1. Valid Informed Consent Education Pilot Project 2 nd Annual Nursing Research & Evidence-Based Practice Symposium Sandra Knowlton-Soho, MS, RN Sara Simeone, BSN, RN November 5, 2010

2. Financial Disclosure We do not have any conflict of interest to report in relation the information being presented today.

3. Objectives 1. Explain the need to educate research staff in obtaining valid informed consent 2. Describe how the Valid Informed Consent Project seeks to determine if the teach back method is effective to assess study participant understanding

4. Background: Clinical Research Clinical study of a drug to device to test safety and/or efficacy Involve human subjects  Obligation: Protection of Human Subjects  Obligation: Choice

5. Informed Consent in Clinical Research Components of informed consent 1. Voluntary choice o Free from coercion an undue influence 2. Information disclosure o Risks, benefits, burdens, alternatives 3. Decision-making capacity o Able to understand nature and consequences of decisions

6. Informed Consent in Clinical Research A Process  Conversation with PI or designee such as Research RN  Review of Informed Consent Document  Signature  Documentation of process  Ongoing assessment of consent to participate

7. Nursing and Clinical Research Role of the Research Nurse Overlap with Nursing Research

8. Framework Identify Need Understand what is already known (literature search) Project development and implementation Project assessment and sharing of knowledge (present/publish)

9. Challenge: Health Literacy National Center for Education Statistics, 2003; Baker, 2010

10. Challenges: Regulations October 2009 FDA Guidance  Guidance for the Industry on Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects

11. Framework Identify Need Understand what is already known (literature search) Project development and implementation Project assessment and sharing of knowledge (present/publish)

12. Literature Review: Teach Back & Simulation Importance of a volunteer’s level of understanding when discussing participation in study (Flory & Emanuel, 2004; Paris et al, 2010; Titus, 1996). Different interventions have been proposed to improved the process (Davis et al, 2002; Flowers, 2006; Kripalani et al, 2008; Lorenzen, 2008) but there is limited research on training research staff in using these interventions. As an interactive method to improve skills, simulation training with standardized patients has been proven to be effective (Brindley & Dunn, 2009; Leeper- Majors et al, 2003; Taekman et al, 2004). No literature describing the use of an Informed Consent Simulation Training to improve the consent process. University of Michigan developed a training program similar to the one we are proposing, but we were unable to find any citations for articles related to validating their project (Valid consent and refusal to participate in research, S. Goold).

13. A Solution: The Teach Back Method ● Asking patients to repeat in their own words what they need to know or do, in a non-shaming way. ● NOT a test of the patient, but of how well you explained a concept. ● A chance to check for understanding and, if necessary, re-teach the information.

14. Framework Identify Need Understand what is already known (literature search) Project development and implementation Project assessment and sharing of knowledge (present/publish)

15. The Intervention An Educational Program: Two hour class that will involve lecture, video, discussion, and role playing. Objectives: explain the purpose of obtaining informed consent describe the components of informed consent identify issues associated with health literacy and informed consent demonstrate the use of the teach-back method in informed consent discussions

16. Study Design Pilot study utilizing quantitative and qualitative design Pre-intervention, immediately post- intervention, 3 months post-intervention Assess participants:  Knowledge - multiple choice test  Attitude - self reported confidence  Skills - observation of simulated consent process

17. Study Execution Recruitment  Internal staff responsible for conducting informed consent discussions with potential clinical trial volunteers Intervention  2 cohorts of 14-16 participants Data analysis  Quantitative: Analysis of Variance over the 3 time points  Qualitative: Participant feedback

18. Framework Identify Need Understand what is already known (literature search) Project development and implementation Sharing of knowledge (present/publish)

19. Lessons Learned Thus Far Multidisciplinary Collaboration Regular meetings to stay on track Realistic timeline Make adjustments as needed

20. Acknowledgements Project team members Liz Bankert, Assistant Provost for Research, Dartmouth College Ann O’Hara, Human Research Analyst, Committee for the Protection of Human Subjects, Dartmouth College Dianne Ferris, Human Research Analyst, Committee for the Protection of Human Subjects, Dartmouth College Judi Forman, Research Associate/Program Coordinator, Clinical Trials Unit at The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

21. Acknowledgements Institutional Support  Dartmouth Hitchcock Patient Safety Training Center  D-H Quality Research Grant Program  Dartmouth Clinical Trials Office  Committee for the Protection of Human Subjects  Norris Cotton Cancer Center – Office of Clinical Research  The Dartmouth Institute for Health Policy and Clinical Practice