David W. Klein Helen A. Schartz AERA National Conference Vancouver, B.C., Canada April 16, 2012 Instructional Strategies to Improve Informed Consent in.

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

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, 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• 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