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

NCT05937646 | Completed Results FDA Device

• 2 other identifiers: 20-3384R01LM013606
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Visualization

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Immediately following each intervention, within approximately 2-3 minutes

Secondary Outcomes (2)

• Perceived Workload Score

  Immediately following each intervention, within approximately 1-2 minutes

• Number of Eye Fixations on Screen

  Duration of Single Usability Session, up to 25 minutes

Study Arms (2)

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.

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.

Device: AWARE; Device: Electronic Health Record (EHR)

Interventions

AWARE DEVICE

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.

AWARE Intervention, then EHR (Control); EHR (Control), then AWARE

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.

AWARE Intervention, then EHR (Control); EHR (Control), then AWARE

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Non-ICU Physicians or APPs,
• residents with no prior ICU experience

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Mayo Clinic: collaborator
• University of Pittsburgh Medical Center: collaborator
• MedStar Health: collaborator
• National Library of Medicine (NLM): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• 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.

  PMID: 40925597 DERIVED

MeSH Terms

Conditions

Information Seeking Behavior

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Communication; Behavior

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Saif Khairat, PhD, MPH, FAMIA
• Organization: University of North Carolina at Chapel Hill

Saif@unc.edu

919-543-5413

Study Officials

• Saif Khairat, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: July 24, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 12 months after and continuing for 24 months following publication
• Access Criteria: Investigator has IRB, IEC, or REB approved methodologically sound proposal and an executed data use/sharing agreement with UNC.

Locations

US (1)