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History of Changes for Study: NCT03203759
Hospital-Level Care at Home for Acutely Ill Adults
Latest version (submitted August 27, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 28, 2017 None (earliest Version on record)
2 July 7, 2017 Recruitment Status, Study Status and Contacts/Locations
3 August 27, 2018 Recruitment Status, Study Status, Contacts/Locations, Study Design, Arms and Interventions and Study Description
Comparison Format:

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Study NCT03203759
Submitted Date:  June 28, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: P001337
Brief Title: Hospital-Level Care at Home for Acutely Ill Adults
Official Title: Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Not yet recruiting
Study Start: June 2017
Primary Completion: February 2018 [Anticipated]
Study Completion: April 2018 [Anticipated]
First Submitted: June 5, 2017
First Submitted that
Met QC Criteria:
June 28, 2017
First Posted: June 29, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 28, 2017
Last Update Posted: June 29, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Brigham and Women's Hospital
Responsible Party: Principal Investigator
Investigator: Jeffrey L. Schnipper, MD.,MPH.
Official Title: Associate Professor
Affiliation: Brigham and Women's Hospital
Collaborators: Vital Connect
Smiths Medical
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: Infection
Heart Failure
COPD
Asthma
Gout Flare
Chronic Kidney Diseases
Hypertensive Urgency
Atrial Fibrillation Rapid
Anticoagulants; Increased
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 90 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
Home hospitalization
See above
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Total direct cost of hospitalization, $
From date of admission to date of discharge, an expected average of 4 days
Secondary Outcome Measures:
2. Direct margin, $
Direct margin from total cost of hospitalization

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

[Time Frame: From date of admission to date of discharge, an expected average of 4 days]
4. Total cost, 30-day post discharge
Day of admission to 30-days post-discharge
5. Length of stay, days
From date of admission to date of discharge, an expected average of 4 days
6. Imaging, #
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.

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

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

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

[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. Activities of daily living, score
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. Instrumental activities of daily living, score
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
26. 3-item Care Transition Measure, score
30 days after discharge
27. Picker Experience Questionnaire, score
30 days after discharge
28. Global satisfaction with care, score
30 days after discharge
29. Qualitative interview
30 days after discharge
Other Pre-specified Outcome Measures:
30. Total reimbursement, 30-day post discharge
Exploratory

[Time Frame: Day of admission to 30-days post-discharge]
31. Intravenous medications, days
Exploratory

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

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

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

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

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

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

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

[Time Frame: From date of admission to date of discharge, an expected average of 4 days]
39. Physical therapy/occupational therapy sessions, # notes
Exploratory

[Time Frame: From date of admission to date of discharge, an expected average of 4 days]
40. Primary care provider follow-up within 14 days, y/n
Exploratory

[Time Frame: Day of discharge to 14 days later]
41. Skilled nursing facility utilization, days
Exploratory; the number of days a patient spent in a skilled nursing facility.

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

[Time Frame: Day of discharge to 30 days later]
43. Fall, y/n
Exploratory

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

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

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

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

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

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

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

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

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

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

[Time Frame: Day of discharge to 30 days later]
54. New arrhythmia, y/n
Heart failure patients only; Exploratory

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

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

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

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

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

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

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

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

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

[Time Frame: From date of admission to date of discharge, an expected average of 4 days]
64. Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n
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

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

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

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

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

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

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

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

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

[Time Frame: From date of admission to date of discharge, an expected average of 4 days]
73. >3 medications added to medication list, y/n
Exploratory; comparison made between preadmission and discharge medication list

[Time Frame: Date of discharge, an expected average of 4 days after the date of admission]
74. Patient health questionnaire-2, score
Exploratory

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

[Time Frame: At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge]
76. Days at home since discharge
Exploratory

[Time Frame: 30 days after discharge]
77. Walk around ward/home, y/n
Exploratory

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

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

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

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

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

[Time Frame: Date of discharge, an expected average of 4 days after the date of admission]
83. Time from admission decision to assessment by research assistant, minutes
Exploratory

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

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

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

[Time Frame: On the first day of admission, a maximum 24 hour period]
87. Mean registered nurse to patient ratio
Exploratory, intervention arm only

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

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

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

[Time Frame: From date of admission to date of discharge, an expected average of 4 days]
91. Duration of 1st registered nurse visit, minutes
Exploratory, intervention arm only

[Time Frame: On the first day of admission, a maximum 24 hour period]
92. Mean duration of subsequent registered nurse visit, minutes
Exploratory, intervention arm only

[Time Frame: From date of admission to date of discharge, an expected average of 4 days]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Central Contact Person: Jeffrey Schnipper, MD MPH
Telephone: 617-732-7063
Email: jschnipper@partners.org
Central Contact Backup: David Levine, MD MA
Telephone: 617-732-7063
Email: dmlevine@partners.org
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. PubMed 16330791
Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132. PubMed 22665835
Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478. PubMed 23608775
Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24. Review. PubMed 19347026
Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. PubMed 11129745
Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. PubMed 21077817
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