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Improving Providers' Decision-Making and Reducing Information Overload Using Information Visualization in EHRs

Improving Providers' Decision-Making and Reducing Information Overload Using Information Visualization in EHRs

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05937646
Enrollment
113
Registered
2023-07-10
Start date
2023-07-24
Completion date
2025-05-30
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Electronic Health Records, Information Seeking Behavior, Usability

Keywords

Visualization

Brief 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 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.

Interventions

DEVICEAWARE

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.

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.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER
Mayo Clinic
CollaboratorOTHER
University of Pittsburgh Medical Center
CollaboratorOTHER
MedStar Health
CollaboratorOTHER
National Library of Medicine (NLM)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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, * 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

Design outcomes

Primary

MeasureTime frameDescription
Time to Task CompletionDuration of Single Usability Session, up to 25 minutesTo 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 ScoresDuration of Single Usability Session, up to 25 minutesTo 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 CompletionDuration of Single Usability Session, up to 25 minutesTo measure efficiency, participants' time to complete a patient case (chart review and tasks) will be recorded and reported in minutes.
Number of Clicks Per CaseDuration of Single Usability Session, up to 25 minutesTo measure efficiency, participants' number of mouse clicks to complete case review and tasks will be recorded.
Mean Number of Fatigue Instances Per CaseDuration of Single Usability Session, up to 25 minutesPhysiologic 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 ScoreImmediately following each intervention, within approximately 2-3 minutesPerceived 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.

Secondary

MeasureTime frameDescription
Perceived Workload ScoreImmediately following each intervention, within approximately 1-2 minutesThe 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.
Number of Eye Fixations on ScreenDuration of Single Usability Session, up to 25 minutesInformation seeking load measures the amount of information being processed by participants using an eye-tracking device to measure fixation points (which represents thought-processing).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSaif Khairat, PhD

University of North Carolina, Chapel Hill

Participant flow

Pre-assignment details

A total of 113 participants signed informed consent; however, 1 participant who signed consent was not randomized

Baseline characteristics

Characteristic
Age, Continuous33.51 years
STANDARD_DEVIATION 7.27
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
112 Participants
Sex: Female, Male
Female
27 Participants
Sex: Female, Male
Male
26 Participants
Sleepiness Score3.03 scores on a scale
STANDARD_DEVIATION 1.81
Stress Score2.59 scores on a scale
STANDARD_DEVIATION 1.62

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1120 / 112
other
Total, other adverse events
0 / 1120 / 112
serious
Total, serious adverse events
0 / 1120 / 112

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026