NCT04639102

Brief Summary

The investigators test the PATH program to evaluate whether the program allows patients to spend more days at home in comparison to patients who receive regular care. The program will involve patients from Penn Presbyterian Medical Center with a set of diagnoses and will provide patients with enhanced services upon discharge from the emergency department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

November 16, 2020

Last Update Submit

August 9, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Days at home over 30 days

    The number 30 minus the amount of days that patients spend in a hospital, nursing facility, or ED after discharge from the initial ED visit

    30 days

  • Days that patients are expired

    The number of days that patients are expired

    30 days

Secondary Outcomes (5)

  • Impact of PATH on hospital operations - Capture rate

    5 months

  • Quality of life at 30 days

    5 months

  • Functional status at 30 days

    5 months

  • Estimated cost (allowed charges) based on healthcare utilization

    5 months

  • Impact of PATH on hospital operations - percentage of hospitalized patients

    5 months

Study Arms (2)

PATH Intervention

EXPERIMENTAL

Patients in the treatment arm will receive a personalized plan of care upon discharge from the emergency department.

Other: PATH Intervention

Routine Care

NO INTERVENTION

Patients in the control arm will receive standard-of-care services (the care plan that the emergency physician would normally offer if PATH were not available) without PATH enrollment.

Interventions

Patients will receive an enhanced level of care and service: 1. Discharge planning- PATH clinicians will develop an individualized treatment plan at time of ED discharge. Each patient will receive next-day phone call to monitor status. There will be additional patient and family education, triage of new or worsening symptoms, and additional telephone contact as determined in treatment plan. There will be communication with home health teams as needed. 2. Care coordination- PATH clinicians will arrange necessary primary medical doctor and specialty appointments. They will also communicate treatment plan to outpatient provider and arrange transportation for patients. 3. Home monitoring/ Home Health Services- If patients are eligible and consent to home health services, they will be enrolled in Penn Medicine Home Health (PMHH). This will include virtual home monitoring, skilled nurse care, home physical and occupational therapists, social work services, and wound care.

PATH Intervention

Eligibility Criteria

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

You may qualify if:

  • Stable (Patients are deemed stable by ED clinician and PATH clinician per review of vital signs, history, exam, test results, and functional status)
  • Have active insurance
  • Domiciled at home (Patients must live in the community and not in nursing facility, shelter, or otherwise homeless)
  • Safe home environment
  • Live in Penn Medicine Home Health (PMHH) geographic catchment if enrolled in PMHH services

You may not qualify if:

  • Substance use disorder (No active untreated SUD, including alcohol, opioids, cocaine, or stimulants)
  • Serious mental health condition
  • Police custody
  • Homelessness
  • Anticipated procedures or surgeries
  • IV access (Patients with need for home infusion services or frequent blood testing after discharge must have standard level of IV access)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

EmergenciesPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Austin Kilaru, MD, MSHP

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

February 9, 2021

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations