Practical Alternative to Hospitalization (PATH)

August 9, 2022 updated by: University of Pennsylvania
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PATH Intervention
Patients in the treatment arm will receive a personalized plan of care upon discharge from the emergency department.

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days at home over 30 days
Time Frame: 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
Time Frame: 30 days
The number of days that patients are expired
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of PATH on hospital operations - Capture rate
Time Frame: 5 months
Percentage of eligible patients enrolled into the program (capture rate)
5 months
Quality of life at 30 days
Time Frame: 5 months
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.
5 months
Functional status at 30 days
Time Frame: 5 months

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.

5 months
Estimated cost (allowed charges) based on healthcare utilization
Time Frame: 5 months
This will be determined by calculating allowed charges for healthcare services delivered to patient over 30-day follow up period.
5 months
Impact of PATH on hospital operations - percentage of hospitalized patients
Time Frame: 5 months
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).
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Austin Kilaru, MD, MSHP, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Actual)

July 2, 2021

Study Completion (Actual)

July 2, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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