Upper Gastrointestinal Bleeding, Peptic Ulcer Hemorrhage, Anticoagulant-induced Bleeding
Conditions
Keywords
Warfarin, Proton pump inhibitor, Antiplatelet therapy, Gastroprotection, Aspirin, Thienopyridine, Patient safety, Anticoagulation
Brief 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 GI bleeding risk in patients prescribed anticoagulant-antiplatelet therapy (AAT) relative to usual care.
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.
Interventions
BEHAVIORALClinician 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.
BEHAVIORALWait list control
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Neither patients, clinicians, or anticoagulation staff can practically be blinded. We will attempt to blind the research staff who are making patient calls at week 7-10 to the randomization group of the patient by not providing them with any information that would allow them to infer the randomization group, by not having them enter the electronic health record for the patients, where such information could be obtained, and by excluding any information from the call script that might help identify the randomization group. However, if due to staffing or personnel issues, blinded research staff are unable to complete all patient calls within the specified time frame, unblinded research staff will assist with completing patient calls.
Intervention 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.
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 ≥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 Inclusion Criteria for Clinicians: * 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
Exclusion criteria
for Patients: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ITT Analysis - Percent of Patients Reporting Medication Optimization | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Up to 10 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) 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. | 110 |
| Patient Arm - Wait List Control (Usual Care) Wait list control: 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. | 110 |
| Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF) 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. | 61 |
| Clinician Arm - Wait List Control (Usual Care) Wait list control: 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. | 60 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 22 | 19 | 0 | 0 |
| Overall Study | Patient hospitalized for entirety of primary outcome assessment timeframe | 0 | 1 | 0 | 0 |
| Overall Study | Patient medication change - warfarin discontinuation, switch to DOAC therapy | 1 | 2 | 0 | 0 |
| Overall Study | Patient unenrollment from Anticoagulation Monitoring Service prior to primary outcome assessment | 4 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Patient Arm - Wait List Control (Usual Care) | Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF) | Clinician Arm - Wait List Control (Usual Care) |
|---|---|---|---|---|---|
| Age, Customized Patient Characteristics - Age | 62 years STANDARD_DEVIATION 15 | 65 years | 64 years | — | — |
| Antiplatelet Therapy Aspirin | 201 Participants | 96 Participants | 105 Participants | — | — |
| Antiplatelet Therapy Clopidogrel | 16 Participants | 12 Participants | 4 Participants | — | — |
| Antiplatelet Therapy Dual Antiplatelet Therapy | 3 Participants | 2 Participants | 1 Participants | — | — |
| Clinician Proceduralist Status Clinician Characteristics - Clinician Proceduralist Status Non-Proceduralist | 104 Participants | — | — | 53 Participants | 51 Participants |
| Clinician Proceduralist Status Clinician Characteristics - Clinician Proceduralist Status Proceduralist | 17 Participants | — | — | 8 Participants | 9 Participants |
| Clinician Proceduralist Status Patient Characteristics - Clinician Proceduralist Status Non-Proceduralist | 183 Participants | 89 Participants | 94 Participants | — | — |
| Clinician Proceduralist Status Patient Characteristics - Clinician Proceduralist Status Proceduralist | 37 Participants | 21 Participants | 16 Participants | — | — |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Cardiology | 45 Participants | — | — | 23 Participants | 22 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Electrophysiology | 2 Participants | — | — | 1 Participants | 1 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Hematology | 4 Participants | — | — | 2 Participants | 2 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Hepatology | 1 Participants | — | — | 0 Participants | 1 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Primary Care | 52 Participants | — | — | 27 Participants | 25 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Pulmonology | 1 Participants | — | — | 0 Participants | 1 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Radiology | 3 Participants | — | — | 2 Participants | 1 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Rheumatology | 1 Participants | — | — | 1 Participants | 0 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Thoracic Surgery | 8 Participants | — | — | 4 Participants | 4 Participants |
| Clinician Specialty Clinician Characteristics - Clinician Specialty Vascular Surgery | 4 Participants | — | — | 1 Participants | 3 Participants |
| Clinician Specialty Patient Characteristics - Clinician Specialty Cardiology | 110 Participants | 56 Participants | 54 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Electrophysiology | 4 Participants | 2 Participants | 2 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Hematology | 6 Participants | 3 Participants | 3 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Hepatology | 1 Participants | 1 Participants | 0 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Primary Care | 61 Participants | 28 Participants | 33 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Pulmonology | 1 Participants | 1 Participants | 0 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Radiology | 5 Participants | 1 Participants | 4 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Rheumatology | 4 Participants | 0 Participants | 4 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Thoracic Surgery | 16 Participants | 8 Participants | 8 Participants | — | — |
| Clinician Specialty Patient Characteristics - Clinician Specialty Vascular Surgery | 12 Participants | 10 Participants | 2 Participants | — | — |
| Concomitant Medications Aldosterone Antagonist Use | 39 Participants | 17 Participants | 22 Participants | — | — |
| Concomitant Medications H2 Receptor Antagonist Use | 16 Participants | 5 Participants | 11 Participants | — | — |
| Concomitant Medications Oral Glucocorticoid Use | 10 Participants | 5 Participants | 5 Participants | — | — |
| Concomitant Medications Oral Non-Steroidal Anti-Inflammatory Drug (NSAID) Use | 4 Participants | 2 Participants | 2 Participants | — | — |
| Concomitant Medications Selective Serotonin Reuptake Inhibitor (SSRI) Use | 28 Participants | 11 Participants | 17 Participants | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | — | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 212 Participants | 104 Participants | 108 Participants | — | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 5 Participants | 1 Participants | — | — |
| Medical History Antiphospholipid Syndrome | 15 Participants | 4 Participants | 11 Participants | — | — |
