Upper Gastrointestinal BleedingAEGISNCT05563714

Anticoagulation With Enhanced Gastrointestinal Safety

A study testing Clinician Notification with Nurse Facilitation (CNNF) in people with Upper Gastrointestinal Bleeding and Peptic Ulcer Hemorrhage, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a pragmatic cluster randomized controlled trial to evaluate the effectiveness of a clinician-facing implementation strategy on the use of medication optimization (defined as either discontinuation of all antiplatelet therapy or initiation of and adherence to a proton pump inhibitor (PPI)) to reduce upper… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Upper Gastrointestinal Bleeding, Peptic Ulcer Hemorrhage, Anticoagulant-induced Bleeding
What is being tested?: Clinician Notification with Nurse Facilitation (CNNF)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2022to 4 Jan 2023
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 ≥90 days on day 1 of trial enrollment, according to the electronic health record documentation.
Currently prescribed an antiplatelet medication (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic health record medication list
Cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria
Michigan Medicine primary care providers for patients who meet eligibility criteria
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

Age less than 18
Currently prescribed a PPI
Documented intolerance or allergy to PPI use
Left ventricular assist device
Heart transplant
Participation in a previous pilot study of these implementation strategies
Cardiologists specializing in electrophysiology or who saw the patient for a clinic visit related to a TAVI procedure unless they are the clinician of record for a patient followed by the anticoagulation service who does not have a Michigan Medicine PCP.
Participation in a previous pilot study of these QI strategies

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pragmatic Randomized Trial to Evaluate Clinician Outreach to Reduce Upper Gastrointestinal Bleeding Risk in Patients Taking Warfarin and Antiplatelet Therapy

Read the detailed description

This is a pragmatic, single-center cluster randomized controlled trial to evaluate a clinician-facing implementation strategy to increase the use of evidence-based practices (EBPs) to reduce bleeding in patients who are using AAT and who are managed by the Michigan Medicine anticoagulation monitoring service. The active intervention is clinician notification with nurse facilitation (CNNF), which consists of an anticoagulation clinic nurse sending an electronic health record message that identifies the patient as high risk for upper GI bleeding and recommends either discontinuing the antiplatelet agent or initiating a PPI; the nurse also pends medication orders for PPIs and provides patient education upon request. Clinicians will be cluster randomized, such that up to 4 patients cared for by each clinician will receive the same clinician-level notification.

This study will use a "wait-listed design," in which patients will be randomized to either have their clinicians receive CNNF or be included in a wait-list control group. At the completion of the study, the patients who were randomized to the wait-list control group will receive the intervention.

Conditions: Upper Gastrointestinal Bleeding, Peptic Ulcer Hemorrhage, Anticoagulant-induced Bleeding
Being tested: Clinician Notification with Nurse Facilitation (CNNF), Wait list control
Keywords: Warfarin, Proton pump inhibitor, Antiplatelet therapy, Gastroprotection, Aspirin, Thienopyridine, Patient safety, Anticoagulation
Medical subject headings: Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clinician Notification with Nurse Facilitation (CNNF)Behavioural
An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
Wait list controlBehavioural
The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.

Study groups in NCT05563714
Study group	Role	What they receive
Clinician Notification with Nurse Facilitation (CNNF)	Experimental	Not described Receives: Behavioral: Clinician Notification with Nurse Facilitation (CNNF)
Wait List Control (Usual care)	Other	Not described Receives: Behavioral: Wait list control

What is being measured

The primary outcome is the main question the study is designed to answer.

ITT Analysis - Percent of Patients Reporting Medication Optimization
The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.
Measured: Up to 10 weeks
Modified Completer Analysis - Percent of Patients Reporting Medication Optimization
The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.
Measured: Up to 10 weeks

Secondary outcomes (1)

ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation
The number of patients who have a recommendation from a Michigan Medicine clinician to either discontinue all antiplatelet medications or initiate a PPI divided by the total number of patients in that randomization arm.
Measured: Up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 20224 Jan 2023

First posted3 Oct 2022
Study start5 Oct 2022
Primary completion4 Jan 2023
Study completion4 Jan 2023

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.
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: Parallel groups
Model description: Randomization (1:1) of clinicians and patients to CNNF vs. wait list control will be done at the cluster level according to the identity of the clinician to be contacted. Clinician randomization will be stratified by number of eligible patients, and by procedural vs. non-procedural specialty. Randomization will be carried out by the study statistician. For each included clinician, up to 4 patients will be included in their cluster. If a clinician is selected to participate who has more than 4 eligible patients, 4 of their patients will be randomly selected to participate.
Masking: None (open label)
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05563714
Sponsor's protocol ID: HUM00217771
Other IDs: K23DK118179
Acronym: AEGIS
Status last verified: Apr 2024
First submitted: 28 Sep 2022
Last updated: 30 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Upper Gastrointestinal Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pragmatic Randomized Trial to Evaluate Clinician Outreach to Reduce Upper Gastrointestinal Bleeding Risk in Patients Taking Warfarin and Antiplatelet Therapy
ClinicalTrials.gov ID: NCT05563714
Acronym / sponsor ID: AEGIS / HUM00217771
Conditions: Upper Gastrointestinal Bleeding, Peptic Ulcer Hemorrhage, Anticoagulant-induced Bleeding
Keywords: Warfarin, Proton pump inhibitor, Antiplatelet therapy, Gastroprotection, Aspirin, Thienopyridine, Patient safety, Anticoagulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 5 Oct 2022 (actual)
Primary completion: 4 Jan 2023 (actual)
Study completion: 4 Jan 2023 (actual)
First posted: 3 Oct 2022 (actual)
Results: Posted 30 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomization (1:1) of clinicians and patients to CNNF vs. wait list control will be done at the cluster level according to the identity of the clinician to be contacted. Clinician randomization will be stratified by number of eligible patients, and by procedural vs. non-procedural specialty. Randomization will be carried out by the study statistician. For each included clinician, up to 4 patients will be included in their cluster. If a clinician is selected to participate who has more than 4 eligible patients, 4 of their patients will be randomly selected to participate.

