NCT Number: NCT02864420
Hospitalization at Home: The Acute Care Home Hospital Program for Adults
The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Brigham and Women's Faulkner Hospital, Boston, Massachusetts, United States
About this study
Hospitals are the standard of care for acute illness in the United States, but hospital care is expensive and often unsafe, especially for older individuals. While admitted, 20% suffer delirium, over 5% contract hospital-acquired infections, and most lose functional status that is never regained. Timely access to inpatient care is poor: many hospital wards are typically over 100% capacity, and emergency department waits can be protracted. Moreover, hospital care is increasingly costly: many internal medicine admissions have a negative margin (i.e., expenditures exceed hospital revenues) and incur patient debt.
The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, 20% reduced cost, and 20% improved patient experience. While this is the standard of care in several developed countries, only 2 non-randomized demonstration projects have been conducted in the United States, each with highly local needs. Taken together, home hospital evidence is promising but falls short due to non-robust experimental design, failure to implement modern medical technology, and poor enlistment of community support.
The home hospital module offers most of the same medical components that are standard of care in an acute care hospital. The typical staff (medical doctor [MD], registered nurse [RN], case manager), diagnostics (blood tests, vital signs, telemetry, x-ray, and ultrasound), intravenous therapy, and oxygen/nebulizer therapy will all be available for home hospital. Optional deployment of food services, home health aide, physical therapist, occupational therapist, and social worker will be tailored to patient need. Home hospital improves upon the components of a typical ward's standard of care in several ways:
- Point of care blood diagnostics (results at the bedside in <5 minutes);
- Minimally invasive continuous vital signs, telemetry, activity tracking, and sleep tracking;
- On-demand 24/7 clinician video visits;
- 4 to 1 patient to MD ratio, compared to typical 16 to 1;
- Ambulatory/portable infusion pumps that can be worn on the hip;
- Optional access to a personal home health aide
Should a matter be emergent (that is, requiring in-person assistance in less than 20 minutes), then 9-1-1 will be called and the patient will be returned to the hospital immediately. In previous iterations of home hospital this happens in about 2% of patients.
Clinical parameters measured will be at the discretion of the physician and nurse, who treat the participant following evidence-based practice guidelines, just as in the usual care setting. In addition, the investigators will be tracking a wide variety of measures of quality and safety, including some measures tailored to each primary diagnosis.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Resides within 5-mile radius of emergency room
- English- or Spanish-speaker
- 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.
- This criterion may be waived for highly competent patients at the patient and clinician's discretion.
- >=18 years old
- Primary diagnosis of cellulitis, heart failure, complicated urinary tract infection, or pneumonia that requires inpatient admission as determined by blinded emergency room team.
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
- Cared for by a private primary care physician who rounds in the hospital
- Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
- Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
- Primary diagnosis requires narcotics for pain control
- Cannot independently ambulate to bedside commode
- As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
- For pneumonia:
- Most recent CURB65 > 3: new confusion, blood urea nitrogen > 19mg/dL, respiratory rate>=30/min, systolic blood pressure<90mmHg, Age>=65
- Most recent SMRTCO > 2: systolic blood pressure < 90mmHg (2pts), multilobar chest xray involvement (1pt), respiratory rate >= 30/min, heart rate >= 125, new confusion, oxygen saturation <= 90%
- Absence of clear infiltrate on imaging
- Cavitary lesion on imaging
- O2 saturation < 90% despite 5L O2
- For heart failure:
- Has a left ventricular assist device or paced rhythm
- Get with the Guidelines - Heart Failure (>10% in-hospital mortality) or The Acute Decompensated Heart Failure National Registry score (high risk or intermediate risk 1)
- Anasarca
- Pulmonary hypertension
- For complicated urinary tract infection:
- Absence of pyuria
- Most recent quick sepsis related organ failure assessment > 1
- Home hospital census is full (maximum 4 patients at any time)
Treatment and study plan
Inpatient Hospitalization
OtherPrimary outcomes
-
Total cost of hospitalization, $
Time frame: Day of admission to day of discharge
Secondary outcomes
-
Direct margin, $
Time frame: Day of admission to day of discharge
Direct margin from total cost of hospitalization
-
Direct margin, modeled with backfill, $
Time frame: Day of admission to day of discharge
Backfill uses a model that estimates the cost of patients who take the place of home hospital patients
-
Length of stay, days
Time frame: Day of admission to day of discharge
-
Imaging, #
Time frame: Day of admission to day of discharge
-
Lab Orders, #
Time frame: Day of admission to day of discharge
-
Discharge Disposition
Time frame: Day of discharge
Routine, skilled nursing facility, home health, other
-
Readmission(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Dichotomous outcome
-
Time to readmission after index hospitalization, days
Time frame: Day of discharge to 30 days later
Survival curve (hazard analysis)
-
Emergency Department (ED) observation stay(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Dichotomous outcome
-
Time to ED observation stay(s) after index hospitalization, days
Time frame: Day of discharge to 30 days later
Survival curve (hazard analysis)
-
ED visit(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Dichotomous outcome
-
Time to ED visit(s) after index hospitalization, days
Time frame: Day of discharge to 30 days later
Survival curve (hazard analysis)
-
Delirium, y/n
Time frame: Day of admission to day of discharge
-
Transfer back to hospital, y/n
Time frame: Day of admission to day of discharge
intervention arm only
-
Hours of sleep, #
Time frame: Day of admission to day of discharge
-
Daily steps, #
Time frame: Day of admission to day of discharge
-
EuroQol -5D-5L, composite score
Time frame: At admission, at discharge, and at 30 days after discharge
-
Short Form 1
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
1-5 Likert scale
-
Activities of daily living, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
-
Instrumental activities of daily living, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
-
3-item Care Transition Measure, score
Time frame: 30 days after discharge
-
Picker Experience Questionnaire, score
Time frame: 30 days after discharge
-
Global satisfaction with care, score
Time frame: 30 days after discharge
-
Qualitative interview
Time frame: 30 days after discharge
Other outcomes
-
Total cost of episode of care, $
Time frame: Day of admission to 30 days after discharge
Exploratory; Subset of sample for which claims data is available
-
Intraveneous medications, days
Time frame: Day of admission to day of discharge
Exploratory
-
Intraveneous fluids, days
Time frame: Day of admission to day of discharge
Exploratory
-
Intraveneous diuretics, days
Time frame: Day of admission to day of discharge
Exploratory
-
Intraveneous antibiotics, days
Time frame: Day of admission to day of discharge
Exploratory
-
Supplemental oxygen required, days
Time frame: Day of admission to day of discharge
Exploratory
-
Nebulizer treatment, days
Time frame: Day of admission to day of discharge
Exploratory
-
Medical Doctor sessions, # notes
Time frame: Day of admission to day of discharge
Exploratory
-
Consultant sessions, # notes
Time frame: Day of admission to day of discharge
Exploratory
-
Physical therapy/occupational therapy sessions, # notes
Time frame: Day of admission to day of discharge
Exploratory
-
Primary care provider follow-up within 14 days, y/n
Time frame: Day of discharge to 14 days later
Exploratory
-
Skilled nursing facility utilization, days
Time frame: Day of discharge to 30 days later
Exploratory
-
Home health utilization, days
Time frame: Day of discharge to 30 days later
Exploratory
-
Fall, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Diagnosis of hospital-acquired or post-discharge deep vein thrombosis or pulmonary embolism
Time frame: Day of admission to 30 days after discharge
Exploratory
-
Hospital-acquired pressure ulcer, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Thrombophlebitis at peripheral intravenous site, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Catheter-associated urinary tract infection, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Clostridium difficile infection, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Methicillin resistant staph aureus infection, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Mortality during admission, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Post-discharge mortality, y/n
Time frame: Day of discharge to 30 days later
Exploratory
-
New arrhythmia, y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory
-
Hypokalemia, y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory
-
Acute kidney injury, y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory
-
Mean Likert scale pain score, 0-10
Time frame: Day of admission to day of discharge
Exploratory
-
Pneumococcal vaccination if appropriate, y/n
Time frame: Day of admission to day of discharge
Pneumonia patients only; Exploratory
-
Influenza vaccination if appropriate, y/n
Time frame: Day of admission to day of discharge
Pneumonia patients only; Exploratory
-
Smoking cessation counseling if appropriate, y/n
Time frame: Day of admission to day of discharge
Pneumonia and heart failure patients only; Exploratory
-
Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography
-
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory
-
Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory
-
Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory
-
Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n
Time frame: Day of admission to day of discharge
Heart failure patients only; Exploratory
-
Smoking status post-discharge
Time frame: 30 days after day of discharge
Heart failure and pneumonia patients only; Exploratory; current/never/quit.
-
Use of inappropriate medications in the elderly, y/n
Time frame: Day of admission to day of discharge
Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria
-
Use of Foley catheter, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Use of restraints, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
>3 medications added to medication list, y/n
Time frame: Day of discharge (compared with preadmission med list)
Exploratory
-
Patient health questionnaire-2, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Exploratory
-
Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Exploratory
-
Walk around ward/home, y/n
Time frame: Day of discharge
Exploratory
-
Get to (non-commode) bathroom, y/n
Time frame: Day of discharge
Exploratory
-
Walk 1 flight of stairs, y/n
Time frame: Day of discharge
Exploratory
-
Visit with friends/family, y/n
Time frame: Day of admission to day of discharge
Exploratory
-
Walk outside around my home, y/n
Time frame: 30 days after discharge
Exploratory
-
Go shopping, y/n
Time frame: 30 days after discharge
Exploratory
-
Time from admission decision to assessment by research assistant, minutes
Time frame: Day of admission
Exploratory
-
Time from research assistant assessment to emergency department dismissal, minutes
Time frame: Day of admission
Exploratory
-
Time from arrival home or to floor and medical doctor evaluation, minutes
Time frame: Day of admission
Exploratory
-
Time from arrival home or to floor and registered nurse evaluation, minutes
Time frame: Day of admission
Exploratory
-
Average Registered nurse to patient ratio
Time frame: Day of admission to day of discharge
Exploratory
-
Number of registered nurse visits, total
Time frame: Day of admission to day of discharge
Exploratory
-
Number of "on call" medical doctor interactions (video or phone), total
Time frame: Day of admission to day of discharge
Exploratory, intervention arm only
-
Number of "on call" medical doctor in-person visits, total
Time frame: Day of admission to day of discharge
Exploratory, intervention arm only
-
Duration of 1st registered nurse visit, minutes
Time frame: Day of admission
Exploratory, intervention arm only
-
Average Duration of subsequent registered nurse visit, minutes
Time frame: Day of admission to day of discharge
Exploratory, intervention arm only
Sponsors and collaborators
Lead sponsor
Brigham and Women's Hospital
Other
Collaborators
- Partners HealthCare
- Smiths Medical, ASD, Inc.
- Vital Connect, Inc.
Registry information
Official study title
Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Aug 12, 2016
- Registry last updated
- Jul 11, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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