The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding

NCT ID: NCT00840008

Last Updated: 2011-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Peptic Ulcer Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Educational intervention

see protocol

Group Type EXPERIMENTAL

Educational intervention

Intervention Type OTHER

As per detailed protocol.

Standard care

distribution of guidelines and a published algorithm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational intervention

As per detailed protocol.

Intervention Type OTHER

Other Intervention Names

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Multifacetted tailored educational intervention

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horizon Health Network

OTHER

Sponsor Role collaborator

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role collaborator

St-Johns Health Sciences Centre

UNKNOWN

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role collaborator

Jewish General Hospital

OTHER

Sponsor Role collaborator

Montreal General Hospital

OTHER

Sponsor Role collaborator

Royal Victoria Hospital, Canada

OTHER

Sponsor Role collaborator

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role collaborator

St Mary's Hospital, London

OTHER

Sponsor Role collaborator

Centre Hospitalier Pierre Boucher

UNKNOWN

Sponsor Role collaborator

Cité de la Santé Hospital

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Anna Laberge

UNKNOWN

Sponsor Role collaborator

Hotel Dieu Hospital

OTHER

Sponsor Role collaborator

CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus

UNKNOWN

Sponsor Role collaborator

CISSS de Chaudière-Appalaches

OTHER_GOV

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Toronto General Hospital

OTHER

Sponsor Role collaborator

York Central Hospital, Ontario

OTHER

Sponsor Role collaborator

Lakeridge Health Corporation

OTHER

Sponsor Role collaborator

Guelph General Hospital

UNKNOWN

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

Kingston Health Sciences Centre

OTHER

Sponsor Role collaborator

Scarborough General Hospital

OTHER

Sponsor Role collaborator

Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital

UNKNOWN

Sponsor Role collaborator

Vancouver General Hospital

OTHER

Sponsor Role collaborator

Peter Lougheed Centre

OTHER

Sponsor Role collaborator

Foothills Medical Centre

OTHER

Sponsor Role collaborator

Alberta Health services

OTHER

Sponsor Role collaborator

Grey Nuns Hospital

UNKNOWN

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Royal Alexandra Hospital

OTHER

Sponsor Role collaborator

Misericordia

UNKNOWN

Sponsor Role collaborator

Royal University Hospital Foundation

OTHER

Sponsor Role collaborator

Regina General Hospital

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Alan Barkun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Barkun, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

References

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Barkun AN, Bhat M, Armstrong D, Dawes M, Donner A, Enns R, Martin J, Moayyedi P, Romagnuolo J, Stitt L. Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial. CMAJ. 2013 Feb 19;185(3):E156-66. doi: 10.1503/cmaj.120095. Epub 2013 Jan 14.

Reference Type DERIVED
PMID: 23318399 (View on PubMed)

Other Identifiers

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MCT-88113

Identifier Type: -

Identifier Source: org_study_id

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