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NCT Number: NCT03203759

Hospital-Level Care at Home for Acutely Ill Adults

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.

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Key information

Conditions

Infection Anticoagulants; Increased Asthma Atrial Fibrillation Rapid Bronchial Diseases COPD Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gout Flare Heart Diseases Heart Failure Hypersensitivity Hypersensitivity, Immediate Hypertension Hypertensive Crisis Hypertensive Urgency Immune System Diseases Infections Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Hypersensitivity Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Faulkner Hospital, Boston, Massachusetts, United States

Loading trial locations.

About this study

Hospitals are the standard of care for acute illness in the United States, but hospital care is expensive and often unsafe, especially for older individuals. While admitted, 20% suffer delirium, over 5% contract hospital-acquired infections, and most lose functional status that is never regained. Timely access to inpatient care is poor: many hospital wards are typically over 100% capacity, and emergency department waits can be protracted. Moreover, hospital care is increasingly costly: many internal medicine admissions have a negative margin (i.e., expenditures exceed hospital revenues) and incur patient debt.

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, 20% reduced cost, and 20% improved patient experience. While this is the standard of care in several developed countries, only 2 non-randomized demonstration projects have been conducted in the United States, each with highly local needs. Taken together, home hospital evidence is promising but falls short due to non-robust experimental design, failure to implement modern medical technology, and poor enlistment of community support.

The home hospital module offers most of the same medical components that are standard of care in an acute care hospital. The typical staff (medical doctor [MD], registered nurse [RN], case manager), diagnostics (blood tests, vital signs, telemetry, x-ray, and ultrasound), intravenous therapy, and oxygen/nebulizer therapy will all be available for home hospital. Optional deployment of food services, home health aide, physical therapist, occupational therapist, and social worker will be tailored to patient need. Home hospital improves upon the components of a typical ward's standard of care in several ways:

Point of care blood diagnostics (results at the bedside in <5 minutes); Minimally invasive continuous vital signs, telemetry, activity tracking, and sleep tracking; 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Home hospitalization

Other

See above

Traditional inpatient hospitalization

Other

See above

Primary outcomes

  1. Total direct cost of hospitalization, $

    Time frame: From date of admission to date of discharge, an expected average of 4 days

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Smiths Medical
  • Vital Connect

Registry information

Official study title

Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2017
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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