InfectionsNCT05256303
Rural Hospital-Level Care at Home for Acutely Ill Adults
A study testing Home Hospital care and Traditional Hospital care in people with Infections and Heart Failure, run by Brigham and Women's Hospital at 3 sites in 2 countries.
Trial summary
This study examines the implications of providing hospital-level care in rural homes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Home Hospital care and Traditional Hospital care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Feb 2022to 17 Jan 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient clinical inclusion criteria:
- >=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
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- Diabetes and its complications
- Venous thromboembolism
- Gout exacerbation
- Chronic kidney disease with volume overload
- Hypertensive urgency
- End of life / desires only medical management
- Patient environmental inclusion criteria:
- 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.
- Patient caregiver inclusion criteria: (not required for patient participation):
- Age >= 18 years old
- Has capacity to consent to study
- Lives within 15 minutes travel time.
- Clinician inclusion criteria:
- 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.
- Sites without continuous monitoring will make amendments to the above inclusion criteria
Who cannot join
- Patient exclusion clinical 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
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- 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
- Patient environmental exclusion criteria:
- 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
- Sites without continuous monitoring will make amendments to the above exclusion criteria
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Appalachian Regional Healthcare, Inc.
Hazard, Kentucky, 41701
Blessing Health System
Quincy, Illinois, 62301
About this study
Official title: Hospital-Level Care at Home for Acutely Ill Adults in Rural Settings: A Randomized Controlled Trial
This study examines the implications of providing hospital-level care in rural homes.
Read the detailed description
Home hospital is hospital-level care at home for acutely ill patients. In multiple publications mostly in urban environments, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models deliver care in urban environments, not in rural environments.
To determine the effect of home hospital care in rural homes, the investigators propose to the following randomized control trial.
- Conditions
- Infections, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Gout Flare, Chronic Kidney Diseases
- Being tested
- Home Hospital care, Traditional Hospital care
- Keywords
- home hospital, hospital at home, hospital in the home
- Medical subject headings
- Infections, Heart Failure, Pulmonary Disease, Chronic Obstructive, Asthma, Renal Insufficiency, Chronic, Hypertensive Crisis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Hospital careOther
Patients receive hospital-level care in their home
Traditional Hospital careOther
Patients receive hospital-level care in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Home Hospital care | Experimental | Patients receive hospital-level care in their home, as a substitute to traditional hospital care. Receives: Other: Home Hospital care |
| Traditional Hospital care | Active comparator | Patients receive hospital-level care in the hospital. Receives: Other: Traditional Hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cost, hospitalization
Published as percent change given sensitivity of these data
Measured: Date of admission to date of discharge, estimated 10 days later
Secondary outcomes (4)
Total cost, discharge to 30-days post discharge
Published as percent change given sensitivity of these data
Measured: Day of discharge to 30 days later
Unplanned readmission within 30-days of discharge
Percentage
Measured: Day of discharge to 30 days later
Days at home
The number of days spent at home from the day of discharge to 30-days later
Measured: Day of discharge to 30 days later
Percent of day lying down
Measured: Day of admission to day of discharge, assessed up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start16 Feb 2022
- Primary completion17 Dec 2023
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Thompson Family Foundation Inc
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256303
- Sponsor's protocol ID
- 2021P000334
- Status last verified
- Nov 2025
- First submitted
- 25 Oct 2021
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23608775Fong 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.
PubMed 193470262014 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.
PubMed 11129745Leff 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.
PubMed 16330791Cryer 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.
PubMed 22665835Levine 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.
PubMed 29411238Levine 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.
PubMed 31842232Bureau 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.
PubMed 31697657Parker 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.
PubMed 8417639Joynt 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.
PubMed 23549583Joynt 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.
PubMed 21730240Desai MP, Findeisen SM, Blitzer SC, Barthel MF, Grinman MN, Wicker M, Dykes P, Harrison SM, Amrhein SC, Levine DM. Hospital Care at Home for Adults Living in Rural Settings: A Qualitative Evaluation. J Rural Health. 2026 Jun;42(3):e70199. doi: 10.1111/jrh.70199.
PubMed 42555132