Hospital-Level Care at Home for Acutely Ill Adults

Study Overview
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Brief Summary
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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
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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; Automated alerting of MDs by mobile phone for any worrisome vital sign patterns; On-demand 24/7 clinician video visits; 4 to 1 patient to attending 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.

Official Title
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Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial

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

Intervention / Treatment
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* Other: Home hospitalization
* Other: Traditional inpatient hospitalization


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inpatient hospitalization<br>Control / usual care arm. Patients are admitted per usual to an inpatient service. Patients' medical records will be closely monitored. Patients will wear a vital sign and activity monitor whose data is used only retrospectively. On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health. | Other: Traditional inpatient hospitalization<br>* See above<br>|
| Experimental: Home hospitalization<br>Intervention arm. 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<br>* See above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total direct cost of hospitalization, $ |  | From date of admission to date of discharge, an expected average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct margin, $ | Direct margin from total cost of hospitalization | 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 | From date of admission to date of discharge, an expected average of 4 days | 
| Total cost, 30-day post discharge |  | Day of admission to 30-days post-discharge | 
| Length of stay, days |  | 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. | 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. | 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 | 
| All-cause readmission(s) after index, y/n |  | Day of discharge to 30 days later | 
| Unplanned readmission(s) after index, # |  | Day of discharge to 30 days later | 
| Unplanned readmission(s) after index, y/n |  | Day of discharge to 30 days later | 
| Emergency Department observation stay(s) after index hospitalization, # |  | 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, # |  | Day of discharge to 30 days later | 
| Emergency Department visit(s) after index hospitalization, 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 | Intervention arm only | From date of admission to date of discharge, an expected average of 4 days | 
| 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 | 
| Hours of sitting upright per day, # |  | 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 | 
| EuroQol -5D-5L, composite score |  | 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 | 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 |  | 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 | 
| 3-item Care Transition Measure, score |  | 30 days after discharge | 
| Picker Experience Questionnaire, score |  | 30 days after discharge | 
| Global satisfaction with care, score |  | 30 days after discharge | 
| Qualitative interview |  | 30 days after discharge |