Hospital-level care delivered at home for acutely ill adults
Home Hospital for Suddenly Ill Adults: A Clinical Trial
This trial tries to deliver hospital-level care at home to adults with sudden illnesses like infections, heart failure, COPD, asthma, or gout flares to see if it's as safe, improves patient experience, and lowers costs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT03524222 on ClinicalTrials.gov |
What this trial studies
The investigators test a home hospital model that substitutes for inpatient acute care to avoid hospital-associated harms, long waits, and high costs. The home hospital team provides the typical inpatient components (physician, registered nurse, medications including IV therapy, monitoring, and use of modern medical technology) directly in the patient's home. Eligible adults must live within a roughly 5-mile or 20-minute driving radius of the participating emergency department, be able to consent (or have a proxy), and identify a caregiver for the first 24 hours of admission. Outcomes include quality and safety metrics, cost measures, and patient experience compared against usual hospital care, building on limited prior US demonstrations.
Who should consider this trial
Good fit: Adults 18 or older with acute conditions such as cellulitis, heart failure, pneumonia, COPD/asthma exacerbations, complicated urinary tract infection, gout flare, or similar illnesses who live within the program's service radius and can consent and arrange an initial caregiver are ideal candidates.
Not a fit: Patients who require ICU-level care or continuous invasive monitoring, are clinically unstable, lack a caregiver or live outside the coverage area are unlikely to benefit from this home hospital model.
Why it matters
Potential benefit: If successful, patients could receive hospital-level care at home with fewer hospital-associated complications, better experience, and lower costs.
How similar studies have performed: International programs and two non-randomized US demonstration projects have shown promising safety, roughly 20% cost reductions, and improved patient experience, but robust randomized evidence in the US is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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)
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Faulkner Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: David M Levine, MD MPH MA
- Email: dmlevine@partners.org
- Phone: 617-732-7063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.