Anticoagulation, Asthma, Atrial Fibrillation Rapid, Chronic Kidney Diseases, Chronic Obstructive Pulmonary Disease, Diabetes and Its Complications, End of Life/Desires Only Medical Management, Gout Flare, Heart Failure, Hypertensive Urgency, Infections
Conditions
Keywords
home hospital, hospital at home, hospital in the home
Brief summary
This study examines the implications of providing hospital-level care in rural homes.
Detailed description
Home hospital is hospital-level care at home for acutely ill patients. In multiple publications mostly in urban environments, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models deliver care in urban environments, not in rural environments. To determine the effect of home hospital care in rural homes, the investigators propose to the following randomized control trial.
Interventions
OTHERHome Hospital care
Patients receive hospital-level care in their home
OTHERTraditional Hospital care
Patients receive hospital-level care in the hospital.
Sponsors
The Thompson Family Foundation Inc
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total cost, hospitalization | Date of admission to date of discharge, estimated 10 days later | Published as percent change given sensitivity of these data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cost, discharge to 30-days post discharge | Day of discharge to 30 days later | Published as percent change given sensitivity of these data |
| Unplanned readmission within 30-days of discharge | Day of discharge to 30 days later | Percentage |
| Days at home | 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 | Day of admission to day of discharge, assessed up to 2 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Home health utilization, days | Up to 30 days from day of discharge, assessed up to 2 months | Exploratory |
| Length of stay, days | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| IV medication, days | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Intravenous fluids, days | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Intravenous diuretics, days | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Intravenous antibiotics, days | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Oxygen requirement, days | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Nebulizer treatment, days | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Imaging, % | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Lab orders, # | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| MD sessions, # of notes | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Unplanned readmission(s) after index, # and y/n + date | Up to 30 days from day of discharge, assessed up to 2 months | Exploratory |
| ED observation stay(s), # and y/n + date | Up to 30 days from day of discharge, assessed up to 2 months | Exploratory |
| ED visit(s), # and y/n + date | Up to 30 days from day of discharge, assessed up to 2 months | Exploratory |
| Fall, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Delirium, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| DVT/PE, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| New pressure ulcer, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Thrombophlebitis at peripheral IV site, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hospital-acquired catheter-associated urinary tract infection, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hospital-acquired Clostridium difficile infection, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| New arrhythmia, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hypokalemia, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Acute kidney injury, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Medication error, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Unanticipated mortality, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Loss of consciousness, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Transfer back to hospital, y/n | Day of admission to day of discharge, assessed up to 2 months | Intervention arm only; Exploratory |
| Unplanned mortality during admission | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Unplanned 30-day mortality | 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 | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hours of sleep per day | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hours of sleep per night | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hours of activity per day | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hours of activity per night | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hours of sitting upright per day | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Hours of sitting upright per night | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Daily steps | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Use of inappropriate medications in the elderly, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Use of Foley catheter, y/n | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Use of restraints, y/n | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Within 30 days after discharge, assessed up to 2 months | Exploratory |
| Recommend care, score, 0-10, where 10 is the best recommendation possible | Within 30 days after discharge, assessed up to 2 months | Exploratory |
| Qualitative interview | 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 | Day of admission and within 30 days after discharge, assessed up to 2 months | Exploratory |
| Number of RN visits, in-person | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Number of RN visits, virtual | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Number of RN visits, total | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| RN travel time | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Failed connectivity, % | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Number of on call MD interactions (video or phone) | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Duration of 1st RN visit | Day of admission, assessed up to 2 months | Exploratory |
| Duration of subsequent RN visit, in-person | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Duration of subsequent RN visit, virtual | 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 | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Insufficient handoff | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Documentation error | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Equipment malfunction | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Age | Day of admission, assessed up to 2 months | Exploratory |
| Gender | Day of admission, assessed up to 2 months | Exploratory |
| Race/ethnicity | Day of admission, assessed up to 2 months | Exploratory |
| Primary language | Day of admission, assessed up to 2 months | Exploratory |
| Health insurance states, public/private/none | Day of admission, assessed up to 2 months | Exploratory |
| BMI | Day of admission, assessed up to 2 months | Exploratory |
| Comorbidities, type and # | Day of admission, assessed up to 2 months | Exploratory |
| Partner status | Day of admission, assessed up to 2 months | Exploratory |
| Education | Day of admission, assessed up to 2 months | Exploratory |
| Zip code | Day of admission, assessed up to 2 months | Exploratory |
| Employment | Day of admission, assessed up to 2 months | Exploratory |
| Smoking status | Day of admission, assessed up to 2 months | Exploratory |
| Medications used as outpatient, # | Day of admission, assessed up to 2 months | Exploratory |
| DNR/I code status | Day of admission, assessed up to 2 months | Exploratory |
| Lives alone | Day of admission, assessed up to 2 months | Exploratory |
| Home health aide prior to admission | Day of admission, assessed up to 2 months | Exploratory |
| Elective and urgent admissions in the previous year, # | Day of admission, assessed up to 2 months | Exploratory |
| ED visits in the previous 6 months, # | Day of admission, assessed up to 2 months | Exploratory |
| Interqual disease-specific leveling | Day of admission, assessed up to 2 months | Exploratory |
| PRISMA-7 | Day of admission, assessed up to 2 months | Exploratory |
| Eight-item Interview to Differentiate Aging and Dementia | Day of admission, assessed up to 2 months | Exploratory |
| Would you be surprised if this patient died in the next year? | Day of admission, assessed up to 2 months | Exploratory |
| BRIEF health literacy screening tool | Day of admission, assessed up to 2 months | Exploratory |
| Consultant sessions, # of notes | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Admitting diagnosis | Day of admission, assessed up to 2 months | Exploratory |
| Admission source | Day of admission, assessed up to 2 months | Exploratory |
| COVID case count on day of admission | Day of admission, assessed up to 2 months | Exploratory |
| Degree of rurality | Day of admission, assessed up to 2 months | Exploratory |
| [intervention arm only] RHH admission, daily care, and discharge processes accomplished | 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 | Day of discharge to 30 days postdischarge, assessed up to 2 months | Exploratory |
| [intervention arm only] Perceived safety, quality of care, caregiver burden | Day of discharge to 30 days, assessed up to 2 months | Exploratory |
| Qualitative interviews | Day of enrollment to day of final discharge, assessed up to 4 months | Interviews with patients, caregivers, and rural home hospital clinicians. |
| Readmission risk score on discharge (HOSPITAL) | Day of discharge, assessed up to 2 months | Exploratory |
| PT/OT sessions, # of notes | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Frequency of disposition, routine, SNF, home health, other | Day of admission to day of discharge, assessed up to 2 months | Exploratory |
| Follow up with patient's PCP within 14 days, y/n | Up to 30 days from day of discharge, assessed up to 2 months | Exploratory |
| SNF utilization, days | Up to 30 days from day of discharge, assessed up to 2 months | Exploratory |
Countries
Canada, United States
Outcome results
None listed