Assessing Decisional Capacity & Enhancing the Consent Process

Assessing Decisional Capacity & Enhancing the Consent Process Dilip V. Jeste, MD University of California, San Diego VA San Diego Healthcare System

Outline • Assessing Decisional Capacity • Enhancing the Consent Process: I. PowerPoint Slide Presentation II. Multimedia DVD Consent

Informed Consent “The manner and context in which information is conveyed is as important as the information itself.” - Belmont Report, 1978

Informed Consent Forms • “As consent forms become increasingly lengthy and complicated and come to include more and more information …….. the very existence of such consent forms may obstruct rather than improve the process of obtaining informed consent.”- Roth et al., 1982

History of Informed Consent for Research • Early 1970s: Informed consent for research became mandatory --- Focus on signed “generic” consent form • Late 1980s: Emphasis shifted to consent process & detailed protocol-specific risks • Late 1990s: Increasing attention to ensuring a research subject’s understanding of consent form

Bioethics Unit of an Intervention Research Center • Bioethicist: Larry Schneiderman, MD • Investigators: Laura Dunn, MD, Lisa Eyler, PhD, Barton Palmer, PhD, Dilip Jeste, MD • Law Professor: Elyn Saks, JD • Biostatistician: Shah Golshan, PhD • Consultant: Paul Appelbaum, MD Goals: 1) To ensure ethics in research; 2) To conduct research on ethics (Jeste DV, et al., Psychopharmacology, 2003)

UCSD Task Force on Decisional Capacity Explicit assessment of decisional capacity is required for: (a) Any study involving more than minimal risk (as defined in federal guidelines) & (b) The protocol is intended for participants at least a portion of whom can be reasonably expected to have diminished decision-making capacity --- www.irb.ucsd.edu/decisional.shtml

UCSD Task Force on Decisional Capacity The assessment can be done with one of the following methods: A standardized and validated instrument that can be tailored to the specific study protocol (e.g., MacCAT-CR) A post-consent quiz documenting the subjects’ knowledge of critical elements in the consent Study investigators may develop alternative procedures (reviewed and approved by the IRB.) --- www.irb.ucsd.edu/decisional.shtml

Literature Review 34 Studies of enhancing comprehension of consent for research or treatment Deficits in understanding of consent due to poorly conceived, written, or organized consent forms can be partially remedied with strategies such as corrected feedback, multiple learning trials, & organized or simplified consent forms (Dunn and Jeste, Neuropsychopharmacology, 2001)

PowerPoint Slide Presentation • 80 Outpatients with psychotic disorders (mostly schizophrenia) & 19 normal comparison subjects (NC’s); Age 40-80; Eligible to participate in Intervention Research Center • Randomly Assigned to Routine Consent (RC) or Enhanced Consent (EC) method (Dunn, et al., Am J Psych, 2002; Am J Geriat Psych, 2002)

Methods • Parent Study: Comprehensive medical & psychosocial evaluation, neuropsychological & motor testing, Blood draw, and MRI; Longitudinal follow-up • Outcome Measure: Questionnaire to assess comprehension of consent

Enhanced Consent (EC) Procedure • Consent form was converted verbatim & then “enhanced” into a computer-projected PowerPoint slide show, viewed on a 15” computer monitor • Slideshow was read aloud by staff who manually advanced the slide show, asking subjects at predetermined points if they had any questions • Total time (with assessment): 40 minutes

Assessment of Comprehension • Up to 3 Trials • Trial 1: All questions were asked without providing feedback; Consent form was not available for subjects to refer to; Questions incorrectly answered were reviewed by re-reading relevant sections of the consent form • Trials 2 and 3: Subjects could refer to the consent form • Cumulative total score on each trial: 0 to 20

Rates of Perfect Scores on Assessment of Comprehension ** * Trial 2 Trial 1 * = < .05, * * p < .01

Items Missed by Patients on Initial Presentation • Open-ended questions • Types of assessments • Time required • Potential risks and benefits

Results: Comprehension of Consent • On trial 1, NC’s performed better than Patients • Within each group, EC subjects performed better than RC subjects on trial 1 (& also trial 2 in patients) • EC Patients’ scores did not differ from RC normal subjects’ scores

Multi-Media Presentation of Consent Material • Published studies of video, computer-based, and other multi-media consent procedures in diverse groups of subjects suggest that technologically enhanced consent procedures are feasible, more satisfactory to subjects, and lead to better (understanding and) retention of information than routine paper-based consent procedures

Pilot Study • Hypothetical double-blind treatment study of cognitive enhancer for schizophrenia, involving fMRI • 41 Patients randomly assigned to DVD versus routine paper consent procedure • Of those given DVD, 70% preferred it to routine consent, 20% found the two similar, & 10% preferred routine consent • 70% Of the DVD patients compared to 87% of controls agreed to participate in the hypothetical trial

Decisional Capacity with DVD versus Routine Consent

Newly Funded RO1 • 192 Patients with schizophrenia & 192 Normal comparison subjects, age >40 • Randomly assigned to: a) Hypothetical low-risk vs. high-risk protocols, and to b) DVD vs. routine consent • Outcome Measures: MacCAT-CR, UCSD Brief Assessment of Capacity, Subject satisfaction

Summary Even in older, cognitively impaired persons with very chronic psychotic disorders, deficits in understanding of research consent can be corrected with feedback, repeated learning trials, & more “consumer-friendly” presentation of material

Thank You!

Assessing Decisional Capacity & Enhancing the Consent Process