NCT02864420

Brief Summary

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

First Submitted

Initial submission to the registry

August 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

August 3, 2016

Last Update Submit

July 7, 2017

Conditions

PneumoniaHeart FailureCellulitisUrinary Tract Infections

Keywords

home hospitalacute care homecare redesigndelivery innovationheart failurepneumoniacellulitisurinary tract infections

Outcome Measures

Primary Outcomes (1)

  • Total cost of hospitalization, $

    Day of admission to day of discharge

Secondary Outcomes (24)

  • Direct margin, $

    Day of admission to day of discharge

  • Direct margin, modeled with backfill, $

    Day of admission to day of discharge

  • Length of stay, days

    Day of admission to day of discharge

  • Imaging, #

    Day of admission to day of discharge

  • Lab Orders, #

    Day of admission to day of discharge

  • +19 more secondary outcomes

Other Outcomes (57)

  • Total cost of episode of care, $

    Day of admission to 30 days after discharge

  • Intraveneous medications, days

    Day of admission to day of discharge

  • Intraveneous fluids, days

    Day of admission to day of discharge

  • +54 more other outcomes

Study Arms (2)

Inpatient hospitalization

ACTIVE COMPARATOR

Control / usual care arm. Patients are admitted per usual to an inpatient service. Patients' medical records will be closely monitored. Patients will wear a vitals and activity monitor whose data is used only retrospectively. On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health.

Other: Inpatient Hospitalization

Home hospitalization

EXPERIMENTAL

Intervention arm. Patients will return home after triage, diagnosis, and the beginning of treatment in the emergency department with a set of specialized patient-tailored services (listed above). On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health.

Other: Home hospitalization

Interventions

Home hospitalizationOTHER
Home hospitalization
Inpatient HospitalizationOTHER
Inpatient hospitalization

Eligibility Criteria

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

You may qualify if:

  • Resides within 5-mile radius of emergency room
  • English- or Spanish-speaker
  • 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.
  • This criterion may be waived for highly competent patients at the patient and clinician's discretion.
  • \>=18 years old
  • Primary diagnosis of cellulitis, heart failure, complicated urinary tract infection, or pneumonia that requires inpatient admission as determined by blinded 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
  • Cared for by a private primary care physician who rounds in the hospital
  • Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
  • Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
  • Primary diagnosis requires narcotics for pain control
  • Cannot independently ambulate to bedside commode
  • As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
  • For pneumonia:
  • Most recent CURB65 \> 3: new confusion, blood urea nitrogen \> 19mg/dL, respiratory rate\>=30/min, systolic blood pressure\<90mmHg, Age\>=65
  • Most recent SMRTCO \> 2: systolic blood pressure \< 90mmHg (2pts), multilobar chest xray involvement (1pt), respiratory rate \>= 30/min, heart rate \>= 125, new confusion, oxygen saturation \<= 90%
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (7)

  • 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

  • Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478.

    PMID: 23608775BACKGROUND

  • Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.

    PMID: 19347026BACKGROUND

  • Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x.

    PMID: 11129745BACKGROUND

  • 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: 29411238DERIVED

MeSH Terms

Conditions

PneumoniaHeart FailureCellulitisUrinary Tract Infections

Interventions

Length of Stay

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesHeart DiseasesCardiovascular DiseasesSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

HospitalizationPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jeffrey L Schnipper, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

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
Associate Physician

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 12, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)