Emergency Department Waiting Room CongestionNCT05831046
Emergency Department Re-evaluation Software Pilot Study
A study testing ED management software in people with Emergency Department Waiting Room Congestion, run by Duke University at 1 site in United States.
Trial summary
This is a research study to determine a method in improving emergency department waiting room care by using new software program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Department Waiting Room Congestion
- What is being tested?
- ED management software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minors
- Emergency Severity Index (ESI) class 1 patients
- Individual who cannot legally give consent
- Pregnant patients
- Non-english speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital Emergency Department
Durham, North Carolina, 27710
About this study
Official title: Pilot Study for Patient Re-evaluation Software to Improve Emergency Department Waiting Room Congestion
This is a research study to determine a method in improving emergency department waiting room care by using new software program.
Read the 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.
- Being tested
- ED management software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED management softwareOther
Patients utilize software after being screened, but prior to being re-evaluated by physician
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Patients who undergo use of the software prior to being re-evaluated by a physician Receives: Other: ED management software |
| Healthy Control | No intervention | Patients undergo care without using the software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 1 year
Secondary outcomes (1)
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.
Measured: Baseline, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start3 Oct 2023
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Department Waiting Room CongestionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Siewny, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831046
- Sponsor's protocol ID
- PRO00113113
- Status last verified
- Jan 2025
- First submitted
- 14 Apr 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Patient Re-evaluation Software to Improve Emergency Department Waiting Room Congestion
- ClinicalTrials.gov ID
- NCT05831046
- Acronym / sponsor ID
- PRO00113113
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Other: ED management softwarePatients who undergo use of the software prior to being re-evaluated by a physician |
| Healthy Control | No intervention | –Patients undergo care without using the software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Minors
- Emergency Severity Index (ESI) class 1 patients
- Individual who cannot legally give consent
- Pregnant patients
- Non-english speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED management softwarePatients utilize software after being screened, but prior to being re-evaluated by physician | Other | Study Arm |
Primary outcome
Change in LBTC (left before treatment complete) rates
Time frame: Baseline, up to 1 year
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.
1 secondary outcome
Change in disposition time
Time frame: Baseline, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Siewny, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED management software in people with Emergency Department Waiting Room Congestion, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LBTC (left before treatment complete) rates (time frame: Baseline, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.