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Rural Hospital-Level Care at Home for Acutely Ill Adults

Primary Purpose

Infections, Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Home Hospital care
Traditional Hospital care
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections focused on measuring home hospital, hospital at home, hospital in the home

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Blessing Health SystemRecruiting
  • Appalachian Regional Healthcare, Inc.Recruiting
  • Wetaskiwin Hospital and Care CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home Hospital care

Traditional Hospital care

Arm Description

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

Patients receive hospital-level care in the hospital.

Outcomes

Primary Outcome Measures

Total cost, hospitalization
Published as percent change given sensitivity of these data

Secondary Outcome Measures

Total cost, discharge to 30-days post discharge
Published as percent change given sensitivity of these data
Unplanned readmission within 30-days of discharge
Percentage
Days at home
The number of days spent at home from the day of discharge to 30-days later
Percent of day lying down

Full Information

First Posted
October 25, 2021
Last Updated
October 17, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
The Thompson Family Foundation Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05256303
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
The Thompson Family Foundation Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home Hospital care
Arm Type
Experimental
Arm Description
Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
Arm Title
Traditional Hospital care
Arm Type
Active Comparator
Arm Description
Patients receive hospital-level care in the hospital.
Intervention Type
Other
Intervention Name(s)
Home Hospital care
Intervention Description
Patients receive hospital-level care in their home
Intervention Type
Other
Intervention Name(s)
Traditional Hospital care
Intervention Description
Patients receive hospital-level care in the hospital.
Primary Outcome Measure Information:
Title
Total cost, hospitalization
Description
Published as percent change given sensitivity of these data
Time Frame
Date of admission to date of discharge, estimated 10 days later
Secondary Outcome Measure Information:
Title
Total cost, discharge to 30-days post discharge
Description
Published as percent change given sensitivity of these data
Time Frame
Day of discharge to 30 days later
Title
Unplanned readmission within 30-days of discharge
Description
Percentage
Time Frame
Day of discharge to 30 days later
Title
Days at home
Description
The number of days spent at home from the day of discharge to 30-days later
Time Frame
Day of discharge to 30 days later
Title
Percent of day lying down
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Other Pre-specified Outcome Measures:
Title
Length of stay, days
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
IV medication, days
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Intravenous fluids, days
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Intravenous diuretics, days
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Intravenous antibiotics, days
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Oxygen requirement, days
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Nebulizer treatment, days
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Imaging, %
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Lab orders, #
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
MD sessions, # of notes
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Consultant sessions, # of notes
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
PT/OT sessions, # of notes
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Frequency of disposition, routine, SNF, home health, other
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Follow up with patient's PCP within 14 days, y/n
Description
Exploratory
Time Frame
Up to 30 days from day of discharge, assessed up to 2 months
Title
SNF utilization, days
Description
Exploratory
Time Frame
Up to 30 days from day of discharge, assessed up to 2 months
Title
Home health utilization, days
Description
Exploratory
Time Frame
Up to 30 days from day of discharge, assessed up to 2 months
Title
Unplanned readmission(s) after index, # and y/n + date
Description
Exploratory
Time Frame
Up to 30 days from day of discharge, assessed up to 2 months
Title
ED observation stay(s), # and y/n + date
Description
Exploratory
Time Frame
Up to 30 days from day of discharge, assessed up to 2 months
Title
ED visit(s), # and y/n + date
Description
Exploratory
Time Frame
Up to 30 days from day of discharge, assessed up to 2 months
Title
Fall, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Delirium, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
DVT/PE, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
New pressure ulcer, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Thrombophlebitis at peripheral IV site, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hospital-acquired catheter-associated urinary tract infection, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hospital-acquired Clostridium difficile infection, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
New arrhythmia, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hypokalemia, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Acute kidney injury, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Medication error, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Unanticipated mortality, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Loss of consciousness, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Transfer back to hospital, y/n
Description
Intervention arm only; Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Unplanned mortality during admission
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Unplanned 30-day mortality
Description
Exploratory
Time Frame
Day of discharge to 30-days post discharge, assessed up to 2 months
Title
Pain management, mean pain score on a scale from 0-10 where 10 is the worst pain imaginable
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hours of sleep per day
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hours of sleep per night
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hours of activity per day
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hours of activity per night
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hours of sitting upright per day
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Hours of sitting upright per night
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Daily steps
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Use of inappropriate medications in the elderly, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Use of Foley catheter, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Use of restraints, y/n
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
EuroQol-5D-5L, visual analogue scale, 0-100, where 100 is the best imaginable health today
Description
Exploratory
Time Frame
At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Title
SF-1
Description
Exploratory; 1-5 Likert scale: Excellent, very good, good, fair poor
Time Frame
At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Title
Activities of daily living, score
Description
Exploratory
Time Frame
At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Title
Instrumental activities of daily living, score
Description
Exploratory
Time Frame
At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Title
Patient health questionnaire-2, score
Description
Exploratory
Time Frame
At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Title
PROMIS Emotional Support Short Form 4a, score
Description
Exploratory; I have someone who will listen to me when I need to talk I have someone to confide in or talk to about myself or my problems I have someone who makes me feel appreciated I have someone to talk with when I have a bad day Scale for each: never, rarely, sometimes, usually, always
Time Frame
At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Title
Picker Experience Questionnaire -15, score, measured 0-15, where 15 is the best patient experience
Description
Exploratory
Time Frame
Within 30 days after discharge, assessed up to 2 months
Title
Global satisfaction with care, score, 0-10, where 10 is the best global satisfaction
Description
Exploratory
Time Frame
Within 30 days after discharge, assessed up to 2 months
Title
Recommend care, score, 0-10, where 10 is the best recommendation possible
Description
Exploratory
Time Frame
Within 30 days after discharge, assessed up to 2 months
Title
Qualitative interview
Description
Exploratory
Time Frame
Day of discharge to 30 days after discharge, assessed up to 2 months
Title
Caregiver burden (Zarit), 0-48, where 48 indicates the worst possible caregiver burden
Description
Exploratory
Time Frame
Day of admission and within 30 days after discharge, assessed up to 2 months
Title
Number of RN visits, in-person
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Number of RN visits, virtual
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Number of RN visits, total
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
RN travel time
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Failed connectivity, %
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Number of "on call" MD interactions (video or phone)
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Duration of 1st RN visit
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Duration of subsequent RN visit, in-person
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Duration of subsequent RN visit, virtual
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Other metrics captured on the clinician process survey and nursing visit form
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Insufficient handoff
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Documentation error
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Equipment malfunction
Description
Exploratory
Time Frame
Day of admission to day of discharge, assessed up to 2 months
Title
Age
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Gender
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Race/ethnicity
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Primary language
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Health insurance states, public/private/none
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
BMI
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Comorbidities, type and #
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Partner status
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Education
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Zip code
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Employment
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Smoking status
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Medications used as outpatient, #
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
DNR/I code status
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Lives alone
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Home health aide prior to admission
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Elective and urgent admissions in the previous year, #
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
ED visits in the previous 6 months, #
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Interqual disease-specific leveling
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
PRISMA-7
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Eight-item Interview to Differentiate Aging and Dementia
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Would you be surprised if this patient died in the next year?
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
BRIEF health literacy screening tool
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Readmission risk score on discharge (HOSPITAL)
Description
Exploratory
Time Frame
Day of discharge, assessed up to 2 months
Title
Admitting diagnosis
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Admission source
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
COVID case count on day of admission
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
Degree of rurality
Description
Exploratory
Time Frame
Day of admission, assessed up to 2 months
Title
[intervention arm only] RHH admission, daily care, and discharge processes accomplished
Description
Exploratory
Time Frame
Twice a week, day of enrollment to day of final discharge, assessed up to 2 months
Title
[intervention arm only] Perceived acceptability of RHH care
Description
Exploratory
Time Frame
Day of discharge to 30 days postdischarge, assessed up to 2 months
Title
[intervention arm only] Perceived safety, quality of care, caregiver burden
Description
Exploratory
Time Frame
Day of discharge to 30 days, assessed up to 2 months
Title
Qualitative interviews
Description
Interviews with patients, caregivers, and rural home hospital clinicians.
Time Frame
Day of enrollment to day of final discharge, assessed up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M Levine, MD, MPH, MA
Phone
6177327063
Email
dmlevine@bwh.harvard.edu
Facility Information:
Facility Name
Blessing Health System
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Barthel, MD
Email
mary.barthel@blessinghealth.org
Facility Name
Appalachian Regional Healthcare, Inc.
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Braman, MD, MBA
Email
mbraman@arh.org
Facility Name
Wetaskiwin Hospital and Care Centre
City
Wetaskiwin
State/Province
Alberta
ZIP/Postal Code
T9A 3N3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Luebbert
Email
David.Luebbert@albertahealthservices.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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23608775
Citation
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Results Reference
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Rural Hospital-Level Care at Home for Acutely Ill Adults

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