1. Human Research Protection Program (HRPP) Brown Bag Series August 2, 2017
Topic:  Using 'teach back' in obtaining consent for research
The VoICE program: Valid Informed Consent Education Program GIVING RESEARCH PARTICIPANTS A VOICE

2. Valid Informed Consent Education Program
VoICE
Valid Informed Consent Education Program
Using teach back in the research setting
Elizabeth Bankert, M.A.
Dartmouth College Hanover, NH

3. History: 2000 Consent Form: Clear, understandable, plain language
Summary page
Process:
Informed Consent Evaluation Feedback Tool (ICE FT)
Take you way back to 2000

4. Consent Form --
Requires that informed consent begin with a “concise and focused presentation of the key information” likely to help a prospective subject understand the reasons for and against participation. The information must be organized and presented in a manner that facilitates comprehension

5. Informed Consent Evaluation Feedback Tool : ICE FT 2000
What is the purpose of the research? What are the possible benefits of the research? What are the possible risks of the research? Does everyone in the study receive the same treatment ? How is this research different than the treatment I would get if I wasn’t in this research study ?

6. ICE FT 2000
Does the research cost me anything extra?
Can I stop being in the research once I’ve started?
Who will view my medical records?
Who do I call if I have questions about being a research subject?
My questions are:

7. Informed Consent Evaluation Feedback Tool (ICE FT)
Checklist
Tanzania

8. ICE FT Checklist
“Instructions: After reading the patient a paragraph of the consent form, ask the patient the following questions. If the patient answers correctly, check the box and move on to the next paragraph. If the patient answers incorrectly, explain the answer of the question again. Then, check the box and move on to the next paragraph.”

9. What is the purpose of the study? 
What is the purpose of the study?
Are there risks for participating in the research?
Are there possible benefits for you participating in the research?
Will everyone receive the protein supplement?
Does being in the research cost you anything?
Are you allowed to remove yourself from the study after enrollment?
Will your confidentiality be protected?
If you have any questions, who will you contact?

10. The Valid Informed Consent Education Program
FAST FORWARD TO 2012…..
VoICE:
The Valid Informed Consent Education Program

11. Dartmouth VoICE Team (2012) history
Sandra Knowlton-Soho Manager, Palliative Care/Critical Care Elizabeth Bankert, Assistant Provost Judi Forman, Research Director, Center for Genomic Medicine Dianne Ferris, Human Research Analyst, IRB Sara Simeone, Research Nurse Manager, Cancer Center Ann O’Hara, Human Research Analyst, IRB

12. We asked ourselves:
Who are the stakeholders in the research community for whom obtaining consent is important ?

13. Institutional Official Risk Management Office
Who are the stakeholders in the research community for whom obtaining consent is important ?
Researcher 
Regulators (FDA, OHRP)
IRB
Institutional Official
Risk Management Office
Individual enrolling in the study 
Public

14. Acknowledgements University of Michigan
Grant Sponsored by Health and Human Services
NIH T15 HL
Agency for Healthcare Research and Quality
Health Literacy Universal Precautions Toolkit
Iowa Health System: Quality Healthcare
American Medical Association
American Medical Association Foundation
New Readers of Iowa
Audrey Riffenburgh, MA, Riffenburgh & Associates
Quality Research Grant Dartmouth-Hitchcock Medical Center

15. Pilot Project at Dartmouth
Purpose: To determine if ‘we ’can teach ‘teach back’
Methods: Simulated consent process:
Video taped
Pre & Post education 1 week & 3 months
Results: We can Teach Back! 15

16. Pilot Project Debrief
Research nurses/coordinators requested feedback after video taped sessions
Education session: reduce regulatory information
Health literacy info very helpful
Requested add’l education on complicated projects and difficult situations
Teach back : need to practice, does improve dialogue

17. VoICE Education Session Outline
Background:
Why Obtain Informed Consent?
Elements of Informed Consent
Early Efforts
Health Literacy
Teach-Back Method
Experiential learning with teach-back

18. The Belmont Report Respect for Persons Beneficence Justice
Informed consent, respect for privacy
Beneficence
Good research design, competent investigators, favorable risk/benefit analysis, minimize risks
Justice
Equitable selection of subjects, appropriate inclusion and exclusion criteria
Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection Of Human Subjects of Biomedical and Behavioral Research April 18, 1979

19. “Most codes dealing with human experimentation start out with the bland assumption that consent is ours for the asking. This is a myth. The reality is that informed consent is often exceedingly difficult to obtain in any complete sense. . .
Nevertheless, it remains a goal toward which one must strive for sociological, ethical, and legal reasons.”
- Henry Beecher, MD, 1966

20. Ethical Rationale Demonstrates respect for persons Validates trust
Demonstrates honesty and openness
Consent matters to research participants

21. October 2009 FDA Guidance
Guidance for the Industry on Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects:
“It is common practice for investigators to delegate certain study-related tasks to employees, colleagues, or other third parties (individuals or entities not under the direct supervision of the investigator). When tasks are delegated by an investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated. The investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of the clinical study.”

