Clinical trial NCT03678441: Electronic Neurocognitive Tools in Screening for Mental Capability in Patients Undergoing Liver Surgery
Official title: A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver and Intrahepatic Bile Duct Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Completion rate of the BrainCheck battery
timeFrame: Up to 1 year
measure: Completion rate of the pen and paper assessment
timeFrame: Up to 1 year
measure: Average time to complete the BrainCheck battery
timeFrame: Up to 1 year
measure: Average time to complete the pen and paper assessment
timeFrame: Up to 1 year
measure: Difference in completion rate between the BrainCheck battery and paper and pen assessment
timeFrame: Up to 1 year
measure: Difference in time to completion between the BrainCheck battery and the pen and paper assessment
timeFrame: Up to 1 year
measure: Difference in score between the BrainCheck battery and the pen and paper assessments
timeFrame: Up to 1 year
measure: 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)
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Timothy Newhook, MD
role: PRINCIPAL_INVESTIGATOR
References: