- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06299774
Emergency Care at Home
Emergency Care at Home: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual care
Emergency care in a brick-and-mortar emergency department.
|
Standard emergency care delivered in a brick-and-mortar emergency department.
|
|
Experimental: Emergency care at home
Emergency care in the patient's home.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From the day after emergency care visit until 9 days later, up to 9 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
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 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).
|
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
|
The number of days the patient spends at home in the 9 days following the index emergency care visit.
|
From the day after emergency care visit until 9 days later
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P003383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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