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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK118179 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician Notification with Nurse Facilitation (CNNF) | Experimental |
| |
| Wait List Control (Usual care) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician Notification with Nurse Facilitation (CNNF) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 weeks |
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Inclusion Criteria for Patients:
Inclusion Criteria for Clinicians:
Exclusion Criteria for Patients:
Exclusion Criteria for Clinicians:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob E Kurlander, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | This data was not collected for clinician participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Up to 10 weeks |
|
Up to 10 weeks
This study did not proactively monitor for adverse events as the trial constituted a quality improvement effort intended to improve the use of evidence-based practices, and decisions regarding changes in drug treatment were made as part of usual care. However, if any adverse events affecting patient participants were identified during data collection, they were documented in a database for regulatory review. No adverse events were assessed/monitored for clinician participant arms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob E. Kurlander, MD, MS | University of Michigan | 734-660-4883 | jkurland@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2022 | Nov 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D010438 | Peptic Ulcer Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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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.
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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.
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|
| Wait list control | Behavioral | 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. |
|
| Patient unenrollment from Anticoagulation Monitoring Service prior to primary outcome assessment |
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| Patient medication change - warfarin discontinuation, switch to DOAC therapy |
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| Patient hospitalized for entirety of primary outcome assessment timeframe |
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| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | This data was not collected for clinician participants. | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Patient and clinician data are reported separately. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | This data was not collected for clinician participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | This data was not collected for clinician participants. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Antiplatelet Therapy | This data was not collected for clinician participants. | Count of Participants | Participants |
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| Concomitant Medications | This data was not collected for clinician participants. | Count of Participants | Participants |
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| Medical History | This data was not collected for clinician participants. | Count of Participants | Participants |
|
| Clinician Specialty | As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants. | Count of Participants | Participants |
|
| Clinician Proceduralist Status | As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants. | Count of Participants | Participants |
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| Years Since Medical School Completed | This measure applies only to Clinician participants. | This measure applies only to clinician participants and data was not collected for patient participants. | Mean | Standard Deviation | years |
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| Years Since Medical School Completed | This measure applies only to clinician participants and data was not collected for patient participants. | Median | Inter-Quartile Range | years |
|
| 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. |
| OG001 | 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. |
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | Up to 10 weeks |
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|
|
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| 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. | Posted | Count of Participants | Participants | Up to 10 weeks |
|
|
|
|
| 2 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
| EG001 | 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. | 2 | 110 | 0 | 110 | 0 | 110 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Dual Antiplatelet Therapy |
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|
|
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| Hematology |
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| Hepatology |
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| Primary Care |
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| Pulmonology |
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| Radiology |
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| Rheumatology |
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| Thoracic Surgery |
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| Vascular Surgery |
|
|
|
| Started a PPI |
|
| Stopped antiplatelet therapy and started a PPI |
|
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.
| generalized linear mixed effects model |
| <0.001 |
| Odds Ratio (OR) |
| 43.6 |
| 2-Sided |
| 95 |
| 6.56 |
| 289.88 |
Adjusted OR (expanded model) |
| Superiority |
| Received a recommendation to initiate a PPI |
|
| Received a recommendation to discontinue antiplatelet therapy and to initiate a PPI |
|
Adjusted OR, 95% CI (base model) - Included clinician proceduralist vs non-proceduralist status as a co-variate.