- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04639102
Practical Alternative to Hospitalization (PATH)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Austin Kilaru, MD, MSHP, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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