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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK118179 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician Notification only | Experimental |
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| Clinician Notification with Nurse Facilitation only | Experimental |
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| Clinician Notification / Patient Activation | Experimental |
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| Clinician Notification with Nurse Facilitation / Patient Activation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician notification | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 1 |
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Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
Inclusion Criteria for Clinicians:
Exclusion Criteria for Clinicians:
- Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Kurlander, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35090577 | Derived | Kurlander JE, Helminski D, Lanham M, Henstock JL, Kidwell KM, Krein SL, Saini SD, Richardson CR, De Vries R, Resnicow K, Ruff AL, Wallace DM, Jones EK, Perry LK, Parsons J, Ha N, Alexandris-Souphis T, Dedrick D, Aldridge E, Barnes GD. Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial. Implement Sci Commun. 2022 Jan 28;3(1):8. doi: 10.1186/s43058-022-00256-8. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Mar 31, 2022 |
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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).
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| Clinician Notification with Nurse Facilitation | Behavioral | 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. |
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| Clinician Notification / Patient Activation | Behavioral | 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. |
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| Clinician Notification with Nurse Facilitation / Patient Activation | Behavioral | 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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| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| COMPLETED | Patients were considered to have completed the overall study if they continued to meet all eligibility criteria at the time of study entry (e.g., not screen failures), and if they were still enrolled in the Anticoagulation Monitoring Service 5 weeks after study entry and eligible for the week 5 patient phone assessment per study protocol. Clinicians were considered to have completed the overall study if they received the clinician-level intervention for any of their eligible patients. |
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| NOT COMPLETED |
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Per study protocol, patient participants who were randomized but no longer met eligibility criteria at the time of study entry (e.g., screen failures), and those who received the study interventions but discontinued warfarin therapy or unenrolled from the Anticoagulation Monitoring Service during the first 5 weeks of study participation were not included in the study analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| 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 physician participants. | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | This data was not collected for physician participants. | Count of Participants | Participants |
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| Race (NIH/OMB) | This data was not collected for physician participants. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Concomitant Medication - Oral Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) | This data was not collected for physician participants. | Count of Participants | Participants |
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| Concomitant Medication - Selective Serotonin Reuptake Inhibitors (SSRIs) | This data was not collected for physician participants. | Count of Participants | Participants |
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| Concomitant Medication - Aldosterone Antagonists | This data was not collected for physician participants. | Count of Participants | Participants |
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| Concomitant Medication - Oral Glucocorticoids | This data was not collected for physician participants. | Count of Participants | Participants |
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| Clinician Specialty | This measure applies only to Clinician participants. | This data was not collected for patient participants. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| 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. | Posted | Count of Participants | Participants | Week 5 |
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| 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. | Posted | Count of Participants | Participants | week 1 |
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Up to 5 weeks
Per protocol, 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 all decisions regarding changes in drug treatment were made by patients' own clinicians as part of usual care. However, if any adverse events were identified during data collection, the study team was instructed to document them in an adverse events database for regulatory review.
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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) |
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| EG000 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob E Kurlander, MD, MS | University of Michigan | 734-647-9252 | jkurland@umich.edu |
| Jan 5, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2021 | Apr 8, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
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| OG002 | 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. |
| OG003 | 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. |
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