Hospital-Level Care at Home for Acutely Ill Adults

NCT03203759 | Completed

• 1 other identifier: P001337
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Infection; Heart Failure; COPD; Asthma; Gout Flare; Chronic Kidney Diseases; Hypertensive Urgency; Atrial Fibrillation Rapid; Anticoagulants; Increased

Outcome Measures

Primary Outcomes (1)

• Total direct cost of hospitalization, $

  From date of admission to date of discharge, an expected average of 4 days

Secondary Outcomes (28)

• Direct margin, $

  From date of admission to date of discharge, an expected average of 4 days

• Direct margin, modeled with backfill

  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, #

  From date of admission to date of discharge, an expected average of 4 days

Other Outcomes (63)

• Total reimbursement, 30-day post discharge

  Day of admission to 30-days post-discharge

• Intravenous medications, days

  From date of admission to date of discharge, an expected average of 4 days

• Intravenous fluids, days

  From date of admission to date of discharge, an expected average of 4 days

Study Arms (2)

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.

Other: Traditional inpatient hospitalization

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.

Other: Home hospitalization

Interventions

Home hospitalization OTHER

See above

Home hospitalization

Traditional inpatient hospitalization OTHER

See above

Inpatient hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Vital Connect: collaborator
• Smiths Medical: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (9)

• 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 BACKGROUND

• 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 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.

  PMID: 23608775 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.

  PMID: 19347026 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.

  PMID: 11129745 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.

  PMID: 21077817 BACKGROUND

• 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.

  PMID: 33954888 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.

  PMID: 33479931 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.

  PMID: 31842232 DERIVED

MeSH Terms

Conditions

Infections; Heart Failure; Pulmonary Disease, Chronic Obstructive; Asthma; Renal Insufficiency, Chronic; Hypertensive Crisis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases

Study Officials

• Jeffrey Schnipper, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 29, 2017
• Study Start: June 6, 2017
• Primary Completion: February 17, 2018
• Study Completion: May 15, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)