22. In assessing the adequacy of supervision FDA focuses on four major areas:
Whether individuals who were delegated tasks were qualified to perform such tasks
Whether study staff received adequate training on how to conduct the delegated tasks and were provided with an adequate understanding of the study
Whether there was adequate supervision and involvement in the ongoing conduct of the study
Whether there was adequate supervision or oversight of any third parties involved in the conduct of a study to the extent such supervision or oversight was reasonably possible.

23. FDA Guidance
During inspections of investigation sites, FDA has identified instances in which study tasks have been delegated to individuals lacking appropriate qualifications.

24. Examples of tasks that have been inappropriately delegated include:
Screening evaluations, including obtaining medical histories and assessment of inclusion/exclusion criteria
Physical examinations
Evaluation of adverse events
Assessments of primary study endpoints
Obtaining informed consent

25. Elements of Informed Consent

26. 45 CFR 46.116 Study involves RESEARCH Purpose
Description of procedures
expected duration
experimental procedures
Description of potential risks
Description of potential benefit

27. 45 CFR 46.116 (continued) Alternatives, if any Confidentiality
Compensation for Injury/Medical treatment if > minimal risk
Who will answer questions
Participation is voluntary

28. Additional Elements (if applicable)
Unforeseeable risks
Termination by researcher
Additional Costs
Decision to withdrawal
Significant new findings
Number of participants

29. The Consent Process

30. The Setting and The Conversation
Who
What
Where
When

31. WHEN? Before any study procedures are performed
Throughout the course of participation in a study

32. Where?
Private
Quiet
Comfortable

33. WHO?
Patient
Research Team
Family members
Other supports or advocates

34. What?
Information for the potential subject to decide whether or not to participate …
In addition:
Build rapport
Be responsive
Answer questions
Assess understanding……..

35. Does a signature on the consent form equal informed consent?

37. HEALTH LITERACY

38. Health Literacy
The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.
(HHS 2000 and Institute of Medicine 2004)

39. Health literacy and patient safety: Help patients understand

40. Common Misconceptions
People will tell you if they cannot read or understand you well.
People who are well-spoken and well-dressed are literate.

41. Reality
People hide their limited reading skills or lack of understanding with a variety of coping techniques.
The health care environment can make it difficult for patients to tell us they don’t read well or do not understand.
Ley, Communicating with patients: improving communication satisfaction, and compliance 1988
Rost, Predictors of recall of medication regimens and recommendations for lifestyle change in elderly patients 1987

42. Research shows that patients remember and understand less than half of what clinicians explain to them
Well-educated people may become functionally health illiterate when in pain or confronted with a serious disease, new diagnosis.

43. How Many?
The number of Americans with limited health literacy totals more then 89 million.

45. The Challenge
Low literacy is associated with poor comprehension of consent materials
Coyne et al. 2003; Davis et al. 1998; Sudore et al. 2006;
Tait et al. 2005
How do we ensure potential subjects provide valid informed consent when enrolling in a research study?

46. Teach Back

47. Teach-Back creates an opportunity for dialogue:
The provider gives information, then asks the potential subject to teach-back or explain the information to confirm understanding before adding any new information.

48. Why Use Teach Back?
Agency for Healthcare Research and Quality (AHRQ), NCI, National Quality Forum, AMA
Teach back is a widely recommended practice for effectively communicating with patients with limited literacy
+ Doak CC, Doak LG, Root JH. Teaching Patients with Low Literacy Skills. 2nd ed. Philadelphia: JB Lippincott Company; 1996, 24.
+ Weiss BD. Health Literacy: AManual for Clinicians. Chicago: AMA Foundation and AMA; 2003.
+ National Cancer Institute, Comprehensive Working Group on Informed Consent in Cancer Clinical Trials. Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials;October Available at
+ Partnership for Clear Health Communication,
+ Schillinger D, Piette J, Grumbach K, et al. Physician communication with diabetic patients who have low health literacy. Arch Intern Med. 2003;163(1):83-90.
+ Meade CD. Improving understanding of the informed consent process and document. Semin Oncol Nurs.1999;15(2):
+ Schwartzberg JG, VanGeest JB, Wang CC, eds. Understanding Health Literacy: Implications for Medicine and Public Health. AMA; 2005.

