Home Hospital for Suddenly Ill Adults

Официальное название

Home Hospital for Suddenly Ill Adults: A Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Home Hospitalization
  See above

Первичные конечные точки

• Total direct cost of hospitalization, $ [Срок оценки: From date of admission to date of discharge, an expected average of 4 days]

Вторичные конечные точки (12)

• Direct margin, $ [Срок оценки: From date of admission to date of discharge, an expected average of 4 days]
• Direct margin, modeled with backfill [Срок оценки: From date of admission to date of discharge, an expected average of 4 days]
• Total cost, 30-day post discharge [Срок оценки: Day of admission to 30-days post-discharge]
• Length of stay, days [Срок оценки: From date of admission to date of discharge, an expected average of 4 days]
• Imaging, # [Срок оценки: From date of admission to date of discharge, an expected average of 4 days]
• Lab orders, # [Срок оценки: From date of admission to date of discharge, an expected average of 4 days]
• All-cause readmission(s) after index, # [Срок оценки: Day of discharge to 30 days later]
• All-cause readmission(s) after index, y/n [Срок оценки: Day of discharge to 30 days later]
• Unplanned readmission(s) after index, # [Срок оценки: Day of discharge to 30 days later]
• Unplanned readmission(s) after index, y/n [Срок оценки: Day of discharge to 30 days later]
• Emergency Department observation stay(s) after index hospitalization, # [Срок оценки: Day of discharge to 30 days later]
• Emergency Department observation stay(s) after index hospitalization, y/n [Срок оценки: Day of discharge to 30 days later]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Brigham and Women's Hospital — Boston
• Brigham and Women's Faulkner Hospital — Boston

Публикации

• 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. PMID 16330791
• 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. PMID 22665835
• 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. PMID 23608775
• 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. PMID 19347026
• 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.t PMID 11129745
• 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. PMID 21077817
• 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. PMID 29411238

Идентификаторы

NCT: NCT03524222 · 2017P002583

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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