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Completed

NCT Number: NCT00840008

The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding

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).

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Key information

Conditions

Peptic Ulcer Hemorrhage Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational Intervention

Other

As per detailed protocol.

Other names: Multifacetted tailored educational intervention

Primary outcomes

  1. Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding.

    Time frame: 1 year

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Alberta Health services
  • CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus
  • CISSS de Chaudière-Appalaches
  • Centre Hospitalier Anna Laberge
  • Centre Hospitalier Pierre Boucher
  • Centre hospitalier de l'Université de Montréal (CHUM)
  • Cité de la Santé Hospital
  • Foothills Medical Centre
  • Grey Nuns Hospital
  • Guelph General Hospital
  • Hamilton Health Sciences Corporation
  • Horizon Health Network
  • Hotel Dieu Hospital
  • Jewish General Hospital
  • Kingston Health Sciences Centre
  • Lakeridge Health Corporation
  • London Health Sciences Centre
  • Maisonneuve-Rosemont Hospital
  • Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital
  • Misericordia
  • Montreal General Hospital
  • Peter Lougheed Centre
  • Queen Elizabeth II Health Sciences Centre
  • Regina 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
  • Sunnybrook Health Sciences Centre
  • The Ottawa Hospital
  • Toronto General Hospital
  • Unity Health Toronto
  • University of Alberta
  • University of Manitoba
  • Vancouver General Hospital
  • York Central Hospital, Ontario

Registry information

Official study 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

Acronym: REASON-II

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Feb 10, 2009
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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