49. Teach-Back is Supported by Research
“Asking that patients recall and restate what they have been told” is one of the 11 top patient safety practices based on the strength of scientific evidence.”
AHQR 2001 Report, Making Health Care Safer
“Physicians’ application of interactive communication to assess recall or comprehension was associated with better glycemic control for diabetic patients.”
Schillinger, Arch Inter Med/Vol 163 Jan 13, 2003 “Closing the Loop”

50. UVA Medical Center – Charlottesville, VA
Dr. Claudette Dalton, Medical Director of Preanesthesia Evaluation and Testing Center (PETC)
Cancellation rate of 8%
Loss of ~$2million/year (OR costs, staff)
Implemented use of teach back by surgeons, anesthesiologists, preop nurses, incorporated into visits and reminder phone calls
Reduced cancellation rate to 0.8%
Saved millions of dollars per year
OR Manager; Mar 2006; 22, 3; ProQuest Health and Medical Complete

51. Teach Back (AHRQ)
A way to confirm that you have explained what the patient needs to know
Not a test of the patient but rather a test of how well you explained a concept
Should be used with every patient; never assume literacy or healthy literacy

52. Teach Back (AHRQ) Use simple lay language; avoid technical terms
Ask the patient or caregiver to repeat the concept in his or her own words
Identify and correct misunderstandings
Ask the patient or caregiver to repeat to demonstrate understanding
Repeat steps 3 and 4 until clinician is convinced comprehension and ability to perform process is adequate and safe
*Society of Hospital Medicine

53. Do not ask a patient, “Do you understand?”
- patients will typically respond automatically and say, “Yes,” regardless of their level of understanding *
Do not ask Yes/No questions
Ask open-ended questions
- “how would you know if”, “tell me what you would do if”, “who would you call if” etc.

54. Re-teach in a different way.
Teach Back (AHRQ)
Ask patients to explain in their own words.
Assume that you have not been successful if the participant does not explain correctly, or parrots back the information:
Re-teach in a different way.
*TC Davis et al. Health Literacy and Cancer Communication CA Cancer J Clin 2002;52:

55. Teach back - examples (AHRQ)
“I want to be sure I didn’t leave anything out that I should have told you. Would you tell me what you are to do so that I can be sure you know what is important?” (Doak et al.)
“I want to be sure that I did a good job explaining the research ” (Pfizer Web site)
“When you go home and your grandchild asks you what the doctor said about your heart, how are you going to explain this to your grandchild?” (Schillinger interview on AHRQ Web site)

56. Physician Experience about Learning Teach-back
From: Always Teach-back

57. The Future: VoICE One page summary Difficult situations Assent
Continuing consent
PI’s

58. Research Summary Information Sheet
You are being asked if you want to enroll in a research study: A Phase xx in Combination with xx in Patients with xx Cell Lung Cancer 
This research is being carried out to learn more about how two drugs (c and p) work together. This is the first time this combination of drugs has been tested in patients with xxx .
If you enroll you will be in Part I or Part II of the study:
Part I: Patients will be given different doses of these drugs until the ‘best’ dose is determined. OR
Part II: All patients will be given the dose determined in Part I.
The length of time spent on this study depends on how your cancer responds to the drugs.
It is our responsibility to be sure you understand the research. We will discuss the research study with you. Please carefully review the attached consent form and ask any questions before you decide whether or not to enroll in the research study. The consent form provides information about the background, risks, and procedures involved in the study.

59. VoICE: The Valid Informed Consent Education Program
Using teach back in the research setting
Thank you for your time !
VoICE :

60. Resources
AMA Foundation Health Literacy and Patient Safety: Help patients Understand
National Action Plan to Improve Health Literacy US Department of Health and Human Services
Kutner, M. et al (2006) The Health Literacy of American’s Adults:Results from the 2003 National Assessment of Adult Literacy
Research and development of The Newest Vital Sign was funded by Pfizer, Inc. Dr. Barry D. Weiss, Professor of family and community medicine at The University of Arizona College of Med.
AHRQ: Health Literacy Universal Precautions Toolkit
Thanks to Lou Anne McLeod for slides related to Health Literacy