RecruitingNCT03524222Updated Mar 17, 2026

Home Hospital for Suddenly Ill Adults

An interventional study of Home Hospitalization in Infection, Heart Failure and COPD, sponsored by Brigham and Women's Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 3 months after the study started (first participant enrolled Jan 2018, registered May 2018).
Started Jan 2018; still recruiting 8 years 8 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 3,000
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.

Read the detailed description

Hospitals are the standard of care for acute illness in the United States, but hospital care is expensive and often unsafe, especially for older individuals. While admitted, 20% suffer delirium, over 5% contract hospital-acquired infections, and most lose functional status that is never regained. Timely access to inpatient care is poor: many hospital wards are typically over 100% capacity, and emergency department waits can be protracted. Moreover, hospital care is increasingly costly: many internal medicine admissions have a negative margin (i.e., expenditures exceed hospital revenues) and incur patient debt.

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, 20% reduced cost, and 20% improved patient experience. While this is the standard of care in several developed countries, only 2 non-randomized demonstration projects have been conducted in the United States, each with highly local needs. Taken together, home hospital evidence is promising but falls short due to non-robust experimental design, failure to implement modern medical technology, and poor enlistment of community support.

The home hospital module offers most of the same medical components that are standard of care in an acute care hospital. The typical staff (medical doctor [MD], registered nurse [RN], case manager), diagnostics (blood tests, vital signs, telemetry, x-ray, and ultrasound), intravenous therapy, and oxygen/nebulizer therapy will all be available for home hospital. Optional deployment of food services, home health aide, physical therapist, occupational therapist, and social worker will be tailored to patient need. Home hospital improves upon the components of a typical ward's standard of care in several ways:

Point of care blood diagnostics (results at the bedside in \<5 minutes); Minimally invasive continuous vital signs, telemetry, activity tracking, and sleep tracking; On-demand 24/7 clinician video visits; 4 to 1 patient to MD ratio, compared to typical 16 to 1; Ambulatory/portable infusion pumps that can be worn on the hip; Optional access to a personal home health aide Should a matter be emergent (that is, requiring in-person assistance in less than 20 minutes), then 9-1-1 will be called and the patient will be returned to the hospital immediately. In previous iterations of home hospital this happens in about 2% of patients.

Clinical parameters measured will be at the discretion of the physician and nurse, who treat the participant following evidence-based practice guidelines, just as in the usual care setting. In addition, the investigators will be tracking a wide variety of measures of quality and safety, including some measures tailored to each primary diagnosis.

Conditions studied

Infection
Heart Failure
COPD
Asthma
Gout Flare
Chronic Kidney Diseases
Hypertensive Urgency
Atrial Fibrillation Rapid
Anticoagulants; Increased

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Resides within either a 5-mile or 20 minute driving radius of emergency department
Has capacity to consent to study OR can assent to study and has proxy who can consent
>= 18 years-old
Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. This criterion may be waived for highly competent patients at the patient and clinician's discretion.
Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team.

Exclusion criteria

Exclusion Criteria:

Undomiciled
No working heat (October-April), no working air conditioning if forecast > 80°F (June-September), or no running water
On methadone requiring daily pickup of medication
In police custody
Resides in facility that provides on-site medical care (e.g., skilled nursing facility)
Domestic violence screen positive
Acute delirium, as determined by the Confusion Assessment Method
Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
Secondary condition: end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control
Cannot independently ambulate to bedside commode
As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
High risk for clinical deterioration
Home hospital census is full (maximum 5 patients at any time)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 3,000 participants (estimated)

Study arms

Experimental
Home Hospitalization
Patients will return home after triage, diagnosis, and the beginning of treatment in the emergency department with a set of specialized patient-tailored services (listed above). On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health.
Other: Home Hospitalization

Interventions

OtherHome Hospitalization
See above

What researchers measure

Primary outcomes

Total direct cost of hospitalization, $
Time frame: From date of admission to date of discharge, an expected average of 4 days

