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Completed

NCT Number: NCT05256303

Rural Hospital-Level Care at Home for Acutely Ill Adults

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Hospital care

Other

Patients receive hospital-level care in their home

Traditional Hospital care

Other

Patients receive hospital-level care in the hospital.

Primary outcomes

  1. Total cost, hospitalization

    Time frame: Date of admission to date of discharge, estimated 10 days later

    Published as percent change given sensitivity of these data

Secondary outcomes

  1. Total cost, discharge to 30-days post discharge

    Time frame: Day of discharge to 30 days later

    Published as percent change given sensitivity of these data

  2. Unplanned readmission within 30-days of discharge

    Time frame: Day of discharge to 30 days later

    Percentage

  3. Days at home

    Time frame: Day of discharge to 30 days later

    The number of days spent at home from the day of discharge to 30-days later

  4. Percent of day lying down

    Time frame: Day of admission to day of discharge, assessed up to 2 months

Other outcomes

  1. Length of stay, days

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  2. IV medication, days

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  3. Intravenous fluids, days

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  4. Intravenous diuretics, days

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  5. Intravenous antibiotics, days

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  6. Oxygen requirement, days

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  7. Nebulizer treatment, days

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  8. Imaging, %

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  9. Lab orders, #

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  10. MD sessions, # of notes

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  11. Consultant sessions, # of notes

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  12. PT/OT sessions, # of notes

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  13. Frequency of disposition, routine, SNF, home health, other

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  14. Follow up with patient's PCP within 14 days, y/n

    Time frame: Up to 30 days from day of discharge, assessed up to 2 months

    Exploratory

  15. SNF utilization, days

    Time frame: Up to 30 days from day of discharge, assessed up to 2 months

    Exploratory

  16. Home health utilization, days

    Time frame: Up to 30 days from day of discharge, assessed up to 2 months

    Exploratory

  17. Unplanned readmission(s) after index, # and y/n + date

    Time frame: Up to 30 days from day of discharge, assessed up to 2 months

    Exploratory

  18. ED observation stay(s), # and y/n + date

    Time frame: Up to 30 days from day of discharge, assessed up to 2 months

    Exploratory

  19. ED visit(s), # and y/n + date

    Time frame: Up to 30 days from day of discharge, assessed up to 2 months

    Exploratory

  20. Fall, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  21. Delirium, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  22. DVT/PE, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  23. New pressure ulcer, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  24. Thrombophlebitis at peripheral IV site, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  25. Hospital-acquired catheter-associated urinary tract infection, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  26. Hospital-acquired Clostridium difficile infection, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  27. Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  28. New arrhythmia, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  29. Hypokalemia, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  30. Acute kidney injury, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  31. Medication error, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  32. Unanticipated mortality, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  33. Loss of consciousness, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  34. Transfer back to hospital, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Intervention arm only; Exploratory

  35. Unplanned mortality during admission

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  36. Unplanned 30-day mortality

    Time frame: Day of discharge to 30-days post discharge, assessed up to 2 months

    Exploratory

  37. Pain management, mean pain score on a scale from 0-10 where 10 is the worst pain imaginable

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  38. Hours of sleep per day

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  39. Hours of sleep per night

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  40. Hours of activity per day

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  41. Hours of activity per night

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  42. Hours of sitting upright per day

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  43. Hours of sitting upright per night

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  44. Daily steps

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  45. Use of inappropriate medications in the elderly, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  46. Use of Foley catheter, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  47. Use of restraints, y/n

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  48. EuroQol-5D-5L, visual analogue scale, 0-100, where 100 is the best imaginable health today

    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

    Exploratory

  49. SF-1

    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

    Exploratory; 1-5 Likert scale: Excellent, very good, good, fair poor

  50. Activities of daily living, score

    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

    Exploratory

  51. Instrumental activities of daily living, score

    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

    Exploratory

  52. Patient health questionnaire-2, score

    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

    Exploratory

  53. PROMIS Emotional Support Short Form 4a, score

    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

    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

  54. Picker Experience Questionnaire -15, score, measured 0-15, where 15 is the best patient experience

    Time frame: Within 30 days after discharge, assessed up to 2 months

    Exploratory

  55. Global satisfaction with care, score, 0-10, where 10 is the best global satisfaction

    Time frame: Within 30 days after discharge, assessed up to 2 months

    Exploratory

  56. Recommend care, score, 0-10, where 10 is the best recommendation possible

    Time frame: Within 30 days after discharge, assessed up to 2 months

    Exploratory

  57. Qualitative interview

    Time frame: Day of discharge to 30 days after discharge, assessed up to 2 months

    Exploratory

  58. Caregiver burden (Zarit), 0-48, where 48 indicates the worst possible caregiver burden

    Time frame: Day of admission and within 30 days after discharge, assessed up to 2 months

    Exploratory

  59. Number of RN visits, in-person

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  60. Number of RN visits, virtual

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  61. Number of RN visits, total

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  62. RN travel time

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  63. Failed connectivity, %

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  64. Number of "on call" MD interactions (video or phone)

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  65. Duration of 1st RN visit

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  66. Duration of subsequent RN visit, in-person

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  67. Duration of subsequent RN visit, virtual

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  68. Other metrics captured on the clinician process survey and nursing visit form

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  69. Insufficient handoff

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  70. Documentation error

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  71. Equipment malfunction

    Time frame: Day of admission to day of discharge, assessed up to 2 months

    Exploratory

  72. Age

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  73. Gender

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  74. Race/ethnicity

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  75. Primary language

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  76. Health insurance states, public/private/none

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  77. BMI

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  78. Comorbidities, type and #

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  79. Partner status

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  80. Education

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  81. Zip code

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  82. Employment

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  83. Smoking status

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  84. Medications used as outpatient, #

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  85. DNR/I code status

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  86. Lives alone

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  87. Home health aide prior to admission

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  88. Elective and urgent admissions in the previous year, #

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  89. ED visits in the previous 6 months, #

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  90. Interqual disease-specific leveling

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  91. PRISMA-7

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  92. Eight-item Interview to Differentiate Aging and Dementia

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  93. Would you be surprised if this patient died in the next year?

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  94. BRIEF health literacy screening tool

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  95. Readmission risk score on discharge (HOSPITAL)

    Time frame: Day of discharge, assessed up to 2 months

    Exploratory

  96. Admitting diagnosis

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  97. Admission source

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  98. COVID case count on day of admission

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  99. Degree of rurality

    Time frame: Day of admission, assessed up to 2 months

    Exploratory

  100. [intervention arm only] RHH admission, daily care, and discharge processes accomplished

    Time frame: Twice a week, day of enrollment to day of final discharge, assessed up to 2 months

    Exploratory

  101. [intervention arm only] Perceived acceptability of RHH care

    Time frame: Day of discharge to 30 days postdischarge, assessed up to 2 months

    Exploratory

  102. [intervention arm only] Perceived safety, quality of care, caregiver burden

    Time frame: Day of discharge to 30 days, assessed up to 2 months

    Exploratory

  103. Qualitative interviews

    Time frame: Day of enrollment to day of final discharge, assessed up to 4 months

    Interviews with patients, caregivers, and rural home hospital clinicians.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • The Thompson Family Foundation Inc

Registry information

Official study title

Hospital-Level Care at Home for Acutely Ill Adults in Rural Settings: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 25, 2022
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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