Remote Physician Care for Home Hospital Patients

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080570
• Other study ID #: P002583
• Status: Completed
• Phase: N/A
• Start date: August 3, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: November 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Remote Visit
After an initial in-home visit, the physician will see home hospitalized patients by facilitated video.

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 (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Unplanned readmission after index admission, y/n		Day of discharge to 30 days later
Secondary	Picker experience questionnaire, score	Score between 0 and 15, with higher scores signifying better experience	Day of discharge, an expected average of 4 days
Secondary	Global experience, score	Score between 0 and 10, with higher scores signifying better experience	Day of discharge, an expected average of 4 days