Electronic Health RecordsNCT05937646
Improving Providers' Decision-Making and Reducing Information Overload Using Information Visualization in EHRs
A study testing AWARE and Electronic Health Record (EHR) in people with Electronic Health Records and Usability, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study aims to test the efficacy of an information visualization dashboard on decision-making using a randomized controlled trial with crossover. This study aims to test the efficacy of using an information visualization dashboard on ICU providers' decision-making, efficiency, and performance compared to their… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Electronic Health Records, Usability, Information Seeking Behavior
- What is being tested?
- AWARE and Electronic Health Record (EHR)
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 30 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU physicians and advanced practice providers (APPs),
- active full time ICU service,
- use an institutional EHR (Epic or Cerner) to deliver care, and
- reads and speaks English;
- Residents
- prior ICU rotation experience,
Show all 11Show fewer
- use an institutional EHR (Epic or Cerner) to deliver care, and
- reads and speaks English;
- Combined Exclusion Criteria:
- Non-ICU Physicians or APPs,
- residents with no prior ICU experience
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
This study aims to test the efficacy of an information visualization dashboard on decision-making using a randomized controlled trial with crossover.
This study aims to test the efficacy of using an information visualization dashboard on ICU providers' decision-making, efficiency, and performance compared to their institutional EHR through a randomized control trial with crossover.
Read the detailed description
Electronic Health Records (EHRs) are a major source of data for ICU clinicians. Synthesizing complex, electronic patient data is key to effective care delivery. EHRs contain both a record of past medical data and present continuous flows of new clinical data from various sources such as physiological inputs, laboratory results, imaging studies, and clinician notes. This complex, continuous stream of patient data can contribute to information overload, which can create barriers to the key cognitive tasks of data identification, extraction, and interpretation. Intensive Care Unit (ICU) providers must quickly synthesize data from more than 200 variables during critical care rounds, with critically ill patients generating a median of 1348 individual data points per day. Information overload has been identified as a key factor in the misinterpretation of data, leading to medical errors such as misdiagnoses. Improving our understanding of information overload-and investigations into new efforts to minimize it-can improve clinician workflow and productivity as well as patient safety. The objective of this study is to explore the impact of current data representation in the EHR on ICU clinicians' cognitive workload, performance, and satisfaction. The research design uses a mixed methods approach, including eye-tracking assessment and surveys, to assess the efficacy of current EHR interfaces for ICU clinicians in live and simulated environments.
The investigators will randomize consented participants into two groups: the control (EHR) group and the intervention (AWARE) group. During the Randomized Controlled Trial (RCT) crossover, providers in each group will review the same patient records and will perform the same tasks, and complete the same survey instruments. Providers in the control groups will review two patient cases in their institution EHR (Epic or Cerner) first and then, two new cases in AWARE, and providers in the intervention group will review two patient cases in AWARE and then two new cases in the EHR. Cases will be randomized to eliminate order bias and selection bias.
For the cases in the EHR, participants will navigate through the EHR as per their usual routine in the ICU, with no added training sessions before the study. For the cases in AWARE, participants will receive a short training presentation by the study team, explaining the functionality and design of AWARE. Also, a day before each session, the RA will send an email to the provider with a short demonstration video of AWARE to become familiar with the tool.
The study will be conducted in simulation or Biobehavioral labs at each site. The PI, or research assistant, will explain the study procedure and obtain consent; participants will be asked to use Tobii Pro Fusion during the session, participants will not need to wear anything, the eye-tracker will be mounted to the monitor. During the session, participants will review 2 patient cases in their institutional EHR and two in AWARE. After the participant completes the patient record review, the research assistant (RA) will ask the participant a series of decision-based Q\&A activities requiring verbal responses or task completion in the EHR or AWARE. The provider may use the EHR or AWARE to complete the Q\&A activity. Cases will be in random order for each participant to avoid selection or order bias. After usability testing, the investigators will ask the participant to fill out the NASA-TLX survey and the System Usability Scale (SUS). The NASA-TLX measures the perceived workload of using the EHR, and the SUS measures the level of satisfaction as a result of using the EHR. All sessions will be recorded.
