Clinical trial NCT06299774: Emergency Care at Home
Official title: Emergency Care at Home: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergency Medical Services
Emergency Department Visits
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: 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

Primary outcomes:
measure: Participant with an emergency department presentation, observation, or hospitalization within 9 days
timeFrame: From the day after emergency care visit until 9 days later, up to 9 days
Secondary outcomes:
measure: Time to care initiation
timeFrame: 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.
measure: Time spent receiving care
timeFrame: From the time a patient is seen by a clinician to the time a patient completes their emergency care, up to 1440 minutes.
measure: Number of days at home within 9 days
timeFrame: From the day after emergency care visit until 9 days later
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: