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| Name | Class |
|---|---|
| Partners HealthCare | OTHER |
| Smiths Medical, ASD, Inc. | INDUSTRY |
| Vital Connect, Inc. | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient hospitalization | Active Comparator | 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. |
|
| Home hospitalization | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home hospitalization | Other |
| ||
| Inpatient Hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Total cost of hospitalization, $ | Day of admission to day of discharge |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Schnipper, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States | ||
| Brigham and Women's Faulkner Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16330791 | Background | 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. | |
| 22665835 |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D006333 | Heart Failure |
| D002481 | Cellulitis |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007902 | Length of Stay |
| ID | Term |
|---|---|
| D006760 | Hospitalization |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
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| Other |
|
| 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 |
| 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 |
| Boston |
| Massachusetts |
| 02130 |
| United States |
| 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. |
| 23608775 | Background | 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. |
| 19347026 | Background | 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. |
| 11129745 | Background | 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. |
| 21077817 | Background | 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. |
| 29411238 | Derived | 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. |
| D006331 |
| Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |