Back to resultsED Re-evaluation Software Pilot Study
Primary Purpose
Emergency Department Waiting Room Congestion
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ED management software
Sponsored by
About this trial
This is an interventional health services research trial for Emergency Department Waiting Room Congestion
Eligibility Criteria
Inclusion: Individuals that are 18 and older who have been identified with completed lab work. Their primary language must be English to follow the instructions of the study. Cognitively sound Exclusion: Minors Emergency Severity Index (ESI) class 1 patients Individual who cannot legally give consent Pregnant patients Non-english speakers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study Arm
Healthy Control
Arm Description
Patients who undergo use of the software prior to being re-evaluated by a physician
Patients undergo care without using the software
Outcomes
Primary Outcome Measures
Change in LBTC (left before treatment complete) rates
The primary objective of this study is to determine efficacy of the designed software, which focuses on the identification and disposition of patients who would otherwise become left before treatment complete (LBTC) patients in the ED waiting room.
Secondary Outcome Measures
Change in disposition time
This study will also track the total time from study intervention to disposition to determine if utilization of the software decreases disposition time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05831046
Brief Title
ED Re-evaluation Software Pilot Study
Official Title
Pilot Study for Patient Re-evaluation Software to Improve Emergency Department Waiting Room Congestion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a research study to determine a method in improving emergency department waiting room care by using new software program.
Detailed Description
This is a pilot study to determine the effectiveness of an emergency department re-evaluation software, to improve patient flow through an emergency department. The end goal of the study is to provide proof of the efficacy of the software and provide data such that the software can be improved upon. The study will include ED waiting room patients. The study will involve interaction with the software on a tablet for patients and software on a desktop for providers. The providers utilizing the software will not be considered part of the study, but rather focusing on the outcomes of the patients using the software. Patients will be selected by the provider as available for re-evaluation. Each patient will then be randomized into either a control group (software not used) and a "study" group (software used). Data analysis will be performed in conjunction with clinical statisticians at our institution. The risks of this study are primarily derived from patient privacy concerns, which have been addressed in the risk section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Department Waiting Room Congestion
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Patients who undergo use of the software prior to being re-evaluated by a physician
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Patients undergo care without using the software
Intervention Type
Other
Intervention Name(s)
ED management software
Intervention Description
Patients utilize software after being screened, but prior to being re-evaluated by physician
Primary Outcome Measure Information:
Title
Change in LBTC (left before treatment complete) rates
Description
The primary objective of this study is to determine efficacy of the designed software, which focuses on the identification and disposition of patients who would otherwise become left before treatment complete (LBTC) patients in the ED waiting room.
Time Frame
Baseline, up to 1 year
Secondary Outcome Measure Information:
Title
Change in disposition time
Description
This study will also track the total time from study intervention to disposition to determine if utilization of the software decreases disposition time.
Time Frame
Baseline, up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion:
Individuals that are 18 and older who have been identified with completed lab work.
Their primary language must be English to follow the instructions of the study.
Cognitively sound
Exclusion:
Minors
Emergency Severity Index (ESI) class 1 patients
Individual who cannot legally give consent
Pregnant patients
Non-english speakers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell Veverka, MD
Phone
919-681-0907
Email
mitchell.veverka@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Siewny, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ED Re-evaluation Software Pilot Study
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