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

Not Applicable

Active, not recruiting

• Conditions: Liver and Intrahepatic Bile Duct Disorder

• 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.

Study Timeline

• Study Start: 2018-08-17
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States