Transcript Instructional Strategies to Improve Informed Consent in Healthcare

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
• Currently IC process cumbersome, especially for
healthcare research
• Recall and understanding disappointing
• Remembering name of study drug
• Remembering side effects
• Understanding random assignment
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
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)
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
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
Method
• 95 participants
• Students, staff, faculty at Midwestern university
• IRB-approved IC document (drug trial)
• Controlled, randomized experimental design
• 3 conditions
Control Condition
• Conventional paper-based IC document from a
recently completed clinical drug strial
• 7 pages
• Experienced research assistants
• Each sentence was summarized
Multimedia Condition
Interactive Multimedia Condition
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
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
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
Time
• Times
• Control – 18.7 min.
• Multimedia – 19.2 min.
• Interactive Multimedia – 20.8 min.
• Significant difference between Interactive
Multimedia and Control
Discussion
• Using multimedia and interactivity improved
participants’ knowledge over conventional, paperbased 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.
Limitations
• Sample
• Single Midwestern university
• Relatively well educated
• Mostly Caucasian
• Mock study / simulation
• Unrealistic scenario (emergency room or ICU)
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
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