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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
162
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).
UMass Medical School
Worcester, Massachusetts, United States
Care Transition Measure (CTM-15)
15 item measure; measures 4 aspects of quality of transitional care
Time frame: 30 days post hospital discharge
Clinical Outcome: VTE Recurrence
Measure the difference in recurrent VTE between intervention and comparison groups.
Time frame: 30 and 90 days post hospital discharge
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.
Time frame: 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.
Time frame: 30 and 90 days post hospital discharge
Clinical Outcome: Mortality
Measure the difference in mortality between intervention and comparison groups.
Time frame: 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.
Time frame: 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
Time frame: 30 and 90 days post hospital discharge
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