The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2009

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.

Interventions

  • Other: Educational intervention
    • As per detailed protocol.

Arms, Groups and Cohorts

  • Experimental: Educational intervention
    • see protocol
  • No Intervention: Standard care
    • distribution of guidelines and a published algorithm

Clinical Trial Outcome Measures

Primary Measures

  • Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding.
    • Time Frame: 1 year

Secondary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Collaborator
    • Horizon Health Network
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alan Barkun, Principal Investigator – McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Overall Official(s)
    • Alan Barkun, MD, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

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