Peptic Ulcer HemorrhagePhase 4REASON-IINCT00840008
The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding
A Phase 4 study testing Educational intervention in people with Peptic Ulcer Hemorrhage, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,157 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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).
Read the 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.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Educational intervention
- Keywords
- peptic ulcer bleeding, upper GI hemorrhage, adherence to guidelines, knowledge transfer
- Medical subject headings
- Peptic Ulcer Hemorrhage, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
Also called Multifacetted tailored educational intervention
As per detailed protocol.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | see protocol Receives: Other: Educational intervention |
| Standard care | No intervention | distribution of guidelines and a published algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon Health Network, Queen Elizabeth II Health Sciences Centre, St-Johns Health Sciences Centre, Centre hospitalier de l'Université de Montréal (CHUM), Jewish General Hospital, Montreal General Hospital, Royal Victoria Hospital, Canada, Maisonneuve-Rosemont Hospital, St Mary's Hospital, London, Centre Hospitalier Pierre Boucher, Cité de la Santé Hospital, Centre Hospitalier Anna Laberge, Hotel Dieu Hospital, CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus, CISSS de Chaudière-Appalaches, Hamilton Health Sciences Corporation, Unity Health Toronto, Sunnybrook Health Sciences Centre, Toronto General Hospital, York Central Hospital, Ontario, Lakeridge Health Corporation, Guelph General Hospital, London Health Sciences Centre, The Ottawa Hospital, Kingston Health Sciences Centre, Scarborough General Hospital, Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital, Vancouver General Hospital, Peter Lougheed Centre, Foothills Medical Centre, Alberta Health services, Grey Nuns Hospital, University of Alberta, Royal Alexandra Hospital, Misericordia, Royal University Hospital Foundation, Regina General Hospital, University of Manitoba
- Responsible party
- Principal investigator, Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Alan Barkun, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840008
- Sponsor's protocol ID
- MCT-88113
- Acronym
- REASON-II
- Status last verified
- Aug 2011
- First submitted
- 4 Feb 2009
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23318399
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00840008
- Acronym / sponsor ID
- REASON-II / MCT-88113
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- peptic ulcer bleeding, upper GI hemorrhage, adherence to guidelines, knowledge transfer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,157 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Horizon Health Network, Queen Elizabeth II Health Sciences Centre, St-Johns Health Sciences Centre, Centre hospitalier de l'Université de Montréal (CHUM), Jewish General Hospital, Montreal General Hospital, Royal Victoria Hospital, Canada, Maisonneuve-Rosemont Hospital, St Mary's Hospital, London, Centre Hospitalier Pierre Boucher, Cité de la Santé Hospital, Centre Hospitalier Anna Laberge, Hotel Dieu Hospital, CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus, CISSS de Chaudière-Appalaches, Hamilton Health Sciences Corporation, Unity Health Toronto, Sunnybrook Health Sciences Centre, Toronto General Hospital, York Central Hospital, Ontario, Lakeridge Health Corporation, Guelph General Hospital, London Health Sciences Centre, The Ottawa Hospital, Kingston Health Sciences Centre, Scarborough General Hospital, Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital, Vancouver General Hospital, Peter Lougheed Centre, Foothills Medical Centre, Alberta Health services, Grey Nuns Hospital, University of Alberta, Royal Alexandra Hospital, Misericordia, Royal University Hospital Foundation, Regina General Hospital, University of Manitoba
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Other: Educational interventionsee protocol |
| Standard care | No intervention | –distribution of guidelines and a published algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionAlso: Multifacetted tailored educational interventionAs per detailed protocol. | Other | Educational intervention |
Primary outcome
Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding.
Time frame: 1 year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
- Derived from this study: PubMed 23318399Barkun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Barkun, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Educational intervention in people with Peptic Ulcer Hemorrhage, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00840008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.