- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05937646
Improving Providers' Decision-Making and Reducing Information Overload Using Information Visualization in EHRs
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 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.
|
|
Experimental: 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Duration of Single Usability Session, up to 25 minutes
|
|
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.
|
Duration of Single Usability Session, up to 25 minutes
|
|
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.
|
Duration of Single Usability Session, up to 25 minutes
|
|
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.
|
Duration of Single Usability Session, up to 25 minutes
|
|
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.
|
Duration of Single Usability Session, up to 25 minutes
|
|
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.
|
Immediately following each intervention, within approximately 2-3 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Workload Score
Time Frame: Immediately following each intervention, within approximately 1-2 minutes
|
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.
|
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
|
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).
|
Duration of Single Usability Session, up to 25 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Saif Khairat, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavior
- Communication
- Information Seeking Behavior
- Organization and Administration
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Records
- Medical Records Systems, Computerized
- Medical Records
- Electronic Health Records
Other Study ID Numbers
- 20-3384
- R01LM013606 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Care
-
Lisbon Academic Medical Center - Centro Académico...Centro Hospitalar de Vila Nova de Gaia/Espinho; Centro Hospitalar Lisboa Ocidental and other collaboratorsRecruitingCritical Illness | Critical Care | Critical Care, Intensive Care | Critical Care Medicine | Recovery OutcomesPortugal
-
Radiometer Medical ApSTerminated
-
Potrero MedicalCompletedCritical Care, Intensive Care
-
Davy van de SandeRecruitingCritical Care | Intensive Care MedicineNetherlands
-
Hospital Israelita Albert EinsteinActive, not recruitingCritical Care | Intensive Care UnitBrazil
-
Ruijin HospitalNot yet recruiting
-
University College, LondonCompleted
-
Hospital do CoracaoD'Or Institute for Research and Education; Sociedade Hospital SamaritanoCompleted
-
University Hospital, ToursRecruitingCritical Care, Intensive CareFrance
-
Hospital Israelita Albert EinsteinMinistry of Health, BrazilCompletedTelemedicine | Critical Care | Intensive Care UnitsBrazil
Clinical Trials on AWARE
-
Innovation Research & TrainingCompletedSexual BehaviorUnited States
-
Innovation Research & TrainingCompleted
-
Innovation Research & TrainingCompleted
-
Mental Health Services in the Capital Region, DenmarkCompletedMood Disorders | Quality of Life | Activities of Daily LivingDenmark
-
Boston University Charles River CampusHarvard UniversityCompletedDepression | PTSD | Anxiety | Suicidal Ideation | Substance Use Disorders | Coping Behavior | Unsafe SexUnited States
-
Boston University Charles River CampusRutgers UniversityCompletedMental Health Disorder
-
Innovation Research & TrainingEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedSexual Behavior | Violence, Domestic | Sexual AssaultUnited States
-
Boston Children's HospitalNot yet recruitingPatient Outcome Assessment
-
Innovation Research & TrainingEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Mental Health Services in the Capital Region, DenmarkKarolinska InstitutetCompleted