The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding - Full Text View

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

This study has been completed.

First Received on February 4, 2009. Last Updated on August 25, 2011 History of Changes

Sponsor:	McGill University Health Center
Collaborators:	Saint John Regional Hospital 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 Centre Hospitalier Pierre Boucher Cité de la Santé Hospital Centre Hospitalier Anna Laberge CHUQ-Hotel Dieu de Quebec Hospital CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus Centre Hospitalier Affilie Hotel-Dieu de Levis 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

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 IV

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:

MedlinePlus related topics: Gastrointestinal Bleeding Peptic Ulcer

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840008

Sponsors and Collaborators

McGill University Health Center

Saint John Regional Hospital

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

Centre Hospitalier Pierre Boucher

Cité de la Santé Hospital

Centre Hospitalier Anna Laberge

CHUQ-Hotel Dieu de Quebec Hospital

CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus

Centre Hospitalier Affilie Hotel-Dieu de Levis

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
Ulcer
Gastrointestinal Diseases

Digestive System Diseases
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on February 09, 2012