NCT05256303Completed
Rural Hospital-Level Care at Home for Acutely Ill Adults
Hospital-Level Care at Home for Acutely Ill Adults in Rural Settings: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 Nov 2025
Brief summary (registry, in English)
This study examines the implications of providing hospital-level care in rural homes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 25 Oct 2021
- Start date
- 16 Feb 2022
- Primary completion date
- 17 Dec 2023
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Chronic kidney disease, Heart failure, Asthma, Atrial fibrillation, COPD, High blood pressure
- NCT number
- NCT05256303
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From 16 Feb 2022 to the primary completion date, 17 Dec 2023
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On methadone requiring daily pickup of medication
Lab values
- 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
- 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:
Other
- Undomiciled
- No working heat (October-April), no working air conditioning if forecast \> 80°F (June-September), or no running water
- 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
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wetaskiwin Hospital and Care Centre Coordinator of this site? Confirm its status | Wetaskiwin | Canada | Unknown status |
| Appalachian Regional Healthcare, Inc. Coordinator of this site? Confirm its status | Hazard | United States | Unknown status |
| Blessing Health System Coordinator of this site? Confirm its status | Quincy | United States | Unknown status |
Related publications
- Hospital-Level Care at Home for Adults Living in Rural Settings: A Randomized Clinical Trial.JAMA Netw Open · 2025 · PMID 41324962
This page is information, not medical advice. Discuss any trial with your doctor.