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

Status

Completed

Intervention / Treatment

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.

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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