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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03203759
Other study ID # P001337
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2017
Est. completion date May 15, 2018

Study information

Verified date August 2018
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Home hospitalization
See above
Traditional inpatient hospitalization
See above

Locations

Country Name City State
United States Brigham and Women's Faulkner Hospital Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Brigham and Women's Hospital Smiths Medical, Vital Connect

Country where clinical trial is conducted

United States, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Other Total reimbursement, 30-day post discharge Exploratory Day of admission to 30-days post-discharge
Other Intravenous medications, days Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Intravenous fluids, days Exploratory; the number of days intravenous fluids (for example, normal saline) were received by the patient. From date of admission to date of discharge, an expected average of 4 days
Other Intravenous diuretics, days Exploratory; the number of days intravenous diuretics (for example, furosemide) were received by the patient. From date of admission to date of discharge, an expected average of 4 days
Other Intravenous antibiotics, days Exploratory; the number of days intravenous antibiotics (for example, ceftriaxone) were received by the patient. From date of admission to date of discharge, an expected average of 4 days
Other Supplemental oxygen required, days Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Nebulizer treatment, days Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Medical Doctor sessions, # notes Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Consultant sessions, # notes Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Physical therapy/occupational therapy sessions, # notes Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Primary care provider follow-up within 14 days, y/n Exploratory Day of discharge to 14 days later
Other Skilled nursing facility utilization, days Exploratory; the number of days a patient spent in a skilled nursing facility. Day of discharge to 30 days later
Other Home health utilization, days Exploratory Day of discharge to 30 days later
Other Fall, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hospital-acquired deep vein thrombosis or pulmonary embolism, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hospital-acquired pressure ulcer, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hospital-acquired thrombophlebitis at peripheral IV site, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hospital-acquired catheter-associated urinary tract infection, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hospital-acquired Clostridium difficile infection, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other All-cause mortality, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Unplanned mortality, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Post-discharge all-cause mortality, y/n Exploratory Day of discharge to 30 days later
Other Post-discharge unplanned mortality, y/n Exploratory Day of discharge to 30 days later
Other New arrhythmia, y/n Heart failure patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hypokalemia, y/n Heart failure patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Acute Kidney Injury, y/n Heart failure patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Mean Likert scale pain score, 0-10 Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hours of sleep per night, # Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hours of activity per night, # Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Hours of sitting upright per night, # Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Pneumococcal vaccination if appropriate, y/n Pneumonia patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Influenza vaccination if appropriate, y/n Pneumonia patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Smoking cessation counseling if appropriate, y/n Pneumonia and heart failure patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other 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 From date of admission to date of discharge, an expected average of 4 days
Other 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 From date of admission to date of discharge, an expected average of 4 days
Other Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n Heart failure patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n Heart failure patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n Heart failure patients only; Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Smoking status post-discharge; current/never/quit Heart failure and pneumonia patients only; Exploratory; Self-report of smoking status: current/never/quit. From date of admission to date of discharge, an expected average of 4 days
Other Use of inappropriate medications in the elderly, y/n Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria From date of admission to date of discharge, an expected average of 4 days
Other Use of Foley catheter, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other Use of restraints, y/n Exploratory From date of admission to date of discharge, an expected average of 4 days
Other >3 medications added to medication list, y/n Exploratory; comparison made between preadmission and discharge medication list Date of discharge, an expected average of 4 days after the date of admission
