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

This study has been completed.
Sponsor:
Collaborators:
Horizon Health Network
QEII Health Sciences Centre
St-Johns Health Sciences Centre
Centre hospitalier de l'Université de Montréal (CHUM)
Jewish General Hospital
MUHC - 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
Misericordia
Royal University Hospital Foundation
Regina General Hospital
University of Manitoba
Information provided by (Responsible Party):
Alan Barkun, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00840008
First received: February 4, 2009
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Peptic Ulcer Hemorrhage
Other: Educational intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 3157
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
MUHC - 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
Misericordia
Royal University Hospital Foundation
Regina General Hospital
University of Manitoba
Investigators
Principal Investigator: Alan Barkun, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Alan Barkun, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00840008     History of Changes
Other Study ID Numbers: MCT-88113
Study First Received: February 4, 2009
Last Updated: August 25, 2011
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on November 24, 2014