Practical Alternative to Hospitalization

NCT ID: NCT04639102

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-09

Study Completion Date

2021-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emergency Department Health, Subjective Health Care Utilization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PATH Intervention

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

Group Type EXPERIMENTAL

PATH Intervention

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PATH Intervention

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Independence Blue Cross

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Austin Kilaru, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

844436

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Reducing Transition Drug Risk
NCT00370916 COMPLETED NA
The eDosette Pilot Study
NCT03513224 COMPLETED NA