david w. klein helen a. schartz aera national conference vancouver, b.c., canada april 16, 2012
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Instructional Strategies to Improve Informed Consent in Healthcare Research: Pilot Study of Interactivity and Multimedia. David W. Klein Helen A. Schartz AERA National Conference Vancouver, B.C., Canada April 16, 2012. Overview. Informed consent (IC) ethically and legally necessary - PowerPoint PPT PresentationTRANSCRIPT
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David W. Klein
Helen A. Schartz
AERA National Conference
Vancouver, B.C., Canada
April 16, 2012
Instructional Strategies to Improve Informed Consent in Healthcare Research:Pilot Study of Interactivity and Multimedia
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Overview• Informed consent (IC) ethically and legally
necessary
• Currently IC process cumbersome, especially for healthcare research
• Recall and understanding disappointing• Remembering name of study drug
• Remembering side effects
• Understanding random assignment
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Interventions• Simplifying (language, length)• Decision aids• Simulations (vignettes, case studies)• Multimedia• However, much of the results have been inconsistent• IRBs slow to adopt non-paper-based approaches
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Problem• Assume the IC process as a learning process
• Most *healthcare* studies do not use an empirically based theoretical model
• (Work with the IRB and domain experts)
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Multimedia• Combination of visual and auditory delivery of
information
• Paivio’s Dual Coding Theory – verbal plus spatial improves learning
• Cognitive Load Theory• Reduce extraneous load by careful design of content and
display
• Increase generative (germane) load by adding interactivity
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Interactivity• Simplified definition: • User asked to respond to or use information
• Feedback provided
• Multiple choice questions that require more than rote response
• Feedback giving correct answer and addresses common misconceptions
• Facilitate schema acquisition• Promote engagement
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Method• 95 participants
• Students, staff, faculty at Midwestern university
• IRB-approved IC document (drug trial)
• Controlled, randomized experimental design
• 3 conditions
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Control Condition• Conventional paper-based IC document from a
recently completed clinical drug strial
• 7 pages
• Experienced research assistants
• Each sentence was summarized
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Multimedia Condition
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Interactive Multimedia Condition
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Instruments• Knowledge assessment• Based on federal guidelines (Protection of Human Subjects
Subjects 45 CFR §46.166, 2009)
• 18 multiple-choice questions
• Satisfaction questions• Perceived length of IC
• Perceived difficulty
• Importance
• Demographic questions
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Results – Knowledge assessment• Main effect for knowledge • F(2,92) = 5.10, p = .008
• Interactive Multimedia scored higher than Control
• Multimedia Condition n.s. but scored in the middle
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Satisfaction• Perceived length• Effect for length
• Interactive Multimedia perceived shorter than Control
• Perceived difficulty• Effect for difficulty
• Interactive Multimedia perceived as easier than Control
• No effect for importance
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Time• Times• Control – 18.7 min.
• Multimedia – 19.2 min.
• Interactive Multimedia – 20.8 min.
• Significant difference between Interactive Multimedia and Control
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Discussion• Using multimedia and interactivity improved
participants’ knowledge over conventional, paper-based IC
• Participants took 2 min. longer using interactive multimedia than paper-based
• Yet they perceived the interactive multimedia to take less time and to be easier
• Multimedia without interactivity consistently in the middle and n.s.
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Limitations• Sample• Single Midwestern university
• Relatively well educated
• Mostly Caucasian
• Mock study / simulation
• Unrealistic scenario (emergency room or ICU)
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Implications• Multimedia consistently between other conditions,
suggesting multimedia and interactivity had separate, positive impacts
• Use of interactive questions and knowledge assessments could be useful for clinical research
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Implications• Satisfaction or affective constructs need to be
researched further, especially for highly stressful clinical investigations (e.g., cancer studies)
• Role of extraneous load?• Interface
• Face to face
• Efficiency and effectiveness in clinical research