| Medical History Atrial Fibrillation | 86 Participants | 40 Participants | 46 Participants | — | — |
| Medical History Cerebrovascular Disease | 46 Participants | 19 Participants | 27 Participants | — | — |
| Medical History Coronary Artery Disease | 91 Participants | 48 Participants | 43 Participants | — | — |
| Medical History GI Bleeding or Peptic Ulcer Disease | 8 Participants | 2 Participants | 6 Participants | — | — |
| Medical History Peripheral Artery Disease | 37 Participants | 17 Participants | 20 Participants | — | — |
| Medical History Valve Replacement | 98 Participants | 52 Participants | 46 Participants | — | — |
| Medical History Venous Thromboembolism | 62 Participants | 28 Participants | 34 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | — | — |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 4 Participants | — | — |
| Race (NIH/OMB) Black or African American | 21 Participants | 6 Participants | 15 Participants | — | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 4 Participants | 4 Participants | — | — |
| Race (NIH/OMB) White | 185 Participants | 99 Participants | 86 Participants | — | — |
| Region of Enrollment United States | 341 participants | 110 participants | 110 participants | 61 participants | 60 participants |
| Sex: Female, Male Clinician Characteristics - Sex Female | 49 Participants | — | — | 26 Participants | 23 Participants |
| Sex: Female, Male Clinician Characteristics - Sex Male | 72 Participants | — | — | 35 Participants | 37 Participants |
| Sex: Female, Male Patient Characteristics - Sex Female | 79 Participants | 36 Participants | 43 Participants | — | — |
| Sex: Female, Male Patient Characteristics - Sex Male | 141 Participants | 74 Participants | 67 Participants | — | — |
| Years Since Medical School Completed | 22 years | — | — | 22 years | 22 years |
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 | 2 / 110 | 2 / 110 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 110 | 0 / 110 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 110 | 0 / 110 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Up to 10 weeks
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Reached by phone but reported non-use of antiplatelet therapy at baseline | 15 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Patients lost to follow-up due to death or hospitalization | 2 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Reached by phone & did not achieve medication optimization | 29 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Patients closed to the anticoagulation service or who discontinued warfarin therapy | 5 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Reached by phone but reported use of or uncertain use of PPIs at baseline | 8 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Patients unable to be reached by phone or who declined to participate in the survey | 21 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Reached by phone & achieved medication optimization | 30 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Patients unable to be reached by phone or who declined to participate in the survey | 19 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Reached by phone & achieved medication optimization | 2 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Reached by phone & did not achieve medication optimization | 65 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Reached by phone but reported non-use of antiplatelet therapy at baseline | 10 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Reached by phone but reported use of or uncertain use of PPIs at baseline | 6 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Patients lost to follow-up due to death or hospitalization | 3 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients Reporting Medication Optimization | Data Imputed - Patients closed to the anticoagulation service or who discontinued warfarin therapy | 5 Participants |
Comparison: Adjusted OR (base model), 95% CI - Includes clinician proceduralist vs non-proceduralist status as a co-variate.p-value: <0.00195% CI: [2.41, 11.33]generalized linear mixed effects model
Comparison: Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.p-value: <0.00195% CI: [2.54, 13.05]generalized linear mixed effects model
Primary
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.
Time frame: Up to 10 weeks
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | Started a PPI | 11 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | All patients who reported non-use of antiplatelet therapy or use of PPI gastroprotection | 30 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | Stopped antiplatelet therapy and started a PPI | 2 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | Stopped antiplatelet therapy | 17 Participants |
| Patient Arm - Wait List Control (Usual Care) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | Stopped antiplatelet therapy and started a PPI | 0 Participants |
| Patient Arm - Wait List Control (Usual Care) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | All patients who reported non-use of antiplatelet therapy or use of PPI gastroprotection | 2 Participants |
| Patient Arm - Wait List Control (Usual Care) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | Started a PPI | 1 Participants |
| Patient Arm - Wait List Control (Usual Care) | Modified Completer Analysis - Percent of Patients Reporting Medication Optimization | Stopped antiplatelet therapy | 1 Participants |
Comparison: Adjusted OR (base model), 95% CI - Included clinician proceduralist vs non-proceduralist status as a co-variate.p-value: <0.00195% CI: [6.07, 141.49]generalized linear mixed effects model
Comparison: Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.p-value: <0.00195% CI: [6.56, 289.88]generalized linear mixed effects model
Secondary
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.
Time frame: Up to 10 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation to initiate a PPI | 38 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation for medication optimization | 75 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation to discontinue antiplatelet therapy and to initiate a PPI | 5 Participants |
| Patient Arm - Clinician Notification With Nurse Facilitation (CNNF) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation to discontinue antiplatelet therapy | 32 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation to discontinue antiplatelet therapy and to initiate a PPI | 0 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation to initiate a PPI | 0 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation to discontinue antiplatelet therapy | 1 Participants |
| Patient Arm - Wait List Control (Usual Care) | ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation | Received a recommendation for medication optimization | 1 Participants |
Comparison: We used generalized linear mixed effects modeling (logit link) to estimate the odds of medication optimization at week 7-10. This model included fixed effects for CNNF (vs. usual care), target provider specialty and size, and a random effect for clinician to account for the clustering of patients. We report the log odds ratios with corresponding confidence intervals for the main effect. The main effect was tested at a two-sided 5% significance level.p-value: <0.00195% CI: [10.63, 29.09]generalized linear mixed effects model