COVID-19NCT04452695
Acceptability of Telehealth Triage Using Robotic Systems in COVID-19
An observational study of COVID-19 and Telemedicine, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Telemedicine, Robotics
- What is being tested?
- Doctor Spot
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 10 Aug 2020
- Phase
- Observational
- 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
Study population: Emergency department patients
Who may be able to join
- Presenting to the emergency department for evaluation
- > 18 years old
Who cannot join
- Brought to emergency department via ambulance
- <18 years old
- non-english speaking
- in extremis, or unable to participate due to underlying acute medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.
- Conditions
- COVID-19, Telemedicine, Robotics, Emergencies, Emerging Infectious Disease
- Being tested
- Doctor Spot
- Medical subject headings
- COVID-19, Emergencies, Communicable Diseases, Emerging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doctor SpotDevice
Robotic platform (Boston Dynamics) controlled by clinician with video interface to facilitate telemedicine triage
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Patients presenting to the emergency department are triaged using a novel robotic telehealth triage system. Once triage is complete, patients complete a quantitative assessment to measure their acceptance and willingness to interact with the robotic telehealth system. Receives: Device: Doctor Spot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of robotic telehealth system
Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)
Measured: Immediately after completion of triage
Willingness to interact with robotic telehealth system
Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)
Measured: Immediately after completion of triage
Satisfaction of interacting with a robotic telehealth system
Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)
Measured: Immediately after completion of triage
Secondary outcomes (1)
Use of robotic system versus in-person triage
Quantitative questionnaire comparing robotic triage process with in-person triage: Do you think your interaction with the robotic system was better, the same or no different than an in-person evaluation?)
Measured: Immediately after completion of triage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start10 Mar 2020
- Primary completion3 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter R Chai, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452695
- Sponsor's protocol ID
- 2020P000957
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chai PR, Dadabhoy FZ, Huang HW, Chu JN, Feng A, Le HM, Collins J, da Silva M, Raibert M, Hur C, Boyer EW, Traverso G. Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation. JAMA Netw Open. 2021 Mar 1;4(3):e210667. doi: 10.1001/jamanetworkopen.2021.0667.
PubMed 33662134Huang HW, Chen J, Chai PR, Ehmke C, Rupp P, Dadabhoy FZ, Feng A, Li C, Thomas AJ, da Silva M, Boyer EW, Traverso G. Mobile Robotic Platform for Contactless Vital Sign Monitoring. Cyborg Bionic Syst. 2022;2022:9780497. doi: 10.34133/2022/9780497. Epub 2022 Apr 30.
PubMed 35571871
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Telehealth Triage Using Robotic Systems in COVID-19
- ClinicalTrials.gov ID
- NCT04452695
- Acronym / sponsor ID
- 2020P000957
- Conditions
- COVID-19, Telemedicine, Robotics, Emergencies, Emerging Infectious Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 30 Jun 2020 (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 overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | – | Device: Doctor SpotPatients presenting to the emergency department are triaged using a novel robotic telehealth triage system. Once triage is complete, patients complete a quantitative assessment to measure their acceptance and willingness to interact with the robotic telehealth system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients
Key inclusion criteria (2 listed)
- Presenting to the emergency department for evaluation
- > 18 years old
Key exclusion criteria (4 listed)
- Brought to emergency department via ambulance
- <18 years old
- non-english speaking
- in extremis, or unable to participate due to underlying acute medical condition
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 |
|---|---|---|
| Doctor SpotRobotic platform (Boston Dynamics) controlled by clinician with video interface to facilitate telemedicine triage | Device | Intervention arm |
Primary outcome
Acceptance of robotic telehealth system
Time frame: Immediately after completion of triage
Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)
Willingness to interact with robotic telehealth system
Time frame: Immediately after completion of triage
Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)
Satisfaction of interacting with a robotic telehealth system
Time frame: Immediately after completion of triage
Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)
1 secondary outcome
Use of robotic system versus in-person triage
Time frame: Immediately after completion of triage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Results publication: PubMed 33662134Chai PR, Dadabhoy FZ, Huang HW, Chu JN, Feng A, Le HM, Collins J, da Silva M, Raibert M, Hur C, Boyer EW, Traverso G. Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation. JAMA Netw Open. 2021 Mar 1;4(3):e210667. doi: 10.1001/jamanetworkopen.2021.0667.
- Results publication: PubMed 35571871Huang HW, Chen J, Chai PR, Ehmke C, Rupp P, Dadabhoy FZ, Feng A, Li C, Thomas AJ, da Silva M, Boyer EW, Traverso G. Mobile Robotic Platform for Contactless Vital Sign Monitoring. Cyborg Bionic Syst. 2022;2022:9780497. doi: 10.34133/2022/9780497. Epub 2022 Apr 30.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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?
An observational study of COVID-19 and Telemedicine, run by Brigham and Women's Hospital 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptance of robotic telehealth system (time frame: Immediately after completion of triage). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452695, which also lists 2 linked publications.
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 Sep 2022.