Anticoagulation Medical Home

University of Massachusetts, Worcester

Status: Completed

Conditions: Venous Thromboembolism; Patient-Centered Care

Treatments: Behavioral: Enhanced Assessment and Education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02870296

H00010242

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

162 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will receive usual care; no interventions will be administered.

Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Enhanced Assessment and Education