Clinical trial NCT02864420: Hospitalization at Home: The Acute Care Home Hospital Program for Adults
Official title: Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Heart Failure
Cellulitis
Urinary Tract Infections
Keywords: home hospital
acute care home
care redesign
delivery innovation
heart failure
pneumonia
cellulitis
urinary tract infections
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Partners HealthCare
name: Smiths Medical, ASD, Inc.
name: Vital Connect, Inc.
First posted: 2016-08-12
Enrollment: 21
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;
* 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total cost of hospitalization, $
timeFrame: Day of admission to day of discharge
Secondary outcomes:
measure: Direct margin, $
timeFrame: Day of admission to day of discharge
measure: Direct margin, modeled with backfill, $
timeFrame: Day of admission to day of discharge
measure: Length of stay, days
timeFrame: Day of admission to day of discharge
measure: Imaging, #
timeFrame: Day of admission to day of discharge
measure: Lab Orders, #
timeFrame: Day of admission to day of discharge
measure: Discharge Disposition
timeFrame: Day of discharge
measure: Readmission(s) after index hospitalization, y/n
timeFrame: Day of discharge to 30 days later
measure: Time to readmission after index hospitalization, days
timeFrame: Day of discharge to 30 days later
measure: Emergency Department (ED) observation stay(s) after index hospitalization, y/n
timeFrame: Day of discharge to 30 days later
measure: Time to ED observation stay(s) after index hospitalization, days
timeFrame: Day of discharge to 30 days later
measure: ED visit(s) after index hospitalization, y/n
timeFrame: Day of discharge to 30 days later
measure: Time to ED visit(s) after index hospitalization, days
timeFrame: Day of discharge to 30 days later
measure: Delirium, y/n
timeFrame: Day of admission to day of discharge
measure: Transfer back to hospital, y/n
timeFrame: Day of admission to day of discharge
measure: Hours of sleep, #
timeFrame: Day of admission to day of discharge
measure: Daily steps, #
timeFrame: Day of admission to day of discharge
measure: EuroQol -5D-5L, composite score
timeFrame: At admission, at discharge, 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, 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, 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, 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 cost of episode of care, $
timeFrame: Day of admission to 30 days after discharge
measure: Intraveneous medications, days
timeFrame: Day of admission to day of discharge
measure: Intraveneous fluids, days
timeFrame: Day of admission to day of discharge
measure: Intraveneous diuretics, days
timeFrame: Day of admission to day of discharge
measure: Intraveneous antibiotics, days
timeFrame: Day of admission to day of discharge
measure: Supplemental oxygen required, days
timeFrame: Day of admission to day of discharge
measure: Nebulizer treatment, days
timeFrame: Day of admission to day of discharge
measure: Medical Doctor sessions, # notes
timeFrame: Day of admission to day of discharge
measure: Consultant sessions, # notes
timeFrame: Day of admission to day of discharge
measure: Physical therapy/occupational therapy sessions, # notes
timeFrame: Day of admission to day of discharge
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: Day of admission to day of discharge
measure: Diagnosis of hospital-acquired or post-discharge deep vein thrombosis or pulmonary embolism
timeFrame: Day of admission to 30 days after discharge
measure: Hospital-acquired pressure ulcer, y/n
timeFrame: Day of admission to day of discharge
measure: Thrombophlebitis at peripheral intravenous site, y/n
timeFrame: Day of admission to day of discharge
measure: Catheter-associated urinary tract infection, y/n
timeFrame: Day of admission to day of discharge
measure: Clostridium difficile infection, y/n
timeFrame: Day of admission to day of discharge
measure: Methicillin resistant staph aureus infection, y/n
timeFrame: Day of admission to day of discharge
measure: Mortality during admission, y/n
timeFrame: Day of admission to day of discharge
measure: Post-discharge mortality, y/n
timeFrame: Day of discharge to 30 days later
measure: New arrhythmia, y/n
timeFrame: Day of admission to day of discharge
measure: Hypokalemia, y/n
timeFrame: Day of admission to day of discharge
measure: Acute kidney injury, y/n
timeFrame: Day of admission to day of discharge
measure: Mean Likert scale pain score, 0-10
timeFrame: Day of admission to day of discharge
measure: Pneumococcal vaccination if appropriate, y/n
timeFrame: Day of admission to day of discharge
measure: Influenza vaccination if appropriate, y/n
timeFrame: Day of admission to day of discharge
measure: Smoking cessation counseling if appropriate, y/n
timeFrame: Day of admission to day of discharge
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: Day of admission to day of discharge
measure: Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: Day of admission to day of discharge
measure: Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: Day of admission to day of discharge
measure: Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
timeFrame: Day of admission to day of discharge
measure: Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
timeFrame: Day of admission to day of discharge
measure: Smoking status post-discharge
timeFrame: 30 days after day of discharge
measure: Use of inappropriate medications in the elderly, y/n
timeFrame: Day of admission to day of discharge
measure: Use of Foley catheter, y/n
timeFrame: Day of admission to day of discharge
measure: Use of restraints, y/n
timeFrame: Day of admission to day of discharge
measure: >3 medications added to medication list, y/n
timeFrame: Day of discharge (compared with preadmission med list)
measure: Patient health questionnaire-2, score
timeFrame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
measure: Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score
timeFrame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
measure: Walk around ward/home, y/n
timeFrame: Day of discharge
measure: Get to (non-commode) bathroom, y/n
timeFrame: Day of discharge
measure: Walk 1 flight of stairs, y/n
timeFrame: Day of discharge
measure: Visit with friends/family, y/n
timeFrame: Day of admission to day of discharge
measure: Walk outside around my home, y/n
timeFrame: 30 days after discharge
measure: Go shopping, y/n
timeFrame: 30 days after discharge
measure: Time from admission decision to assessment by research assistant, minutes
timeFrame: Day of admission
measure: Time from research assistant assessment to emergency department dismissal, minutes
timeFrame: Day of admission
measure: Time from arrival home or to floor and medical doctor evaluation, minutes
timeFrame: Day of admission
measure: Time from arrival home or to floor and registered nurse evaluation, minutes
timeFrame: Day of admission
measure: Average Registered nurse to patient ratio
timeFrame: Day of admission to day of discharge
measure: Number of registered nurse visits, total
timeFrame: Day of admission to day of discharge
measure: Number of "on call" medical doctor interactions (video or phone), total
timeFrame: Day of admission to day of discharge
measure: Number of "on call" medical doctor in-person visits, total
timeFrame: Day of admission to day of discharge
measure: Duration of 1st registered nurse visit, minutes
timeFrame: Day of admission
measure: Average Duration of subsequent registered nurse visit, minutes
timeFrame: Day of admission to day of discharge
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 L Schnipper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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, 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.