Rural Home Hospital: Proof of Concept

NCT ID: NCT04531280

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2021-05-07

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.

Conditions

Infection; Heart Failure; Chronic Obstructive Pulmonary Disease; Asthma; Gout Flare; Chronic Kidney Diseases; Hypertensive Urgency; Atrial Fibrillation Rapid; Anticoagulants; Increased

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home hospital care

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

Group Type: EXPERIMENTAL

Home hospital care

Intervention Type: OTHER

Patients receive hospital-level care in their home.

Interventions

Home hospital care

Patients receive hospital-level care in their home.

Intervention Type: OTHER

Eligibility Criteria

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: This includes a patient who requires therapeutic anticoagulation and concomitant monitoring (thus requiring inpatient status)
• Gout exacerbation
• Chronic kidney disease with volume overload
• Hypertensive urgency
• End of life / desires only medical management: Regarding a patient who desires only medical management, this includes a patient who requires acute care for symptom management but declines any surgical intervention. This may include a patient who is about to transition to hospice care, for example, but still has the functional capacity to meet our criteria below. Under these circumstances, we would make sure that various contingencies, including possible transition to hospice care or hospital readmission, are completely understood by patients and caregivers as applicable.

• Lives in rural or ultra-rural area (see definitions in Appendix) that can be served by one of our RHH clinicians.
• Has capacity to consent to study
• 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 maybe waived for highly competent patients at the patient and clinician's discretion.

• Age >= 18 years old
• Has capacity to consent to study
• Lives with or nearby to patient

-Any member of the rural home hospital (RHH) clinical team (MD, RN, paramedic, NP) who will be participating in the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention.

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rx Foundation

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Levine

Dr. David Levine MD, MPH, MA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Utah Health

Salt Lake City, Utah, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020P000708

Identifier Type: -

Identifier Source: org_study_id