Alexa, What is Eliquis and Xarelto?

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04790773
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Engagement; Patient Satisfaction	Other: Amazon Alexa based voice recording patient education	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Alexa, What is Eliquis and Xarelto?
• Actual Study Start Date: May 21, 2021
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Oct 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. % Change in pre- and post test scores [Within 72 hours of education]

   Effectiveness of Alexa based education by assessing understanding of Eliquis and Xarelto pre and post Alexa education

Secondary Outcome Measures

1. 7-day post-education retention rate [1 week post discharge]

   Assess education retention rate 7-days after initial Alexa based education performed

2. Nursing satisfaction [72 hours]

   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

3. Patient satisfaction [72 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaman Chung, Pharmacy Manager, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT04790773
• Other Study ID Numbers: STUDY00001194
• First Posted: Mar 10, 2021
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaman Chung, Pharmacy Manager, Cedars-Sinai Medical Center: Technology; Patient Education

Study Results

No Results Posted as of Mar 21, 2022