Clinical trial NCT03203759: Hospital-Level Care at Home for Acutely Ill Adults
Official title: Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Heart Failure
COPD
Asthma
Gout Flare
Chronic Kidney Diseases
Hypertensive Urgency
Atrial Fibrillation Rapid
Anticoagulants; Increased
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Vital Connect
name: Smiths Medical
First posted: 2017-06-29
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total direct cost of hospitalization, $
timeFrame: From date of admission to date of discharge, an expected average of 4 days
Secondary outcomes:
measure: Direct margin, $
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Direct margin, modeled with backfill
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Total cost, 30-day post discharge
timeFrame: Day of admission to 30-days post-discharge
measure: Length of stay, days
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Imaging, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Lab orders, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: All-cause readmission(s) after index, #
timeFrame: Day of discharge to 30 days later
measure: All-cause readmission(s) after index, y/n
timeFrame: Day of discharge to 30 days later
measure: Unplanned readmission(s) after index, #
timeFrame: Day of discharge to 30 days later
measure: Unplanned readmission(s) after index, y/n
timeFrame: Day of discharge to 30 days later
measure: Emergency Department observation stay(s) after index hospitalization, #
timeFrame: Day of discharge to 30 days later
measure: Emergency Department observation stay(s) after index hospitalization, y/n
timeFrame: Day of discharge to 30 days later
measure: Emergency Department visit(s) after index hospitalization, #
timeFrame: Day of discharge to 30 days later
measure: Emergency Department visit(s) after index hospitalization, y/n
timeFrame: Day of discharge to 30 days later
measure: Delirium, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Transfer back to hospital, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hours of sleep per day, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hours of activity per day, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hours of sitting upright per day, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Steps per day, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: EuroQol -5D-5L, composite score
timeFrame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
measure: Short Form 1
timeFrame: 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
measure: Activities of daily living, score
timeFrame: 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
measure: Instrumental activities of daily living, score
timeFrame: 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
measure: 3-item Care Transition Measure, score
timeFrame: 30 days after discharge
measure: Picker Experience Questionnaire, score
timeFrame: 30 days after discharge
measure: Global satisfaction with care, score
timeFrame: 30 days after discharge
measure: Qualitative interview
timeFrame: 30 days after discharge
Other outcomes:
measure: Total reimbursement, 30-day post discharge
timeFrame: Day of admission to 30-days post-discharge
measure: Intravenous medications, days
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Intravenous fluids, days
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Intravenous diuretics, days
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Intravenous antibiotics, days
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Supplemental oxygen required, days
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Nebulizer treatment, days
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Medical Doctor sessions, # notes
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Consultant sessions, # notes
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Physical therapy/occupational therapy sessions, # notes
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Primary care provider follow-up within 14 days, y/n
timeFrame: Day of discharge to 14 days later
measure: Skilled nursing facility utilization, days
timeFrame: Day of discharge to 30 days later
measure: Home health utilization, days
timeFrame: Day of discharge to 30 days later
measure: Fall, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hospital-acquired deep vein thrombosis or pulmonary embolism, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hospital-acquired pressure ulcer, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hospital-acquired thrombophlebitis at peripheral IV site, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hospital-acquired catheter-associated urinary tract infection, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hospital-acquired Clostridium difficile infection, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: All-cause mortality, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Unplanned mortality, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Post-discharge all-cause mortality, y/n
timeFrame: Day of discharge to 30 days later
measure: Post-discharge unplanned mortality, y/n
timeFrame: Day of discharge to 30 days later
measure: New arrhythmia, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hypokalemia, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Acute Kidney Injury, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Mean Likert scale pain score, 0-10
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hours of sleep per night, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hours of activity per night, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Hours of sitting upright per night, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Pneumococcal vaccination if appropriate, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Influenza vaccination if appropriate, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Smoking cessation counseling if appropriate, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Smoking status post-discharge; current/never/quit
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Use of inappropriate medications in the elderly, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Use of Foley catheter, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Use of restraints, y/n
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: >3 medications added to medication list, y/n
timeFrame: Date of discharge, an expected average of 4 days after the date of admission
measure: Patient health questionnaire-2, score
timeFrame: At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
measure: Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score
timeFrame: At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
measure: Days at home since discharge
timeFrame: 30 days after discharge
measure: Walk around ward/home, y/n
timeFrame: Date of discharge, an expected average of 4 days after the date of admission
measure: Get to (non-commode) bathroom, y/n
timeFrame: Date of discharge, an expected average of 4 days after the date of admission
measure: Walk 1 flight of stairs, y/n
timeFrame: Date of discharge, an expected average of 4 days after the date of admission
measure: Visit with friends/family, y/n
timeFrame: Date of discharge, an expected average of 4 days after the date of admission
measure: Walk outside around my home, y/n
timeFrame: Date of discharge, an expected average of 4 days after the date of admission
measure: Go shopping, y/n
timeFrame: Date of discharge, an expected average of 4 days after the date of admission
measure: Time from admission decision to assessment by research assistant, minutes
timeFrame: On the first day of admission, a maximum 24 hour period
measure: Time from research assistant assessment to emergency department dismissal, minutes
timeFrame: On the first day of admission, a maximum 24 hour period
measure: Time from arrival home or to floor and medical doctor evaluation, minutes
timeFrame: On the first day of admission, a maximum 24 hour period
measure: Time from arrival home or to floor and registered nurse evaluation, minutes
timeFrame: On the first day of admission, a maximum 24 hour period
measure: Mean registered nurse to patient ratio
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Total registered nurse visits, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Total "on call" medical doctor interactions (video or phone), #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Total "on call" medical doctor in-person visits, #
timeFrame: From date of admission to date of discharge, an expected average of 4 days
measure: Duration of 1st registered nurse visit, minutes
timeFrame: On the first day of admission, a maximum 24 hour period
measure: Mean duration of subsequent registered nurse visit, minutes
timeFrame: From date of admission to date of discharge, an expected average of 4 days
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeffrey Schnipper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Levine DM, Paz M, Burke K, Schnipper JL. Predictors and Reasons Why Patients Decline to Participate in Home Hospital: a Mixed Methods Analysis of a Randomized Controlled Trial. J Gen Intern Med. 2022 Feb;37(2):327-331. doi: 10.1007/s11606-021-06833-2. Epub 2021 May 5.
citation: Levine DM, Pian J, Mahendrakumar K, Patel A, Saenz A, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Qualitative Evaluation of a Randomized Controlled Trial. J Gen Intern Med. 2021 Jul;36(7):1965-1973. doi: 10.1007/s11606-020-06416-7. Epub 2021 Jan 21.
citation: Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17.