Trial Outcomes & Findings for Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial (NCT NCT05085405)
NCT ID: NCT05085405
Last Updated: 2023-06-29
Results Overview
The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Week 5
Results posted on
2023-06-29
Participant Flow
Clinicians (n=8) and patients (n=9) in the PCP substudy did not undergo data collection for the primary or secondary outcome measures. Clinician participants were invited by email to participate in semi-structured qualitative interviews for exploratory outcome measures. Review of patient charts occurred at week 5 solely to ascertain whether the clinician responded to the clinician-facing intervention to inform clinician interviews, but no additional chart review or patient assessments were done.
Participant milestones
| Measure |
Patient Arm - Clinician Notification Only
Clinician notification: 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.
|
Patient Arm - Clinician Notification With Nurse Facilitation Only
Clinician Notification with Nurse Facilitation: 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.
|
Patient Arm - Clinician Notification / Patient Activation
Clinician Notification / Patient Activation: 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.
|
Patient Arm - Clinician Notification With Nurse Facilitation / Patient Activation
Clinician Notification with Nurse Facilitation / Patient Activation: 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.
|
Clinician Arm - Notification Only
Clinician notification: 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.
|
Clinician Arm - Notification With Nurse Facilitation
Clinician Notification with Nurse Facilitation: 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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
12
|
13
|
6
|
6
|
|
Overall Study
COMPLETED
|
13
|
13
|
11
|
10
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Patient Arm - Clinician Notification Only
Clinician notification: 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.
|
Patient Arm - Clinician Notification With Nurse Facilitation Only
Clinician Notification with Nurse Facilitation: 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.
|
Patient Arm - Clinician Notification / Patient Activation
Clinician Notification / Patient Activation: 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.
|
Patient Arm - Clinician Notification With Nurse Facilitation / Patient Activation
Clinician Notification with Nurse Facilitation / Patient Activation: 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.
|
Clinician Arm - Notification Only
Clinician notification: 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.
|
Clinician Arm - Notification With Nurse Facilitation
Clinician Notification with Nurse Facilitation: 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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Patient closed to the anticoagulation clinic monitoring service
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Patient started PPI prior to intervention delivery.
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
This data was not collected for physician participants.
Baseline characteristics by cohort
| Measure |
Patient Arm - Clinician Notification Only
n=13 Participants
Clinician notification: 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.
|
Patient Arm - Clinician Notification With Nurse Facilitation Only
n=13 Participants
Clinician Notification with Nurse Facilitation: 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.
|
Patient Arm - Clinician Notification / Patient Activation
n=11 Participants
Clinician Notification / Patient Activation: 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.
|
Patient Arm - Clinician Notification With Nurse Facilitation / Patient Activation
n=10 Participants
Clinician Notification with Nurse Facilitation / Patient Activation: 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.
|
Clinician Arm - Clinician Notification
n=6 Participants
Clinician notification: 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.
|
Clinician Arm - Clinician Notification With Nurse Facilitation
n=6 Participants
Clinician Notification with Nurse Facilitation: 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.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age of Participants at Baseline · Age 18-59
|
5 Participants
n=13 Participants • This data was not collected for physician participants.
|
7 Participants
n=13 Participants • This data was not collected for physician participants.
|
3 Participants
n=11 Participants • This data was not collected for physician participants.
|
5 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
20 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Age, Customized
Age of Participants at Baseline · Age 60-69
|
3 Participants
n=13 Participants • This data was not collected for physician participants.
|
2 Participants
n=13 Participants • This data was not collected for physician participants.
|
4 Participants
n=11 Participants • This data was not collected for physician participants.
|
1 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
10 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Age, Customized
Age of Participants at Baseline · Age 70-79
|
4 Participants
n=13 Participants • This data was not collected for physician participants.
|
4 Participants
n=13 Participants • This data was not collected for physician participants.
|
3 Participants
n=11 Participants • This data was not collected for physician participants.
|
3 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
14 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Age, Customized
Age of Participants at Baseline · Age 80+
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=11 Participants • This data was not collected for physician participants.
|
1 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
3 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
4 Participants
n=11 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
20 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
10 Participants
n=13 Participants
|
7 Participants
n=11 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
39 Participants
n=59 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
1 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=13 Participants • This data was not collected for physician participants.