Arm	Type	Receives
Clinician Notification with Nurse Facilitation (CNNF)	Experimental	Behavioral: Clinician Notification with Nurse Facilitation (CNNF)
Wait List Control (Usual care)	Other	Behavioral: Wait list control

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Enrollment with the Michigan Medicine anticoagulation monitoring service
Currently prescribed warfarin with anticipated use for ≥90 days on day 1 of trial enrollment, according to the electronic health record documentation.
Currently prescribed an antiplatelet medication (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic health record medication list
Cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria
Michigan Medicine primary care providers for patients who meet eligibility criteria

Key exclusion criteria (8 listed)

Age less than 18
Currently prescribed a PPI
Documented intolerance or allergy to PPI use
Left ventricular assist device
Heart transplant

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 Notification with Nurse Facilitation (CNNF)An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.	Behavioural	Clinician Notification with Nurse Facilitation (CNNF)
Wait list controlThe anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.	Behavioural	Wait List Control (Usual care)

Primary outcome

ITT Analysis - Percent of Patients Reporting Medication Optimization
Time frame: Up to 10 weeks
The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.
Modified Completer Analysis - Percent of Patients Reporting Medication Optimization
Time frame: Up to 10 weeks
The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.

1 secondary outcome

ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation
Time frame: Up to 10 weeks

Results and safety

Results posted to the registry on 30 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)	110	81
Patient Arm - Wait List Control (Usual Care)	110	83
Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF)	61	61
Clinician Arm - Wait List Control (Usual Care)	60	60

Primary outcome: ITT Analysis - Percent of Patients Reporting Medication Optimization

Time frame: Up to 10 weeks. Count of participants. Unit: Participants

Measure	Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) n = 110	Patient Arm - Wait List Control (Usual Care) n = 110
Reached by phone & achieved medication optimization	30	2
Reached by phone & did not achieve medication optimization	29	65
Data Imputed - Reached by phone but reported non-use of antiplatelet therapy at baseline	15	10
Data Imputed - Reached by phone but reported use of or uncertain use of PPIs at baseline	8	6
Data Imputed - Patients lost to follow-up due to death or hospitalization	2	3
Data Imputed - Patients closed to the anticoagulation service or who discontinued warfarin therapy	5	5
Data Imputed - Patients unable to be reached by phone or who declined to participate in the survey	21	19

Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) vs Patient Arm - Wait List Control (Usual Care): Odds Ratio (OR): 5.22 (95% CI 2.41 to 11.33), p <0.001, generalized linear mixed effects model
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) vs Patient Arm - Wait List Control (Usual Care): Odds Ratio (OR): 5.76 (95% CI 2.54 to 13.05), p <0.001, generalized linear mixed effects model

Population analysed: All patients who entered the study were included in this intention-to-treat analysis. Multiple imputation was used to account for missing data for patients lost to follow-up, including patients who were closed to the anticoagulation service, discontinued warfarin therapy, died or were hospitalized throughout the data collection window, were unreachable by phone, declined to participate in the phone survey, or self-reported non-use of antiplatelet therapy or use of PPIs at baseline.

Primary outcome: Modified Completer Analysis - Percent of Patients Reporting Medication Optimization

Time frame: Up to 10 weeks. Count of participants. Unit: Participants

Measure	Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) n = 59	Patient Arm - Wait List Control (Usual Care) n = 67
All patients who reported non-use of antiplatelet therapy or use of PPI gastroprotection	30	2
Stopped antiplatelet therapy	17	1
Started a PPI	11	1
Stopped antiplatelet therapy and started a PPI	2	0

Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) vs Patient Arm - Wait List Control (Usual Care): Odds Ratio (OR): 29.3 (95% CI 6.07 to 141.49), p <0.001, generalized linear mixed effects model
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) vs Patient Arm - Wait List Control (Usual Care): Odds Ratio (OR): 43.6 (95% CI 6.56 to 289.88), p <0.001, generalized linear mixed effects model

Population analysed: Patients who self-reported either not using antiplatelet therapy or using a PPI at the start of the trial during the week 7-10 phone survey, and those who were lost to follow up were excluded from the modified completer analysis (n=94).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)	0 of 110 (0%)	0 of 110 (0%)	2 of 110
Patient Arm - Wait List Control (Usual Care)	0 of 110 (0%)	0 of 110 (0%)	2 of 110
Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF)	0 of 0	0 of 0	0
Clinician Arm - Wait List Control (Usual Care)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 E Kurlander, MD, MS 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?

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 6 inclusion and 8 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 30 Apr 2024. 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 30 Apr 2024). 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?

ITT Analysis - Percent of Patients Reporting Medication Optimization (time frame: Up to 10 weeks). The study lists 2 primary outcomes in all. 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 NCT05563714.

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 30 Apr 2024.