Upper Gastrointestinal BleedingAEGISNCT05085405
Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial
A study testing Clinician notification, Clinician Notification with Nurse Facilitation and Clinician Notification / Patient Activation in people with Upper Gastrointestinal Bleeding, run by University of Michigan at 1 site in United States.
Trial summary
This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- Clinician notification, Clinician Notification with Nurse Facilitation and Clinician Notification / Patient Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Enrollment with the Michigan Medicine anticoagulation monitoring service
- Currently prescribed warfarin with anticipated use for greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation
- Currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list
- Practicing cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study
- Practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria
Who cannot join
- Prescribed a Proton Pump Inhibitor (PPI)
- Documented intolerance or allergy to PPI use
- Left ventricular assist device
- Heart transplant
- Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pilot Trial to Evaluate Clinician- and Patient-facing Strategies to Reduce Upper Gastrointestinal Bleeding Risk in Patients on Combination Antithrombotic Therapy
This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.
Read the detailed description
In February 2022, the IRB approved adding a small additional substudy for the collection of exploratory qualitative outcomes only, involving up to 8 primary care physicians. As no data for the primary and secondary outcome measures was collected for this substudy, and all data collection for this group was related to exploratory outcome measures and collected through qualitative interviews with clinicians, no inclusion exclusion criteria specific to the participants in this substudy are listed, nor does the data collection from them show in the study completion date or results data. However, these physicians (n=8) and their patients (n=9) are counted in the actual enrollment total since they were randomized to intervention arms and received study interventions.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- Clinician notification, Clinician Notification with Nurse Facilitation, Clinician Notification / Patient Activation, Clinician Notification with Nurse Facilitation / Patient Activation
- Keywords
- combination antithrombotic therapy, proton pump inhibitor, peptic ulcer disease, gastroprotection, warfarin, anticoagulation, patient safety
- Medical subject headings
- Gastrointestinal Hemorrhage, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician notificationBehavioural
An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes.
In this arm, patients receive no additional interventions beyond that provided during treatment as usual.
Clinician Notification with Nurse FacilitationBehavioural
An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician.
In this arm, patients receive no additional interventions beyond that provided during treatment as usual.
Clinician Notification / Patient ActivationBehavioural
An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes.
Patient Activation:
An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk.
Clinician Notification with Nurse Facilitation / Patient ActivationBehavioural
An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician.
Patient Activation:
An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk.
| Study group | Role | What they receive |
|---|---|---|
| Clinician Notification only | Experimental | Not described Receives: Behavioral: Clinician notification |
| Clinician Notification with Nurse Facilitation only | Experimental | Not described Receives: Behavioral: Clinician Notification with Nurse Facilitation |
| Clinician Notification / Patient Activation | Experimental | Not described Receives: Behavioral: Clinician Notification / Patient Activation |
| Clinician Notification with Nurse Facilitation / Patient Activation | Experimental | Not described Receives: Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5
The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.
Measured: Week 5
Secondary outcomes (1)
Feasibility of Delivering Intervention Components as Intended
The proportion of patient participants that received all implementation components to which they were randomized in the appropriate time frame.
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start11 Oct 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Assignment to one of two clinician-level implementation strategies will be done at the cluster level according to the identity of the clinician to be contacted. Clinicians will be randomized 1:1 to receive either clinician notification (CN) or clinician notification + nurse facilitation (CN+NF). Patients within each clinician cluster will also be individually randomized to receive a patient activation guide or to a usual care arm. There are 2 arms for each group (patients and clinicians).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jacob E Kurlander, University of Michigan
- Investigators
- Jacob Kurlander, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085405
- Sponsor's protocol ID
- HUM00201535
- Other IDs
- K23DK118179
- Acronym
- AEGIS
- Status last verified
- Jun 2023
- First submitted
- 8 Oct 2021
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurlander JE, Helminski D, Lanham M, Henstock JL, Kidwell KM, Krein SL, Saini SD, Richardson CR, De Vries R, Resnicow K, Ruff AL, Wallace DM, Jones EK, Perry LK, Parsons J, Ha N, Alexandris-Souphis T, Dedrick D, Aldridge E, Barnes GD. Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial. Implement Sci Commun. 2022 Jan 28;3(1):8. doi: 10.1186/s43058-022-00256-8.
