Rural Hospital-Level Care at Home for Acutely Ill Adults

Mass General Brigham

Status: Completed

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

Treatments: Other: Home Hospital care; Other: Traditional Hospital care

Study type: Interventional

Funder types: Other

Identifiers

NCT05256303

2021P000334

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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:

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Home Hospital care

Experimental group

Description:

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

Treatment:

Other: Home Hospital care

Traditional Hospital care

Active Comparator group

Description:

Patients receive hospital-level care in the hospital.

Treatment:

Other: Traditional Hospital care