- Being tested
- AWARE, Electronic Health Record (EHR)
- Keywords
- Visualization
- Medical subject headings
- Information Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWAREDevice
AWARE is a platform with a visualization dashboard that sits on top of pre-existing, comprehensive EHR systems. AWARE provides clinical decision support tools for the ICU, Emergency Departments and other critical care areas right at the patient's bedside.
Electronic Health Record (EHR)Device
An Electronic Health Record (EHR) is an electronic version of a patients medical history, that is maintained by the provider over time, and may include all of the key administrative clinical data relevant to that persons care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports.
| Study group | Role | What they receive |
|---|---|---|
| EHR (Control), then AWARE | Experimental | In this hour-long task, participants in this arm will first review and complete tasks using the institutional EHR. Then after an approximate 5 minute rest, participants will then review and complete tasks using AWARE. Receives: Device: AWARE; Device: Electronic Health Record (EHR) |
| AWARE Intervention, then EHR (Control) | Experimental | In this hour-long task, participants in this arm will first review and complete tasks using the AWARE intervention. Then after an approximate 5 minute rest, participants will then review and complete tasks using the institutional EHR. Receives: Device: AWARE; Device: Electronic Health Record (EHR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Task Completion
To assess the amount of time required to make a decision (i.e., complete a task), participants will be asked to find the answers to clinical questions and the average amount of time needed to answer will be reported.
Measured: Duration of Single Usability Session, up to 25 minutes
Overall Mean Task Scores
To measure performance, participants will be scored on the overall average responses to 8 questions using the following: 0 points for an incorrect response, 0.5 points for a partially correct response, and 1 point for correct responses. Overall mean score for the 8 questions combined is reported.
Measured: Duration of Single Usability Session, up to 25 minutes
Time to Case Completion
To measure efficiency, participants' time to complete a patient case (chart review and tasks) will be recorded and reported in minutes.
Measured: Duration of Single Usability Session, up to 25 minutes
Number of Clicks Per Case
To measure efficiency, participants' number of mouse clicks to complete case review and tasks will be recorded.
Measured: Duration of Single Usability Session, up to 25 minutes
Mean Number of Fatigue Instances Per Case
Physiologic fatigue will be measured using an eye tracking device to capture changes in pupil size (which represents cognitive fatigue). A fatigue instance was recorded whenever the participant's pupil diameter dropped below the subject-specific fatigue threshold. For every provider-interface combination, the investigators calculated the mean and standard deviation of these one-second pupil diameter values and defined the subject-specific fatigue threshold as the individual mean minus 1.5 standard deviations.
Measured: Duration of Single Usability Session, up to 25 minutes
System Usability Scale Survey Score
Perceived satisfaction measured using the System Usability Scale survey. Values range from a minimum of 0 to a maximum of 10. Higher scores indicate higher satisfaction (better). The overall score is reported and ranges from 0 to 100. It is expected to take 2-3 minutes to complete this survey.
Measured: Immediately following each intervention, within approximately 2-3 minutes
Secondary outcomes (2)
Perceived Workload Score
The NASA-Task Load Index (TLX) measures perceived workload using 6 subscale questions. Scores are reported as an overall total ranging from a minimum of 0 to a maximum of 100. Higher scores indicate higher workload (worse). It is expected to take 1-2 minutes to complete this index.
Measured: Immediately following each intervention, within approximately 1-2 minutes
Number of Eye Fixations on Screen
Information seeking load measures the amount of information being processed by participants using an eye-tracking device to measure fixation points (which represents thought-processing).
Measured: Duration of Single Usability Session, up to 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start24 Jul 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electronic Health RecordsStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to a control or an intervention and then conduct a crossover stage. For example, a participant who is in the control group (EHR) will review two patient cases in the EHR. Then, the participant will review two other patient cases in AWARE (intervention), i.e., the crossover stage. Similarly, a participant who is in the intervention group (AWARE) will review two patient cases in AWARE. Then, the participant will review two other patient cases in the EHR (control), i.e., the crossover stage.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of Pittsburgh Medical Center, MedStar Health, National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Saif Khairat, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937646
- Sponsor's protocol ID
- 20-3384
- Other IDs
- R01LM013606
- Status last verified
- Mar 2026
- First submitted
- 30 Jun 2023
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has a methodologically sound proposal, approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Khairat S, Morelli J, Boynton MH, Bice T, Gold JA, Carson SS. Investigating Information Visualization to Combat Information Overload in Electronic Health Records: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 9;14:e74247. doi: 10.2196/74247.
PubMed 40925597
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Providers' Decision-Making and Reducing Information Overload Using Information Visualization in EHRs
- ClinicalTrials.gov ID
- NCT05937646
- Acronym / sponsor ID
- 20-3384
- Keywords
- Visualization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of Pittsburgh Medical Center, MedStar Health, National Library of Medicine (NLM)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the efficacy of an information visualization dashboard on decision-making using a randomized controlled trial with crossover.
This study aims to test the efficacy of using an information visualization dashboard on ICU providers' decision-making, efficiency, and performance compared to their institutional EHR through a randomized control trial with crossover.
Detailed description
Electronic Health Records (EHRs) are a major source of data for ICU clinicians. Synthesizing complex, electronic patient data is key to effective care delivery. EHRs contain both a record of past medical data and present continuous flows of new clinical data from various sources such as physiological inputs, laboratory results, imaging studies, and clinician notes. This complex, continuous stream of patient data can contribute to information overload, which can create barriers to the key cognitive tasks of data identification, extraction, and interpretation. Intensive Care Unit (ICU) providers must quickly synthesize data from more than 200 variables during critical care rounds, with critically ill patients generating a median of 1348 individual data points per day. Information overload has been identified as a key factor in the misinterpretation of data, leading to medical errors such as misdiagnoses. Improving our understanding of information overload-and investigations into new efforts to minimize it-can improve clinician workflow and productivity as well as patient safety. The objective of this study is to explore the impact of current data representation in the EHR on ICU clinicians' cognitive workload, performance, and satisfaction. The research design uses a mixed methods approach, including eye-tracking assessment and surveys, to assess the efficacy of current EHR interfaces for ICU clinicians in live and simulated environments.
The investigators will randomize consented participants into two groups: the control (EHR) group and the intervention (AWARE) group. During the Randomized Controlled Trial (RCT) crossover, providers in each group will review the same patient records and will perform the same tasks, and complete the same survey instruments. Providers in the control groups will review two patient cases in their institution EHR (Epic or Cerner) first and then, two new cases in AWARE, and providers in the intervention group will review two patient cases in AWARE and then two new cases in the EHR. Cases will be randomized to eliminate order bias and selection bias.
For the cases in the EHR, participants will navigate through the EHR as per their usual routine in the ICU, with no added training sessions before the study. For the cases in AWARE, participants will receive a short training presentation by the study team, explaining the functionality and design of AWARE. Also, a day before each session, the RA will send an email to the provider with a short demonstration video of AWARE to become familiar with the tool.
The study will be conducted in simulation or Biobehavioral labs at each site. The PI, or research assistant, will explain the study procedure and obtain consent; participants will be asked to use Tobii Pro Fusion during the session, participants will not need to wear anything, the eye-tracker will be mounted to the monitor. During the session, participants will review 2 patient cases in their institutional EHR and two in AWARE. After the participant completes the patient record review, the research assistant (RA) will ask the participant a series of decision-based Q\&A activities requiring verbal responses or task completion in the EHR or AWARE. The provider may use the EHR or AWARE to complete the Q\&A activity. Cases will be in random order for each participant to avoid selection or order bias. After usability testing, the investigators will ask the participant to fill out the NASA-TLX survey and the System Usability Scale (SUS). The NASA-TLX measures the perceived workload of using the EHR, and the SUS measures the level of satisfaction as a result of using the EHR. All sessions will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to a control or an intervention and then conduct a crossover stage. For example, a participant who is in the control group (EHR) will review two patient cases in the EHR. Then, the participant will review two other patient cases in AWARE (intervention), i.e., the crossover stage. Similarly, a participant who is in the intervention group (AWARE) will review two patient cases in AWARE. Then, the participant will review two other patient cases in the EHR (control), i.e., the crossover stage.
