Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery
- Conditions
- Liver and Intrahepatic Bile Duct Disorder
- Interventions
- Behavioral: BrainCheck Cognitive AssessmentProcedure: Cognitive Assessment
- Registration Number
- NCT03678441
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I (BrainCheck and paper and pen cognitive assessment) BrainCheck Cognitive Assessment 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. Group I (BrainCheck and paper and pen cognitive assessment) Cognitive Assessment 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. Group II (pen and paper and BrainCheck cognitive assessment) BrainCheck Cognitive Assessment 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. Group II (pen and paper and BrainCheck cognitive assessment) Cognitive Assessment 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.
- Primary Outcome Measures
Name Time Method Difference in score between the BrainCheck battery and the pen and paper assessments Up to 1 year Will be calculated along with 95% CIs.
Average time to complete the pen and paper assessment Up to 1 year Will be calculated along with a 95% CI.
Difference in completion rate between the BrainCheck battery and paper and pen assessment Up to 1 year Will be calculated along with 95% CIs.
Difference in time to completion between the BrainCheck battery and the pen and paper assessment Up to 1 year Will be calculated along with 95% CIs.
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) Up to 1 year Will be calculated along with 95% CIs.
Completion rate of the BrainCheck battery Up to 1 year Will be calculated along with a 95% confidence interval (CI).
Average time to complete the BrainCheck battery Up to 1 year Will be calculated along with a 95% CI.
Completion rate of the pen and paper assessment Up to 1 year Will be calculated along with a 95% CI.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States