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CompletedNCT04639102PATHUpdated Aug 10, 2022

Practical Alternative to Hospitalization

An interventional study of PATH Intervention in Emergency Department, Health, Subjective and Health Care Utilization, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The PATH program seeks to provide patients with enhanced services upon discharge from the emergency department, including visiting home nurses, visiting home physical and occupational therapists, scheduled frequent telephone visits with a medical provider, care coordination to arrange outpatient evaluation and testing, social work services, and other services. The purpose of this study is to evaluate whether the PATH program allows patients to spend more days at home in comparison to patients who receive regular care.

The broad goal of this program is to provide patients with a personalized package of enhanced services following discharge from the emergency department. In some cases, patients enrolled in the PATH program are likely to be discharged home regardless of enrollment, but are deemed potentially high-risk for returning to the hospital due to their illness or other factors. In other cases, enrolled patients might otherwise have been hospitalized but decide with their clinician that recovery at home is possible with the increased supervision and care provided by PATH. For all patients, we seek to determine whether PATH is effective in expediting patient recovery from acute illness and reduce the time spent in hospital or nursing facilities.

02

Conditions studied

  • Emergency Department
  • Health, Subjective
  • Health Care Utilization
03

In context

Emergencies

1,721 studies on the registry are indexed under Emergencies; 335 are open to participants now.

This study's enrollment of 72 is below the median of 144 across 948 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    PATH Intervention

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

    Other: PATH Intervention

  • No intervention
    Routine Care

    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

  • OtherPATH Intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

  2. Days that patients are expired

    The number of days that patients are expired

    Time frame: 30 days

Secondary outcomes

  1. Impact of PATH on hospital operations - Capture rate

    Percentage of eligible patients enrolled into the program (capture rate)

    Time frame: 5 months

  2. Quality of life at 30 days

    This will be measured using the EQ-5D-5L questionnaire. This questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area.

    Time frame: 5 months

  3. Functional status at 30 days

    This will be measured using the Lawton and Brody Instrumental Activities of Daily Living (Lawton-Brody IADL) Scale. This instrument assesses independent living skills and functional ability with 8 questions, including behaviors like telephoning, shopping, food preparation, housekeeping, laundering, use of transportation, use of medicine, and financial behavior. The scale is scored dichotomously (0= less able, 1= more able). The higher the score, the greater the person's abilities. Women are scored on all 8 areas of function, but, for men, the areas of food preparation, housekeeping, laundering are excluded. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 to 5 for men.

    Time frame: 5 months

  4. Estimated cost (allowed charges) based on healthcare utilization

    This will be determined by calculating allowed charges for healthcare services delivered to patient over 30-day follow up period.

    Time frame: 5 months

  5. Impact of PATH on hospital operations - percentage of hospitalized patients

    Measured by potential eligible hospitalizations (patients screened as eligible if more likely to have been hospitalized from the ED); actual avoided hospitalizations (patients more likely to have been hospitalized from the ED who are enrolled in either treatment or control arm); and actual avoided hospitalizations (patients more likely to have been hospitalized from the ED and enrolled in the treatment arm).

    Time frame: 5 months

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04639102
Collaborators
Independence Blue Cross
Responsible party
Sponsor
First posted
Nov 20, 2020
Start date
Feb 9, 2021
Primary completion
Jul 2, 2021
Completion
Jul 2, 2021
Last update
Aug 10, 2022

Study contacts

Austin Kilaru, MD, MSHP
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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