Rural Hospital-Level Care at Home for Acutely Ill Adults
NCT ID: NCT05256303
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2022-02-16
2024-01-17
Brief Summary
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Detailed Description
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To determine the effect of home hospital care in rural homes, the investigators propose to the following randomized control trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Home Hospital care
Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
Home Hospital care
Patients receive hospital-level care in their home
Traditional Hospital care
Patients receive hospital-level care in the hospital.
Traditional Hospital care
Patients receive hospital-level care in the hospital.
Interventions
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Home Hospital care
Patients receive hospital-level care in their home
Traditional Hospital care
Patients receive hospital-level care in the hospital.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Age \>= 18 years old
* Has capacity to consent to study
* Lives within 15 minutes travel time.
* The rural home hospital clinical team will be identified by the site PI at each study site prior to the start of the study. The site PI will recruit local RNs and/or EMT-Ps, and attending physicians (MD) to deploy and provide rural home hospital care.
* Any member of the rural home hospital clinical team (a clinician providing care in the home) who will be participating in research activities, including the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention.
Exclusion Criteria
* 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
* GWTG-HF17 (\>10% in-hospital mortality) or ADHERE18 (high risk or intermediate risk 1)\*
* Severe pulmonary hypertension
* For complicated urinary tract infection:
* Absence of pyuria
* Most recent qSOFA \> 1 (SBP≤100 mmHg, RR≥22, GCS\<15 \[any AMS\]) (if sepsis, \>10% mortality)19
* For other infection
* Most recent qSOFA \> 1 (SBP≤100 mmHg, RR≥22, GCS\<15 \[any AMS\]) (if sepsis, \>10% mortality)19
* For COPD
* BAP-65 score \> 3 (BUN\>25, altered mental status, HR\>109, age\>65) (\<13% chance in-hospital mortality): exercise caution
* For asthma
o Peak expiratory flow \< 50% of normal: exercise caution
* For diabetes and its complications
o Requires IV insulin
* For hypertensive urgency
* Systolic blood pressure \> 190 mmHg
* Evidence of end-organ damage; for example, acute kidney injury, focal neurologic deficits, myocardial infarction
* For atrial fibrillation with rapid ventricular response
* Likely to require cardioversion
* New atrial fibrillation with rapid ventricular response
* Unstable blood pressure, respiratory rate, or oxygenation
* Despite IV beta and/or calcium channel blockade in the emergency department, HR remains \> 125 and SBP remains different than baseline
* Less than 1 hour of time has elapsed with HR \< 125 and SBP similar or higher than baseline
* Home hospital census is full
* GWTG-HF: AHA Get with the Guidelines: SBP, BUN, Na, Age, HR, Black race, COPD ADHERE: Acute decompensated heart failure national registry: BUN, creatinine, SBP
* 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
18 Years
ALL
No
Sponsors
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The Thompson Family Foundation Inc
UNKNOWN
Brigham and Women's Hospital
OTHER
Responsible Party
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David Levine
Dr. David Levine MD, MPH, MA, Director
Locations
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Blessing Health System
Quincy, Illinois, United States
Appalachian Regional Healthcare, Inc.
Hazard, Kentucky, United States
Wetaskiwin Hospital and Care Centre
Wetaskiwin, Alberta, Canada
Countries
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References
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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.
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.
2014 National and State Healthcare-Associated Infections Progress Report.; 2016. http://www.cdc.gov/hai/surveillance/progress-report/index.html. Accessed April 19, 2016.
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.
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.
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.
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.
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.
Bureau UC. What is Rural America?https://www.census.gov/library/stories/2017/08/rural-america.html. Published 2017. Accessed May 31, 2019.
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.
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
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.
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.
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.
Other Identifiers
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2021P000334
Identifier Type: -
Identifier Source: org_study_id