NCT00840008

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,157

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2008

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1.2 years

First QC Date

February 4, 2009

Last Update Submit

August 25, 2011

Conditions

Peptic Ulcer Hemorrhage

Keywords

peptic ulcer bleedingupper GI hemorrhageadherence to guidelinesknowledge transfer

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 year

Study Arms (2)

Educational intervention

EXPERIMENTAL

see protocol

Other: Educational intervention

Standard care

NO INTERVENTION

distribution of guidelines and a published algorithm

Interventions

Educational interventionOTHER

As per detailed protocol.

Also known as: Multifacetted tailored educational intervention
Educational intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23318399DERIVED

MeSH Terms

Conditions

Peptic Ulcer HemorrhageGastrointestinal Hemorrhage

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Alan Barkun, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 10, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

August 26, 2011

Record last verified: 2011-08