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

Liver and Intrahepatic Bile Duct Disorder Clinical Trial

Official title:

A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03678441
• Other study ID #: 2018-0093
• Secondary ID: NCI-2018-0189520
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bile Duct Diseases
• Liver and Intrahepatic Bile Duct Disorder
• Liver Diseases

Intervention

Behavioral:
• BrainCheck Cognitive Assessment
Receive BrainCheck cognitive assessment

Procedure:
• Cognitive Assessment
Receive pen and paper cognitive assessment

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of the BrainCheck battery	Will be calculated along with a 95% confidence interval (CI).	Up to 1 year
Primary	Completion rate of the pen and paper assessment	Will be calculated along with a 95% CI.	Up to 1 year
Primary	Average time to complete the BrainCheck battery	Will be calculated along with a 95% CI.	Up to 1 year
Primary	Average time to complete the pen and paper assessment	Will be calculated along with a 95% CI.	Up to 1 year
Primary	Difference in completion rate between the BrainCheck battery and paper and pen assessment	Will be calculated along with 95% CIs.	Up to 1 year
Primary	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
Primary	Difference in score between the BrainCheck battery and the pen and paper assessments	Will be calculated along with 95% CIs.	Up to 1 year
Primary	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

External Links

•   MD Anderson Cancer Center Website