LEAVE Safe With DOACs for VTE Patients
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|ClinicalTrials.gov Identifier: NCT04068727|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Clinical Pharmacist Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04068727
|Contact: Alok Kapoor, MD||508-856-2956||Alok.Kapoor@umassmemorial.org|
|Contact: Kathryn Anzuoni, MPH||508-595-2600 ext 45940||Kathryn.firstname.lastname@example.org|
|United States, Massachusetts|
|UMass Memorial Medical Center||Recruiting|
|Worcester, Massachusetts, United States, 01605|
|Contact: All Departments 508-334-1000|
|Principal Investigator:||Alok Kapoor, MD||UMass Medical School|