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Hospital-Level Care at Home for Acutely Ill 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: NCT03203759
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
Vital Connect
Smiths Medical
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
Infection Heart Failure COPD Asthma Gout Flare Chronic Kidney Diseases Hypertensive Urgency Atrial Fibrillation Rapid Anticoagulants; Increased Other: Home hospitalization Other: Traditional 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; Automated alerting of MDs by mobile phone for any worrisome vital sign patterns; On-demand 24/7 clinician video visits; 4 to 1 patient to attending 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 : 91 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: A Randomized Controlled Trial
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : February 17, 2018
Actual Study Completion Date : May 15, 2018


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 vital sign 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: Traditional inpatient hospitalization
See above

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
See above




Primary Outcome Measures :
  1. Total direct cost of hospitalization, $ [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]

Secondary Outcome Measures :
  1. Direct margin, $ [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Direct margin from total cost of hospitalization

  2. Direct margin, modeled with backfill [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Backfill uses a model that estimates the cost of patients who take the place of home hospital patients

  3. Total cost, 30-day post discharge [ Time Frame: Day of admission to 30-days post-discharge ]
  4. Length of stay, days [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
  5. Imaging, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Count of any diagnostic imaging (for example, x-ray, computed tomography, magnetic resonance, ultrasound, and nuclear imaging) that occurred through the course of the hospitalization.

  6. Lab orders, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Count of any lab order (for example, basic metabolic panel, complete blood count, hepatic function panel) that occurred through the course of the hospitalization.

  7. All-cause readmission(s) after index, # [ Time Frame: Day of discharge to 30 days later ]
  8. All-cause readmission(s) after index, y/n [ Time Frame: Day of discharge to 30 days later ]
  9. Unplanned readmission(s) after index, # [ Time Frame: Day of discharge to 30 days later ]
  10. Unplanned readmission(s) after index, y/n [ Time Frame: Day of discharge to 30 days later ]
  11. Emergency Department observation stay(s) after index hospitalization, # [ Time Frame: Day of discharge to 30 days later ]
  12. Emergency Department observation stay(s) after index hospitalization, y/n [ Time Frame: Day of discharge to 30 days later ]
  13. Emergency Department visit(s) after index hospitalization, # [ Time Frame: Day of discharge to 30 days later ]
  14. Emergency Department visit(s) after index hospitalization, y/n [ Time Frame: Day of discharge to 30 days later ]
  15. Delirium, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
  16. Transfer back to hospital, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Intervention arm only

  17. Hours of sleep per day, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
  18. Hours of activity per day, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
  19. Hours of sitting upright per day, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
  20. Steps per day, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
  21. EuroQol -5D-5L, composite score [ Time Frame: At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge ]
  22. Short Form 1 [ Time Frame: 30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge ]
    1-5 Likert scale

  23. Activities of daily living, score [ Time Frame: 30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge ]
  24. Instrumental activities of daily living, score [ Time Frame: 30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge ]
  25. 3-item Care Transition Measure, score [ Time Frame: 30 days after discharge ]
  26. Picker Experience Questionnaire, score [ Time Frame: 30 days after discharge ]
  27. Global satisfaction with care, score [ Time Frame: 30 days after discharge ]
  28. Qualitative interview [ Time Frame: 30 days after discharge ]

Other Outcome Measures:
  1. Total reimbursement, 30-day post discharge [ Time Frame: Day of admission to 30-days post-discharge ]
    Exploratory

  2. Intravenous medications, days [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  3. Intravenous fluids, days [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory; the number of days intravenous fluids (for example, normal saline) were received by the patient.

  4. Intravenous diuretics, days [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory; the number of days intravenous diuretics (for example, furosemide) were received by the patient.

  5. Intravenous antibiotics, days [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory; the number of days intravenous antibiotics (for example, ceftriaxone) were received by the patient.

  6. Supplemental oxygen required, days [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  7. Nebulizer treatment, days [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  8. Medical Doctor sessions, # notes [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  9. Consultant sessions, # notes [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  10. Physical therapy/occupational therapy sessions, # notes [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    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; the number of days a patient spent in a skilled nursing facility.

