Alexa, What is Eliquis and Xarelto?

The purpose of this study is to evaluate the effectiveness of providing patient medication education about Eliquis and Xarelto through an Amazon Alexa based voice recording.

Study Overview

• Status: Terminated
• Conditions: Patient Engagement; Patient Satisfaction
• Intervention / Treatment: Other: Amazon Alexa based voice recording patient education

Detailed Description

Anticoagulants are considered high-risk medications due to the risk of major bleeding. The Federal Drug and Food Administration (FDA) MedWatch reporting system found that anticoagulants had the most adverse drug event (ADE) reports in 2011. Anticoagulants have also been reported as one of the leading drug classes contributing to emergency department visits3. Given the potential for serious adverse events, providing effective education to increase patient knowledge and awareness of those risks are essential. Incorporating technology into health care is becoming increasingly popular and has been shown to be effective for patient education. One reason is that technology can consistently provide complete patient education and is not subject to educator variability in providing this education.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (Patients):

• 18 years of age or older
• Have been prescribed either apixaban or rivaroxaban during their inpatient stay
• Consent to participating in the study

Inclusion Criteria (Nurses):

• Providing direct patient care in select general medicine and orthopedic surgical units
• Consent to participating in the study

Exclusion Criteria:

• Patients will be excluded if they have documented altered mental status, do not speak English, or are being prescribed rivaroxaban or apixaban on discharge only.
• Nurses will be excluded if not providing direct patient care in select general medicine and orthopedic surgical units
• Nurses declining participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of care; Patient's will receive standard education on Xarelto and Eliquis per usual process without use of Alexa based voice recording.
ACTIVE_COMPARATOR: Alexa Education; Patient's will opt in to receive initial education via Alexa based voice recording on Xarelto and Eliquis.	Other: Amazon Alexa based voice recording patient education; Amazon Alexa based voice recording of medication education material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Change in pre- and post test scores	Effectiveness of Alexa based education by assessing understanding of Eliquis and Xarelto pre and post Alexa education	Within 72 hours of education

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day post-education retention rate	Assess education retention rate 7-days after initial Alexa based education performed	1 week post discharge
Nursing satisfaction	Nursing satisfaction assessed by likert type scale questionnaire; How satisfied are you with the Alexa anticoagulation education process compared to standard of care? Responses: Very dissatisfied - Dissatisfied - Neutral - Satisfied - Very Satisfied; Do you agree or disagree that Alexa helps with your day-to-day workload? Responses: Strongly Agree - Agree - Neutral - Disagree - Strongly disagree	72 hours
Patient satisfaction	Patient satisfaction assessed by likert type scale questionnaire; How satisfied are you with the anticoagulant education provided by Alexa? Responses: Very dissatisfied - Dissatisfied - Neutral - Satisfied - Very Satisfied; How strongly would you recommend using Alexa anticoagulant education to your friends, family and/or other patients? Responses: Highly recommend - Recommend - Neutral - Do not recommend	72 hours

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2021
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Patient Education; Technology
• Other Study ID Numbers: STUDY00001194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No