Home Hospital for Suddenly Ill Adults: A Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 3,000
- Locations
- 2
- Primary Endpoint
- Total direct cost of hospitalization, $
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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)
Arms & Interventions
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.
Intervention: Home Hospitalization (Other)
Outcomes
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
- Global satisfaction with care, score(30 days after discharge)
- Total cost, 30-day post discharge(Day of admission to 30-days post-discharge)
- Emergency Department visit(s) after index hospitalization, #(Day of discharge to 30 days later)
- Activities of daily living, score(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(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)
- Direct margin, modeled with backfill(From date of admission to date of discharge, an expected average of 4 days)
- All-cause readmission(s) after index, #(Day of discharge to 30 days later)
- Hours of sitting upright per day, #(From date of admission to date of discharge, an expected average of 4 days)
- EuroQol-5D-5L, composite score(At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge)
- Direct margin, $(From date of admission to date of discharge, an expected average of 4 days)
- Length of stay, days(From date of admission to date of discharge, an expected average of 4 days)
- All-cause readmission(s) after index, y/n(Day of discharge to 30 days later)
- Emergency Department observation stay(s) after index hospitalization, y/n(Day of discharge to 30 days later)
- Emergency Department visit(s) after index hospitalization, y/n(Day of discharge to 30 days later)
- Hours of sleep per day, #(From date of admission to date of discharge, an expected average of 4 days)
- Hours of activity per day, #(From date of admission to date of discharge, an expected average of 4 days)
- 3-item Care Transition Measure, score(30 days after discharge)
- Short Form 1(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)
- Picker Experience Questionnaire, score(30 days after discharge)
- Imaging, #(From date of admission to date of discharge, an expected average of 4 days)
- Lab orders, #(From date of admission to date of discharge, an expected average of 4 days)
- Unplanned readmission(s) after index, y/n(Day of discharge to 30 days later)
- Delirium, y/n(From date of admission to date of discharge, an expected average of 4 days)
- Transfer back to hospital, y/n(From date of admission to date of discharge, an expected average of 4 days)
- Steps per day, #(From date of admission to date of discharge, an expected average of 4 days)
- Unplanned readmission(s) after index, #(Day of discharge to 30 days later)
- Emergency Department observation stay(s) after index hospitalization, #(Day of discharge to 30 days later)
- Qualitative interview(30 days after discharge)
Investigators
David Levine
David M Levine, MD, MPH, MA, Associate Physician, Brigham and Women's Hospital
Brigham and Women's Hospital