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

  14. Fall, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  15. Hospital-acquired deep vein thrombosis or pulmonary embolism, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  16. Hospital-acquired pressure ulcer, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  17. Hospital-acquired thrombophlebitis at peripheral IV site, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  18. Hospital-acquired catheter-associated urinary tract infection, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  19. Hospital-acquired Clostridium difficile infection, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  20. Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  21. All-cause mortality, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  22. Unplanned mortality, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

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

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

  25. New arrhythmia, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory

  26. Hypokalemia, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory

  27. Acute Kidney Injury, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory

  28. Mean Likert scale pain score, 0-10 [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  29. Hours of sleep per night, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  30. Hours of activity per night, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  31. Hours of sitting upright per night, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  32. Pneumococcal vaccination if appropriate, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Pneumonia patients only; Exploratory

  33. Influenza vaccination if appropriate, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Pneumonia patients only; Exploratory

  34. Smoking cessation counseling if appropriate, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Pneumonia and heart failure patients only; Exploratory

  35. 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: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory; Whether or not an appropriate study occurred and/or was scheduled if not done within 1 year; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography

  36. Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory

  37. Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory

  38. Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory

  39. Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure patients only; Exploratory

  40. Smoking status post-discharge; current/never/quit [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Heart failure and pneumonia patients only; Exploratory; Self-report of smoking status: current/never/quit.

  41. Use of inappropriate medications in the elderly, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria

  42. Use of Foley catheter, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  43. Use of restraints, y/n [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory

  44. >3 medications added to medication list, y/n [ Time Frame: Date of discharge, an expected average of 4 days after the date of admission ]
    Exploratory; comparison made between preadmission and discharge medication list

  45. Patient health questionnaire-2, score [ Time Frame: At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge ]
    Exploratory

  46. Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score [ Time Frame: At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge ]
    Exploratory

  47. Days at home since discharge [ Time Frame: 30 days after discharge ]
    Exploratory

  48. Walk around ward/home, y/n [ Time Frame: Date of discharge, an expected average of 4 days after the date of admission ]
    Exploratory

  49. Get to (non-commode) bathroom, y/n [ Time Frame: Date of discharge, an expected average of 4 days after the date of admission ]
    Exploratory

  50. Walk 1 flight of stairs, y/n [ Time Frame: Date of discharge, an expected average of 4 days after the date of admission ]
    Exploratory

  51. Visit with friends/family, y/n [ Time Frame: Date of discharge, an expected average of 4 days after the date of admission ]
    Exploratory

  52. Walk outside around my home, y/n [ Time Frame: Date of discharge, an expected average of 4 days after the date of admission ]
    Exploratory

  53. Go shopping, y/n [ Time Frame: Date of discharge, an expected average of 4 days after the date of admission ]
    Exploratory

  54. Time from admission decision to assessment by research assistant, minutes [ Time Frame: On the first day of admission, a maximum 24 hour period ]
    Exploratory

  55. Time from research assistant assessment to emergency department dismissal, minutes [ Time Frame: On the first day of admission, a maximum 24 hour period ]
    Exploratory

  56. Time from arrival home or to floor and medical doctor evaluation, minutes [ Time Frame: On the first day of admission, a maximum 24 hour period ]
    Exploratory

  57. Time from arrival home or to floor and registered nurse evaluation, minutes [ Time Frame: On the first day of admission, a maximum 24 hour period ]
    Exploratory

  58. Mean registered nurse to patient ratio [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory, intervention arm only

  59. Total registered nurse visits, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory, intervention arm only

  60. Total "on call" medical doctor interactions (video or phone), # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory, intervention arm only

  61. Total "on call" medical doctor in-person visits, # [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    Exploratory, intervention arm only

  62. Duration of 1st registered nurse visit, minutes [ Time Frame: On the first day of admission, a maximum 24 hour period ]
    Exploratory, intervention arm only

  63. Mean duration of subsequent registered nurse visit, minutes [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]
    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 either a 5-mile or 20 minute driving radius of emergency department
  • Has capacity to consent to study OR can assent to study and has proxy who can consent
  • >= 18 years-old
  • 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.
  • Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the 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
  • Acute delirium, as determined by the Confusion Assessment Method
  • Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
  • Secondary condition: end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
  • Primary diagnosis requires multiple or routine administrations of intravenous 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
  • High risk for clinical deterioration
  • Home hospital census is full (maximum 5 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): NCT03203759


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Vital Connect
Smiths Medical
Investigators
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Principal Investigator: Jeffrey 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 Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03203759    
Other Study ID Numbers: P001337
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Urologic Diseases
Renal Insufficiency