1. 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

2. 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

3. 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

4. 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)

5. 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

6. 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

7. Method 95 participants Students, staff, faculty at Midwestern university IRB-approved IC document (drug trial) Controlled, randomized experimental design 3 conditions

8. Control Condition Conventional paper-based IC document from a recently completed clinical drug strial 7 pages Experienced research assistants Each sentence was summarized

9. Multimedia Condition

10. Interactive Multimedia Condition

11. 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

12. 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

13. 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

14. Time Times Control – 18.7 min. Multimedia – 19.2 min. Interactive Multimedia – 20.8 min. Significant difference between Interactive Multimedia and Control

15. 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.

16. Limitations Sample Single Midwestern university Relatively well educated Mostly Caucasian Mock study / simulation Unrealistic scenario (emergency room or ICU)

17. 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

18. 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