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases