From Informed Consent to Informed Choice

1. From Informed Consent to Informed Choice

2. Informed Consent to Informed Choice

3. Topics Patient Friendly Informed Consent Documents Patient Friendly Informed Consent Process Patient Advocates Improving Patient Compliance Recommended Websites

4. Patient Friendly Informed Consent Documents Use plain English at the 8th grade level (can be checked in MS WORD) Don�t use jargon or acronyms (see word substitution list) Use attractive, well-organized layout Lots of white space Pictures and tables Different fonts, styles, boxing for emphasis Bullet list

5. Patient Friendly Informed Consent Documents Clearly distinguish between standard and experimental therapy Treatments Tests Side effect When describing side effects indicate: How likely they are How severe, including whether or not they are life threatening, they are likely to be What can be done to minimize them and how effective these options are Whether they will resolve once treatment ends

6. Example of Potential Side Effects

7. Phase I

9. Phase II & III Time Flow Use a time line Use shading to distinguish between �standard of care� and �investigational� interventions Present treatments above the line and diagnostic tests below the line Use plain English in a version you will provide the patient (schedule) Use medical jargon/abbreviation in a version you will use for your protocol If the trial is long,consider one chart showing days within a treatment cycle and a second showing weeks (or months) of the study and tests per week (or month)

11. How much does this patient already understand about her condition and options? How much does this patient want/need to understand about her condition and options? [ What are the issues that will be of most importance to this patient? Logistics Travel Financial Issues Statistics Alternatives Side effects

12. Five Questions to Ask Yourself to Prepare for a Patient Interaction What are the best ways to help this patient understand what she wants/needs to understand? Consider: Involving a significant other Using analogies and metaphors Using or avoiding statistics Providing pictures, flow charts, plus/minus table Providing take homes What additional support can I offer to this patient? Psychology referral Social worker referral Patient navigator referral Clergy referral Access to another patient

13. The Flow of an Interactive Patient Meeting

14. How Patient Advocates Can Help You Reviewing, protocol, informed consent, patient information Patient recruitment, retention, and support Community outreach, public relations Finding funding Public policy Etc.

15. Finding Patient Advocates At Your Hospital Outreach Communications Support Groups Social Workers In the Community Other patients Advocacy Organizations ACS Chapter Health fairs, health writers, etc. Community groups, churches

16. Improving Patient Compliance Make sure patients understand what is required; ask them to repeat what you said. Provide patients with written instructions that are easy to follow. Provide patients with a telephone number to call if they have questions. Have someone proactively call to check-in with patients. Have patients maintain treatment diaries and review them. Consider using �medicine boxes� for oral medications.

17. Recommended Websites https://www.dana-farber.org/res/clinical/trials-info/ Dana Farber has produced a really good, generic, patient friendly video (available as a download, DVD or VHS) that would be useful to provide to patients before you talk about any specific trails. http://www.cancer.gov/clinicaltrials/learning NCI has lots of online and free print material; about clinical trials. Some of it is meant for patients; others for investigators http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide NCI�s recommendations for informed consent, including content, style and format http://ncilistens.cancer.gov/moderator.asp?action=groups&view=in&gap=10 This NCI sites lists dozens of advocacy organizations and their focus. It can help you find people interested in your disease. http://www.cancer.org/docroot/home/index.asp?promo=gaw ACS and their local chapters (available from the home page)