- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05256303
Rural Hospital-Level Care at Home for Acutely Ill Adults
Hospital-Level Care at Home for Acutely Ill Adults in Rural Settings: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David M Levine, MD, MPH, MA
- Phone Number: 6177327063
- Email: dmlevine@bwh.harvard.edu
Study Locations
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-
Alberta
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Wetaskiwin, Alberta, Canada, T9A 3N3
- Wetaskiwin Hospital and Care Centre
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-
-
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Illinois
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Quincy, Illinois, United States, 62301
- Blessing Health System
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Kentucky
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Hazard, Kentucky, United States, 41701
- Appalachian Regional Healthcare, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home Hospital care
Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
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Patients receive hospital-level care in their home
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Active Comparator: Traditional Hospital care
Patients receive hospital-level care in the hospital.
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Patients receive hospital-level care in the hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cost, hospitalization
Time Frame: Date of admission to date of discharge, estimated 10 days later
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Published as percent change given sensitivity of these data
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Date of admission to date of discharge, estimated 10 days later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cost, discharge to 30-days post discharge
Time Frame: Day of discharge to 30 days later
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Published as percent change given sensitivity of these data
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Day of discharge to 30 days later
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Unplanned readmission within 30-days of discharge
Time Frame: Day of discharge to 30 days later
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Percentage
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Day of discharge to 30 days later
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Days at home
Time Frame: Day of discharge to 30 days later
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The number of days spent at home from the day of discharge to 30-days later
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Day of discharge to 30 days later
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Percent of day lying down
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Day of admission to day of discharge, assessed up to 2 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay, days
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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IV medication, days
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Intravenous fluids, days
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Intravenous diuretics, days
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Intravenous antibiotics, days
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Oxygen requirement, days
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Nebulizer treatment, days
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Imaging, %
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Lab orders, #
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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MD sessions, # of notes
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Consultant sessions, # of notes
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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PT/OT sessions, # of notes
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Frequency of disposition, routine, SNF, home health, other
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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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
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Exploratory
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Up to 30 days from day of discharge, assessed up to 2 months
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SNF utilization, days
Time Frame: Up to 30 days from day of discharge, assessed up to 2 months
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Exploratory
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Up to 30 days from day of discharge, assessed up to 2 months
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Home health utilization, days
Time Frame: Up to 30 days from day of discharge, assessed up to 2 months
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Exploratory
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Up to 30 days from day of discharge, assessed up to 2 months
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Unplanned readmission(s) after index, # and y/n + date
Time Frame: Up to 30 days from day of discharge, assessed up to 2 months
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Exploratory
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Up to 30 days from day of discharge, assessed up to 2 months
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ED observation stay(s), # and y/n + date
Time Frame: Up to 30 days from day of discharge, assessed up to 2 months
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Exploratory
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Up to 30 days from day of discharge, assessed up to 2 months
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ED visit(s), # and y/n + date
Time Frame: Up to 30 days from day of discharge, assessed up to 2 months
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Exploratory
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Up to 30 days from day of discharge, assessed up to 2 months
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Fall, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Delirium, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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DVT/PE, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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New pressure ulcer, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Thrombophlebitis at peripheral IV site, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hospital-acquired catheter-associated urinary tract infection, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hospital-acquired Clostridium difficile infection, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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New arrhythmia, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hypokalemia, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Acute kidney injury, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Medication error, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Unanticipated mortality, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Loss of consciousness, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Transfer back to hospital, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Intervention arm only; Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Unplanned mortality during admission
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Unplanned 30-day mortality
Time Frame: Day of discharge to 30-days post discharge, assessed up to 2 months
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Exploratory
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Day of discharge to 30-days post discharge, assessed up to 2 months
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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
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hours of sleep per day
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hours of sleep per night
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hours of activity per day
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hours of activity per night
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hours of sitting upright per day
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Hours of sitting upright per night
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Daily steps
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Use of inappropriate medications in the elderly, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Use of Foley catheter, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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Use of restraints, y/n
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
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Day of admission to day of discharge, assessed up to 2 months
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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
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Exploratory
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At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
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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
