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Remote Physician Care for Home Hospital Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080570
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
David Levine, Brigham and Women's Hospital

Brief Summary:
This study examines the implications of providing remote physician care to home hospitalized patients compared to usual home hospital care with in-person/in-home physician visits.

Condition or disease Intervention/treatment Phase
Infection Heart Failure Chronic Obstructive Pulmonary Disease Asthma Gout Flare Chronic Kidney Diseases Hypertensive Urgency Atrial Fibrillation Rapid Anticoagulants; Increased Other: Remote Visit Not Applicable

Detailed Description:

Home hospital care is hospital-level care at home for acutely ill patients. In multiple publications, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models require a licensed independent practitioner to see their patients physically in their home.

To further improve the efficiency and scalability of home hospital care, the investigators propose to test remote care, where the physician would provide care via a video interaction, instead of in-home/in-person care. The investigators propose a non-inferiority evaluation of this intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Physician Care for Home Hospital Patients: A Randomized Controlled Trial
Actual Study Start Date : August 3, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remote Visit
After an initial physical in-home visit, the physician will see home hospitalized patients by facilitated video each day.
Other: Remote Visit
After an initial in-home visit, the physician will see home hospitalized patients by facilitated video.

No Intervention: In-Home Visit
The physician will see home hospitalized patients physically in their homes each day, as is usual care.



Primary Outcome Measures :
  1. Adverse events, # [ Time Frame: From date of admission to date of discharge (except for 30-day mortality), an expected average of 4 days ]
    The per patient count of adverse events, including fall, delirium, potentially preventable venous thromboembolism, new pressure ulcer, thrombophlebitis at peripheral IV site, catheter-associated urinary tract infection, new Clostridium difficile, new methicillin-resistant Staphylococcus aureus, new arrhythmia, hypokalemia, acute kidney injury, transfer back to hospital, mortality (unplanned) during admission, mortality (unplanned) 30-day post-discharge.


Secondary Outcome Measures :
  1. Unplanned readmission after index admission, y/n [ Time Frame: Day of discharge to 30 days later ]
  2. Picker experience questionnaire, score [ Time Frame: Day of discharge, an expected average of 4 days ]
    Score between 0 and 15, with higher scores signifying better experience

  3. Global experience, score [ Time Frame: Day of discharge, an expected average of 4 days ]
    Score between 0 and 10, with higher scores signifying better experience



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 Method2
  • Cannot establish peripheral access in emergency department (or access requires ultrasound guidance, unless point-of-care ultrasound is available)
  • Secondary condition: end-stage renal disease on hemodialysis, 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, unless home-based aides are available
  • As deemed by on-call MD, 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

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): NCT04080570


Contacts
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Contact: David Levine, MD, MPH, MA 617-732-7063 dmlevine@bwh.harvard.edu
Contact: Jeffrey Schnipper, MD, MPH 617-732-7063 jschnipper@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: David M Levine, MD MPH MA    617-732-7063    dmlevine@partners.org   
Principal Investigator: David M Levine, MD MPH MA         
Brigham and Women's Faulkner Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: David M Levine, MD MPH MA    617-732-5500    dmlevine@partners.org   
Principal Investigator: David M Levine, MD MPH MA         
Sponsors and Collaborators
Brigham and Women's Hospital
Publications:
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Responsible Party: David Levine, Instructor in Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04080570    
Other Study ID Numbers: P002583
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
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
Keywords provided by David Levine, Brigham and Women's Hospital:
home hospital
hospital at home
hospital in the home
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Kidney Diseases
Renal Insufficiency, Chronic
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency