Clinical trial NCT05256303: Rural Hospital-Level Care at Home for Acutely Ill Adults
Official title: Hospital-Level Care at Home for Acutely Ill Adults in Rural Settings: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: home hospital
hospital at home
hospital in the home
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: The Thompson Family Foundation Inc
First posted: 2022-02-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total cost, hospitalization
timeFrame: Date of admission to date of discharge, estimated 10 days later
Secondary outcomes:
measure: Total cost, discharge to 30-days post discharge
timeFrame: Day of discharge to 30 days later
measure: Unplanned readmission within 30-days of discharge
timeFrame: Day of discharge to 30 days later
measure: Days at home
timeFrame: Day of discharge to 30 days later
measure: Percent of day lying down
timeFrame: Day of admission to day of discharge, assessed up to 2 months
Other outcomes:
measure: Length of stay, days
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: IV medication, days
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Intravenous fluids, days
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Intravenous diuretics, days
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Intravenous antibiotics, days
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Oxygen requirement, days
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Nebulizer treatment, days
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Imaging, %
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Lab orders, #
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: MD sessions, # of notes
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Consultant sessions, # of notes
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: PT/OT sessions, # of notes
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Frequency of disposition, routine, SNF, home health, other
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Follow up with patient's PCP within 14 days, y/n
timeFrame: Up to 30 days from day of discharge, assessed up to 2 months
measure: SNF utilization, days
timeFrame: Up to 30 days from day of discharge, assessed up to 2 months
measure: Home health utilization, days
timeFrame: Up to 30 days from day of discharge, assessed up to 2 months
measure: Unplanned readmission(s) after index, # and y/n + date
timeFrame: Up to 30 days from day of discharge, assessed up to 2 months
measure: ED observation stay(s), # and y/n + date
timeFrame: Up to 30 days from day of discharge, assessed up to 2 months
measure: ED visit(s), # and y/n + date
timeFrame: Up to 30 days from day of discharge, assessed up to 2 months
measure: Fall, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Delirium, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: DVT/PE, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: New pressure ulcer, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Thrombophlebitis at peripheral IV site, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hospital-acquired catheter-associated urinary tract infection, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hospital-acquired Clostridium difficile infection, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: New arrhythmia, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hypokalemia, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Acute kidney injury, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Medication error, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Unanticipated mortality, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Loss of consciousness, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Transfer back to hospital, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Unplanned mortality during admission
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Unplanned 30-day mortality
timeFrame: Day of discharge to 30-days post discharge, assessed up to 2 months
measure: Pain management, mean pain score on a scale from 0-10 where 10 is the worst pain imaginable
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hours of sleep per day
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hours of sleep per night
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hours of activity per day
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hours of activity per night
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hours of sitting upright per day
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Hours of sitting upright per night
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Daily steps
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Use of inappropriate medications in the elderly, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Use of Foley catheter, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Use of restraints, y/n
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: EuroQol-5D-5L, visual analogue scale, 0-100, where 100 is the best imaginable health today
timeFrame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
measure: SF-1
timeFrame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
measure: Activities of daily living, score
timeFrame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
measure: Instrumental activities of daily living, score
timeFrame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
measure: Patient health questionnaire-2, score
timeFrame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
measure: PROMIS Emotional Support Short Form 4a, score
timeFrame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
measure: Picker Experience Questionnaire -15, score, measured 0-15, where 15 is the best patient experience
timeFrame: Within 30 days after discharge, assessed up to 2 months
measure: Global satisfaction with care, score, 0-10, where 10 is the best global satisfaction
timeFrame: Within 30 days after discharge, assessed up to 2 months
measure: Recommend care, score, 0-10, where 10 is the best recommendation possible
timeFrame: Within 30 days after discharge, assessed up to 2 months
measure: Qualitative interview
timeFrame: Day of discharge to 30 days after discharge, assessed up to 2 months
measure: Caregiver burden (Zarit), 0-48, where 48 indicates the worst possible caregiver burden
timeFrame: Day of admission and within 30 days after discharge, assessed up to 2 months
measure: Number of RN visits, in-person
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Number of RN visits, virtual
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Number of RN visits, total
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: RN travel time
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Failed connectivity, %
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Number of "on call" MD interactions (video or phone)
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Duration of 1st RN visit
timeFrame: Day of admission, assessed up to 2 months
measure: Duration of subsequent RN visit, in-person
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Duration of subsequent RN visit, virtual
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Other metrics captured on the clinician process survey and nursing visit form
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Insufficient handoff
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Documentation error
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Equipment malfunction
timeFrame: Day of admission to day of discharge, assessed up to 2 months
measure: Age
timeFrame: Day of admission, assessed up to 2 months
measure: Gender
timeFrame: Day of admission, assessed up to 2 months
measure: Race/ethnicity
timeFrame: Day of admission, assessed up to 2 months
measure: Primary language
timeFrame: Day of admission, assessed up to 2 months
measure: Health insurance states, public/private/none
timeFrame: Day of admission, assessed up to 2 months
measure: BMI
timeFrame: Day of admission, assessed up to 2 months
measure: Comorbidities, type and #
timeFrame: Day of admission, assessed up to 2 months
measure: Partner status
timeFrame: Day of admission, assessed up to 2 months
measure: Education
timeFrame: Day of admission, assessed up to 2 months
measure: Zip code
timeFrame: Day of admission, assessed up to 2 months
measure: Employment
timeFrame: Day of admission, assessed up to 2 months
measure: Smoking status
timeFrame: Day of admission, assessed up to 2 months
measure: Medications used as outpatient, #
timeFrame: Day of admission, assessed up to 2 months
measure: DNR/I code status
timeFrame: Day of admission, assessed up to 2 months
measure: Lives alone
timeFrame: Day of admission, assessed up to 2 months
measure: Home health aide prior to admission
timeFrame: Day of admission, assessed up to 2 months
measure: Elective and urgent admissions in the previous year, #
timeFrame: Day of admission, assessed up to 2 months
measure: ED visits in the previous 6 months, #
timeFrame: Day of admission, assessed up to 2 months
measure: Interqual disease-specific leveling
timeFrame: Day of admission, assessed up to 2 months
measure: PRISMA-7
timeFrame: Day of admission, assessed up to 2 months
measure: Eight-item Interview to Differentiate Aging and Dementia
timeFrame: Day of admission, assessed up to 2 months
measure: Would you be surprised if this patient died in the next year?
timeFrame: Day of admission, assessed up to 2 months
measure: BRIEF health literacy screening tool
timeFrame: Day of admission, assessed up to 2 months
measure: Readmission risk score on discharge (HOSPITAL)
timeFrame: Day of discharge, assessed up to 2 months
measure: Admitting diagnosis
timeFrame: Day of admission, assessed up to 2 months
measure: Admission source
timeFrame: Day of admission, assessed up to 2 months
measure: COVID case count on day of admission
timeFrame: Day of admission, assessed up to 2 months
measure: Degree of rurality
timeFrame: Day of admission, assessed up to 2 months
measure: [intervention arm only] RHH admission, daily care, and discharge processes accomplished
timeFrame: Twice a week, day of enrollment to day of final discharge, assessed up to 2 months
measure: [intervention arm only] Perceived acceptability of RHH care
timeFrame: Day of discharge to 30 days postdischarge, assessed up to 2 months
measure: [intervention arm only] Perceived safety, quality of care, caregiver burden
timeFrame: Day of discharge to 30 days, assessed up to 2 months
measure: Qualitative interviews
timeFrame: Day of enrollment to day of final discharge, assessed up to 4 months
Locations:
city: Quincy
country: United States
facility: Blessing Health System
state: Illinois
city: Hazard
country: United States
facility: Appalachian Regional Healthcare, Inc.
state: Kentucky
city: Wetaskiwin
country: Canada
facility: Wetaskiwin Hospital and Care Centre
state: Alberta
Study officials:
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