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LEAVE Safe With DOACs for VTE Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04068727
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : January 13, 2020
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Alok Kapoor, University of Massachusetts, Worcester

Brief Summary:
Given the growth of the ambulatory venous thromboembolism (VTE) population prescribed direct oral anticoagulants (DOAC)s, the risks associated with this class of medications, and the lack of defined pathways for these patients, the study intervention has the potential for enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with DOAC therapy.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Clinical Pharmacist Intervention Not Applicable

Detailed Description:
Patients with a diagnosed venous thromboembolism (VTE) and first treated with direct oral anticoagulants (DOACs) in an ambulatory setting are at an elevated risk for adverse drug events (ADEs) or potential ADEs from medication errors. An intervention that integrates clinical pharmacists, a pharmacy technician, and follows a checklist published by experts at the Anticoagulation Forum can prevent adverse outcomes. The Investigators propose research on the effectiveness, implementation, and dissemination for a care transition intervention that follows the checklist which includes evaluation for appropriateness of DOAC use, assistance with drug procurement, telephone access to an anticoagulation expert, and other best practice recommendations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Leveraging Evidence-based Practices for Ambulatory Venous Thromboembolism Patients to be Safe With Direct Oral Anticoagulants: LEAVE Safe With DOACs
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Control Patients will be provided with educational materials. Control patients will receive no additional guidance.
Experimental: Clinical Pharmacist Intervention
Two intervention pharmacists will deliver the intervention. First, a pharmacy technician will call the patient to ensure access and affordability. Next the clinical pharmacist will call to conduct an initial consultation and educational session, documenting the findings and recommendations related to this consultation in the Electronic Medical Record (EMR). Finally, the intervention staff will send educational materials customized to the patient preference - short video clips, print materials, or an email with links to print materials. Over the remaining weeks of the study, the intervention pharmacists will field questions from patients, perform two follow up monthly phone calls, order and follow up on renal and hepatic function lab work, and write an off-service note.
Behavioral: Clinical Pharmacist Intervention
The Intervention Clinical Pharmacist(s) will provide the components of the intervention to all intervention study subjects, including: conducting initial consultations, providing patient education, conducting follow-up phone consultation, fielding safety net access line inquiries, and corresponding with the patient's clinical care team.

Primary Outcome Measures :
  1. Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors [ Time Frame: 90 Days Post Enrollment ]
    The number of preventable, ameliorable and potential Adverse Drug Events (ADEs) that physician reviewers attribute to Direct Oral Anticoagulant (DOAC) medication. Each DOAC related clinically important medication error is counted as a separate event, enabling patients to have multiple events consistent with the literature.

Secondary Outcome Measures :
  1. Quality of Care Transition using the Care Transitions Measure (CTM 15) instrument [ Time Frame: 90 Days Post Enrollment ]
    The Care Transitions Measure (CTM-15) is a 15-item instrument which assesses how well health care professionals communicate with and support patients during the time of transition and is used to predict likelihood for return to emergency department (ED) and readmission for patients discharged from the hospital. Range of score is 0-100 reflecting the overall quality of the care transition, with lower scores indicating a poorer quality transition, and higher scores indicating a better transition.

  2. Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire [ Time Frame: 90 Days Post Enrollment ]
    Patient knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) will be evaluated using a modified version of a 22-item instrument previously developed and tested by the institution. This instrument assesses patients' knowledge of warning signs of bleeding and new VTE, interactions with other medications, and complications of VTE. A low score indicate a low level of knowledge and a high score indicates a high level of knowledge regarding anticoagulation and VTE.

  3. Number of missed or extra doses to assess medication adherence [ Time Frame: 90 Days Post Enrollment ]
    Patients are asked to to count out the number of remaining pills from the last filled prescription and provide the fill date, number of pills dispensed, the schedule prescribed (either once or twice a day depending on DOAC), and skipped doses for deliberate interruption to determine medication adherence with the number of missed or extra doses.

  4. Medication Possession Ratio (MPR) to assess medication adherence [ Time Frame: 90 Days Post Enrollment ]
    Medication adherence is measured with Medication Possession Ratio (MPR) which is the ratio between the time a patient had medication on hand, the time that a patient is eligible to have a medication on hand, and the time that a patient is covered by the medication. The MPR ratio will be calculated by using available pharmacy data.

  5. Proportion of days covered (PDC) to assess medication adherence [ Time Frame: 90 Days Post Enrollment ]
    Proportion of Days Covered (PDC) is the ratio between the time that a patient has a medication on hand, the time that a patient is eligible to have a medication on hand, and the time that a patient is covered by the medication.Medication adherence will be evaluated using the mean PDC using available pharmacy data.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older
  • New episode of VTE
  • Positive radiological exam within 7 days of obtaining consent
  • DOAC based anticoagulation
  • UMass Memorial Medical Group primary care provider
  • Patient able to consent in English, Portuguese or Spanish

Exclusion Criteria:

  • Hospitalized with inpatient status (as opposed to observation status) within 7 days of VTE Diagnosis
  • Prisoner
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04068727

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Contact: Alok Kapoor, MD 508-856-2956
Contact: Kathryn Anzuoni, MPH 508-595-2600 ext 45940

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United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01605
Contact: All Departments    508-334-1000      
Sponsors and Collaborators
University of Massachusetts, Worcester
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Alok Kapoor, MD UMass Medical School
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Responsible Party: Alok Kapoor, Associate Professor of Medicine, University of Massachusetts, Worcester Identifier: NCT04068727    
Other Study ID Numbers: H00017891
1R18HS02592401 ( Other Grant/Funding Number: Agency for Healthcare Research and Quality (AHRQ) )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases