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Hospitalization at Home: The Acute Care Home Hospital Program for Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02864420
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : July 11, 2017
Sponsor:
Collaborators:
Partners HealthCare
Smiths Medical, ASD, Inc.
Vital Connect, Inc.
Information provided by (Responsible Party):
Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Heart Failure Cellulitis Urinary Tract Infections Other: Home hospitalization Other: Inpatient Hospitalization Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Inpatient hospitalization
Control / usual care arm. Patients are admitted per usual to an inpatient service. Patients' medical records will be closely monitored. Patients will wear a vitals and activity monitor whose data is used only retrospectively. On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health.
Other: Inpatient Hospitalization
Experimental: Home hospitalization
Intervention arm. Patients will return home after triage, diagnosis, and the beginning of treatment in the emergency department with a set of specialized patient-tailored services (listed above). On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health.
Other: Home hospitalization



Primary Outcome Measures :
  1. Total cost of hospitalization, $ [ Time Frame: Day of admission to day of discharge ]

Secondary Outcome Measures :
  1. Direct margin, $ [ Time Frame: Day of admission to day of discharge ]
    Direct margin from total cost of hospitalization

  2. 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

  3. Length of stay, days [ Time Frame: Day of admission to day of discharge ]
  4. Imaging, # [ Time Frame: Day of admission to day of discharge ]
  5. Lab Orders, # [ Time Frame: Day of admission to day of discharge ]
  6. Discharge Disposition [ Time Frame: Day of discharge ]
    Routine, skilled nursing facility, home health, other

  7. Readmission(s) after index hospitalization, y/n [ Time Frame: Day of discharge to 30 days later ]
    Dichotomous outcome

  8. Time to readmission after index hospitalization, days [ Time Frame: Day of discharge to 30 days later ]
    Survival curve (hazard analysis)

  9. Emergency Department (ED) observation stay(s) after index hospitalization, y/n [ Time Frame: Day of discharge to 30 days later ]
    Dichotomous outcome

  10. Time to ED observation stay(s) after index hospitalization, days [ Time Frame: Day of discharge to 30 days later ]
    Survival curve (hazard analysis)

  11. ED visit(s) after index hospitalization, y/n [ Time Frame: Day of discharge to 30 days later ]
    Dichotomous outcome

  12. Time to ED visit(s) after index hospitalization, days [ Time Frame: Day of discharge to 30 days later ]
    Survival curve (hazard analysis)

  13. Delirium, y/n [ Time Frame: Day of admission to day of discharge ]
  14. Transfer back to hospital, y/n [ Time Frame: Day of admission to day of discharge ]
    intervention arm only

  15. Hours of sleep, # [ Time Frame: Day of admission to day of discharge ]
  16. Daily steps, # [ Time Frame: Day of admission to day of discharge ]
  17. EuroQol -5D-5L, composite score [ Time Frame: At admission, at discharge, and at 30 days after discharge ]
  18. 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

  19. 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 ]
  20. 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 ]
  21. 3-item Care Transition Measure, score [ Time Frame: 30 days after discharge ]
  22. Picker Experience Questionnaire, score [ Time Frame: 30 days after discharge ]
  23. Global satisfaction with care, score [ Time Frame: 30 days after discharge ]
  24. Qualitative interview [ Time Frame: 30 days after discharge ]

Other Outcome Measures:
  1. 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

  2. Intraveneous medications, days [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  3. Intraveneous fluids, days [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  4. Intraveneous diuretics, days [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  5. Intraveneous antibiotics, days [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  6. Supplemental oxygen required, days [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  7. Nebulizer treatment, days [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  8. Medical Doctor sessions, # notes [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  9. Consultant sessions, # notes [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  10. Physical therapy/occupational therapy sessions, # notes [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  11. Primary care provider follow-up within 14 days, y/n [ Time Frame: Day of discharge to 14 days later ]
    Exploratory

  12. Skilled nursing facility utilization, days [ Time Frame: Day of discharge to 30 days later ]
    Exploratory

  13. Home health utilization, days [ Time Frame: Day of discharge to 30 days later ]
    Exploratory

  14. Fall, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  15. Diagnosis of hospital-acquired or post-discharge deep vein thrombosis or pulmonary embolism [ Time Frame: Day of admission to 30 days after discharge ]
    Exploratory

  16. Hospital-acquired pressure ulcer, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  17. Thrombophlebitis at peripheral intravenous site, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  18. Catheter-associated urinary tract infection, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  19. Clostridium difficile infection, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  20. Methicillin resistant staph aureus infection, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  21. Mortality during admission, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  22. Post-discharge mortality, y/n [ Time Frame: Day of discharge to 30 days later ]
    Exploratory

  23. New arrhythmia, y/n [ Time Frame: Day of admission to day of discharge ]
    Heart failure patients only; Exploratory

  24. Hypokalemia, y/n [ Time Frame: Day of admission to day of discharge ]
    Heart failure patients only; Exploratory

  25. Acute kidney injury, y/n [ Time Frame: Day of admission to day of discharge ]
    Heart failure patients only; Exploratory

  26. Mean Likert scale pain score, 0-10 [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  27. Pneumococcal vaccination if appropriate, y/n [ Time Frame: Day of admission to day of discharge ]
    Pneumonia patients only; Exploratory

  28. Influenza vaccination if appropriate, y/n [ Time Frame: Day of admission to day of discharge ]
    Pneumonia patients only; Exploratory

  29. Smoking cessation counseling if appropriate, y/n [ Time Frame: Day of admission to day of discharge ]
    Pneumonia and heart failure patients only; Exploratory

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. Smoking status post-discharge [ Time Frame: 30 days after day of discharge ]
    Heart failure and pneumonia patients only; Exploratory; current/never/quit.

  36. 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

  37. Use of Foley catheter, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  38. Use of restraints, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  39. >3 medications added to medication list, y/n [ Time Frame: Day of discharge (compared with preadmission med list) ]
    Exploratory

  40. 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

  41. 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

  42. Walk around ward/home, y/n [ Time Frame: Day of discharge ]
    Exploratory

  43. Get to (non-commode) bathroom, y/n [ Time Frame: Day of discharge ]
    Exploratory

  44. Walk 1 flight of stairs, y/n [ Time Frame: Day of discharge ]
    Exploratory

  45. Visit with friends/family, y/n [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  46. Walk outside around my home, y/n [ Time Frame: 30 days after discharge ]
    Exploratory

  47. Go shopping, y/n [ Time Frame: 30 days after discharge ]
    Exploratory

  48. Time from admission decision to assessment by research assistant, minutes [ Time Frame: Day of admission ]
    Exploratory

  49. Time from research assistant assessment to emergency department dismissal, minutes [ Time Frame: Day of admission ]
    Exploratory

  50. Time from arrival home or to floor and medical doctor evaluation, minutes [ Time Frame: Day of admission ]
    Exploratory

  51. Time from arrival home or to floor and registered nurse evaluation, minutes [ Time Frame: Day of admission ]
    Exploratory

  52. Average Registered nurse to patient ratio [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  53. Number of registered nurse visits, total [ Time Frame: Day of admission to day of discharge ]
    Exploratory

  54. Number of "on call" medical doctor interactions (video or phone), total [ Time Frame: Day of admission to day of discharge ]
    Exploratory, intervention arm only

  55. Number of "on call" medical doctor in-person visits, total [ Time Frame: Day of admission to day of discharge ]
    Exploratory, intervention arm only

  56. Duration of 1st registered nurse visit, minutes [ Time Frame: Day of admission ]
    Exploratory, intervention arm only

  57. Average Duration of subsequent registered nurse visit, minutes [ Time Frame: Day of admission to day of discharge ]
    Exploratory, intervention arm only



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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): NCT02864420


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Partners HealthCare
Smiths Medical, ASD, Inc.
Vital Connect, Inc.
Investigators
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Principal Investigator: Jeffrey L Schnipper, MD, MPH Brigham and Women's Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey L. Schnipper, MD.,MPH., Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02864420    
Other Study ID Numbers: 2016P001337
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital:
home hospital
acute care home
care redesign
delivery innovation
heart failure
pneumonia
cellulitis
urinary tract infections
Additional relevant MeSH terms:
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Pneumonia
Urinary Tract Infections
Cellulitis
Heart Failure
Infections
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Skin Diseases, Infectious
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes