Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Blood Coagulation Disorders; Thromboembolism; Vascular Disease
• Intervention / Treatment: Other: Patient Self-Monitoring vs Anticoagulation Clinic

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anticoagulation Clinic; 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.	Other: Patient Self-Monitoring vs Anticoagulation Clinic; 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. 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.
Experimental: Patient Self-Monitoring; 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.	Other: Patient Self-Monitoring vs Anticoagulation Clinic; 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent time in therapeutic range (TTR)	TTR will be calculated for each patient using the linear interpolation method. This method has been associated with clinical outcomes such as risk for thromboembolic events, and thus was selected over other methods of expressing the TTR such as fraction of International Normalized Ratio (INR) in range and cross-section of files	Month 1, Month 2, Month 4, Month 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Related Quality of Life	It will be evaluated using a 25 item validated questionnaire that assesses limitations, hassles, and positive impact with a Cronbach alpha for each of 0.87, 0.88 and 0.78 respectively	Baseline, Month 1, Month 7
Anticoagulation Related Knowledge	It will be measured with an instrument containing 29 items at different levels of difficulty to allow differences in patient knowledge to be evaluated and has a person reliability coefficient of 0.75.	Baseline, Month 1, Month 7
Adherence with Monitoring	It is defined as the INR test completed within 24 hours of scheduled time and measured via the Coaguchek® device in home or clinic.	Month 1, Month 2, Month 4, Month 7
Self-Testing Competency (Intervention group only)	It is defined as the ability to attain an INR reading and provider observed technique.	Baseline to 7 months
Self-Testing Accuracy (Intervention group only)	It is defined as the concordance of self-reported and device-stored INR measurements.	Baseline to 7 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Roche Pharma AG
• Investigators: Principal Investigator: Edith A Nutescu, PharmD, MS, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Anticoagulation; Cardiovascular Disease; African American; Self-Management; Warfarin; Minorities; Health Disparities; Hispanic; Blood Coagulation Disorders; Thromboembolism; Tele-Health; Anticoagulation Management; Self-Testing; Models of Anticoagulation Care; Home Self-Testing
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Cardiovascular Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Vascular Diseases; Thromboembolism
• Other Study ID Numbers: 2015-1193; K23HL112908 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED