The Dissemination of Consensus Recommendations on Upper G... | NCT00840008

Studies
The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding

NCT00840008

Sponsor

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

Status

Completed

Last Update Posted

Aug 26, 2011Estimated

Enrollment

3,157Actual

Phase

Phase 4

Conditions

Peptic Ulcer Hemorrhage

Interventions

Educational intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2011

Last Update Posted Date

Aug 26, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alan Barkun, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health CentrePrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Horizon Health Network	OTHER
Queen Elizabeth II Health Sciences Centre	OTHER
St-Johns Health Sciences Centre	UNKNOWN
Centre hospitalier de l'Université de Montréal (CHUM)

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Educational intervention	Experimental	see protocol	Other: Educational intervention
Standard care	No Intervention	distribution of guidelines and a published algorithm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Educational intervention	Other	As per detailed protocol.	Educational intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Barkun, MD	McGill University Health Centre/Research Institute of the McGill University Health Centre	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23318399	Derived	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.

ID	Term
D010438	Peptic Ulcer Hemorrhage
D006471	Gastrointestinal Hemorrhage

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

ID	Term
D002662	Child Health Services
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services