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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04790773
Other study ID # STUDY00001194
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 21, 2021
Est. completion date October 31, 2021

Study information

Verified date March 2022
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 36
Est. completion date October 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Amazon Alexa based voice recording patient education
Amazon Alexa based voice recording of medication education material

Locations

Country Name City State
United States Cedars Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary % 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 7-day post-education retention rate Assess education retention rate 7-days after initial Alexa based education performed 1 week post discharge
Secondary 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
Secondary 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
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