Clinical trial NCT04531280: Rural Home Hospital: Proof of Concept
Official title: Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Heart Failure
Chronic Obstructive Pulmonary Disease
Asthma
Gout Flare
Chronic Kidney Diseases
Hypertensive Urgency
Atrial Fibrillation Rapid
Anticoagulants; Increased
Keywords: home hospital
hospital at home
hospital in the home
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Rx Foundation
First posted: 2020-08-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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: 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.

Patient social inclusion criteria:

* 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.

Patient caregiver inclusion criteria: (not required for patient participation):

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

Clinician inclusion criteria:

-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.

Patient Clinical 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

Primary outcomes:
measure: Number of Patients That Completed Their Rural Home Hospitalization
timeFrame: Day of admission to day of discharge, estimated 10 days later
Secondary outcomes:
measure: 3-item Care Transition Measure
timeFrame: Once, within Day of discharge to 7 days later
measure: Picker Experience Questionnaire
timeFrame: Once, within Day of discharge to 7 days later
measure: Global Satisfaction: Scale
timeFrame: Once, between Day of discharge to 7 days later
measure: Perceived Acceptability of RHH Care
timeFrame: Day of discharge to 30 days later
measure: Perceived Safety, Quality of Care, Caregiver Burden
timeFrame: Day of discharge to 30 days later
measure: Number of Rural Home Hospital Patients Escalated to Hospital for Care
timeFrame: Day of admission to day of discharge, estimated 10 days later
measure: Number of Patients With an Adverse Event
timeFrame: Day of admission to day of discharge, estimated 10 days later
measure: Number of Patients With Unplanned Mortality During Admission
timeFrame: Day of admission to day of discharge, estimated 10 days later
measure: Lab Orders, Number
timeFrame: Day of admission to day of discharge, estimated 10 days later
measure: Length of Stay
timeFrame: Day of admission to day of discharge, estimated 10 days later
measure: Unplanned Readmission(s), Number or Patients
timeFrame: 30-days post-discharge
measure: ED Visit(s), Number
timeFrame: 30-days post-discharge
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
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