Rural Hospital-Level Care at Home for Acutely Ill Adults

Completed · Not applicable

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT05256303

Run by

Brigham and Women's Hospital

People needed

160

Starts

2022-02-16

Expected to finish

2024-01-17

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Blessing Health System — Quincy, Illinois, United States
• Appalachian Regional Healthcare, Inc. — Hazard, Kentucky, United States
• Wetaskiwin Hospital and Care Centre — Wetaskiwin, Alberta, Canada

Full record on ClinicalTrials.gov

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