Clinical trial NCT02870296: Anticoagulation Medical Home
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Patient-Centered Care
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-08-17
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: Care Transition Measure (CTM-15)
timeFrame: 30 days post hospital discharge
Secondary outcomes:
measure: Clinical Outcome: VTE Recurrence
timeFrame: 30 and 90 days post hospital discharge
measure: Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report)
timeFrame: 30 and 90 days post hospital discharge
measure: Clinical Outcome: Hospital Readmission (any unplanned hospital admissions noted in Medical Record and/or via patient self-report)
timeFrame: 30 and 90 days post hospital discharge
measure: Clinical Outcome: Mortality
timeFrame: 30 and 90 days post hospital discharge
measure: Other Measure: Patient Knowledge (via questionnaire developed by Mazor et. al. 2007 Patient Educ Counsel and via investigator developed items)
timeFrame: 30 and 90 days post hospital discharge
measure: Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire)
timeFrame: 30 and 90 days post hospital discharge
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Alok Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.