Hospital-Level Care at Home for Acutely Ill Adults in Rural Settings: A Randomized Controlled Trial

Brigham and Women's Hospital3 sites in 2 countries160 target enrollmentFebruary 16, 2022

ConditionsInfections Heart Failure Chronic Obstructive Pulmonary Disease Asthma Gout Flare Chronic Kidney Diseases Hypertensive Urgency Atrial Fibrillation Rapid Anticoagulation Diabetes and Its Complications End of Life/Desires Only Medical Management

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infections
Sponsor: Brigham and Women's Hospital
Enrollment: 160
Locations: 3
Primary Endpoint: Total cost, hospitalization
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study examines the implications of providing hospital-level care in rural homes.

Detailed Description

Home hospital is hospital-level care at home for acutely ill patients. In multiple publications mostly in urban environments, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models deliver care in urban environments, not in rural environments. To determine the effect of home hospital care in rural homes, the investigators propose to the following randomized control trial.

Registry

clinicaltrials.gov

Start Date

February 16, 2022

End Date

January 17, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Brigham and Women's Hospital

Responsible Party

Principal Investigator

David Levine

Dr. David Levine MD, MPH, MA, Director

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

•Patient clinical inclusion criteria:
•\>=18 years old
•Any infectious process (e.g., pneumonia, diverticulitis, cellulitis, complicated urinary tract infection)
•Heart failure exacerbation
•Asthma and chronic obstructive pulmonary disease exacerbation
•Atrial fibrillation with rapid ventricular response
•Diabetes and its complications
•Venous thromboembolism
•Gout exacerbation
•Chronic kidney disease with volume overload

Exclusion Criteria

•Patient exclusion clinical criteria:
•Acute delirium, as determined by the Confusion Assessment Method
•Cannot establish peripheral access by any means
•Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage (unless part of end of life pathway)
•Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control
•Cannot independently ambulate to bedside commode, unless home-based aides are available
•As deemed by on-call MD, patient likely to require any of the following procedures that have not already occurred: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery (unless these can be coordinated with appropriate facilities during the home hospitalization)
•For pneumonia:
•Most recent CURB65 \> 3: new confusion, BUN \> 19mg/dL, respiratory rate\>=30/min, systolic blood pressure\<90mmHg, Age\>=65 (\<14% 30-day mortality)15
•Most recent SMRTCO \> 2: systolic blood pressure \< 90mmHg (2pts), multilobar CXR involvement (1pt), respiratory rate \>= 30/min, heart rate \>= 125, new confusion, oxygen saturation \<= 90% (\<10% chance of intensive respiratory or vasopressor support)16

Outcomes

Primary Outcomes

Total cost, hospitalization

Time Frame: Date of admission to date of discharge, estimated 10 days later

Published as percent change given sensitivity of these data

Secondary Outcomes

Total cost, discharge to 30-days post discharge(Day of discharge to 30 days later)
Percent of day lying down(Day of admission to day of discharge, assessed up to 2 months)
Unplanned readmission within 30-days of discharge(Day of discharge to 30 days later)
Days at home(Day of discharge to 30 days later)