Back to resultsTrial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care (ETOC)
Primary Purpose
Patient Discharge, Emergency Care
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ETOC
Sponsored by
About this trial
This is an interventional supportive care trial for Patient Discharge
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
ETOC
Arm Description
Discharge from emergency department by usual care
Discharge from emergency department with increased support services provided by BoardRounds after ED discharge
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02533856
First Posted
August 21, 2015
Last Updated
October 19, 2016
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT02533856
Brief Title
Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care
Acronym
ETOC
Official Title
Randomized Control Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Discharge, Emergency Care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Discharge from emergency department by usual care
Arm Title
ETOC
Arm Type
Experimental
Arm Description
Discharge from emergency department with increased support services provided by BoardRounds after ED discharge
Intervention Type
Other
Intervention Name(s)
ETOC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Total number of ED visits, hospital admissions, and outpatient office visits as determined by medical record review and patient report
Description
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.
Time Frame
9 days
Title
Description of types of and count (per type) of assistance received by patients in accessing needed healthcare services as assessed by patient survey
Description
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.
Time Frame
30 days
Title
Description of types of and count (per type) of assistance received by patients in accessing needed healthcare services as assessed by patient survey
Description
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.
Time Frame
9 days
Title
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Description
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.
Time Frame
30 days
Title
Assessment of whether patient had unmet needs in accessing needed healthcare services, as determined by patient survey
Description
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.
Time Frame
9 days
Other Pre-specified Outcome Measures:
Title
Description of unmet needs in accessing needed healthcare services as assessed in a patient survey
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Trial of Emergency Department Discharge With Enhanced Transitions of Care Compared to Usual Care
We'll reach out to this number within 24 hrs