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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

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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
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
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
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
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
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
Method
  • 95 participants
  • Students, staff, faculty at Midwestern university
  • IRB-approved IC document (drug trial)
  • Controlled, randomized experimental design
  • 3 conditions
control condition
Control Condition
  • Conventional paper-based IC document from a recently completed clinical drug strial
  • 7 pages
  • Experienced research assistants
  • Each sentence was summarized
instruments
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
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
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
slide14
Time
  • Times
    • Control – 18.7 min.
    • Multimedia – 19.2 min.
    • Interactive Multimedia – 20.8 min.
  • Significant difference between Interactive Multimedia and Control
discussion
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.
limitations
Limitations
  • Sample
    • Single Midwestern university
    • Relatively well educated
    • Mostly Caucasian
  • Mock study / simulation
  • Unrealistic scenario (emergency room or ICU)
implications
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
implications1
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
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