Practical Alternative to Hospitalization

Not Applicable

Completed

• Conditions: Health, Subjective; Health Care Utilization; Emergency Department
• Interventions: Other: PATH Intervention

• Registration Number: NCT04639102
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Study Start: 2021-02-09
• Primary Completion: 2021-07-02
• Study Completion: 2021-07-02
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Days at home over 30 days	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	30 days	The number of days that patients are expired

Secondary Outcome Measures

Name	Time	Method
Impact of PATH on hospital operations - percentage of hospitalized patients	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).
Impact of PATH on hospital operations - Capture rate	5 months	Percentage of eligible patients enrolled into the program (capture rate)
Quality of life at 30 days	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.
Functional status at 30 days	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.
Estimated cost (allowed charges) based on healthcare utilization	5 months	This will be determined by calculating allowed charges for healthcare services delivered to patient over 30-day follow up period.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States