Remote Physician Care for Home Hospital Patients

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04080570
Collaborator
(none)
172
2
2
8.8
86
9.8

Study Details

Study Description

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.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
172 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 :
Aug 3, 2019
Actual Primary Completion Date :
Apr 27, 2020
Actual Study Completion Date :
Apr 27, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adverse events, # [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 [Day of discharge to 30 days later]

  2. Picker experience questionnaire, score [Day of discharge, an expected average of 4 days]

    Score between 0 and 15, with higher scores signifying better experience

  3. Global experience, score [Day of discharge, an expected average of 4 days]

    Score between 0 and 10, with higher scores signifying better experience

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 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

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, Instructor in Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04080570
Other Study ID Numbers:
  • P002583
First Posted:
Sep 6, 2019
Last Update Posted:
Nov 30, 2020
Last Verified:
Nov 1, 2020
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
Keywords provided by David Levine, Instructor in Medicine, Brigham and Women's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2020