David W. Klein Helen A. Schartz AERA National Conference Vancouver, B.C., Canada April 16, 2012

1. 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

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