| Arm | Type | Receives |
|---|---|---|
| EHR (Control), then AWARE | Experimental | Device: AWARE, Device: Electronic Health Record (EHR)In this hour-long task, participants in this arm will first review and complete tasks using the institutional EHR. Then after an approximate 5 minute rest, participants will then review and complete tasks using AWARE. |
| AWARE Intervention, then EHR (Control) | Experimental | Device: AWARE, Device: Electronic Health Record (EHR)In this hour-long task, participants in this arm will first review and complete tasks using the AWARE intervention. Then after an approximate 5 minute rest, participants will then review and complete tasks using the institutional EHR. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ICU physicians and advanced practice providers (APPs),
- active full time ICU service,
- use an institutional EHR (Epic or Cerner) to deliver care, and
- reads and speaks English;
- Residents
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AWAREAWARE is a platform with a visualization dashboard that sits on top of pre-existing, comprehensive EHR systems. AWARE provides clinical decision support tools for the ICU, Emergency Departments and other critical care areas right at the patient's bedside. | Device | AWARE Intervention, then EHR (Control), EHR (Control), then AWARE |
| Electronic Health Record (EHR)An Electronic Health Record (EHR) is an electronic version of a patients medical history, that is maintained by the provider over time, and may include all of the key administrative clinical data relevant to that persons care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports. | Device | AWARE Intervention, then EHR (Control), EHR (Control), then AWARE |
Primary outcome
Time to Task Completion
Time frame: Duration of Single Usability Session, up to 25 minutes
To assess the amount of time required to make a decision (i.e., complete a task), participants will be asked to find the answers to clinical questions and the average amount of time needed to answer will be reported.
Overall Mean Task Scores
Time frame: Duration of Single Usability Session, up to 25 minutes
To measure performance, participants will be scored on the overall average responses to 8 questions using the following: 0 points for an incorrect response, 0.5 points for a partially correct response, and 1 point for correct responses. Overall mean score for the 8 questions combined is reported.
Time to Case Completion
Time frame: Duration of Single Usability Session, up to 25 minutes
To measure efficiency, participants' time to complete a patient case (chart review and tasks) will be recorded and reported in minutes.
Number of Clicks Per Case
Time frame: Duration of Single Usability Session, up to 25 minutes
To measure efficiency, participants' number of mouse clicks to complete case review and tasks will be recorded.
Mean Number of Fatigue Instances Per Case
Time frame: Duration of Single Usability Session, up to 25 minutes
Physiologic fatigue will be measured using an eye tracking device to capture changes in pupil size (which represents cognitive fatigue). A fatigue instance was recorded whenever the participant's pupil diameter dropped below the subject-specific fatigue threshold. For every provider-interface combination, the investigators calculated the mean and standard deviation of these one-second pupil diameter values and defined the subject-specific fatigue threshold as the individual mean minus 1.5 standard deviations.
System Usability Scale Survey Score
Time frame: Immediately following each intervention, within approximately 2-3 minutes
Perceived satisfaction measured using the System Usability Scale survey. Values range from a minimum of 0 to a maximum of 10. Higher scores indicate higher satisfaction (better). The overall score is reported and ranges from 0 to 100. It is expected to take 2-3 minutes to complete this survey.
2 secondary outcomes
Perceived Workload Score
Time frame: Immediately following each intervention, within approximately 1-2 minutes
Number of Eye Fixations on Screen
Time frame: Duration of Single Usability Session, up to 25 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40925597Khairat S, Morelli J, Boynton MH, Bice T, Gold JA, Carson SS. Investigating Information Visualization to Combat Information Overload in Electronic Health Records: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 9;14:e74247. doi: 10.2196/74247.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has a methodologically sound proposal, approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Saif Khairat, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARE and Electronic Health Record (EHR) in people with Electronic Health Records and Usability, run by University of North Carolina, Chapel Hill 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 11 inclusion and 0 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 5 May 2026. 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?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Task Completion (time frame: Duration of Single Usability Session, up to 25 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937646, which also lists 1 linked publication.
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 5 May 2026.