InfectionNCT03524222
Home Hospital for Suddenly Ill Adults
A study testing Home Hospitalization in people with Infection and Heart Failure, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Heart Failure, COPD
- What is being tested?
- Home Hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2018to Sep 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
David M Levine, MD MPH MA, 617-732-7063, dmlevine@partners.org
David M Levine, MD MPH MA
- Recruiting
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
David M Levine, MD MPH MA, 617-732-5500, dmlevine@partners.org
David M Levine, MD MPH MA
About this study
Official title: Home Hospital for Suddenly Ill Adults: A Clinical Trial
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
- Infection, Heart Failure, COPD, Asthma, Gout Flare, Chronic Kidney Diseases
- Being tested
- Home Hospitalization
- Medical subject headings
- Infections, Heart Failure, Pulmonary Disease, Chronic Obstructive, Asthma, Renal Insufficiency, Chronic, Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home HospitalizationOther
See above
| Study group | Role | What they receive |
|---|---|---|
| Home Hospitalization | Experimental | 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. Receives: Other: Home Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total direct cost of hospitalization, $
Measured: From date of admission to date of discharge, an expected average of 4 days
Secondary outcomes (28)
Direct margin, $
Direct margin from total cost of hospitalization
Measured: 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
Measured: From date of admission to date of discharge, an expected average of 4 days
Total cost, 30-day post discharge
Measured: Day of admission to 30-days post-discharge
Length of stay, days
Measured: 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.
Measured: 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.
Measured: From date of admission to date of discharge, an expected average of 4 days
All-cause readmission(s) after index, #
Measured: Day of discharge to 30 days later
All-cause readmission(s) after index, y/n
Measured: Day of discharge to 30 days later
Unplanned readmission(s) after index, #
Measured: Day of discharge to 30 days later
Unplanned readmission(s) after index, y/n
Measured: Day of discharge to 30 days later
Emergency Department observation stay(s) after index hospitalization, #
Measured: Day of discharge to 30 days later
Emergency Department observation stay(s) after index hospitalization, y/n
Measured: Day of discharge to 30 days later
Emergency Department visit(s) after index hospitalization, #
Measured: Day of discharge to 30 days later
Emergency Department visit(s) after index hospitalization, y/n
Measured: Day of discharge to 30 days later
Delirium, y/n
Measured: From date of admission to date of discharge, an expected average of 4 days
Transfer back to hospital, y/n
Measured: From date of admission to date of discharge, an expected average of 4 days
Hours of sleep per day, #
Measured: From date of admission to date of discharge, an expected average of 4 days
Hours of activity per day, #
Measured: From date of admission to date of discharge, an expected average of 4 days
Hours of sitting upright per day, #
Measured: From date of admission to date of discharge, an expected average of 4 days
Steps per day, #
Measured: From date of admission to date of discharge, an expected average of 4 days
EuroQol-5D-5L, composite score
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days after discharge
Picker Experience Questionnaire, score
Measured: 30 days after discharge
Global satisfaction with care, score
Measured: 30 days after discharge
Qualitative interview
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start18 Jan 2018
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524222
- Sponsor's protocol ID
- 2017P002583
- Status last verified
- Mar 2026
- First submitted
- 2 May 2018
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 16330791Cryer 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 22665835Hung 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 23608775Fong 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 19347026Counsell 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 11129745Montalto 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 21077817Levine 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