Secondary outcomes

Direct margin, $
Direct margin from total cost of hospitalization
Time frame: From date of admission to date of discharge, an expected average of 4 days
Direct margin, modeled with backfill
Backfill uses a model that estimates the cost of patients who take the place of home hospital patients
Time frame: From date of admission to date of discharge, an expected average of 4 days
Total cost, 30-day post discharge
Time frame: Day of admission to 30-days post-discharge
Length of stay, days
Time frame: From date of admission to date of discharge, an expected average of 4 days
Imaging, #
Count of any diagnostic imaging (for example, x-ray, computed tomography, magnetic resonance, ultrasound, and nuclear imaging) that occurred through the course of the hospitalization.
Time frame: From date of admission to date of discharge, an expected average of 4 days
Lab orders, #
Count of any lab order (for example, basic metabolic panel, complete blood count, hepatic function panel) that occurred through the course of the hospitalization.
Time frame: From date of admission to date of discharge, an expected average of 4 days
All-cause readmission(s) after index, #
Time frame: Day of discharge to 30 days later
All-cause readmission(s) after index, y/n
Time frame: Day of discharge to 30 days later
Unplanned readmission(s) after index, #
Time frame: Day of discharge to 30 days later
Unplanned readmission(s) after index, y/n
Time frame: Day of discharge to 30 days later
Emergency Department observation stay(s) after index hospitalization, #
Time frame: Day of discharge to 30 days later
Emergency Department observation stay(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Emergency Department visit(s) after index hospitalization, #
Time frame: Day of discharge to 30 days later
Emergency Department visit(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Delirium, y/n
Time frame: From date of admission to date of discharge, an expected average of 4 days
Transfer back to hospital, y/n
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hours of sleep per day, #
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hours of activity per day, #
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hours of sitting upright per day, #
Time frame: From date of admission to date of discharge, an expected average of 4 days
Steps per day, #
Time frame: From date of admission to date of discharge, an expected average of 4 days
EuroQol-5D-5L, composite score
Time frame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Short Form 1
1-5 Likert scale: Excellent, very good, good, fair poor
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Activities of daily living, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Instrumental activities of daily living, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
3-item Care Transition Measure, score
Time frame: 30 days after discharge
Picker Experience Questionnaire, score
Time frame: 30 days after discharge
Global satisfaction with care, score
Time frame: 30 days after discharge
Qualitative interview
Time frame: 30 days after discharge

