Back to results

Remote Physician Care for Home Hospital Patients

Primary Purpose

Infection, Heart Failure, Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Remote Visit

About this trial

This is an interventional treatment trial for Infection focused on measuring home hospital, hospital at home, hospital in the home

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham and Women's Hospital
Brigham and Women's Faulkner Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Remote Visit

In-Home Visit

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Unplanned readmission after index admission, y/n

Picker experience questionnaire, score

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

Global experience, score

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

Full Information

NCT ID

NCT04080570

First Posted

September 4, 2019

Last Updated

November 26, 2020

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04080570

Brief Title

Remote Physician Care for Home Hospital Patients

Official Title

Remote Physician Care for Home Hospital Patients: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

August 3, 2019 (Actual)

Primary Completion Date

April 27, 2020 (Actual)

Study Completion Date

April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Gout Flare, Chronic Kidney Diseases, Hypertensive Urgency, Atrial Fibrillation Rapid, Anticoagulants; Increased

Keywords

home hospital, hospital at home, hospital in the home

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remote Visit

Arm Type

Experimental

Arm Description

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

Arm Title

In-Home Visit

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Remote Visit

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse events, #

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Unplanned readmission after index admission, y/n

Time Frame

Day of discharge to 30 days later

Title

Picker experience questionnaire, score

Description

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

Time Frame

Day of discharge, an expected average of 4 days

Title

Global experience, score

Description

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

Time Frame

Day of discharge, an expected average of 4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Brigham and Women's Faulkner Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16330791

Citation

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.

Results Reference

background

PubMed Identifier

22665835

Citation

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.

Results Reference

background

PubMed Identifier

21077817

Citation

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.

Results Reference

background

PubMed Identifier

29411238

Citation

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.

Results Reference

background

PubMed Identifier

29946693

Citation

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.

Results Reference

background

PubMed Identifier

36040741

Citation

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.

Results Reference

derived

Learn more about this trial

Remote Physician Care for Home Hospital Patients

We'll reach out to this number within 24 hrs