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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Device: AWARE
* Device: Electronic Health Record (EHR)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EHR (Control), then AWARE<br>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<br>* 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.<br>Device: Electronic Health Record (EHR)<br>* 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.<br>|
| Experimental: AWARE Intervention, then EHR (Control)<br>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<br>* 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.<br>Device: Electronic Health Record (EHR)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Duration of Single Usability Session, up to 25 minutes | 
| Percent of Successfully Completed EHR Tasks | To measure performance, participants will be scored using the following: 0 points for incorrect response, 0.5 points for partially correct response, and 1 point for correct response. | Duration of Single Usability Session, up to 25 minutes | 
| Time to Case Completion | To measure efficiency, participants' time to complete case 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 | 
| Degree of Pupil Constriction | Physiologic fatigue will be measured using eye tracking device to capture changes in pupil size (which represents cognitive fatigue). | 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). It is expected to take 2-3 minutes to complete this survey. | Immediately following each intervention, within approximately 4-5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Duration of Single Usability Session, up to 25 minutes | 
| Number of Screens Per Case | To measure efficiency, participants' number of screens visited to complete case review and tasks will be recorded. | Duration of Single Usability Session, up to 25 minutes | 
| Stress Score | Participants will be asked to rate their current level of stress based pictorial images on a numbered scale ranging from 0 (None) to 10 (Worst possible). | Baseline | 
| Sleepiness Score | Participants will be asked to rate their current level of sleepiness based pictorial images on a numbered scale ranging from 0 (Wide awake, alert) to 10 (Sleep onset soon, having dreamlike thoughts). | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visualization