Other outcomes

Total reimbursement, 30-days post discharge
Exploratory
Time frame: Day of admission to 30-days post-discharge
Intravenous medications, days
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Intravenous fluids, days
Exploratory; the number of days intravenous fluids (for example, normal saline) were received by the patient.
Time frame: From date of admission to date of discharge, an expected average of 4 days
Intravenous diuretics, days
Exploratory; the number of days intravenous diuretics (for example, furosemide) were received by the patient.
Time frame: From date of admission to date of discharge, an expected average of 4 days
Intravenous antibiotics, days
Exploratory; the number of days intravenous antibiotics (for example, ceftriaxone) were received by the patient.
Time frame: From date of admission to date of discharge, an expected average of 4 days
Supplemental oxygen required, days
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Nebulizer treatment, days
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Medical Doctor sessions, # notes
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Consultant Sessions, # notes
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Physical therapy/occupational therapy sessions, # notes
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Primary care provider follow-up within 14 days, y/n
Exploratory
Time frame: up to 14 days from day of discharge
Skilled nursing facility usage, days
Exploratory; the number of days a patient spent in a skilled nursing facility.
Time frame: up to 30 days from day of discharge
Home health utilization, days
Exploratory
Time frame: up to 30 days from day of discharge
Fall, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired deep vein thrombosis or pulmonary embolism, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired pressure ulcer, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired thrombophlebitis at peripheral IV site, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired catheter-associated urinary tract infection, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired Clostridium difficile infection, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
All-cause mortality, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Unplanned mortality, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Post-discharge all-cause mortality, y/n
Exploratory
Time frame: Day of discharge to 30 days later
Post-discharge unplanned mortality, y/n
Exploratory
Time frame: Day of discharge to 30 days later
New arrhythmia, y/n
Heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hypokalemia, y/n
Heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Acute Kidney Injury, y/n
Heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Mean Likert scale pain score, 0-10
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hours of sleep per night, #
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hours of activity per night, #
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Hours of sitting upright per night, #
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Pneumococcal vaccination if appropriate, y/n
Pneumonia patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Influenza vaccination if appropriate, y/n
Pneumonia patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Smoking cessation counseling if appropriate, y/n
Pneumonia and heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year, y/n
Heart failure patients only; Exploratory; Whether or not an appropriate study occurred and/or was scheduled if not done within 1 year; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography
Time frame: From date of admission to date of discharge, an expected average of 4 days
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
Heart failure patients only; Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Smoking status post-discharge, current/never/quit
Heart failure and pneumonia patients only; Exploratory; Self-report of smoking status: current/never/quit.
Time frame: From date of admission to date of discharge, an expected average of 4 days
Use of inappropriate medications in the elderly, y/n
Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria
Time frame: From date of admission to date of discharge, an expected average of 4 days
Use of Foley catheter, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Use of restraints, y/n
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
>3 medications added to medication list, y/n
Exploratory; comparison made between preadmission and discharge medication list
Time frame: Date of discharge, an expected average of 4 days after the date of admission
Patient health questionnaire-2, score
Exploratory
Time frame: At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score
Exploratory: I have someone who will listen to me when I need to talk I have someone to confide in or talk to about myself or my problems I have someone who makes me feel appreciated I have someone to talk with when I have a bad day Scale for each: never, rarely, sometimes, usually, always
Time frame: At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Days at home since discharge
Exploratory
Time frame: 30 days after discharge
Walk around ward/home, y/n
Exploratory
Time frame: Date of discharge, an expected average of 4 days after the date of admission
Get to (non-commode) bathroom, y/n
Exploratory
Time frame: Date of discharge, an expected average of 4 days after the date of admission
Walk 1 flight of stairs, y/n
Exploratory
Time frame: Date of discharge, an expected average of 4 days after the date of admission
Visit with friends/family, y/n
Exploratory
Time frame: Date of discharge, an expected average of 4 days after the date of admission
Walk outside around my home, y/n
Exploratory
Time frame: Date of discharge, an expected average of 4 days after the date of admission
Go shopping, y/n
Exploratory
Time frame: Date of discharge, an expected average of 4 days after the date of admission
Time from admission decision to assessment by research assistant, minutes
Exploratory
Time frame: On the first day of admission, a maximum 24 hour period
Time from research assistant assessment to emergency department dismissal, minutes
Exploratory
Time frame: On the first day of admission, a maximum 24 hour period
Time from arrival home to medical doctor evaluation, minutes
Exploratory
Time frame: On the first day of admission, a maximum 24 hour period
Time from arrival home to registered nurse evaluation, minutes
Exploratory
Time frame: On the first day of admission, a maximum 24 hour period
Mean registered nurse to patient ratio
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Total registered nurse visits, #
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Total "on call" medical doctor interactions (video or phone), #
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Total "on call" medical doctor in-person visits
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days
Duration of 1st registered nurse visit, minutes
Exploratory
Time frame: On the first day of admission, a maximum 24 hour period
Mean duration of subsequent registered nurse visit, minutes
Exploratory
Time frame: From date of admission to date of discharge, an expected average of 4 days

Study locations

2 of 2 sites recruiting

Brigham and Women's Hospital
Boston, Massachusetts 02115, United States
- David M Levine, MD MPH MA · Contact · dmlevine@partners.org · 617-732-7063
- David M Levine, MD MPH MA · Principal investigator
Recruiting
Brigham and Women's Faulkner Hospital
Boston, Massachusetts 02130, United States
- David M Levine, MD MPH MA · Contact · dmlevine@partners.org · 617-732-5500
- David M Levine, MD MPH MA · Principal investigator
Recruiting

References and documents

Publications

Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008. PubMed 16330791 ↗
Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132. PubMed 22665835 ↗
Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478. PubMed 23608775 ↗
Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24. PubMed 19347026 ↗
Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x. PubMed 11129745 ↗
Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. doi: 10.5694/j.1326-5377.2010.tb04070.x. PubMed 21077817 ↗
Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6. PubMed 29411238 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03524222
Lead sponsor: Brigham and Women's Hospital
Responsible party: David Levine (David M Levine, MD, MPH, MA, Associate Physician, Brigham and Women's Hospital, Brigham and Women's Hospital) — Principal investigator
First posted: May 14, 2018
Start date: Jan 18, 2018
Primary completion: Sep 2030 (estimated)
Completion: Sep 2031 (estimated)
Last update: Mar 17, 2026

Study contacts

David M Levine, MD MPH MA

Contact

dmlevine@partners.org

617-732-7063

Jeffrey L Schnipper, MD MPH

Contact

jschnipper@partners.org

617-732-7063

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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