Patient EngagementNCT04790773
Alexa, What is Eliquis and Xarelto?
A study testing Amazon Alexa based voice recording patient education in people with Patient Engagement and Patient Satisfaction, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Engagement, Patient Satisfaction
- What is being tested?
- Amazon Alexa based voice recording patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Have been prescribed either apixaban or rivaroxaban during their inpatient stay
- Consent to participating in the study
- Providing direct patient care in select general medicine and orthopedic surgical units
- Consent to participating in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the 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.
- Conditions
- Patient Engagement, Patient Satisfaction
- Being tested
- Amazon Alexa based voice recording patient education
- Keywords
- Technology, Patient Education
- Medical subject headings
- Patient Participation, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amazon Alexa based voice recording patient educationOther
Amazon Alexa based voice recording of medication education material
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patient's will receive standard education on Xarelto and Eliquis per usual process without use of Alexa based voice recording. |
| Alexa Education | Active comparator | Patient's will opt in to receive initial education via Alexa based voice recording on Xarelto and Eliquis. Receives: Other: Amazon Alexa based voice recording patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change in pre- and post test scores
Effectiveness of Alexa based education by assessing understanding of Eliquis and Xarelto pre and post Alexa education
Measured: Within 72 hours of education
Secondary outcomes (3)
7-day post-education retention rate
Assess education retention rate 7-days after initial Alexa based education performed
Measured: 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
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start21 May 2021
- Primary completion30 Jun 2021
- Study completion31 Oct 2021
Why it stopped: Unable to continue due to low enrollment and lack of resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaman Chung, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790773
- Sponsor's protocol ID
- STUDY00001194
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alexa, What is Eliquis and Xarelto?
- ClinicalTrials.gov ID
- NCT04790773
- Acronym / sponsor ID
- STUDY00001194
- Conditions
- Patient Engagement, Patient Satisfaction
- Keywords
- Technology, Patient Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to continue due to low enrollment and lack of resources.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patient's will receive standard education on Xarelto and Eliquis per usual process without use of Alexa based voice recording. |
| Alexa Education | Active comparator | Other: Amazon Alexa based voice recording patient educationPatient's will opt in to receive initial education via Alexa based voice recording on Xarelto and Eliquis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Have been prescribed either apixaban or rivaroxaban during their inpatient stay
- Consent to participating in the study
- Providing direct patient care in select general medicine and orthopedic surgical units
- Consent to participating in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amazon Alexa based voice recording patient educationAmazon Alexa based voice recording of medication education material | Other | Alexa Education |
Primary outcome
% Change in pre- and post test scores
Time frame: Within 72 hours of education
Effectiveness of Alexa based education by assessing understanding of Eliquis and Xarelto pre and post Alexa education
3 secondary outcomes
7-day post-education retention rate
Time frame: 1 week post discharge
Nursing satisfaction
Time frame: 72 hours
Patient satisfaction
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Unable to continue due to low enrollment and lack of resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amazon Alexa based voice recording patient education in people with Patient Engagement and Patient Satisfaction, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to continue due to low enrollment and lack of resources.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Change in pre- and post test scores (time frame: Within 72 hours of education). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.