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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pneumonia; Cellulitis; Urinary Tract Infections
• Intervention / Treatment: Other: Inpatient Hospitalization; Other: Home hospitalization

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total cost of hospitalization, $	Day of admission to day of discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct margin, $	Direct margin from total cost of hospitalization	Day of admission to day of discharge
Direct margin, modeled with backfill, $	Backfill uses a model that estimates the cost of patients who take the place of home hospital patients	Day of admission to day of discharge
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	Routine, skilled nursing facility, home health, other	Day of discharge
Readmission(s) after index hospitalization, y/n	Dichotomous outcome	Day of discharge to 30 days later
Time to readmission after index hospitalization, days	Survival curve (hazard analysis)	Day of discharge to 30 days later
Emergency Department (ED) observation stay(s) after index hospitalization, y/n	Dichotomous outcome	Day of discharge to 30 days later
Time to ED observation stay(s) after index hospitalization, days	Survival curve (hazard analysis)	Day of discharge to 30 days later
ED visit(s) after index hospitalization, y/n	Dichotomous outcome	Day of discharge to 30 days later
Time to ED visit(s) after index hospitalization, days	Survival curve (hazard analysis)	Day of discharge to 30 days later
Delirium, y/n		Day of admission to day of discharge
Transfer back to hospital, y/n	intervention arm only	Day of admission to day of discharge
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	1-5 Likert scale	30 days prior to admission (asked on day of admission), at admission, at discharge, 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, 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

Outcome Measure	Measure Description	Time Frame
Total cost of episode of care, $	Exploratory; Subset of sample for which claims data is available	Day of admission to 30 days after discharge
Intraveneous medications, days	Exploratory	Day of admission to day of discharge
Intraveneous fluids, days	Exploratory	Day of admission to day of discharge
Intraveneous diuretics, days	Exploratory	Day of admission to day of discharge
Intraveneous antibiotics, days	Exploratory	Day of admission to day of discharge
Supplemental oxygen required, days	Exploratory	Day of admission to day of discharge
Nebulizer treatment, days	Exploratory	Day of admission to day of discharge
Medical Doctor sessions, # notes	Exploratory	Day of admission to day of discharge
Consultant sessions, # notes	Exploratory	Day of admission to day of discharge
Physical therapy/occupational therapy sessions, # notes	Exploratory	Day of admission to day of discharge
Primary care provider follow-up within 14 days, y/n	Exploratory	Day of discharge to 14 days later
Skilled nursing facility utilization, days	Exploratory	Day of discharge to 30 days later
Home health utilization, days	Exploratory	Day of discharge to 30 days later
Fall, y/n	Exploratory	Day of admission to day of discharge
Diagnosis of hospital-acquired or post-discharge deep vein thrombosis or pulmonary embolism	Exploratory	Day of admission to 30 days after discharge
Hospital-acquired pressure ulcer, y/n	Exploratory	Day of admission to day of discharge
Thrombophlebitis at peripheral intravenous site, y/n	Exploratory	Day of admission to day of discharge
Catheter-associated urinary tract infection, y/n	Exploratory	Day of admission to day of discharge
Clostridium difficile infection, y/n	Exploratory	Day of admission to day of discharge
Methicillin resistant staph aureus infection, y/n	Exploratory	Day of admission to day of discharge
Mortality during admission, y/n	Exploratory	Day of admission to day of discharge
Post-discharge mortality, y/n	Exploratory	Day of discharge to 30 days later
New arrhythmia, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Hypokalemia, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Acute kidney injury, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Mean Likert scale pain score, 0-10	Exploratory	Day of admission to day of discharge
Pneumococcal vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	Day of admission to day of discharge
Influenza vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	Day of admission to day of discharge
Smoking cessation counseling if appropriate, y/n	Pneumonia and heart failure patients only; Exploratory	Day of admission to day of discharge
Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n	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	Day of admission to day of discharge
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Smoking status post-discharge	Heart failure and pneumonia patients only; Exploratory; current/never/quit.	30 days after day of discharge
Use of inappropriate medications in the elderly, y/n	Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria	Day of admission to day of discharge
Use of Foley catheter, y/n	Exploratory	Day of admission to day of discharge
Use of restraints, y/n	Exploratory	Day of admission to day of discharge
>3 medications added to medication list, y/n	Exploratory	Day of discharge (compared with preadmission med list)
Patient health questionnaire-2, score	Exploratory	30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score	Exploratory	30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Walk around ward/home, y/n	Exploratory	Day of discharge
Get to (non-commode) bathroom, y/n	Exploratory	Day of discharge
Walk 1 flight of stairs, y/n	Exploratory	Day of discharge
Visit with friends/family, y/n	Exploratory	Day of admission to day of discharge
Walk outside around my home, y/n	Exploratory	30 days after discharge
Go shopping, y/n	Exploratory	30 days after discharge
Time from admission decision to assessment by research assistant, minutes	Exploratory	Day of admission
Time from research assistant assessment to emergency department dismissal, minutes	Exploratory	Day of admission
Time from arrival home or to floor and medical doctor evaluation, minutes	Exploratory	Day of admission
Time from arrival home or to floor and registered nurse evaluation, minutes	Exploratory	Day of admission
Average Registered nurse to patient ratio	Exploratory	Day of admission to day of discharge
Number of registered nurse visits, total	Exploratory	Day of admission to day of discharge
Number of "on call" medical doctor interactions (video or phone), total	Exploratory, intervention arm only	Day of admission to day of discharge
Number of "on call" medical doctor in-person visits, total	Exploratory, intervention arm only	Day of admission to day of discharge
Duration of 1st registered nurse visit, minutes	Exploratory, intervention arm only	Day of admission
Average Duration of subsequent registered nurse visit, minutes	Exploratory, intervention arm only	Day of admission to day of discharge

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Partners HealthCare; Smiths Medical, ASD, Inc.; Vital Connect, Inc.

Publications and helpful links

General Publications

• Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132.
• Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.
• Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478.
• Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.
• Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x.
• Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. doi: 10.5694/j.1326-5377.2010.tb04070.x.
• Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: heart failure; pneumonia; urinary tract infections; cellulitis; home hospital; acute care home; care redesign; delivery innovation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Urologic Diseases; Inflammation; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Heart Failure; Pneumonia; Cellulitis; Urinary Tract Infections
• Other Study ID Numbers: 2016P001337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No