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Comparison of Two Enhanced Consent Procedures for Patients With Mild Alzheimer Disease or Mild Cognitive Impairment

From the Center for Mental Healthcare and Outcomes Research and Central Arkansas Veterans Healthcare System, North Little Rock, Arkansas (DM, DB); South Central Mental Illness Research, Education and Clinical Center (MIRECC) (DM, DB); the Department of Psychiatry and Behavioral Sciences, University of Arkansas for Medical Sciences, Little Rock, Arkansas (DM, DB); the Department of Psychiatry, University of California, San Diego, San Diego, California (BWP, LBD, DVJ); the Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas (RL); the Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas (CG, CRNB); and the VA San Diego Healthcare System, San Diego, California (LBD, SG, DVJ).

Objective: The objective of this study was to evaluate the feasibility, acceptability, and preliminary efficacy of two enhanced consent procedures provided to patients with Alzheimer disease or mild cognitive impairment that used either a PowerPoint presentation or an enhanced printed consent form.

Methods: Patients randomly assigned to an enhanced written consent procedure or slideshow presentation were assessed with the MacArthur Competence Assessment Tool for Clinical Research.

Results: Verbal reexplanation was associated with improved understanding in both conditions. Level of understanding did not significantly differ between the two consent groups, but administration time for slideshow presentation was less than that for an enhanced written consent procedure.

Conclusion: Enhanced consent procedures are feasible and useful for consent to research among patients with mild cognitive impairment or mild Alzheimer disease.

Key Words: Dementia • cognition • bioethics • competency

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