NCT04531280CompletedNot Applicable
Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept
Brigham and Women's Hospital2 sites in 1 country7 target enrollmentStarted: February 18, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Number of Patients That Completed Their Rural Home Hospitalization
Study Overview
Brief Summary
This study examines the implications of providing hospital-level care in rural homes.
Detailed Description
Home hospital care 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 further improve the model, the investigators propose to determine the feasibility of home hospital care in a rural home setting through a proof-of-concept approach.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Acute delirium, as determined by the Confusion Assessment Method
- •Cannot establish peripheral access (or access requires ultrasound guidance, unless ultrasound guidance is available)
- •Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
- •Primary diagnosis requires controlled substances
- •Cannot independently ambulate to bedside commode
- •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
- •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); 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); 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)
- •For other infection: Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)
- •For COPD: BAP-65 score > 3 (BUN>25, altered mental status, HR>109, age>65) (<13% chance in-hospital mortality): exercise caution
- •For asthma: Peak expiratory flow < 50% of normal: exercise caution
- •For diabetes and its complications: 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
- •For patients with end-stage renal disease on peritoneal dialysis: Peritoneal catheter malfunction; Requires temporary hemodialysis
- •Home hospital census is full (maximum 3 patients at any time)
- •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 social exclusion criteria:
- •Non-english speaking
- •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
Outcomes
Primary Outcomes
Number of Patients That Completed Their Rural Home Hospitalization
Time Frame: Day of admission to day of discharge, estimated 10 days later
Rural home hospital is when eligible rural patients receive hospital level care at home. This measure includes patients that were hospitalized in rural home hospital for treatment for their acute condition and were discharged from rural home hospital after their treatment was complete. The number in the data table reflects the number of patients that completed their home hospitalization.
Secondary Outcomes
- 3-item Care Transition Measure(Once, within Day of discharge to 7 days later)
- Picker Experience Questionnaire(Once, within Day of discharge to 7 days later)
- Length of Stay(Day of admission to day of discharge, estimated 10 days later)
- Global Satisfaction: Scale(Once, between Day of discharge to 7 days later)
- Perceived Acceptability of RHH Care(Day of discharge to 30 days later)
- Perceived Safety, Quality of Care, Caregiver Burden(Day of discharge to 30 days later)
- Number of Rural Home Hospital Patients Escalated to Hospital for Care(Day of admission to day of discharge, estimated 10 days later)
- Number of Patients With an Adverse Event(Day of admission to day of discharge, estimated 10 days later)
- Number of Patients With Unplanned Mortality During Admission(Day of admission to day of discharge, estimated 10 days later)
- Unplanned Readmission(s), Number or Patients(30-days post-discharge)
- Lab Orders, Number(Day of admission to day of discharge, estimated 10 days later)
- ED Visit(s), Number(30-days post-discharge)
Investigators
David Levine
Dr. David Levine MD, MPH, MA
Brigham and Women's Hospital
Study Sites (2)
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