Anticoagulants; Increased, Asthma, Atrial Fibrillation Rapid, Chronic Kidney Diseases, COPD, Gout Flare, Heart Failure, Hypertensive Urgency, Infection
Conditions
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; 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.
Interventions
OTHERHome hospitalization
See above
OTHERTraditional inpatient hospitalization
See above
Sponsors
Vital Connect
Smiths Medical
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total direct cost of hospitalization, $ | From date of admission to date of discharge, an expected average of 4 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direct margin, modeled with backfill | From date of admission to date of discharge, an expected average of 4 days | Backfill uses a model that estimates the cost of patients who take the place of home hospital patients |
| 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, # | From date of admission to date of discharge, an expected average of 4 days | 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. |
| Lab orders, # | From date of admission to date of discharge, an expected average of 4 days | Count of any lab order (for example, basic metabolic panel, complete blood count, hepatic function panel) that occurred through the course of the hospitalization. |
| 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 | — |
| Direct margin, $ | From date of admission to date of discharge, an expected average of 4 days | Direct margin from total cost of hospitalization |
| Transfer back to hospital, y/n | From date of admission to date of discharge, an expected average of 4 days | Intervention arm only |
| 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 | 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 | 1-5 Likert scale |
| 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 | — |
| Delirium, y/n | From date of admission to date of discharge, an expected average of 4 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hours of activity per night, # | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hours of sitting upright per night, # | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Pneumococcal vaccination if appropriate, y/n | From date of admission to date of discharge, an expected average of 4 days | Pneumonia patients only; Exploratory |
| Influenza vaccination if appropriate, y/n | From date of admission to date of discharge, an expected average of 4 days | Pneumonia patients only; Exploratory |
| Smoking cessation counseling if appropriate, y/n | From date of admission to date of discharge, an expected average of 4 days | Pneumonia and heart failure patients only; Exploratory |
| Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n | From date of admission to date of discharge, an expected average of 4 days | 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 |
| Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n | From date of admission to date of discharge, an expected average of 4 days | Heart failure patients only; Exploratory |
| Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n | From date of admission to date of discharge, an expected average of 4 days | Heart failure patients only; Exploratory |
| Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n | From date of admission to date of discharge, an expected average of 4 days | Heart failure patients only; Exploratory |
| Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n | From date of admission to date of discharge, an expected average of 4 days | Heart failure patients only; Exploratory |
| Smoking status post-discharge; current/never/quit | From date of admission to date of discharge, an expected average of 4 days | Heart failure and pneumonia patients only; Exploratory; Self-report of smoking status: current/never/quit. |
| Use of inappropriate medications in the elderly, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria |
| Use of Foley catheter, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Use of restraints, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| >3 medications added to medication list, y/n | Date of discharge, an expected average of 4 days after the date of admission | Exploratory; comparison made between preadmission and discharge medication list |
| Patient health questionnaire-2, score | At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge | Exploratory |
| Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score | At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge | Exploratory |
| Days at home since discharge | 30 days after discharge | Exploratory |
| Walk around ward/home, y/n | Date of discharge, an expected average of 4 days after the date of admission | Exploratory |
| Get to (non-commode) bathroom, y/n | Date of discharge, an expected average of 4 days after the date of admission | Exploratory |
| Walk 1 flight of stairs, y/n | Date of discharge, an expected average of 4 days after the date of admission | Exploratory |
| Visit with friends/family, y/n | Date of discharge, an expected average of 4 days after the date of admission | Exploratory |
| Walk outside around my home, y/n | Date of discharge, an expected average of 4 days after the date of admission | Exploratory |
| Go shopping, y/n | Date of discharge, an expected average of 4 days after the date of admission | Exploratory |
| Time from admission decision to assessment by research assistant, minutes | On the first day of admission, a maximum 24 hour period | Exploratory |
| Time from research assistant assessment to emergency department dismissal, minutes | On the first day of admission, a maximum 24 hour period | Exploratory |
| Time from arrival home or to floor and medical doctor evaluation, minutes | On the first day of admission, a maximum 24 hour period | Exploratory |
| Time from arrival home or to floor and registered nurse evaluation, minutes | On the first day of admission, a maximum 24 hour period | Exploratory |
| Total reimbursement, 30-day post discharge | Day of admission to 30-days post-discharge | Exploratory |
| Total registered nurse visits, # | From date of admission to date of discharge, an expected average of 4 days | Exploratory, intervention arm only |
| Total on call medical doctor interactions (video or phone), # | From date of admission to date of discharge, an expected average of 4 days | Exploratory, intervention arm only |
| Total on call medical doctor in-person visits, # | From date of admission to date of discharge, an expected average of 4 days | Exploratory, intervention arm only |
| Duration of 1st registered nurse visit, minutes | On the first day of admission, a maximum 24 hour period | Exploratory, intervention arm only |
| Mean duration of subsequent registered nurse visit, minutes | From date of admission to date of discharge, an expected average of 4 days | Exploratory, intervention arm only |
| Mean registered nurse to patient ratio | From date of admission to date of discharge, an expected average of 4 days | Exploratory, intervention arm only |
| Intravenous medications, days | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Intravenous fluids, days | From date of admission to date of discharge, an expected average of 4 days | Exploratory; the number of days intravenous fluids (for example, normal saline) were received by the patient. |
| Intravenous diuretics, days | From date of admission to date of discharge, an expected average of 4 days | Exploratory; the number of days intravenous diuretics (for example, furosemide) were received by the patient. |
| Intravenous antibiotics, days | From date of admission to date of discharge, an expected average of 4 days | Exploratory; the number of days intravenous antibiotics (for example, ceftriaxone) were received by the patient. |
| Supplemental oxygen required, days | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Nebulizer treatment, days | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Medical Doctor sessions, # notes | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Consultant sessions, # notes | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Physical therapy/occupational therapy sessions, # notes | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Primary care provider follow-up within 14 days, y/n | Day of discharge to 14 days later | Exploratory |
| Skilled nursing facility utilization, days | Day of discharge to 30 days later | Exploratory; the number of days a patient spent in a skilled nursing facility. |
| Home health utilization, days | Day of discharge to 30 days later | Exploratory |
| Fall, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hospital-acquired deep vein thrombosis or pulmonary embolism, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hospital-acquired pressure ulcer, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hospital-acquired thrombophlebitis at peripheral IV site, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hospital-acquired catheter-associated urinary tract infection, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hospital-acquired Clostridium difficile infection, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| All-cause mortality, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Unplanned mortality, y/n | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Post-discharge all-cause mortality, y/n | Day of discharge to 30 days later | Exploratory |
| Post-discharge unplanned mortality, y/n | Day of discharge to 30 days later | Exploratory |
| New arrhythmia, y/n | From date of admission to date of discharge, an expected average of 4 days | Heart failure patients only; Exploratory |
| Hypokalemia, y/n | From date of admission to date of discharge, an expected average of 4 days | Heart failure patients only; Exploratory |
| Acute Kidney Injury, y/n | From date of admission to date of discharge, an expected average of 4 days | Heart failure patients only; Exploratory |
| Mean Likert scale pain score, 0-10 | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
| Hours of sleep per night, # | From date of admission to date of discharge, an expected average of 4 days | Exploratory |
Countries
United States
Outcome results
None listed