Emergency Care at Home

NCT ID: NCT06299774

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2025-03-02

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

Conditions

Emergency Medical Services; Emergency Department Visits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual care

Emergency care in a brick-and-mortar emergency department.

Group Type: ACTIVE_COMPARATOR

Emergency care at a brick-and-mortar emergency department

Intervention Type: OTHER

Standard emergency care delivered in a brick-and-mortar emergency department.

Emergency care at home

Emergency care in the patient's home.

Group Type: EXPERIMENTAL

Emergency care at home

Intervention Type: OTHER

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.

Interventions

Emergency care at 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.

Intervention Type: OTHER

Emergency care at a brick-and-mortar emergency department

Standard emergency care delivered in a brick-and-mortar emergency department.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Levine

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Levine, MD, MPH, MA

Role: CONTACT

dmlevine@bwh.harvard.edu

6177327063

Facility Contacts

David Levine, MD, MPH, MA

Role: primary

dmlevine@bwh.harvard.edu

617-732-7063

Other Identifiers

2023P003383

Identifier Type: -

Identifier Source: org_study_id