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 is ongoing, but not recruiting participants.

First Received: February 4, 2009 Last Updated: February 9, 2009 History of Changes

Sponsor:	McGill University Health Center
Collaborators:	Saint John Regional Hospital QEII Health Sciences Centre St-Johns Health Sciences Centre CHUM - Hopital Saint-Luc Montreal Jewish General Hospital MUHC - Montreal General Hospital Royal Victoria Hospital, Canada Maisonneuve-Rosemont Hospital CHUM-Hotel Dieu de Montreal Hospital St. Mary's Hospital CHUM - Notre Dame 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 St. Joseph Hospital Sunnybrook Health Sciences Centre UHN - Toronto General Hospital York Central Hospital (Richmond Hill) 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 HSC
Information provided by:	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:	Randomized, Open Label, Placebo Control, Parallel Assignment
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 ]

Estimated Enrollment:	3916
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Educational intervention: Experimental see protocol	Other: Educational intervention As per detailed protocol.
Standard care: No Intervention 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

CHUM - Hopital Saint-Luc Montreal

Jewish General Hospital

MUHC - Montreal General Hospital

Royal Victoria Hospital, Canada

Maisonneuve-Rosemont Hospital

CHUM-Hotel Dieu de Montreal Hospital

St. Mary's Hospital

CHUM - Notre Dame 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

St. Joseph Hospital

Sunnybrook Health Sciences Centre

UHN - Toronto General Hospital

York Central Hospital (Richmond Hill)

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 HSC

Investigators

Principal Investigator:

Alan Barkun, MD

McGill University Health Center

More Information

No publications provided

Responsible Party:	McGill University Health Centre ( Alan Barkun )
Study ID Numbers:	MCT-88113
Study First Received:	February 4, 2009
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00840008 History of Changes
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:

Stomach Diseases
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Peptic Ulcer Hemorrhage

Gastrointestinal Hemorrhage
Intestinal Diseases
Hemorrhage
Duodenal Diseases
Peptic Ulcer

ClinicalTrials.gov processed this record on February 08, 2010