Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery

Study Overview
=================
Brief Summary
-----------------
This trial studies how well electronic neurocognitive tools work in screening for mental capability in patients who are undergoing liver surgery. Using electronic neurocognitive screening tools may help to better assess mental impairment.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries. SECONDARY OBJECTIVES: I. Comparison of the completion rate and time to completion between the written and electronic batteries. II. Comparison of the scoring distribution between the screening tools. EXPLORATORY OBJECTIVES: I. Assess if a history of mental or cognitive illness or ongoing treatment with neuropsychiatric medications impact the ability to complete written and/or electronic neurocognitive screening. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen cognitive assessment within 2 months prior to surgery and within 2 months after surgery. GROUP II: Patients receive the paper and pen cognitive assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.

Official Title
-----------------
A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery

Conditions
-----------------
Liver and Intrahepatic Bile Duct Disorder

Intervention / Treatment
-----------------
* Behavioral: BrainCheck Cognitive Assessment
* Procedure: Cognitive Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All English-speaking patients undergoing hepatectomy at main campus University of Texas (UT)-MD Anderson Cancer Center who are cognitively able to provide informed consent in the opinion of the attending physician.

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

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

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (BrainCheck and paper and pen cognitive assessment)<br>Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen assessment 2 months prior to surgery and within 2 months after surgery. | Behavioral: BrainCheck Cognitive Assessment<br>* Receive BrainCheck cognitive assessment<br>* Other names: BrainCheck;Procedure: Cognitive Assessment<br>* Receive pen and paper cognitive assessment<br>|
| Active Comparator: Group II (pen and paper and BrainCheck cognitive assessment)<br>Patients receive the paper and pen assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery. | Behavioral: BrainCheck Cognitive Assessment<br>* Receive BrainCheck cognitive assessment<br>* Other names: BrainCheck;Procedure: Cognitive Assessment<br>* Receive pen and paper cognitive assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of the BrainCheck battery | Will be calculated along with a 95% confidence interval (CI). | Up to 1 year | 
| Completion rate of the pen and paper assessment | Will be calculated along with a 95% CI. | Up to 1 year | 
| Average time to complete the BrainCheck battery | Will be calculated along with a 95% CI. | Up to 1 year | 
| Average time to complete the pen and paper assessment | Will be calculated along with a 95% CI. | Up to 1 year | 
| Difference in completion rate between the BrainCheck battery and paper and pen assessment | Will be calculated along with 95% CIs. | Up to 1 year | 
| Difference in time to completion between the BrainCheck battery and the pen and paper assessment | Will be calculated along with 95% CIs. | Up to 1 year | 
| Difference in score between the BrainCheck battery and the pen and paper assessments | Will be calculated along with 95% CIs. | Up to 1 year | 
| Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of the electronic battery compared to the validated St. Louis University Mental Status Examination (SLUMS) | Will be calculated along with 95% CIs. | Up to 1 year |