Practical Alternative to Hospitalization (PATH)
Primary Purpose
Emergency Department, Health, Subjective, Health Care Utilization
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PATH Intervention
Sponsored by

About this trial
This is an interventional other trial for Emergency Department
Eligibility Criteria
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)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PATH Intervention
Routine Care
Arm Description
Patients in the treatment arm will receive a personalized plan of care upon discharge from the emergency department.
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.
Outcomes
Primary Outcome Measures
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
Days that patients are expired
The number of days that patients are expired
Secondary Outcome Measures
Impact of PATH on hospital operations - Capture rate
Percentage of eligible patients enrolled into the program (capture rate)
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.
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.
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.
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).
Full Information
NCT ID
NCT04639102
First Posted
November 16, 2020
Last Updated
August 9, 2022
Sponsor
University of Pennsylvania
Collaborators
Independence Blue Cross
1. Study Identification
Unique Protocol Identification Number
NCT04639102
Brief Title
Practical Alternative to Hospitalization
Acronym
PATH
Official Title
Practical Alternative to Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Independence Blue Cross
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Department, Health, Subjective, Health Care Utilization
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PATH Intervention
Arm Type
Experimental
Arm Description
Patients in the treatment arm will receive a personalized plan of care upon discharge from the emergency department.
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PATH Intervention
Intervention Description
Patients will receive an enhanced level of care and service:
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.
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.
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.
Primary Outcome Measure Information:
Title
Days at home over 30 days
Description
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
Title
Days that patients are expired
Description
The number of days that patients are expired
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Impact of PATH on hospital operations - Capture rate
Description
Percentage of eligible patients enrolled into the program (capture rate)
Time Frame
5 months
Title
Quality of life at 30 days
Description
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
Title
Functional status at 30 days
Description
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
Title
Estimated cost (allowed charges) based on healthcare utilization
Description
This will be determined by calculating allowed charges for healthcare services delivered to patient over 30-day follow up period.
Time Frame
5 months
Title
Impact of PATH on hospital operations - percentage of hospitalized patients
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Austin Kilaru, MD, MSHP
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Practical Alternative to Hospitalization
We'll reach out to this number within 24 hrs