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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


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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