Rural Hospital-Level Care at Home for Acutely Ill Adults

NCT05256303 | Completed DMC

• 1 other identifier: 2021P000334
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 3

Brief Summary

This study examines the implications of providing hospital-level care in rural homes.

Conditions

Infections; Heart Failure; Chronic Obstructive Pulmonary Disease; Asthma; Gout Flare; Chronic Kidney Diseases; Hypertensive Urgency; Atrial Fibrillation Rapid; Anticoagulation; Diabetes and Its Complications; End of Life/Desires Only Medical Management

Keywords

home hospital; hospital at home; hospital in the home

Outcome Measures

Primary Outcomes (1)

• Total cost, hospitalization

  Published as percent change given sensitivity of these data

  Date of admission to date of discharge, estimated 10 days later

Secondary Outcomes (4)

• Total cost, discharge to 30-days post discharge

  Day of discharge to 30 days later

• Unplanned readmission within 30-days of discharge

  Day of discharge to 30 days later

• Days at home

  Day of discharge to 30 days later

• Percent of day lying down

  Day of admission to day of discharge, assessed up to 2 months

Other Outcomes (103)

• Length of stay, days

  Day of admission to day of discharge, assessed up to 2 months

• IV medication, days

  Day of admission to day of discharge, assessed up to 2 months

• Intravenous fluids, days

  Day of admission to day of discharge, assessed up to 2 months

Study Arms (2)

Home Hospital care

EXPERIMENTAL

Patients receive hospital-level care in their home, as a substitute to traditional hospital care.

Other: Home Hospital care

Traditional Hospital care

ACTIVE COMPARATOR

Patients receive hospital-level care in the hospital.

Other: Traditional Hospital care

Interventions

Home Hospital care OTHER

Patients receive hospital-level care in their home

Home Hospital care

Traditional Hospital care OTHER

Patients receive hospital-level care in the hospital.

Traditional Hospital care

Eligibility Criteria

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

You may qualify if:

• \>=18 years old
• Any infectious process (e.g., pneumonia, diverticulitis, cellulitis, complicated urinary tract infection)
• Heart failure exacerbation
• Asthma and chronic obstructive pulmonary disease exacerbation
• Atrial fibrillation with rapid ventricular response
• Diabetes and its complications
• Venous thromboembolism
• Gout exacerbation
• Chronic kidney disease with volume overload
• Hypertensive urgency
• End of life / desires only medical management
• Lives in a rural area that can be served by the RHH team.
• Has capacity to consent to study OR can assent to study and has proxy who can consent (see subject enrollment, below)
• 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.

You may not qualify if:

• Acute delirium, as determined by the Confusion Assessment Method
• Cannot establish peripheral access by any means
• Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage (unless part of end of life pathway)
• Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control
• Cannot independently ambulate to bedside commode, unless home-based aides are available
• As deemed by on-call MD, patient likely to require any of the following procedures that have not already occurred: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery (unless these can be coordinated with appropriate facilities during the home hospitalization)
• For pneumonia:
• Most recent CURB65 \> 3: new confusion, BUN \> 19mg/dL, respiratory rate\>=30/min, systolic blood pressure\<90mmHg, Age\>=65 (\<14% 30-day mortality)15
• Most recent SMRTCO \> 2: systolic blood pressure \< 90mmHg (2pts), multilobar CXR involvement (1pt), respiratory rate \>= 30/min, heart rate \>= 125, new confusion, oxygen saturation \<= 90% (\<10% chance of intensive respiratory or vasopressor support)16
• Absence of clear infiltrate on imaging
• Cavitary lesion on imaging
• Pulmonary effusion of unknown etiology
• O2 saturation \< 90% despite 5L O2
• For heart failure:
• Has a left ventricular assist device

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Thompson Family Foundation Inc: collaborator

Study Sites (3)

Blessing Health System

Quincy, Illinois, 62301, United States

Location

Appalachian Regional Healthcare, Inc.

Hazard, Kentucky, 41701, United States

Location

Wetaskiwin Hospital and Care Centre

Wetaskiwin, Alberta, T9A 3N3, Canada

Location

Related Publications (15)

• 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

• 2014 National and State Healthcare-Associated Infections Progress Report.; 2016. http://www.cdc.gov/hai/surveillance/progress-report/index.html. Accessed April 19, 2016.

  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

• 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

• 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 BACKGROUND

• 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 BACKGROUND

• Bureau UC. What is Rural America?https://www.census.gov/library/stories/2017/08/rural-america.html. Published 2017. Accessed May 31, 2019.

  BACKGROUND

• Garcia MC, Rossen LM, Bastian B, Faul M, Dowling NF, Thomas CC, Schieb L, Hong Y, Yoon PW, Iademarco MF. Potentially Excess Deaths from the Five Leading Causes of Death in Metropolitan and Nonmetropolitan Counties - United States, 2010-2017. MMWR Surveill Summ. 2019 Nov 8;68(10):1-11. doi: 10.15585/mmwr.ss6810a1.

  PMID: 31697657 BACKGROUND

• Parker K, Horowitz J, Brown A, Fry R, Cohn D, Igielnik R. What Unites and Divides Urban, Suburban and Rural Communities.; 2018. https://www.pewsocialtrends.org/wpcontent/uploads/sites/3/2018/05/Pew-Research-Center-Community-Type-Full-Report-FINAL.pdf. Accessed May 31, 2019

  BACKGROUND

• Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011.

  PMID: 8417639 BACKGROUND

• Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical access and non-critical access hospitals, 2002-2010. JAMA. 2013 Apr 3;309(13):1379-87. doi: 10.1001/jama.2013.2366.

  PMID: 23549583 BACKGROUND

• Joynt KE, Harris Y, Orav EJ, Jha AK. Quality of care and patient outcomes in critical access rural hospitals. JAMA. 2011 Jul 6;306(1):45-52. doi: 10.1001/jama.2011.902.

  PMID: 21730240 BACKGROUND

• Levine DM, Desai MP, Findeisen SM, Blitzer SC, Brewster RCL, Grinman MN, Amrhein SC, Wicker M, Harrison SM, Dykes PC, Barthel MF, Lipsitz SR. Hospital-Level Care at Home for Adults Living in Rural Settings: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2545712. doi: 10.1001/jamanetworkopen.2025.45712.

  PMID: 41324962 DERIVED

MeSH Terms

Conditions

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

Interventions

Home Care Services, Hospital-Based

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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

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: Dr. David Levine MD, MPH, MA, Director

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: February 25, 2022
• Study Start: February 16, 2022
• Primary Completion: December 17, 2023
• Study Completion: January 17, 2024
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)