Cellulitis, Heart Failure, Pneumonia, Urinary Tract Infections
Conditions
Keywords
home hospital, acute care home, care redesign, delivery innovation, heart failure, pneumonia, cellulitis, urinary tract infections
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.
Interventions
OTHERHome hospitalization
OTHERInpatient Hospitalization
Sponsors
Partners HealthCare
Smiths Medical, ASD, Inc.
Vital Connect, Inc.
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 5-mile radius of emergency room * English- or Spanish-speaker * 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. * This criterion may be waived for highly competent patients at the patient and clinician's discretion. * \>=18 years old * Primary diagnosis of cellulitis, heart failure, complicated urinary tract infection, or pneumonia that requires inpatient admission as determined by blinded 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 * Cared for by a private primary care physician who rounds in the hospital * Cannot establish peripheral access in emergency department (or access requires ultrasound guidance) * Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage * Primary diagnosis requires 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 * For pneumonia: * Most recent CURB65 \> 3: new confusion, blood urea nitrogen \> 19mg/dL, respiratory rate\>=30/min, systolic blood pressure\<90mmHg, Age\>=65 * Most recent SMRTCO \> 2: systolic blood pressure \< 90mmHg (2pts), multilobar chest xray involvement (1pt), respiratory rate \>= 30/min, heart rate \>= 125, new confusion, oxygen saturation \<= 90% * Absence of clear infiltrate on imaging * Cavitary lesion on imaging * O2 saturation \< 90% despite 5L O2 * For heart failure: * Has a left ventricular assist device or paced rhythm * Get with the Guidelines - Heart Failure (\>10% in-hospital mortality) or The Acute Decompensated Heart Failure National Registry score (high risk or intermediate risk 1) * Anasarca * Pulmonary hypertension * For complicated urinary tract infection: * Absence of pyuria * Most recent quick sepsis related organ failure assessment \> 1 * Home hospital census is full (maximum 4 patients at any time)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cost of hospitalization, $ | Day of admission to day of discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direct margin, modeled with backfill, $ | Day of admission to day of discharge | Backfill uses a model that estimates the cost of patients who take the place of home hospital patients |
| Length of stay, days | Day of admission to day of discharge | — |
| Imaging, # | Day of admission to day of discharge | — |
| Lab Orders, # | Day of admission to day of discharge | — |
| Discharge Disposition | Day of discharge | Routine, skilled nursing facility, home health, other |
| Readmission(s) after index hospitalization, y/n | Day of discharge to 30 days later | Dichotomous outcome |
| Time to readmission after index hospitalization, days | Day of discharge to 30 days later | Survival curve (hazard analysis) |
| Emergency Department (ED) observation stay(s) after index hospitalization, y/n | Day of discharge to 30 days later | Dichotomous outcome |
| Time to ED observation stay(s) after index hospitalization, days | Day of discharge to 30 days later | Survival curve (hazard analysis) |
| ED visit(s) after index hospitalization, y/n | Day of discharge to 30 days later | Dichotomous outcome |
| Time to ED visit(s) after index hospitalization, days | Day of discharge to 30 days later | Survival curve (hazard analysis) |
| Direct margin, $ | Day of admission to day of discharge | Direct margin from total cost of hospitalization |
| Transfer back to hospital, y/n | Day of admission to day of discharge | intervention arm only |
| Hours of sleep, # | Day of admission to day of discharge | — |
| Daily steps, # | Day of admission to day of discharge | — |
| EuroQol -5D-5L, composite score | At admission, at discharge, and at 30 days after discharge | — |
| Short Form 1 | 30 days prior to admission (asked on day of admission), at admission, at discharge, 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, 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, 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 | Day of admission to day of discharge | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Likert scale pain score, 0-10 | Day of admission to day of discharge | Exploratory |
| Pneumococcal vaccination if appropriate, y/n | Day of admission to day of discharge | Pneumonia patients only; Exploratory |
| Influenza vaccination if appropriate, y/n | Day of admission to day of discharge | Pneumonia patients only; Exploratory |
| Smoking cessation counseling if appropriate, y/n | Day of admission to day of discharge | 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 | Day of admission to day of discharge | Heart failure patients only; Exploratory; 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 | Day of admission to day of discharge | Heart failure patients only; Exploratory |
| Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n | Day of admission to day of discharge | Heart failure patients only; Exploratory |
| Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n | Day of admission to day of discharge | Heart failure patients only; Exploratory |
| Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n | Day of admission to day of discharge | Heart failure patients only; Exploratory |
| Smoking status post-discharge | 30 days after day of discharge | Heart failure and pneumonia patients only; Exploratory; current/never/quit. |
| Use of inappropriate medications in the elderly, y/n | Day of admission to day of discharge | Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria |
| Use of Foley catheter, y/n | Day of admission to day of discharge | Exploratory |
| Use of restraints, y/n | Day of admission to day of discharge | Exploratory |
| >3 medications added to medication list, y/n | Day of discharge (compared with preadmission med list) | Exploratory |
| Patient health questionnaire-2, score | 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge | Exploratory |
| Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score | 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge | Exploratory |
| Walk around ward/home, y/n | Day of discharge | Exploratory |
| Get to (non-commode) bathroom, y/n | Day of discharge | Exploratory |
| Walk 1 flight of stairs, y/n | Day of discharge | Exploratory |
| Visit with friends/family, y/n | Day of admission to day of discharge | Exploratory |
| Walk outside around my home, y/n | 30 days after discharge | Exploratory |
| Go shopping, y/n | 30 days after discharge | Exploratory |
| Time from admission decision to assessment by research assistant, minutes | Day of admission | Exploratory |
| Time from research assistant assessment to emergency department dismissal, minutes | Day of admission | Exploratory |
| Time from arrival home or to floor and medical doctor evaluation, minutes | Day of admission | Exploratory |
| Time from arrival home or to floor and registered nurse evaluation, minutes | Day of admission | Exploratory |
| Total cost of episode of care, $ | Day of admission to 30 days after discharge | Exploratory; Subset of sample for which claims data is available |
| Number of registered nurse visits, total | Day of admission to day of discharge | Exploratory |
| Number of on call medical doctor interactions (video or phone), total | Day of admission to day of discharge | Exploratory, intervention arm only |
| Number of on call medical doctor in-person visits, total | Day of admission to day of discharge | Exploratory, intervention arm only |
| Duration of 1st registered nurse visit, minutes | Day of admission | Exploratory, intervention arm only |
| Average Duration of subsequent registered nurse visit, minutes | Day of admission to day of discharge | Exploratory, intervention arm only |
| Average Registered nurse to patient ratio | Day of admission to day of discharge | Exploratory |
| Intraveneous medications, days | Day of admission to day of discharge | Exploratory |
| Intraveneous fluids, days | Day of admission to day of discharge | Exploratory |
| Intraveneous diuretics, days | Day of admission to day of discharge | Exploratory |
| Intraveneous antibiotics, days | Day of admission to day of discharge | Exploratory |
| Supplemental oxygen required, days | Day of admission to day of discharge | Exploratory |
| Nebulizer treatment, days | Day of admission to day of discharge | Exploratory |
| Medical Doctor sessions, # notes | Day of admission to day of discharge | Exploratory |
| Consultant sessions, # notes | Day of admission to day of discharge | Exploratory |
| Physical therapy/occupational therapy sessions, # notes | Day of admission to day of discharge | 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 |
| Home health utilization, days | Day of discharge to 30 days later | Exploratory |
| Fall, y/n | Day of admission to day of discharge | Exploratory |
| Diagnosis of hospital-acquired or post-discharge deep vein thrombosis or pulmonary embolism | Day of admission to 30 days after discharge | Exploratory |
| Hospital-acquired pressure ulcer, y/n | Day of admission to day of discharge | Exploratory |
| Thrombophlebitis at peripheral intravenous site, y/n | Day of admission to day of discharge | Exploratory |
| Catheter-associated urinary tract infection, y/n | Day of admission to day of discharge | Exploratory |
| Clostridium difficile infection, y/n | Day of admission to day of discharge | Exploratory |
| Methicillin resistant staph aureus infection, y/n | Day of admission to day of discharge | Exploratory |
| Mortality during admission, y/n | Day of admission to day of discharge | Exploratory |
| Post-discharge mortality, y/n | Day of discharge to 30 days later | Exploratory |
| New arrhythmia, y/n | Day of admission to day of discharge | Heart failure patients only; Exploratory |
| Hypokalemia, y/n | Day of admission to day of discharge | Heart failure patients only; Exploratory |
| Acute kidney injury, y/n | Day of admission to day of discharge | Heart failure patients only; Exploratory |
Countries
United States
Outcome results
None listed