Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

University of Illinois

Status: Completed

Conditions: Thromboembolism; Vascular Disease; Blood Coagulation Disorders; Cardiovascular Disease

Treatments: Other: Patient Self-Monitoring vs Anticoagulation Clinic

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02776566

2015-1193

K23HL112908 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.

Full description

Despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. While effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known.

Hypothesis: Patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring.

The research objective of this proposal will be accomplished through 3 specific aims:

1. Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.
2. Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.
3. Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.

Enrollment: 86 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 21 years of age
• African American or Hispanic
• English speaking
• Has been on warfarin therapy > 3 months
• Plan to be on warfarin therapy > 12 months
• Willing ( or caregiver be willing) to do self-monitoring
• Willing to be randomized

Exclusion criteria

• Lack of access to a telephone
• Moderate to severe dementia (if lacks caregiver)
• Severe hearing impairment ( if lacks caregiver)
• Blindness ( if lacks caregiver)
• Life expectancy < 6 months
• Antiphospholipid antibody syndrome

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Anticoagulation Clinic

Active Comparator group

Description:

Usual care through pharmacist managed anticoagulation clinic Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic.

Treatment:

Other: Patient Self-Monitoring vs Anticoagulation Clinic

Patient Self-Monitoring

Experimental group

Description:

In home self-monitoring and pharmacist guided education Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages.

Treatment:

Other: Patient Self-Monitoring vs Anticoagulation Clinic