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| Name | Class |
|---|---|
| Vital Connect | UNKNOWN |
| Smiths Medical | 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:
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.
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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 vital sign 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 | See above |
| |
| Traditional inpatient hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Total direct cost of hospitalization, $ | From date of admission to date of discharge, an expected average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total reimbursement, 30-day post discharge | Exploratory | Day of admission to 30-days post-discharge |
| Intravenous medications, days | Exploratory |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Schnipper, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | 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 |
|---|---|
| D007239 | Infections |
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D051436 | Renal Insufficiency, Chronic |
| D000096003 | Hypertensive Crisis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Other |
See above |
|
| 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 | Intervention arm only | 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 | 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 |
| 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 |
| 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 | Day of discharge to 14 days later |
| Skilled nursing facility utilization, days | Exploratory; the number of days a patient spent in a skilled nursing facility. | Day of discharge to 30 days later |
| Home health utilization, days | Exploratory | Day of discharge to 30 days later |
| 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 | 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 or to floor and medical doctor evaluation, minutes | Exploratory | On the first day of admission, a maximum 24 hour period |
| Time from arrival home or to floor and registered nurse evaluation, minutes | Exploratory | On the first day of admission, a maximum 24 hour period |
| Mean registered nurse to patient ratio | Exploratory, intervention arm only | From date of admission to date of discharge, an expected average of 4 days |
| Total registered nurse visits, # | Exploratory, intervention arm only | From date of admission to date of discharge, an expected average of 4 days |
| Total "on call" medical doctor interactions (video or phone), # | Exploratory, intervention arm only | From date of admission to date of discharge, an expected average of 4 days |
| Total "on call" medical doctor in-person visits, # | Exploratory, intervention arm only | From date of admission to date of discharge, an expected average of 4 days |
| Duration of 1st registered nurse visit, minutes | Exploratory, intervention arm only | On the first day of admission, a maximum 24 hour period |
| Mean duration of subsequent registered nurse visit, minutes | Exploratory, intervention arm only | From date of admission to date of discharge, an expected average of 4 days |
| 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. |
| 33954888 | Derived | 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. |
| 33479931 | Derived | 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. |
| 31842232 | Derived | 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. |
| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |