Rural Hospital-Level Care at Home for Acutely Ill Adults
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ClinicalTrials.gov Identifier: NCT05256303 |
Recruitment Status :
Completed
First Posted : February 25, 2022
Last Update Posted : March 6, 2024
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Condition or disease | Intervention/treatment | Phase |
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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 | Other: Home Hospital care Other: Traditional Hospital care | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hospital-Level Care at Home for Acutely Ill Adults in Rural Settings: A Randomized Controlled Trial |
Actual Study Start Date : | February 16, 2022 |
Actual Primary Completion Date : | December 16, 2023 |
Actual Study Completion Date : | January 17, 2024 |
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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Other: Home Hospital care
Patients receive hospital-level care in their home |
Active Comparator: Traditional Hospital care
Patients receive hospital-level care in the hospital.
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Other: Traditional Hospital care
Patients receive hospital-level care in the hospital. |
- 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
- 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
- Unplanned readmission within 30-days of discharge [ Time Frame: Day of discharge to 30 days later ]Percentage
- 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
- Percent of day lying down [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]
- Length of stay, days [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- IV medication, days [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Intravenous fluids, days [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Intravenous diuretics, days [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Intravenous antibiotics, days [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Oxygen requirement, days [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Nebulizer treatment, days [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Imaging, % [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Lab orders, # [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- MD sessions, # of notes [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Consultant sessions, # of notes [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- PT/OT sessions, # of notes [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Frequency of disposition, routine, SNF, home health, other [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- 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
- SNF utilization, days [ Time Frame: Up to 30 days from day of discharge, assessed up to 2 months ]Exploratory
- Home health utilization, days [ Time Frame: Up to 30 days from day of discharge, assessed up to 2 months ]Exploratory
- 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
- ED observation stay(s), # and y/n + date [ Time Frame: Up to 30 days from day of discharge, assessed up to 2 months ]Exploratory
- ED visit(s), # and y/n + date [ Time Frame: Up to 30 days from day of discharge, assessed up to 2 months ]Exploratory
- Fall, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Delirium, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- DVT/PE, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- New pressure ulcer, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Thrombophlebitis at peripheral IV site, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hospital-acquired catheter-associated urinary tract infection, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hospital-acquired Clostridium difficile infection, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- New arrhythmia, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hypokalemia, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Acute kidney injury, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Medication error, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Unanticipated mortality, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Loss of consciousness, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Transfer back to hospital, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Intervention arm only; Exploratory
- Unplanned mortality during admission [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Unplanned 30-day mortality [ Time Frame: Day of discharge to 30-days post discharge, assessed up to 2 months ]Exploratory
- 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
- Hours of sleep per day [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hours of sleep per night [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hours of activity per day [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hours of activity per night [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hours of sitting upright per day [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Hours of sitting upright per night [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Daily steps [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Use of inappropriate medications in the elderly, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Use of Foley catheter, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Use of restraints, y/n [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Qualitative interview [ Time Frame: Day of discharge to 30 days after discharge, assessed up to 2 months ]Exploratory
- 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
- Number of RN visits, in-person [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Number of RN visits, virtual [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Number of RN visits, total [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- RN travel time [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Failed connectivity, % [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Number of "on call" MD interactions (video or phone) [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Duration of 1st RN visit [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Duration of subsequent RN visit, in-person [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Duration of subsequent RN visit, virtual [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- 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
- Insufficient handoff [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Documentation error [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Equipment malfunction [ Time Frame: Day of admission to day of discharge, assessed up to 2 months ]Exploratory
- Age [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Gender [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Race/ethnicity [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Primary language [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Health insurance states, public/private/none [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- BMI [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Comorbidities, type and # [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Partner status [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Education [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Zip code [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Employment [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Smoking status [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Medications used as outpatient, # [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- DNR/I code status [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Lives alone [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Home health aide prior to admission [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Elective and urgent admissions in the previous year, # [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- ED visits in the previous 6 months, # [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Interqual disease-specific leveling [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- PRISMA-7 [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Eight-item Interview to Differentiate Aging and Dementia [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Would you be surprised if this patient died in the next year? [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- BRIEF health literacy screening tool [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Readmission risk score on discharge (HOSPITAL) [ Time Frame: Day of discharge, assessed up to 2 months ]Exploratory
- Admitting diagnosis [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Admission source [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- COVID case count on day of admission [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- Degree of rurality [ Time Frame: Day of admission, assessed up to 2 months ]Exploratory
- [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
- [intervention arm only] Perceived acceptability of RHH care [ Time Frame: Day of discharge to 30 days postdischarge, assessed up to 2 months ]Exploratory
- [intervention arm only] Perceived safety, quality of care, caregiver burden [ Time Frame: Day of discharge to 30 days, assessed up to 2 months ]Exploratory
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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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)
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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
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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
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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
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For other infection
- Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)19
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For COPD
- BAP-65 score > 3 (BUN>25, altered mental status, HR>109, age>65) (<13% chance in-hospital mortality): exercise caution
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For asthma
o Peak expiratory flow < 50% of normal: exercise caution
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For diabetes and its complications
o Requires IV insulin
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For hypertensive urgency
- Systolic blood pressure > 190 mmHg
- Evidence of end-organ damage; for example, acute kidney injury, focal neurologic deficits, myocardial infarction
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05256303
United States, Illinois | |
Blessing Health System | |
Quincy, Illinois, United States, 62301 | |
United States, Kentucky | |
Appalachian Regional Healthcare, Inc. | |
Hazard, Kentucky, United States, 41701 | |
Canada, Alberta | |
Wetaskiwin Hospital and Care Centre | |
Wetaskiwin, Alberta, Canada, T9A 3N3 |
Responsible Party: | David Levine, Dr. David Levine MD, MPH, MA, Director, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT05256303 |
Other Study ID Numbers: |
2021P000334 |
First Posted: | February 25, 2022 Key Record Dates |
Last Update Posted: | March 6, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
home hospital hospital at home hospital in the home |
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Kidney Diseases Renal Insufficiency, Chronic Atrial Fibrillation Hypertensive Crisis Death Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Urologic Diseases |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Lung Diseases Respiratory Tract Diseases Chronic Disease Disease Attributes Renal Insufficiency Hypertension Vascular Diseases |