Venous Thromboembolism Clinical Trial
Official title:
Anticoagulation Medical Home for High-Risk Patients With Venous Thromboembolism: Patient Education, Anticoagulant Decision-Making, and Patient Self-Efficacy in the Home Coordinated by the UMass Anticoagulation Team
Verified date | November 2018 |
Source | University of Massachusetts, Worcester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | January 5, 2018 |
Est. primary completion date | November 3, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - hospital admission; - diagnosis of: - VTE (first or subsequent episode); or - DVT of leg or pelvis or upper extremities or other site confirmed by ultrasound or CT scan; or - PE with a positive CT spiral exam, pulmonary arteriogram, CT angiogram, or high probability ventilation perfusion scan. - for whom it is anticipated the treating medical team will prescribe an oral anticoagulant upon hospital discharge. Exclusion Criteria: - Not engaged in Primary Care (has not seen a Primary Care Practitioner within the previous 18 months). |
Country | Name | City | State |
---|---|---|---|
United States | UMass Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Care Transition Measure (CTM-15) | 15 item measure; measures 4 aspects of quality of transitional care | 30 days post hospital discharge | |
Secondary | Clinical Outcome: VTE Recurrence | Measure the difference in recurrent VTE between intervention and comparison groups. | 30 and 90 days post hospital discharge | |
Secondary | Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report) | 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 | |
Secondary | 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 | |
Secondary | Clinical Outcome: Mortality | Measure the difference in mortality between intervention and comparison groups. | 30 and 90 days post hospital discharge | |
Secondary | 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 | |
Secondary | 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 |
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