Other Patient health questionnaire-2, score Exploratory At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Other Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score Exploratory At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Other Days at home since discharge Exploratory 30 days after discharge
Other Walk around ward/home, y/n Exploratory Date of discharge, an expected average of 4 days after the date of admission
Other Get to (non-commode) bathroom, y/n Exploratory Date of discharge, an expected average of 4 days after the date of admission
Other Walk 1 flight of stairs, y/n Exploratory Date of discharge, an expected average of 4 days after the date of admission
Other Visit with friends/family, y/n Exploratory Date of discharge, an expected average of 4 days after the date of admission
Other Walk outside around my home, y/n Exploratory Date of discharge, an expected average of 4 days after the date of admission
Other Go shopping, y/n Exploratory Date of discharge, an expected average of 4 days after the date of admission
Other Time from admission decision to assessment by research assistant, minutes Exploratory On the first day of admission, a maximum 24 hour period
Other Time from research assistant assessment to emergency department dismissal, minutes Exploratory On the first day of admission, a maximum 24 hour period
Other Time from arrival home or to floor and medical doctor evaluation, minutes Exploratory On the first day of admission, a maximum 24 hour period
Other Time from arrival home or to floor and registered nurse evaluation, minutes Exploratory On the first day of admission, a maximum 24 hour period
Other Mean registered nurse to patient ratio Exploratory, intervention arm only From date of admission to date of discharge, an expected average of 4 days
Other Total registered nurse visits, # Exploratory, intervention arm only From date of admission to date of discharge, an expected average of 4 days
Other Total "on call" medical doctor interactions (video or phone), # Exploratory, intervention arm only From date of admission to date of discharge, an expected average of 4 days
Other Total "on call" medical doctor in-person visits, # Exploratory, intervention arm only From date of admission to date of discharge, an expected average of 4 days
Other Duration of 1st registered nurse visit, minutes Exploratory, intervention arm only On the first day of admission, a maximum 24 hour period
Other Mean duration of subsequent registered nurse visit, minutes Exploratory, intervention arm only From date of admission to date of discharge, an expected average of 4 days
Primary Total direct cost of hospitalization, $ From date of admission to date of discharge, an expected average of 4 days
Secondary Direct margin, $ Direct margin from total cost of hospitalization From date of admission to date of discharge, an expected average of 4 days
Secondary Direct margin, modeled with backfill Backfill uses a model that estimates the cost of patients who take the place of home hospital patients From date of admission to date of discharge, an expected average of 4 days
Secondary Total cost, 30-day post discharge Day of admission to 30-days post-discharge
Secondary Length of stay, days From date of admission to date of discharge, an expected average of 4 days
Secondary 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. From date of admission to date of discharge, an expected average of 4 days
Secondary 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. From date of admission to date of discharge, an expected average of 4 days
Secondary All-cause readmission(s) after index, # Day of discharge to 30 days later
Secondary All-cause readmission(s) after index, y/n Day of discharge to 30 days later
Secondary Unplanned readmission(s) after index, # Day of discharge to 30 days later
Secondary Unplanned readmission(s) after index, y/n Day of discharge to 30 days later
Secondary Emergency Department observation stay(s) after index hospitalization, # Day of discharge to 30 days later
Secondary Emergency Department observation stay(s) after index hospitalization, y/n Day of discharge to 30 days later
Secondary Emergency Department visit(s) after index hospitalization, # Day of discharge to 30 days later
Secondary Emergency Department visit(s) after index hospitalization, y/n Day of discharge to 30 days later
Secondary Delirium, y/n From date of admission to date of discharge, an expected average of 4 days
Secondary Transfer back to hospital, y/n Intervention arm only From date of admission to date of discharge, an expected average of 4 days
Secondary Hours of sleep per day, # From date of admission to date of discharge, an expected average of 4 days
Secondary Hours of activity per day, # From date of admission to date of discharge, an expected average of 4 days
Secondary Hours of sitting upright per day, # From date of admission to date of discharge, an expected average of 4 days
Secondary Steps per day, # From date of admission to date of discharge, an expected average of 4 days
Secondary EuroQol -5D-5L, composite score At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Secondary Short Form 1 1-5 Likert scale 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
Secondary 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
Secondary 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
Secondary 3-item Care Transition Measure, score 30 days after discharge
Secondary Picker Experience Questionnaire, score 30 days after discharge
Secondary Global satisfaction with care, score 30 days after discharge
Secondary Qualitative interview 30 days after discharge
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