NCT06299774

Brief Summary

This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2024

Completed
Last Updated

March 17, 2026

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

February 26, 2024

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the day after emergency care visit until 9 days later, up to 9 days

Secondary Outcomes (3)

  • Time to care initiation

    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

    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

    From the day after emergency care visit until 9 days later

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Other: Emergency care at a brick-and-mortar emergency department

Emergency care at home

EXPERIMENTAL

Emergency care in the patient's home.

Other: Emergency care at home

Interventions

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

Usual care

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 home

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 8, 2024

Study Start

February 2, 2024

Primary Completion

October 26, 2024

Study Completion

October 26, 2024

Last Updated

March 17, 2026

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations