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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02533856
Other study ID # 15G.242
Secondary ID
Status Completed
Phase N/A
First received August 21, 2015
Last updated October 19, 2016
Start date August 2015
Est. completion date May 2016

Study information

Verified date October 2016
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 316
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Outcome

Type Measure Description Time frame Safety issue
Other Description of unmet needs in accessing needed healthcare services as assessed in a patient survey 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 No
Primary 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. 30 days No
Secondary 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. 9 days No
Secondary 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. 30 days No
Secondary 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. 9 days No
Secondary 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. 30 days No
Secondary 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. 9 days No
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