Liver and Intrahepatic Bile Duct Disorder
Conditions
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.
Interventions
BEHAVIORALBrainCheck Cognitive Assessment
Receive BrainCheck cognitive assessment
PROCEDURECognitive Assessment
Receive pen and paper cognitive assessment
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate of the BrainCheck battery | Up to 1 year | Will be calculated along with a 95% confidence interval (CI). |
| Completion rate of the pen and paper assessment | Up to 1 year | Will be calculated along with a 95% CI. |
| Average time to complete the BrainCheck battery | Up to 1 year | Will be calculated along with a 95% CI. |
| 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. |
| Difference in score between the BrainCheck battery and the pen and paper assessments | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTimothy Newhook, MD
M.D. Anderson Cancer Center
Outcome results
None listed