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| Name | Class |
|---|---|
| The Thompson Family Foundation Inc | UNKNOWN |
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This study examines the implications of providing hospital-level care in rural homes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Hospital care | Experimental | Patients receive hospital-level care in their home, as a substitute to traditional hospital care. |
|
| Traditional Hospital care | Active Comparator | Patients receive hospital-level care in the hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Hospital care | Other | Patients receive hospital-level care in their home |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total cost, hospitalization | Published as percent change given sensitivity of these data | Date of admission to date of discharge, estimated 10 days later |
| Measure | Description | Time Frame |
|---|---|---|
| Total cost, discharge to 30-days post discharge | Published as percent change given sensitivity of these data | Day of discharge to 30 days later |
| Unplanned readmission within 30-days of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay, days | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| IV medication, days | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
Inclusion Criteria:
Patient clinical inclusion criteria:
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.
Patient caregiver inclusion criteria: (not required for patient participation):
Clinician inclusion criteria:
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:
For heart failure:
For complicated urinary tract infection:
For other infection
For COPD
For asthma
o Peak expiratory flow < 50% of normal: exercise caution
For diabetes and its complications
o Requires IV insulin
For hypertensive urgency
For atrial fibrillation with rapid ventricular response
Home hospital census is full
Patient environmental exclusion criteria:
Sites without continuous monitoring will make amendments to the above exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blessing Health System | Quincy | Illinois | 62301 | United States | ||
| Appalachian Regional Healthcare, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23608775 | Background | 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. | |
| 19347026 | Background | 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. |
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| Traditional Hospital care |
| Other |
Patients receive hospital-level care in the hospital. |
|
Percentage
| Day of discharge to 30 days later |
| Days at home | The number of days spent at home from the day of discharge to 30-days later | Day of discharge to 30 days later |
| Percent of day lying down | Day of admission to day of discharge, assessed up to 2 months |
| Intravenous fluids, days | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Intravenous diuretics, days | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Intravenous antibiotics, days | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Oxygen requirement, days | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Nebulizer treatment, days | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Imaging, % | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Lab orders, # | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| MD sessions, # of notes | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Consultant sessions, # of notes | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| PT/OT sessions, # of notes | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Frequency of disposition, routine, SNF, home health, other | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Follow up with patient's PCP within 14 days, y/n | Exploratory | Up to 30 days from day of discharge, assessed up to 2 months |
| SNF utilization, days | Exploratory | Up to 30 days from day of discharge, assessed up to 2 months |
| Home health utilization, days | Exploratory | Up to 30 days from day of discharge, assessed up to 2 months |
| Unplanned readmission(s) after index, # and y/n + date | Exploratory | Up to 30 days from day of discharge, assessed up to 2 months |
| ED observation stay(s), # and y/n + date | Exploratory | Up to 30 days from day of discharge, assessed up to 2 months |
| ED visit(s), # and y/n + date | Exploratory | Up to 30 days from day of discharge, assessed up to 2 months |
| Fall, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Delirium, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| DVT/PE, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| New pressure ulcer, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Thrombophlebitis at peripheral IV site, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hospital-acquired catheter-associated urinary tract infection, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hospital-acquired Clostridium difficile infection, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| New arrhythmia, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hypokalemia, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Acute kidney injury, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Medication error, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Unanticipated mortality, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Loss of consciousness, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Transfer back to hospital, y/n | Intervention arm only; Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Unplanned mortality during admission | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Unplanned 30-day mortality | Exploratory | Day of discharge to 30-days post discharge, assessed up to 2 months |
| Pain management, mean pain score on a scale from 0-10 where 10 is the worst pain imaginable | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hours of sleep per day | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hours of sleep per night | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hours of activity per day | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hours of activity per night | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hours of sitting upright per day | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Hours of sitting upright per night | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Daily steps | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Use of inappropriate medications in the elderly, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Use of Foley catheter, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Use of restraints, y/n | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| EuroQol-5D-5L, visual analogue scale, 0-100, where 100 is the best imaginable health today | Exploratory | At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months |
| SF-1 | Exploratory; 1-5 Likert scale: Excellent, very good, good, fair poor | At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months |
| Activities of daily living, score | Exploratory | At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months |
| Instrumental activities of daily living, score | Exploratory | At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months |
| Patient health questionnaire-2, score | Exploratory | At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months |
| PROMIS Emotional Support Short Form 4a, score | 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 | At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months |
| Picker Experience Questionnaire -15, score, measured 0-15, where 15 is the best patient experience | Exploratory | Within 30 days after discharge, assessed up to 2 months |
| Global satisfaction with care, score, 0-10, where 10 is the best global satisfaction | Exploratory | Within 30 days after discharge, assessed up to 2 months |
| Recommend care, score, 0-10, where 10 is the best recommendation possible | Exploratory | Within 30 days after discharge, assessed up to 2 months |
| Qualitative interview | Exploratory | Day of discharge to 30 days after discharge, assessed up to 2 months |
| Caregiver burden (Zarit), 0-48, where 48 indicates the worst possible caregiver burden | Exploratory | Day of admission and within 30 days after discharge, assessed up to 2 months |
| Number of RN visits, in-person | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Number of RN visits, virtual | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Number of RN visits, total | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| RN travel time | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Failed connectivity, % | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Number of "on call" MD interactions (video or phone) | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Duration of 1st RN visit | Exploratory | Day of admission, assessed up to 2 months |
| Duration of subsequent RN visit, in-person | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Duration of subsequent RN visit, virtual | 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 | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Insufficient handoff | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Documentation error | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Equipment malfunction | Exploratory | Day of admission to day of discharge, assessed up to 2 months |
| Age | Exploratory | Day of admission, assessed up to 2 months |
| Gender | Exploratory | Day of admission, assessed up to 2 months |
| Race/ethnicity | Exploratory | Day of admission, assessed up to 2 months |
| Primary language | Exploratory | Day of admission, assessed up to 2 months |
| Health insurance states, public/private/none | Exploratory | Day of admission, assessed up to 2 months |
| BMI | Exploratory | Day of admission, assessed up to 2 months |
| Comorbidities, type and # | Exploratory | Day of admission, assessed up to 2 months |
| Partner status | Exploratory | Day of admission, assessed up to 2 months |
| Education | Exploratory | Day of admission, assessed up to 2 months |
| Zip code | Exploratory | Day of admission, assessed up to 2 months |
| Employment | Exploratory | Day of admission, assessed up to 2 months |
| Smoking status | Exploratory | Day of admission, assessed up to 2 months |
| Medications used as outpatient, # | Exploratory | Day of admission, assessed up to 2 months |
| DNR/I code status | Exploratory | Day of admission, assessed up to 2 months |
| Lives alone | Exploratory | Day of admission, assessed up to 2 months |
| Home health aide prior to admission | Exploratory | Day of admission, assessed up to 2 months |
| Elective and urgent admissions in the previous year, # | Exploratory | Day of admission, assessed up to 2 months |
| ED visits in the previous 6 months, # | Exploratory | Day of admission, assessed up to 2 months |
| Interqual disease-specific leveling | Exploratory | Day of admission, assessed up to 2 months |
| PRISMA-7 | Exploratory | Day of admission, assessed up to 2 months |
| Eight-item Interview to Differentiate Aging and Dementia | Exploratory | Day of admission, assessed up to 2 months |
| Would you be surprised if this patient died in the next year? | Exploratory | Day of admission, assessed up to 2 months |
| BRIEF health literacy screening tool | Exploratory | Day of admission, assessed up to 2 months |
| Readmission risk score on discharge (HOSPITAL) | Exploratory | Day of discharge, assessed up to 2 months |
| Admitting diagnosis | Exploratory | Day of admission, assessed up to 2 months |
| Admission source | Exploratory | Day of admission, assessed up to 2 months |
| COVID case count on day of admission | Exploratory | Day of admission, assessed up to 2 months |
| Degree of rurality | Exploratory | Day of admission, assessed up to 2 months |
| [intervention arm only] RHH admission, daily care, and discharge processes accomplished | Exploratory | Twice a week, day of enrollment to day of final discharge, assessed up to 2 months |
| [intervention arm only] Perceived acceptability of RHH care | Exploratory | Day of discharge to 30 days postdischarge, assessed up to 2 months |
| [intervention arm only] Perceived safety, quality of care, caregiver burden | Exploratory | Day of discharge to 30 days, assessed up to 2 months |
| Qualitative interviews | Interviews with patients, caregivers, and rural home hospital clinicians. | Day of enrollment to day of final discharge, assessed up to 4 months |
| Hazard |
| Kentucky |
| 41701 |
| United States |
| Wetaskiwin Hospital and Care Centre | Wetaskiwin | Alberta | T9A 3N3 | Canada |
| Background | 2014 National and State Healthcare-Associated Infections Progress Report.; 2016. http://www.cdc.gov/hai/surveillance/progress-report/index.html. Accessed April 19, 2016. |
| 11129745 | Background | 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. |
| 16330791 | Background | 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. |
| 22665835 | Background | 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. |
| 29411238 | Background | 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. |
| 31842232 | Background | 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. |
| Background | Bureau UC. What is Rural America?https://www.census.gov/library/stories/2017/08/rural-america.html. Published 2017. Accessed May 31, 2019. |
| 31697657 | Background | 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. |
| Background | 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 |
| 8417639 | Background | 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. |
| 23549583 | Background | 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. |
| 21730240 | Background | 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. |
| 41324962 | Derived | Levine DM, Desai MP, Findeisen SM, Blitzer SC, Brewster RCL, Grinman MN, Amrhein SC, Wicker M, Harrison SM, Dykes PC, Barthel MF, Lipsitz SR. Hospital-Level Care at Home for Adults Living in Rural Settings: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2545712. doi: 10.1001/jamanetworkopen.2025.45712. |
| ID | Term |
|---|---|
| D007239 | Infections |
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D051436 | Renal Insufficiency, Chronic |
| D000096003 | Hypertensive Crisis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D018575 | Home Care Services, Hospital-Based |
| ID | Term |
|---|---|
| D006699 | Home Care Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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