Hospitalization at Home: The Acute Care Home Hospital Program for Adults

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02864420

Collaborator

Partners HealthCare (Other), Smiths Medical, ASD, Inc. (Industry), Vital Connect, Inc. (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

10.5

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Heart Failure Cellulitis Urinary Tract Infections	Other: Home hospitalization Other: Inpatient Hospitalization	N/A

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

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inpatient hospitalization Control / usual care arm. Patients are admitted per usual to an inpatient service. Patients' medical records will be closely monitored. Patients will wear a vitals 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: Inpatient Hospitalization
Experimental: Home hospitalization 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

Arm

Intervention/Treatment

Active Comparator: Inpatient hospitalization

Control / usual care arm. Patients are admitted per usual to an inpatient service. Patients' medical records will be closely monitored. Patients will wear a vitals 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: Inpatient Hospitalization

Experimental: Home hospitalization

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

Outcome Measures

Primary Outcome Measures

Total cost of hospitalization, $ [Day of admission to day of discharge]

Secondary Outcome Measures

Direct margin, $ [Day of admission to day of discharge]
Direct margin from total cost of hospitalization
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)
Delirium, y/n [Day of admission to day of discharge]
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]

Other Outcome Measures

Total cost of episode of care, $ [Day of admission to 30 days after discharge]
Exploratory; Subset of sample for which claims data is available
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
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
Average Registered nurse to patient ratio [Day of admission to day of discharge]
Exploratory
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)