NCT04080570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

September 4, 2019

Last Update Submit

November 26, 2020

Conditions

Keywords

home hospitalhospital at homehospital in the home

Outcome Measures

Primary Outcomes (1)

  • Adverse events, #

    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.

    From date of admission to date of discharge (except for 30-day mortality), an expected average of 4 days

Secondary Outcomes (3)

  • Unplanned readmission after index admission, y/n

    Day of discharge to 30 days later

  • Picker experience questionnaire, score

    Day of discharge, an expected average of 4 days

  • Global experience, score

    Day of discharge, an expected average of 4 days

Study Arms (2)

Remote Visit

EXPERIMENTAL

After an initial physical in-home visit, the physician will see home hospitalized patients by facilitated video each day.

Other: Remote Visit

In-Home Visit

NO INTERVENTION

The physician will see home hospitalized patients physically in their homes each day, as is usual care.

Interventions

After an initial in-home visit, the physician will see home hospitalized patients by facilitated video.

Remote Visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (6)

  • Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.

    PMID: 16330791BACKGROUND
  • Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132.

    PMID: 22665835BACKGROUND
  • Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. doi: 10.5694/j.1326-5377.2010.tb04070.x.

    PMID: 21077817BACKGROUND
  • Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6.

    PMID: 29411238BACKGROUND
  • Federman AD, Soones T, DeCherrie LV, Leff B, Siu AL. Association of a Bundled Hospital-at-Home and 30-Day Postacute Transitional Care Program With Clinical Outcomes and Patient Experiences. JAMA Intern Med. 2018 Aug 1;178(8):1033-1040. doi: 10.1001/jamainternmed.2018.2562.

    PMID: 29946693BACKGROUND
  • Levine DM, Paz M, Burke K, Beaumont R, Boxer RB, Morris CA, Britton KA, Orav EJ, Schnipper JL. Remote vs In-home Physician Visits for Hospital-Level Care at Home: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2229067. doi: 10.1001/jamanetworkopen.2022.29067.

MeSH Terms

Conditions

InfectionsHeart FailurePulmonary Disease, Chronic ObstructiveAsthmaRenal Insufficiency, ChronicHypertensive Crisis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHypertensionVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Medicine

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 6, 2019

Study Start

August 3, 2019

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations