- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02533856
Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care (ETOC)
October 19, 2016 updated by: Thomas Jefferson University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
316
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
Discharge from emergency department by usual care
|
|
|
Experimental: ETOC
Discharge from emergency department with increased support services provided by BoardRounds after ED discharge
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report
Time Frame: 9 days
|
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.
|
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
|
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.
|
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
|
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.
|
9 days
|
|
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Time Frame: 30 days
|
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.
|
30 days
|
|
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Time Frame: 9 days
|
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.
|
9 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of unmet needs in accessing needed healthcare services as assessed in a patient survey
Time Frame: 30 days
|
This will be a descriptive outcome to describe the types and counts of unmet needs that are identified by patients in the 30-days after ED discharge, as assessed in a survey administered 30 days after discharge.
There will not be statistical analysis performed on this outcome, rather it will be descriptive and exploratory regarding patient primary struggles after ED discharge.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
August 21, 2015
First Submitted That Met QC Criteria
August 24, 2015
First Posted (Estimate)
August 27, 2015
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
October 19, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15G.242
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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