Emergency DepartmentPATHNCT04639102
Practical Alternative to Hospitalization
A study testing PATH Intervention in people with Emergency Department and Health, Subjective, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Department, Health, Subjective, Health Care Utilization
- What is being tested?
- PATH Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 2 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Being tested
- PATH Intervention
- Medical subject headings
- Emergencies, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PATH Intervention | Experimental | Patients in the treatment arm will receive a personalized plan of care upon discharge from the emergency department. Receives: Other: PATH Intervention |
| Routine Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Days that patients are expired
The number of days that patients are expired
Measured: 30 days
Secondary outcomes (5)
Impact of PATH on hospital operations - Capture rate
Percentage of eligible patients enrolled into the program (capture rate)
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
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).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start9 Feb 2021
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency DepartmentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Independence Blue Cross
- Responsible party
- Sponsor
- Investigators
- Austin Kilaru, MD, MSHP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639102
- Sponsor's protocol ID
- 844436
- Acronym
- PATH
- Status last verified
- Aug 2022
- First submitted
- 16 Nov 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Alternative to Hospitalization
- ClinicalTrials.gov ID
- NCT04639102
- Acronym / sponsor ID
- PATH / 844436
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Independence Blue Cross
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATH Intervention | Experimental | Other: PATH InterventionPatients in the treatment arm will receive a personalized plan of care upon discharge from the emergency department. |
| Routine Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Substance use disorder (No active untreated SUD, including alcohol, opioids, cocaine, or stimulants)
- Serious mental health condition
- Police custody
- Homelessness
- Anticipated procedures or surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATH InterventionPatients 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. | Other | PATH Intervention |
Primary outcome
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
Days that patients are expired
Time frame: 30 days
The number of days that patients are expired
5 secondary outcomes
Impact of PATH on hospital operations - Capture rate
Time frame: 5 months
Quality of life at 30 days
Time frame: 5 months
Functional status at 30 days
Time frame: 5 months
Estimated cost (allowed charges) based on healthcare utilization
Time frame: 5 months
Impact of PATH on hospital operations - percentage of hospitalized patients
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austin Kilaru, MD, MSHP principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH Intervention in people with Emergency Department and Health, Subjective, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days at home over 30 days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.