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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: ETOC
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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