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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The primary study goal is to improve the quality of care transitions for patients with new episodes of venous thromboembolism (VTE).
Primary Outcomes: To measure differences in the quality of care transition, as measured by the Care Transition Measure (CTM)-15 in the investigators target population of patients with incident VTE randomized to either a multicomponent, anticoagulation medical home intervention or usual care.
Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage, all-cause re-admissions, and mortality between the investigators intervention and comparison groups at 30 and 90 days in the investigators target population.
Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and time in the therapeutic range (TTR) for patients on warfarin in the investigators target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will receive usual care; no interventions will be administered. | |
| Intervention | Experimental | Interventions will be administered to this group. Patients in the Intervention Group will: 1) have an in-home pharmacist medication assessment; 2) receive enhanced medication instructions (including pictograms); 3) receive an additional individualized assessment and educational session with a clinician provider related to the medication management for their disease (VTE). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Assessment and Education | Behavioral | Patients in the Intervention Group will: 1) have an in-home pharmacist medication assessment; 2) receive enhanced medication instructions (including pictograms); 3) receive an additional individualized assessment and educational session with a clinician provider related to the medication management for their disease (VTE). |
| Measure | Description | Time Frame |
|---|---|---|
| Care Transition Measure (CTM-15) | 15 item measure; measures 4 aspects of quality of transitional care | 30 days post hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome: VTE Recurrence | Measure the difference in recurrent VTE between intervention and comparison groups. | 30 and 90 days post hospital discharge |
| Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report) |
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Inclusion Criteria:
hospital admission;
diagnosis of:
for whom it is anticipated the treating medical team will prescribe an oral anticoagulant upon hospital discharge.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alok Kapoor, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Worcester | Massachusetts | 01566 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31965873 | Derived | Kapoor A, Bloomstone S, Javed S, Silva M, Lynch A, Yogaratnam D, Carlone B, Springer K, Maheswaran A, Chen X, Nagy A, Elhag R, Markaddy E, Aungst T, Bartlett D, Houng D, Darling C, McManus D, Herzig SJ, Barton B, Mazor K. Reducing Hospitalizations and Emergency Department Visits in Patients With Venous Thromboembolism Using a Multicomponent Care Transition Intervention. Inquiry. 2020 Jan-Dec;57:46958019900080. doi: 10.1177/0046958019900080. | |
| 30702452 |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
Measure the difference in major hemorrhage between intervention and comparison groups- ISTH 2005 medical definition 14 - 2 unit drop in hemoglobin, 2 unit transfusion, or critical site bleed.
- ISTH 2009 surgical definition 15 - surgical site 2 unit drop or 2 unit transfusion with increase in LOS, hemodynamic compromise, delay in rehab.
| 30 and 90 days post hospital discharge |
| Clinical Outcome: Hospital Readmission (any unplanned hospital admissions noted in Medical Record and/or via patient self-report) | Measure the difference between all cause hospital readmission (post-diagnosis of VTE) between intervention and comparison groups. | 30 and 90 days post hospital discharge |
| Clinical Outcome: Mortality | Measure the difference in mortality between intervention and comparison groups. | 30 and 90 days post hospital discharge |
| Other Measure: Patient Knowledge (via questionnaire developed by Mazor et. al. 2007 Patient Educ Counsel and via investigator developed items) | Measure patient knowledge and attitudes Mazor KM, Baril J, Dugan E, Spencer F, Burgwinkle P, Gurwitz JH. Patient education about anticoagulant medication: is narrative evidence or statistical evidence more effective? Patient Educ Couns. 2007 Dec;69(1-3):145-57. Epub 2007 Oct 17. | 30 and 90 days post hospital discharge |
| Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire) | Measure health-related quality of life for patients on warfarin and time in the therapeutic range (TTR) in our target population | 30 and 90 days post hospital discharge |
| Derived |
| Kapoor A, Landyn V, Wagner J, Burgwinkle P, Huang W, Gore J, Spencer FA, Goldberg R, McManus DD, Darling C, Boudreaux E, Barton B, Mazor KM. Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation During Transition of Care for Patients With Venous Thromboembolism. J Patient Saf. 2020 Dec;16(4):e367-e375. doi: 10.1097/PTS.0000000000000571. |