Practical Alternative to Hospitalization

Health Care Utilization Clinical Trial

— PATH  

Official title:

Practical Alternative to Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639102
• Other study ID #: 844436
• Status: Completed
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: July 2, 2021

Study information

• Verified date: August 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• PATH Intervention
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Independence Blue Cross

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	Days that patients are expired	The number of days that patients are expired	30 days
Secondary	Impact of PATH on hospital operations - Capture rate	Percentage of eligible patients enrolled into the program (capture rate)	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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.	5 months
Secondary	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).	5 months