Home Hospital for Suddenly Ill Adults

Home Hospital for Suddenly Ill Adults: A Clinical Trial

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: Recruiting
• Conditions: Heart Failure; Chronic Kidney Diseases; Asthma; Infection; COPD; Gout Flare; Hypertensive Urgency; Anticoagulants; Increased; Atrial Fibrillation Rapid
• Intervention / Treatment: 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 (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David M Levine, MD MPH MA; Phone Number: 617-732-7063; Email: dmlevine@partners.org
• Study Contact Backup: Name: Jeffrey L Schnipper, MD MPH; Phone Number: 617-732-7063; Email: jschnipper@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: David M Levine, MD MPH MA; Phone Number: 617-732-7063; Email: dmlevine@partners.org
      • Principal Investigator: David M Levine, MD MPH MA
    • Boston, Massachusetts, United States, 02130
      • Recruiting
      • Brigham and Women's Faulkner Hospital
      • Principal Investigator: David M Levine, MD MPH MA
      • Contact: David M Levine, MD MPH MA; Phone Number: 617-732-5500; Email: dmlevine@partners.org

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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Hospitalization; 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; See above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
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		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: Excellent, very good, good, fair poor	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total reimbursement, 30-days post discharge	Exploratory	Day of admission to 30-days post-discharge
Intravenous medications, days	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Intravenous fluids, days	Exploratory; the number of days intravenous fluids (for example, normal saline) were received by the patient.	From date of admission to date of discharge, an expected average of 4 days
Intravenous diuretics, days	Exploratory; the number of days intravenous diuretics (for example, furosemide) were received by the patient.	From date of admission to date of discharge, an expected average of 4 days
Intravenous antibiotics, days	Exploratory; the number of days intravenous antibiotics (for example, ceftriaxone) were received by the patient.	From date of admission to date of discharge, an expected average of 4 days
Supplemental oxygen required, days	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Nebulizer treatment, days	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Medical Doctor sessions, # notes	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Consultant Sessions, # notes	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Physical therapy/occupational therapy sessions, # notes	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Primary care provider follow-up within 14 days, y/n	Exploratory	up to 14 days from day of discharge
Skilled nursing facility usage, days	Exploratory; the number of days a patient spent in a skilled nursing facility.	up to 30 days from day of discharge
Home health utilization, days	Exploratory	up to 30 days from day of discharge
Fall, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired deep vein thrombosis or pulmonary embolism, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired pressure ulcer, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired thrombophlebitis at peripheral IV site, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired catheter-associated urinary tract infection, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired Clostridium difficile infection, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
All-cause mortality, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Unplanned mortality, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Post-discharge all-cause mortality, y/n	Exploratory	Day of discharge to 30 days later
Post-discharge unplanned mortality, y/n	Exploratory	Day of discharge to 30 days later
New arrhythmia, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hypokalemia, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Acute Kidney Injury, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Mean Likert scale pain score, 0-10	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hours of sleep per night, #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hours of activity per night, #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Hours of sitting upright per night, #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Pneumococcal vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Influenza vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Smoking cessation counseling if appropriate, y/n	Pneumonia and heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
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; 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	From date of admission to date of discharge, an expected average of 4 days
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	From date of admission to date of discharge, an expected average of 4 days
Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Smoking status post-discharge, current/never/quit	Heart failure and pneumonia patients only; Exploratory; Self-report of smoking status: current/never/quit.	From date of admission to date of discharge, an expected average of 4 days
Use of inappropriate medications in the elderly, y/n	Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria	From date of admission to date of discharge, an expected average of 4 days
Use of Foley catheter, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Use of restraints, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
>3 medications added to medication list, y/n	Exploratory; comparison made between preadmission and discharge medication list	Date of discharge, an expected average of 4 days after the date of admission
Patient health questionnaire-2, score	Exploratory	At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score	Exploratory: I have someone who will listen to me when I need to talk I have someone to confide in or talk to about myself or my problems I have someone who makes me feel appreciated I have someone to talk with when I have a bad day Scale for each: never, rarely, sometimes, usually, always	At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Days at home since discharge	Exploratory	30 days after discharge
Walk around ward/home, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Get to (non-commode) bathroom, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Walk 1 flight of stairs, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Visit with friends/family, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Walk outside around my home, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Go shopping, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Time from admission decision to assessment by research assistant, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Time from research assistant assessment to emergency department dismissal, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Time from arrival home to medical doctor evaluation, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Time from arrival home to registered nurse evaluation, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Mean registered nurse to patient ratio	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Total registered nurse visits, #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Total "on call" medical doctor interactions (video or phone), #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Total "on call" medical doctor in-person visits	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Duration of 1st registered nurse visit, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Mean duration of subsequent registered nurse visit, minutes	Exploratory	From date of admission to date of discharge, an expected average of 4 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

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): January 18, 2018
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency; Arrhythmias, Cardiac; Kidney Diseases; Renal Insufficiency, Chronic; Atrial Fibrillation
• Other Study ID Numbers: 2017P002583

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No