Home Hospital for Suddenly Ill Adults

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03524222
Collaborator
(none)
3,000
2
1
67.4
1500
22.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Home Hospitalization
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Home Hospital for Suddenly Ill Adults: A Clinical Trial
Actual Study Start Date :
Jan 18, 2018
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Home Hospitalization

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

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

  1. Direct margin, $ [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 [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 [Day of admission to 30-days post-discharge]

  4. Length of stay, days [From date of admission to date of discharge, an expected average of 4 days]

  5. Imaging, # [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, # [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, # [Day of discharge to 30 days later]

  8. All-cause readmission(s) after index, y/n [Day of discharge to 30 days later]

  9. Unplanned readmission(s) after index, # [Day of discharge to 30 days later]

  10. Unplanned readmission(s) after index, y/n [Day of discharge to 30 days later]

  11. Emergency Department observation stay(s) after index hospitalization, # [Day of discharge to 30 days later]

  12. Emergency Department observation stay(s) after index hospitalization, y/n [Day of discharge to 30 days later]

  13. Emergency Department visit(s) after index hospitalization, # [Day of discharge to 30 days later]

  14. Emergency Department visit(s) after index hospitalization, y/n [Day of discharge to 30 days later]

  15. Delirium, y/n [From date of admission to date of discharge, an expected average of 4 days]

  16. Transfer back to hospital, y/n [From date of admission to date of discharge, an expected average of 4 days]

  17. Hours of sleep per day, # [From date of admission to date of discharge, an expected average of 4 days]

  18. Hours of activity per day, # [From date of admission to date of discharge, an expected average of 4 days]

  19. Hours of sitting upright per day, # [From date of admission to date of discharge, an expected average of 4 days]

  20. Steps per day, # [From date of admission to date of discharge, an expected average of 4 days]

  21. EuroQol-5D-5L, composite score [At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge]

  22. Short Form 1 [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: Excellent, very good, good, fair poor

  23. 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]

  24. 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]

  25. 3-item Care Transition Measure, score [30 days after discharge]

  26. Picker Experience Questionnaire, score [30 days after discharge]

  27. Global satisfaction with care, score [30 days after discharge]

  28. Qualitative interview [30 days after discharge]

Other Outcome Measures

  1. Total reimbursement, 30-days post discharge [Day of admission to 30-days post-discharge]

    Exploratory

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

    Exploratory

  3. Intravenous fluids, days [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 [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 [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 [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

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

    Exploratory

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

    Exploratory

  9. Consultant Sessions, # notes [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

  10. Physical therapy/occupational therapy sessions, # notes [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 [up to 14 days from day of discharge]

    Exploratory

  12. Skilled nursing facility usage, days [up to 30 days from day of discharge]

    Exploratory; the number of days a patient spent in a skilled nursing facility.

  13. Home health utilization, days [up to 30 days from day of discharge]

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

  25. New arrhythmia, y/n [From date of admission to date of discharge, an expected average of 4 days]

    Heart failure patients only; Exploratory

  26. Hypokalemia, y/n [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 [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 [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

  32. Pneumococcal vaccination if appropriate, y/n [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

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

    Exploratory

  44. >3 medications added to medication list, y/n [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 [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 [At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge]

    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

  47. Days at home since discharge [30 days after discharge]

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

  53. Go shopping, y/n [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 [On the first day of admission, a maximum 24 hour period]

    Exploratory

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

    Exploratory

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

    Exploratory

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

    Exploratory

  58. Mean registered nurse to patient ratio [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

  59. Total registered nurse visits, # [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

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

    Exploratory

  61. Total "on call" medical doctor in-person visits [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

  62. Duration of 1st registered nurse visit, minutes [On the first day of admission, a maximum 24 hour period]

    Exploratory

  63. Mean duration of subsequent registered nurse visit, minutes [From date of admission to date of discharge, an expected average of 4 days]

    Exploratory

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115
2 Brigham and Women's Faulkner Hospital Boston Massachusetts United States 02130

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
David Levine, David M Levine, MD, MPH, MA, Associate Physician, Brigham and Women's Hospital, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT03524222
Other Study ID Numbers:
  • 2017P002583
First Posted:
May 14, 2018
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021