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Exploratory; 1-5 Likert scale: Excellent, very good, good, fair poor
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At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
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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
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Exploratory
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At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
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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
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Exploratory
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At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
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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
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Exploratory
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At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
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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
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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
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At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
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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
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Exploratory
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Within 30 days after discharge, assessed up to 2 months
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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
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Exploratory
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Within 30 days after discharge, assessed up to 2 months
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Recommend care, score, 0-10, where 10 is the best recommendation possible
Time Frame: Within 30 days after discharge, assessed up to 2 months
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Exploratory
|
Within 30 days after discharge, assessed up to 2 months
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Qualitative interview
Time Frame: Day of discharge to 30 days after discharge, assessed up to 2 months
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Exploratory
|
Day of discharge to 30 days after discharge, assessed up to 2 months
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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
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Exploratory
|
Day of admission and within 30 days after discharge, assessed up to 2 months
|
Number of RN visits, in-person
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Number of RN visits, virtual
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Number of RN visits, total
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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RN travel time
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Failed connectivity, %
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Number of "on call" MD interactions (video or phone)
Time Frame: Day of admission to day of discharge, assessed up to 2 months
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Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
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Duration of 1st RN visit
Time Frame: Day of admission, assessed up to 2 months
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Exploratory
|
Day of admission, assessed up to 2 months
|
Duration of subsequent RN visit, in-person
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
|
Duration of subsequent RN visit, virtual
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
|
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
|
Day of admission to day of discharge, assessed up to 2 months
|
Insufficient handoff
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
|
Documentation error
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
|
Equipment malfunction
Time Frame: Day of admission to day of discharge, assessed up to 2 months
|
Exploratory
|
Day of admission to day of discharge, assessed up to 2 months
|
Age
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Gender
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Race/ethnicity
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Primary language
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Health insurance states, public/private/none
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
BMI
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Comorbidities, type and #
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Partner status
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Education
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Zip code
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Employment
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Smoking status
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Medications used as outpatient, #
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
DNR/I code status
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Lives alone
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Home health aide prior to admission
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Elective and urgent admissions in the previous year, #
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
ED visits in the previous 6 months, #
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Interqual disease-specific leveling
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
PRISMA-7
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Eight-item Interview to Differentiate Aging and Dementia
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Would you be surprised if this patient died in the next year?
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
BRIEF health literacy screening tool
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Readmission risk score on discharge (HOSPITAL)
Time Frame: Day of discharge, assessed up to 2 months
|
Exploratory
|
Day of discharge, assessed up to 2 months
|
Admitting diagnosis
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Admission source
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
COVID case count on day of admission
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
Degree of rurality
Time Frame: Day of admission, assessed up to 2 months
|
Exploratory
|
Day of admission, assessed up to 2 months
|
[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
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Twice a week, day of enrollment to day of final discharge, assessed up to 2 months
|
[intervention arm only] Perceived acceptability of RHH care
Time Frame: Day of discharge to 30 days postdischarge, assessed up to 2 months
|
Exploratory
|
Day of discharge to 30 days postdischarge, assessed up to 2 months
|
[intervention arm only] Perceived safety, quality of care, caregiver burden
Time Frame: Day of discharge to 30 days, assessed up to 2 months
|
Exploratory
|
Day of discharge to 30 days, assessed up to 2 months
|
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.
|
Day of enrollment to day of final discharge, assessed up to 4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132.
- Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.
- Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478.
- Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.
- Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x.
- 2014 National and State Healthcare-Associated Infections Progress Report.; 2016. http://www.cdc.gov/hai/surveillance/progress-report/index.html. Accessed April 19, 2016.
- Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6.
- Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17.
- Bureau UC. What is Rural America?https://www.census.gov/library/stories/2017/08/rural-america.html. Published 2017. Accessed May 31, 2019.
- Garcia MC, Rossen LM, Bastian B, Faul M, Dowling NF, Thomas CC, Schieb L, Hong Y, Yoon PW, Iademarco MF. Potentially Excess Deaths from the Five Leading Causes of Death in Metropolitan and Nonmetropolitan Counties - United States, 2010-2017. MMWR Surveill Summ. 2019 Nov 8;68(10):1-11. doi: 10.15585/mmwr.ss6810a1.
- Parker K, Horowitz J, Brown A, Fry R, Cohn D, Igielnik R. What Unites and Divides Urban, Suburban and Rural Communities.; 2018. https://www.pewsocialtrends.org/wpcontent/uploads/sites/3/2018/05/Pew-Research-Center-Community-Type-Full-Report-FINAL.pdf. Accessed May 31, 2019
- Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011.
- Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical access and non-critical access hospitals, 2002-2010. JAMA. 2013 Apr 3;309(13):1379-87. doi: 10.1001/jama.2013.2366.
- Joynt KE, Harris Y, Orav EJ, Jha AK. Quality of care and patient outcomes in critical access rural hospitals. JAMA. 2011 Jul 6;306(1):45-52. doi: 10.1001/jama.2011.902.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Arrhythmias, Cardiac
- Hypertension
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Death
- Atrial Fibrillation
- Hypertensive Crisis
Other Study ID Numbers
- 2021P000334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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