Patient DischargeETOCNCT02533856
Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care
A study testing ETOC in people with Patient Discharge and Emergency Care, run by Thomas Jefferson University.
Trial summary
This is a randomized controlled trial to assess the relative effectiveness of providing Enhanced Transitions of Care (ETOC) to improve patient outcomes after discharge from the Emergency Department (ED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Discharge, Emergency Care
- What is being tested?
- ETOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2016
- 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
- Adult (18 yrs and older) patients
- Have had a previous ED visit or hospital admission in the 90 days prior to the current ED visit (at Thomas Jefferson University Hospital or Methodist Hospital)
- Have just completed evaluation in the Thomas Jefferson University Hospital Emergency Department for any problem,
- Are ready for discharge from the Thomas Jefferson University Hospital ED, and
- Provide informed consent
Who cannot join
- Non-English speaking patients
- Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order
- Patients who live outside Philadelphia area (unable to seek follow-up care in Philadelphia) or other condition known to preclude follow-up (such as no reliable access to a telephone)
- Patients in police custody or currently incarcerated individuals
- Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent
About this study
Official title: Randomized Control Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care
This is a randomized controlled trial to assess the relative effectiveness of providing Enhanced Transitions of Care (ETOC) to improve patient outcomes after discharge from the Emergency Department (ED). Patients who are being discharged from the ED and have had a previous ED visit or hospital admission within the Thomas Jefferson Hospital System (TJUH or Methodist) within the past 90 days will be eligible for enrollment in this trial. Patients who consent to enrollment will be randomized to discharge by usual care or discharge with ETOC as provided by the company BoardRounds.
- Conditions
- Patient Discharge, Emergency Care
- Being tested
- ETOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETOCOther
Services provided to assist patients in accessing needed healthcare services after emergency department discharge such as scheduling appointments, finding new doctors, getting medications, or addressing problems with insurance coverage.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Discharge from emergency department by usual care |
| ETOC | Experimental | Discharge from emergency department with increased support services provided by BoardRounds after ED discharge Receives: Other: ETOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report
30-day healthcare utilization will be measured by assessing the total number of ED treat-and-release visits, hospital admissions, and outpatient care visits in the 30 days after study enrollment - will be reported in aggregate and separately for each type of utilization (ED, inpatient hospital stay, office visit). Counts will be determined by medical record review for visits occurring within the health system, and will be supplemented by patient report in a 30-day survey to determine utilization outside the health system.
Measured: 30 days
Secondary outcomes (5)
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report
9-day healthcare utilization will be measured by assessing the total number of ED treat-and-release visits, hospital admissions, and outpatient care visits in the 30 days after study enrollment - will be reported in aggregate and separately for each type of utilization (ED, inpatient hospital stay, office visit). Counts will be determined by medical record review for visits occurring within the health system, and will be supplemented by patient report in a 30-day survey to determine utilization outside the health system.
Measured: 9 days
Description of types of and count (per type) of assistance received by patients in accessing needed healthcare services as assessed by patient survey
Patients will be surveyed at 30 days to determine the types of assistance received, and frequency with which each type was received, in accessing needed healthcare services since their discharge from the ED.
Measured: 30 days
Description of types of and count (per type) of assistance received by patients in accessing needed healthcare services as assessed by patient survey
Patients will be surveyed at 30 days to determine the types of assistance received, and frequency with which each type was received, in accessing needed healthcare services since their discharge from the ED.
Measured: 9 days
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Determination of whether patient had unmet needs (yes/no) in accessing needed healthcare services in the 30-days after ED discharge as identified by patient in a survey administered at 30 days post-discharge.
Measured: 30 days
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Determination of whether patient had unmet needs (yes/no) in accessing needed healthcare services in the 9-days after ED discharge as identified by patient in a survey administered at 9 days post-discharge.
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient DischargeStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533856
- Sponsor's protocol ID
- 15G.242
- Acronym
- ETOC
- Status last verified
- Oct 2016
- First submitted
- 21 Aug 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care
- ClinicalTrials.gov ID
- NCT02533856
- Acronym / sponsor ID
- ETOC / 15G.242
- Conditions
- Patient Discharge, Emergency Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Aug 2015 (estimated)
- 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.
This is a randomized controlled trial to assess the relative effectiveness of providing Enhanced Transitions of Care (ETOC) to improve patient outcomes after discharge from the Emergency Department (ED). Patients who are being discharged from the ED and have had a previous ED visit or hospital admission within the Thomas Jefferson Hospital System (TJUH or Methodist) within the past 90 days will be eligible for enrollment in this trial. Patients who consent to enrollment will be randomized to discharge by usual care or discharge with ETOC as provided by the company BoardRounds.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Discharge from emergency department by usual care |
| ETOC | Experimental | Other: ETOCDischarge from emergency department with increased support services provided by BoardRounds after ED discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18 yrs and older) patients
- Have had a previous ED visit or hospital admission in the 90 days prior to the current ED visit (at Thomas Jefferson University Hospital or Methodist Hospital)
- Have just completed evaluation in the Thomas Jefferson University Hospital Emergency Department for any problem,
- Are ready for discharge from the Thomas Jefferson University Hospital ED, and
- Provide informed consent
Key exclusion criteria (5 listed)
- Non-English speaking patients
- Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order
- Patients who live outside Philadelphia area (unable to seek follow-up care in Philadelphia) or other condition known to preclude follow-up (such as no reliable access to a telephone)
- Patients in police custody or currently incarcerated individuals
- Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent
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 |
|---|---|---|
| ETOCServices provided to assist patients in accessing needed healthcare services after emergency department discharge such as scheduling appointments, finding new doctors, getting medications, or addressing problems with insurance coverage. | Other | ETOC |
Primary outcome
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report
Time frame: 30 days
30-day healthcare utilization will be measured by assessing the total number of ED treat-and-release visits, hospital admissions, and outpatient care visits in the 30 days after study enrollment - will be reported in aggregate and separately for each type of utilization (ED, inpatient hospital stay, office visit). Counts will be determined by medical record review for visits occurring within the health system, and will be supplemented by patient report in a 30-day survey to determine utilization outside the health system.
5 secondary outcomes
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report
Time frame: 9 days
Description of types of and count (per type) of assistance received by patients in accessing needed healthcare services as assessed by patient survey
Time frame: 30 days
Description of types of and count (per type) of assistance received by patients in accessing needed healthcare services as assessed by patient survey
Time frame: 9 days
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Time frame: 30 days
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Time frame: 9 days
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 21 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ETOC in people with Patient Discharge and Emergency Care, run by Thomas Jefferson University.
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 5 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report (time frame: 30 days). 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 21 Oct 2016.