Upper Gastrointestinal Bleeding
Conditions
Keywords
combination antithrombotic therapy, proton pump inhibitor, peptic ulcer disease, gastroprotection, warfarin, anticoagulation, patient safety
Brief 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 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.
Interventions
BEHAVIORALClinician 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.
BEHAVIORALClinician 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.
BEHAVIORALClinician 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.
BEHAVIORALClinician 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.
Sponsors
Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Patients: * 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
Exclusion criteria
for Patients: * Prescribed a Proton Pump Inhibitor (PPI) * Documented intolerance or allergy to PPI use * Left ventricular assist device * Heart transplant Inclusion Criteria for Clinicians: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 | Week 5 | The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Delivering Intervention Components as Intended | week 1 | The proportion of patient participants that received all implementation components to which they were randomized in the appropriate time frame. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 13 |
| 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. | 11 |
| 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. | 10 |
| Clinician Arm - Clinician Notification 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. | 6 |
| Clinician Arm - Clinician 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. | 6 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | Patient Arm - Clinician Notification With Nurse Facilitation Only | Patient Arm - Clinician Notification Only | Patient Arm - Clinician Notification / Patient Activation | Patient Arm - Clinician Notification With Nurse Facilitation / Patient Activation | Total | Clinician Arm - Clinician Notification | Clinician Arm - Clinician Notification With Nurse Facilitation |
|---|---|---|---|---|---|---|---|
| Age, Customized Age of Participants at Baseline Age 18-59 | 7 Participants | 5 Participants | 3 Participants | 5 Participants | 20 Participants | — | — |
| Age, Customized Age of Participants at Baseline Age 60-69 | 2 Participants | 3 Participants | 4 Participants | 1 Participants | 10 Participants | — | — |
| Age, Customized Age of Participants at Baseline Age 70-79 | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 14 Participants | — | — |
| Age, Customized Age of Participants at Baseline Age 80+ | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | — | — |
| Clinician Specialty Cardiology | — | — | — | — | 6 Participants | 3 Participants | 3 Participants |
| Clinician Specialty Neurology | — | — | — | — | 1 Participants | 1 Participants | 0 Participants |
| Clinician Specialty Primary Care | — | — | — | — | 1 Participants | 0 Participants | 1 Participants |
| Clinician Specialty Surgery | — | — | — | — | 4 Participants | 2 Participants | 2 Participants |
| Concomitant Medication - Aldosterone Antagonists | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 7 Participants | — | — |
| Concomitant Medication - Oral Glucocorticoids | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 7 Participants | — | — |
| Concomitant Medication - Oral Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | — | — |
| Concomitant Medication - Selective Serotonin Reuptake Inhibitors (SSRIs) | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 5 Participants | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | — | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 13 Participants | 11 Participants | 10 Participants | 46 Participants | — | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | — | — |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | — | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | — | — |
| Race (NIH/OMB) White | 10 Participants | 11 Participants | 11 Participants | 8 Participants | 40 Participants | — | — |
| Region of Enrollment United States | 13 participants | 13 participants | 11 participants | 10 participants | 47 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants | 3 Participants | 20 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 7 Participants | 7 Participants | 39 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 13 | 0 / 13 | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 11 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Week 5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinician Notification Only | The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 | 7 Participants |
| Clinician Notification With Nurse Facilitation Only | The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 | 12 Participants |
| Clinician Notification / Patient Activation | The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 | 8 Participants |
| Clinician Notification With Nurse Facilitation / Patient Activation | The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 | 8 Participants |
Secondary
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.
Time frame: week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinician Notification Only | Feasibility of Delivering Intervention Components as Intended | 13 Participants |
| Clinician Notification With Nurse Facilitation Only | Feasibility of Delivering Intervention Components as Intended | 13 Participants |
| Clinician Notification / Patient Activation | Feasibility of Delivering Intervention Components as Intended | 11 Participants |
| Clinician Notification With Nurse Facilitation / Patient Activation | Feasibility of Delivering Intervention Components as Intended | 10 Participants |