Trial Outcomes & Findings for Improving Providers' Decision-Making and Reducing Information Overload Using Information Visualization in EHRs (NCT NCT05937646)
NCT ID: NCT05937646
Last Updated: 2026-05-05
Results Overview
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.
COMPLETED
NA
113 participants
Duration of Single Usability Session, up to 25 minutes
2026-05-05
Participant Flow
A total of 113 participants signed informed consent; however, 1 participant who signed consent was not randomized
Participant milestones
| Measure |
EHR (Control), Then AWARE
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: 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): 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.
|
AWARE Intervention, Then EHR (Control)
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.
AWARE: 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): 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.
|
|---|---|---|
|
First Intervention Session (25 Minutes )
STARTED
|
53
|
59
|
|
First Intervention Session (25 Minutes )
COMPLETED
|
53
|
59
|
|
First Intervention Session (25 Minutes )
NOT COMPLETED
|
0
|
0
|
|
Time Between Interventions (5 Minutes)
STARTED
|
53
|
59
|
|
Time Between Interventions (5 Minutes)
COMPLETED
|
53
|
59
|
|
Time Between Interventions (5 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Session (25 Minutes)
STARTED
|
53
|
59
|
|
Second Intervention Session (25 Minutes)
COMPLETED
|
53
|
59
|
|
Second Intervention Session (25 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EHR (Control), Then AWARE
n=53 Participants
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: 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): 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.
|
AWARE Intervention, Then EHR (Control)
n=59 Participants
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.
AWARE: 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): 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.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.81 years
STANDARD_DEVIATION 6.36 • n=53 Participants
|
33.24 years
STANDARD_DEVIATION 8.05 • n=59 Participants
|
33.51 years
STANDARD_DEVIATION 7.27 • n=112 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=53 Participants
|
31 Participants
n=59 Participants
|
58 Participants
n=112 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=53 Participants
|
28 Participants
n=59 Participants
|
54 Participants
n=112 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
53 Participants
n=53 Participants
|
59 Participants
n=59 Participants
|
112 Participants
n=112 Participants
|
|
Stress Score
|
2.49 scores on a scale
STANDARD_DEVIATION 1.67 • n=53 Participants
|
2.68 scores on a scale
STANDARD_DEVIATION 1.59 • n=59 Participants
|
2.59 scores on a scale
STANDARD_DEVIATION 1.62 • n=112 Participants
|
|
Sleepiness Score
|
3.42 scores on a scale
STANDARD_DEVIATION 1.84 • n=53 Participants
|
3.03 scores on a scale
STANDARD_DEVIATION 1.81 • n=59 Participants
|
3.21 scores on a scale
STANDARD_DEVIATION 1.83 • n=112 Participants
|
PRIMARY outcome
Timeframe: Duration of Single Usability Session, up to 25 minutesPopulation: Due to computer file corruption for 2 participants in the EHR Arm/Group and 1 participant in the AWARE Arm/Group, data were lost.
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.
Outcome measures
| Measure |
EHR (Control)
n=110 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=111 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
|
Time to Task Completion
|
1.07 minutes
Standard Deviation 0.81
|
1.00 minutes
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: Duration of Single Usability Session, up to 25 minutesPopulation: Due to computer file corruption for 1 participant in the EHR Arm/Group, data were lost.
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.
Outcome measures
| Measure |
EHR (Control)
n=111 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=112 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
|
Overall Mean Task Scores
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0.78 score on a scale
Standard Deviation 0.20
|
0.80 score on a scale
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: Duration of Single Usability Session, up to 25 minutesPopulation: Due to computer file corruption for 2 participants in the EHR Arm/Group and 1 participant in the AWARE Arm/Group, data were lost.
To measure efficiency, participants' time to complete a patient case (chart review and tasks) will be recorded and reported in minutes.
Outcome measures
| Measure |
EHR (Control)
n=110 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=111 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
|
Time to Case Completion
|
10.12 minutes
Standard Deviation 3.30
|
9.56 minutes
Standard Deviation 3.02
|
PRIMARY outcome
Timeframe: Duration of Single Usability Session, up to 25 minutesPopulation: Due to computer file corruption for 2 participants in the EHR Arm/Group and 1 participant in the AWARE Arm/Group, data were lost.
To measure efficiency, participants' number of mouse clicks to complete case review and tasks will be recorded.
Outcome measures
| Measure |
EHR (Control)
n=110 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=111 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
|
Number of Clicks Per Case
|
182.50 clicks/case
Standard Deviation 93.84
|
146.37 clicks/case
Standard Deviation 70.79
|
PRIMARY outcome
Timeframe: Duration of Single Usability Session, up to 25 minutesPopulation: Due to computer file corruption for 3 participants in the EHR Arm/Group and 1 participant in the AWARE Arm/Group, data were lost.
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.
Outcome measures
| Measure |
EHR (Control)
n=109 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=111 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
|
Mean Number of Fatigue Instances Per Case
|
8.85 fatigue events/case
Standard Deviation 8.65
|
6.61 fatigue events/case
Standard Deviation 6.24
|
PRIMARY outcome
Timeframe: Immediately following each intervention, within approximately 2-3 minutesPopulation: Surveys were administered on paper. Due to staff error, surveys were not distributed to 8 participants in the EHR Arm/Group and 7 participants in the AWARE Arm/Group.
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.
Outcome measures
| Measure |
EHR (Control)
n=104 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=105 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
|
System Usability Scale Survey Score
|
56.20 score on a scale
Standard Deviation 21.21
|
60.40 score on a scale
Standard Deviation 20.19
|
SECONDARY outcome
Timeframe: Immediately following each intervention, within approximately 1-2 minutesPopulation: Surveys were administered on paper. Due to staff error, surveys were not distributed to 7 participants in the EHR Arm/Group and 6 participants in the AWARE Arm/Group.
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.
Outcome measures
| Measure |
EHR (Control)
n=105 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=106 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
|
Perceived Workload Score
|
41.13 score on a scale
Standard Deviation 16.28
|
40.64 score on a scale
Standard Deviation 15.27
|
SECONDARY outcome
Timeframe: Duration of Single Usability Session, up to 25 minutesPopulation: Due to computer file corruption for 3 participants in the EHR Arm/Group and 1 participant in the AWARE Arm/Group, data were lost.
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).
Outcome measures
| Measure |
EHR (Control)
n=109 Participants
Participants in this arm reviewed and completed tasks using the institutional EHR.
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.
|
AWARE Intervention
n=111 Participants
Participants in this arm reviewed and completed tasks using the AWARE intervention.
AWARE: 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.
|
|---|---|---|
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Number of Eye Fixations on Screen
|
1442.28 Eye Fixations
Standard Deviation 592.99
|
1397.13 Eye Fixations
Standard Deviation 561.27
|
Adverse Events
EHR (Control)
AWARE Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Saif Khairat, PhD, MPH, FAMIA
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place