The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding

Peptic Ulcer Hemorrhage Clinical Trial

— REASON-II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840008
• Other study ID #: MCT-88113
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2009
• Last updated: August 25, 2011
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3157
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage

Intervention

Other:
• Educational intervention
As per detailed protocol.

Locations

Country	Name	City	State
n/a

Sponsors (39)

Lead Sponsor

Collaborator

McGill University Health Center

Centre Hospitalier Anna Laberge, Centre hospitalier de l'Université de Montréal (CHUM), Centre Hospitalier Pierre Boucher, CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus, Cité de la Santé Hospital, Foothills Medical Centre, Grey Nuns Hospital, Guelph General Hospital, Hamilton Health Sciences Corporation, Horizon Health Network, Hotel Dieu Hospital, Hôtel-Dieu de Lévis, Jewish General Hospital, Kingston General Hospital, Lakeridge Health Corporation, London Health Sciences Centre, Maisonneuve-Rosemont Hospital, Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital, Misericordia, MUHC - Montreal General Hospital, Peter Lougheed Centre/The Calgary General Hospital, QEII Health Sciences Centre, Regina General Hospital, Rockyview General Hospital, Royal Alexandra Hospital, Royal University Hospital Foundation, Royal Victoria Hospital, Canada, Scarborough General Hospital, St Mary's Hospital, London, St-Johns Health Sciences Centre, St. Joseph Hospital Health Center, Sunnybrook Health Sciences Centre, The Ottawa Hospital, Toronto General Hospital, University of Alberta, University of Manitoba, Vancouver General Hospital, York Central Hospital, Ontario

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding.		1 year	No
Secondary	Adherence to guidelines G10 or G17 alone, G5b, G6, G7a, G7b , G7c, G18 of the 2003 International Consensus Conference on nonvariceal upper GI bleeding.		1 year	No