Emergency Medical ServicesNCT06299774
Emergency Care at Home
A study testing Emergency care at home and Emergency care at a brick-and-mortar emergency department in people with Emergency Medical Services and Emergency Department Visits, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medical Services, Emergency Department Visits
- What is being tested?
- Emergency care at home and Emergency care at a brick-and-mortar emergency department
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 26 Oct 2024
- 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
- Age >= 18 years
- Resides within Home Hospital geographic area
- Lives in permanent housing (i.e., not in temporary housing such as a shelter)
- Patient of a Mass General Brigham primary care provider
- Primary care provider attests that their triage recommendation is the emergency department
- Emergency care at home nurse triages the participant to the emergency department or urgent care
- Patient attests that they intend to go to the emergency department
Who cannot join
- Insurance: workers compensation and motor vehicle accident
- Lives in a healthcare facility (Skilled Nursing, Rehab, long term acute care)
- Patient/caregiver cannot answer phone or door
- Active substance use
- Acute psychiatric concerns (e.g., suicidal ideation, even if passive)
- Home safety concerns (e.g., intimate partner violence)
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- High-risk features:
- oHigh Risk Signs, if available: Heart rate > 120 Systolic blood pressure < 90 Shock Index (heart rate divided by systolic blood pressure) > 1 Oxygen < 93% on ambient air Increase in oxygen requirement new or > 2 liters Respiratory rate > 28 Diaphoresis oHigh Risk Symptoms: Active chest pain Severe work of breathing Syncope Hemoptysis Seizure Other concerning symptom per nurse triage
- Requires inpatient-level care
- Requires specialty consultation
- Requires physical, occupational, or speech therapy
- Requires blood transfusion
- Requires internal physical exam maneuver (e.g. rectal exam, genitourinary exam)
- Requires imaging that is not available at home
- Requires monitoring that is not available at home
- Troubleshooting wound vacs
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Emergency Care at Home: A Randomized Controlled Trial
This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.
Read the detailed description
Care in an emergency department has many benefits. It delivers high-intensity critical care on demand to large populations and serves as an efficient gateway to hospitalization. However, some populations may not be well-served by the traditional emergency department, particularly older adults, adults with serious illness, and those who are homebound. Many harms may come to older adults in the emergency department, including delirium, pressure injuries, infections, anxiety, and others. Emergency department crowding secondary to hospital capacity constraints may also lead to suboptimal care, as patients wait many hours for their inpatient bed even after a disposition decision is made.
As a result, the investigators will evaluate in a randomized controlled trial the efficacy of emergency care delivered at home instead of in the emergency department
- Being tested
- Emergency care at home, Emergency care at a brick-and-mortar emergency department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency care at homeOther
A mobile integrated health paramedic under the direction of a remote emergency care physician will arrive at the patient's home and deliver emergency care.
Emergency care at a brick-and-mortar emergency departmentOther
Standard emergency care delivered in a brick-and-mortar emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Emergency care in a brick-and-mortar emergency department. Receives: Other: Emergency care at a brick-and-mortar emergency department |
| Emergency care at home | Experimental | Emergency care in the patient's home. Receives: Other: Emergency care at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant with an emergency department presentation, observation, or hospitalization within 9 days
Whether a patient presented to the emergency department, was observed in the emergency department, or was hospitalized in the 9 days following their index emergency care visit. Excludes patients who were admitted on their index visit.
Measured: From the day after emergency care visit until 9 days later, up to 9 days
Secondary outcomes (3)
Time to care initiation
Number of minutes from when the consultation for emergency care at home was placed to emergency care (either in the home or in the emergency department) occurs.
Measured: From the time a consultation is placed in the electronic health record to the time a patient is seen by a clinician, up to 2880 minutes.
Time spent receiving care
Number of minutes from when a patient was seen by a clinician to they are dismissed from the emergency room (usual care) or the paramedic leaves their home (experimental).
Measured: From the time a patient is seen by a clinician to the time a patient completes their emergency care, up to 1440 minutes.
Number of days at home within 9 days
The number of days the patient spends at home in the 9 days following the index emergency care visit.
Measured: From the day after emergency care visit until 9 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start2 Feb 2024
- Primary completion26 Oct 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Medical ServicesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299774
- Sponsor's protocol ID
- 2023P003383
- Status last verified
- Nov 2024
- First submitted
- 26 Feb 2024
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Care at Home: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06299774
- Acronym / sponsor ID
- 2023P003383
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 8 Mar 2024 (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.
This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.
Detailed description
Care in an emergency department has many benefits. It delivers high-intensity critical care on demand to large populations and serves as an efficient gateway to hospitalization. However, some populations may not be well-served by the traditional emergency department, particularly older adults, adults with serious illness, and those who are homebound. Many harms may come to older adults in the emergency department, including delirium, pressure injuries, infections, anxiety, and others. Emergency department crowding secondary to hospital capacity constraints may also lead to suboptimal care, as patients wait many hours for their inpatient bed even after a disposition decision is made.
As a result, the investigators will evaluate in a randomized controlled trial the efficacy of emergency care delivered at home instead of in the emergency department
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Emergency care at a brick-and-mortar emergency departmentEmergency care in a brick-and-mortar emergency department. |
| Emergency care at home | Experimental | Other: Emergency care at homeEmergency care in the patient's home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- Resides within Home Hospital geographic area
- Lives in permanent housing (i.e., not in temporary housing such as a shelter)
- Patient of a Mass General Brigham primary care provider
- Primary care provider attests that their triage recommendation is the emergency department
Key exclusion criteria (16 listed)
- Insurance: workers compensation and motor vehicle accident
- Lives in a healthcare facility (Skilled Nursing, Rehab, long term acute care)
- Patient/caregiver cannot answer phone or door
- Active substance use
- Acute psychiatric concerns (e.g., suicidal ideation, even if passive)
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 |
|---|---|---|
| Emergency care at homeA mobile integrated health paramedic under the direction of a remote emergency care physician will arrive at the patient's home and deliver emergency care. | Other | Emergency care at home |
| Emergency care at a brick-and-mortar emergency departmentStandard emergency care delivered in a brick-and-mortar emergency department. | Other | Usual care |
Primary outcome
Participant with an emergency department presentation, observation, or hospitalization within 9 days
Time frame: From the day after emergency care visit until 9 days later, up to 9 days
Whether a patient presented to the emergency department, was observed in the emergency department, or was hospitalized in the 9 days following their index emergency care visit. Excludes patients who were admitted on their index visit.
3 secondary outcomes
Time to care initiation
Time frame: From the time a consultation is placed in the electronic health record to the time a patient is seen by a clinician, up to 2880 minutes.
Time spent receiving care
Time frame: From the time a patient is seen by a clinician to the time a patient completes their emergency care, up to 1440 minutes.
Number of days at home within 9 days
Time frame: From the day after emergency care visit until 9 days later
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 17 Mar 2026.
- 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 Emergency care at home and Emergency care at a brick-and-mortar emergency department in people with Emergency Medical Services and Emergency Department Visits, 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 7 inclusion and 16 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 17 Mar 2026. 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?
Participant with an emergency department presentation, observation, or hospitalization within 9 days (time frame: From the day after emergency care visit until 9 days later, up to 9 days). 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 17 Mar 2026.