"Executive Function Informed Consent"
A memory and organizational aid improves research consent capacity in persons with Alzheimer’s disease Jason Karlawish MD1,2,6,7,8,9,10, Jonathan D Rubright BA1,8,9, Pamela Sankar PhD2,7,10, David J Casarett MD1,7,8,10,11, Ruben Gur PhD3,4,5,8, Sharon Xie PhD6,9 University of Pennsylvania, Departments of Medicine1, Medical Ethics2, Psychiarty3, Radiology4, and Neurology5, Center for Clinical Epidemiology and Biostatistics6, Center for Bioethics7, Institute on Aging8, Alzheimer’s Disease Center9, Leonard David Institute of Health Economics10; Philadelphia Veterans Affairs Center for Health Equity Research and Promotion11 The research reported on this poster was supported by NIH R01-AG020627. The investigators retained full independence in the conduct of this research. THEORY BACKGROUND MEMORY AID • Short-term memory impaired; recognition memory relatively preserved. • AD patients’ early and progressive cognitive impairments • Judgments of competency associated with executive function. • One-page summary of the key elements in consent form. hinder ability to participate in an informed consent. • Intervention which addresses AD difficulties in STM and keeping • Presents information in same sequence and header titles. • No published data show techniques that can improve ability focus may improve performance on measures of decisional capacity. • Text simplifies important points using language of AD patients to participate in an informed consent. at 6 grade reading level. Table 1. Subject characteristics. • Contains content mandated under requirements for OBJECTIVE informed consent in the Common Rule. To demonstrate whether a memory and organizational aid AD intervention (n=40) AD control (n=40) RESULTS improves AD patient performance on measures of capacity • AD groups similar in terms of age, education, and and competency to give informed consent. Sex cognitive status (see table 1). Female 17 (43%) 23 (58%) • Intervention group had higher scores on each METHODS Male 23 (58%) 17 (43%) MacCAT-CR subscale (see table 2). • AD patients randomly assigned to standard consent, or Age 74.4+9.5 (45-92) 76.5+6.6 (59-89) • Expert rater consensus capacity ratings show standard plus a memory and organizational aid. intervention group more likely to be judged Race • Aid text simplifies points from full consent form. competent (see table 3). Caucasian 34 (85%) 36 (90%) • Trend holds for each individual rater. • MacCAT-CR for a phase I clinical trail administered. • Three psychiatrists without access to patient data Black 6 (15%) 4 (10%) independently reviewed MacCAT-CR interviews to judge Education 14.4+3.3 (7-21) 15.3+3.1 (10-22) whether subject capable of consenting. MMSE 23.3+2.7 (18-28) 23.6+2.9 (18-28) SUMMARY • Agreement of at least two experts defined a subject as capable to provide informed consent. No difference between AD control and intervention groups by age (t=1.13, p=0.26), education (t=1.26, p=0.21), or MMSE (t=0.44, p-0.66). • A consent process that addresses an AD patients’ deficits in memory and executive function can Table 2. MacCAT-CR decision-making abilities by intervention. Table 3. Consensus consent ability by intervention. improve capacity to give informed consent for AD intervention (n=40) AD control (n=40) Control Intervention Total early phase AD research. Understanding 17.6+5.6 (5-26)* 13.7+6.1 (2-25) Incapable 33 21 54 • The results also validate the MacCAT-CR as an Appreciation 3.5+1.8 (0-6)* 2.8+1.5 (0-6) Capable 7 19 26 instrument to measure capacity, especially the Reasoning 6.3+1.7 (2-8) 5.7+2.5 (0-8) Total 40 40 80 understanding and appreciation scales. Choice 1.8+0.5 (0-2) 1.7+0.6 (0-2) Chi2=8.2, p=0.004. Logistic regression CI 1.5-11.9, p=0.006. t-test p<0.05.