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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Venous Thromboembolism
- Sponsor
- University of Massachusetts, Worcester
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Care Transition Measure (CTM-15)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Alok Kapoor
Principal Investigator
University of Massachusetts, Worcester
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Care Transition Measure (CTM-15)
Time Frame: 30 days post hospital discharge
15 item measure; measures 4 aspects of quality of transitional care
Secondary Outcomes
- Clinical Outcome: VTE Recurrence(30 and 90 days post hospital discharge)
- Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire)(30 and 90 days post hospital discharge)
- Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report)(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)(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)(30 and 90 days post hospital discharge)
- Clinical Outcome: Mortality(30 and 90 days post hospital discharge)