Clinical trial NCT00840008: The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer Hemorrhage
Keywords: peptic ulcer bleeding
upper GI hemorrhage
adherence to guidelines
knowledge transfer
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Horizon Health Network
name: Queen Elizabeth II Health Sciences Centre
name: St-Johns Health Sciences Centre
name: Centre hospitalier de l'Université de Montréal (CHUM)
name: Jewish General Hospital
name: Montreal General Hospital
name: Royal Victoria Hospital, Canada
name: Maisonneuve-Rosemont Hospital
name: St Mary's Hospital, London
name: Centre Hospitalier Pierre Boucher
name: Cité de la Santé Hospital
name: Centre Hospitalier Anna Laberge
name: Hotel Dieu Hospital
name: CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus
name: CISSS de Chaudière-Appalaches
name: Hamilton Health Sciences Corporation
name: Unity Health Toronto
name: Sunnybrook Health Sciences Centre
name: Toronto General Hospital
name: York Central Hospital, Ontario
name: Lakeridge Health Corporation
name: Guelph General Hospital
name: London Health Sciences Centre
name: The Ottawa Hospital
name: Kingston Health Sciences Centre
name: Scarborough General Hospital
name: Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital
name: Vancouver General Hospital
name: Peter Lougheed Centre
name: Foothills Medical Centre
name: Alberta Health services
name: Grey Nuns Hospital
name: University of Alberta
name: Royal Alexandra Hospital
name: Misericordia
name: Royal University Hospital Foundation
name: Regina General Hospital
name: University of Manitoba
First posted: 2009-02-10
Enrollment: 3157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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 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.

Primary outcomes:
measure: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding.
timeFrame: 1 year
Secondary outcomes:
measure: Adherence to guidelines G10 or G17 alone, G5b, G6, G7a, G7b , G7c, G18 of the 2003 International Consensus Conference on nonvariceal upper GI bleeding.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Alan Barkun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.