|
12 Participants
n=13 Participants • This data was not collected for physician participants.
|
11 Participants
n=11 Participants • This data was not collected for physician participants.
|
10 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
46 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
0 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
0 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
1 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
2 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
0 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
1 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
3 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Race (NIH/OMB)
White
|
11 Participants
n=13 Participants • This data was not collected for physician participants.
|
10 Participants
n=13 Participants • This data was not collected for physician participants.
|
11 Participants
n=11 Participants • This data was not collected for physician participants.
|
8 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
40 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
0 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
2 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
13 participants
n=13 Participants
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
47 participants
n=59 Participants
|
|
Concomitant Medication - Oral Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
1 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Concomitant Medication - Selective Serotonin Reuptake Inhibitors (SSRIs)
|
3 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=11 Participants • This data was not collected for physician participants.
|
1 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
5 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Concomitant Medication - Aldosterone Antagonists
|
2 Participants
n=13 Participants • This data was not collected for physician participants.
|
4 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=11 Participants • This data was not collected for physician participants.
|
0 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
7 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Concomitant Medication - Oral Glucocorticoids
|
4 Participants
n=13 Participants • This data was not collected for physician participants.
|
0 Participants
n=13 Participants • This data was not collected for physician participants.
|
1 Participants
n=11 Participants • This data was not collected for physician participants.
|
2 Participants
n=10 Participants • This data was not collected for physician participants.
|
—
|
—
|
7 Participants
n=47 Participants • This data was not collected for physician participants.
|
|
Clinician Specialty
Cardiology
|
—
|
—
|
—
|
—
|
3 Participants
n=6 Participants • This data was not collected for patient participants.
|
3 Participants
n=6 Participants • This data was not collected for patient participants.
|
6 Participants
n=12 Participants • This data was not collected for patient participants.
|
|
Clinician Specialty
Surgery
|
—
|
—
|
—
|
—
|
2 Participants
n=6 Participants • This data was not collected for patient participants.
|
2 Participants
n=6 Participants • This data was not collected for patient participants.
|
4 Participants
n=12 Participants • This data was not collected for patient participants.
|
|
Clinician Specialty
Primary Care
|
—
|
—
|
—
|
—
|
0 Participants
n=6 Participants • This data was not collected for patient participants.
|
1 Participants
n=6 Participants • This data was not collected for patient participants.
|
1 Participants
n=12 Participants • This data was not collected for patient participants.
|
|
Clinician Specialty
Neurology
|
—
|
—
|
—
|
—
|
1 Participants
n=6 Participants • This data was not collected for patient participants.
|
0 Participants
n=6 Participants • This data was not collected for patient participants.
|
1 Participants
n=12 Participants • This data was not collected for patient participants.
|
PRIMARY outcome
Timeframe: Week 5The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.
Outcome measures
| Measure |
Clinician Notification Only
n=13 Participants
Clinician notification: 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 Facilitation Only
n=13 Participants
Clinician Notification with Nurse Facilitation: 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 Activation
n=11 Participants
Clinician Notification / Patient Activation: 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 Activation
n=10 Participants
Clinician Notification with Nurse Facilitation / Patient Activation: 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.
|
|---|---|---|---|---|
|
The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5
|
7 Participants
|
12 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: week 1The proportion of patient participants that received all implementation components to which they were randomized in the appropriate time frame.
Outcome measures
| Measure |
Clinician Notification Only
n=13 Participants
Clinician notification: 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 Facilitation Only
n=13 Participants
Clinician Notification with Nurse Facilitation: 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 Activation
n=11 Participants
Clinician Notification / Patient Activation: 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 Activation
n=10 Participants
Clinician Notification with Nurse Facilitation / Patient Activation: 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.
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Feasibility of Delivering Intervention Components as Intended
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13 Participants
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13 Participants
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11 Participants
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10 Participants
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Adverse Events
Patient Arm - Clinician Notification Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Arm - Clinician Notification With Nurse Facilitation Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Arm - Clinician Notification / Patient Activation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Arm - Clinician Notification With Nurse Facilitation / Patient Activation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place