PubMed 35090577
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pilot Trial to Evaluate Clinician- and Patient-facing Strategies to Reduce Upper Gastrointestinal Bleeding Risk in Patients on Combination Antithrombotic Therapy
- ClinicalTrials.gov ID
- NCT05085405
- Acronym / sponsor ID
- AEGIS / HUM00201535
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- combination antithrombotic therapy, proton pump inhibitor, peptic ulcer disease, gastroprotection, warfarin, anticoagulation, patient safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.
Detailed description
In February 2022, the IRB approved adding a small additional substudy for the collection of exploratory qualitative outcomes only, involving up to 8 primary care physicians. As no data for the primary and secondary outcome measures was collected for this substudy, and all data collection for this group was related to exploratory outcome measures and collected through qualitative interviews with clinicians, no inclusion exclusion criteria specific to the participants in this substudy are listed, nor does the data collection from them show in the study completion date or results data. However, these physicians (n=8) and their patients (n=9) are counted in the actual enrollment total since they were randomized to intervention arms and received study interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Assignment to one of two clinician-level implementation strategies will be done at the cluster level according to the identity of the clinician to be contacted. Clinicians will be randomized 1:1 to receive either clinician notification (CN) or clinician notification + nurse facilitation (CN+NF). Patients within each clinician cluster will also be individually randomized to receive a patient activation guide or to a usual care arm. There are 2 arms for each group (patients and clinicians).
| Arm | Type | Receives |
|---|---|---|
| Clinician Notification only | Experimental | Behavioral: Clinician notification |
| Clinician Notification with Nurse Facilitation only | Experimental | Behavioral: Clinician Notification with Nurse Facilitation |
| Clinician Notification / Patient Activation | Experimental | Behavioral: Clinician Notification / Patient Activation |
| Clinician Notification with Nurse Facilitation / Patient Activation | Experimental | Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Enrollment with the Michigan Medicine anticoagulation monitoring service
- Currently prescribed warfarin with anticipated use for greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation
- Currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list
- Practicing cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study
- Practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria
Key exclusion criteria (5 listed)
- Prescribed a Proton Pump Inhibitor (PPI)
- Documented intolerance or allergy to PPI use
- Left ventricular assist device
- Heart transplant
- Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.
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 |
|---|---|---|
| Clinician notificationAn anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes. In this arm, patients receive no additional interventions beyond that provided during treatment as usual. | Behavioural | Clinician Notification only |
| Clinician Notification with Nurse FacilitationAn anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician. In this arm, patients receive no additional interventions beyond that provided during treatment as usual. | Behavioural | Clinician Notification with Nurse Facilitation only |
| Clinician Notification / Patient ActivationAn anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes. Patient Activation: An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk. | Behavioural | Clinician Notification / Patient Activation |
| Clinician Notification with Nurse Facilitation / Patient ActivationAn anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician. Patient Activation: An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk. | Behavioural | Clinician Notification with Nurse Facilitation / Patient Activation |
Primary outcome
The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5
Time frame: Week 5
The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.
1 secondary outcome
Feasibility of Delivering Intervention Components as Intended
Time frame: week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35090577Kurlander JE, Helminski D, Lanham M, Henstock JL, Kidwell KM, Krein SL, Saini SD, Richardson CR, De Vries R, Resnicow K, Ruff AL, Wallace DM, Jones EK, Perry LK, Parsons J, Ha N, Alexandris-Souphis T, Dedrick D, Aldridge E, Barnes GD. Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial. Implement Sci Commun. 2022 Jan 28;3(1):8. doi: 10.1186/s43058-022-00256-8.
- Individual participant dataSharing planned: No
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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.
Jacob Kurlander, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician notification, Clinician Notification with Nurse Facilitation and Clinician Notification / Patient Activation in people with Upper Gastrointestinal Bleeding, run by University of Michigan at 1 site in United States.
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 5 inclusion and 5 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 (time frame: Week 5). 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 NCT05085405, 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 29 Jun 2023.