Emergency Department Re-evaluation Software Pilot Study

NCT ID: NCT05831046

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2025-06-10

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.

Conditions

Emergency Department Waiting Room Congestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Study Arm

Patients who undergo use of the software prior to being re-evaluated by a physician

Group Type: EXPERIMENTAL

ED management software

Intervention Type: OTHER

Patients utilize software after being screened, but prior to being re-evaluated by physician

Healthy Control

Patients undergo care without using the software

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ED management software

Patients utilize software after being screened, but prior to being re-evaluated by physician

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Siewny, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Hospital Emergency Department

Durham, North Carolina, United States

Countries

United States

Other Identifiers

PRO00113113

Identifier Type: -

Identifier Source: org_study_id