Importance of the Informed Consent Conversation as well as the Form
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1 Importance of the Informed Consent Conversation as well as the Form Rebecca L. Sudore, MD Associate Professor of Medicine University of California, San Francisco San Francisco VA Medical Center
2 Outline Importance of discussions Advance Care Planning Teach Back Conversation Considerations Patients values The use of stories Geriatric considerations
3 The Ultimate Informed Consent Advance Directives, Physicians Orders for Life Sustaining Treatment (POLST), DNR orders Specific treatments: CPR, mech ventilation, feeding tubes, etc. 38 Code of Federal Regulations Informed Consent and Advance Care Planning Besirevic V. Bioethics Mar;24(3):
4 Advance Directive Confusion My mom passed away.and she had signed the paper in the hospital, -but it was totally wrong, because she didn t really understand it. We had another one filled out, and that one said, Do you want to be resuscitated? Do you want to be on a machine or not? And she said no. And then the questions were in conflict. One said yes; one said no.that really confused us. Sudore RL et. al., J Pain and Symptom Management, 2012 (unpublished quote)
5 Advance Directive RCT: PEC, 2007 Overwhelming preferred Doubled 6-mo. completion rates ~all completed easy form FREE English, Spanish, Chinese, Vietnamese, Russian, Tagalog, Farsi
6 Hypothetical Scenarios 50% of diverse older adults who reported a treatment preference based on a hypothetical scenario were uncertain about their decision Uncertainty associated with: Limited literacy, lower education Minority status Poor health status Sudore RL, et. al., J Health Commun. 2010;15 Suppl 2: Allen RS. et.al., J Am Geriatr Soc, 2008; Volandes AE, et. al,. Med Decis Making. 2005
7 Lessons for Informed Consent Conversations Just because someone makes a choice does not mean they fully understand the meaning and ramifications
8 Why Need to Confirm Understanding What does this mean? I only want to be on machines for a few days. My family knows this. Pilot data: 55% understand, 59% discordant w/ goals Unpublished data provided by Susan Hickman, PhD
9 Forms Alone Do Not Work, Conversations Do Studies of advance directive forms: 70% of documented EOL wishes are wrong! Studies focused on discussions: ~ 90% care consistent with patient s goals Increased patient & surrogate knowledge, satisfaction Cost savings and quality Heyland DK, et al. JAMA Intern Med May 13;173(9):778-87; Hammes BJ, et al. J Am Geriatr Soc Jul;58(7): ; Detering KM, et al. BMJ March;340:c1345; Kirchhoff KT. J Am Geriatr Soc Jul;58(7): ; Wright ZB. Arch Intern Med Mar 9;169(5):480-8
10 Lessons for Informed Consent Conversations Just because someone makes a choice does not mean they fully understand the meaning and ramifications Need to have discussions and confirm understanding not just the form
11 Modified Consent Process 1. Consent form written at 6 th grade reading level in English & Spanish 2. Read verbatim in English or Spanish 3. Knowledge assessment: 7 true/false questions about consent content 4. Teach-to-goal : repeated, targeted education until comprehension was achieved Sudore RL, et al. J Gen Intern Med Aug;21(8):867-73
12 Number of Passes Required to Complete Consent Process 52% Percent 28% 20% Number of Passes Required N=205
13 As Literacy Score Decreased, Odds of Requiring More Passes Increased Odds of Requiring More Passes Literacy Score (36 is perfect, 0 is illiterate)
14 Consent Given in Non-native Language = More Passes All Non-native English speakers required > 1 pass Low health literacy + language discordant provider = poor ratings of doctor-patient communication Sudore RL, et al. J Gen Intern Med Aug;21(8):867-73; Sudore RL, et al. Patient Educ Couns Jun;75(3):
15 Number of Passes Required to Complete Consent Process 52% Percent 28% 20% Number of Passes Required N=205
16 Other Teach Back Studies Literacy is surmountable MDI mastery: 21% 2 nd pass, 10% 3 rd pass DC info: 25% 2 nd pass, 0.6% 3 rd pass Surgical IC at 7 VAs: repeat back Improves comprehension 53% 70% Risks & alternatives Takes about ~ 2.6 min longer Paasche-Orlow, et al. Am J Respir Crit Care Med Oct 15;172(8): Fink AS, et al. Ann Surg Jul;252(1): Prochazka AV, et al. J Patient Saf Feb 11. [Epub ahead of print]
17 Lessons for Informed Consent Conversations Interactive teach to goal process may be necessary Literacy and language need to be addressed
18 Outline Importance of discussions & confirmation Advance Care Planning Teach Back Conversation Considerations Patients values The use of stories Geriatric considerations
19 Teach Back or Teach to Goal Risks Benefits Alternatives We explain before we understan d the patient Schillinger, et.al. Arch Intern Med, 2005
20 What Matters Most to Patients? What matters most to patients is not the treatment BUT the outcome of treatment Not intubation, CPR, surgery, blood txn (the cart) Fried TR, et. al., N Engl J Med. 2002; Quill TE. JAMA. 2000; McMahan. J of Pain & Symptom Manage. 2013, Lockhart LK, et. al., Death Stud & Pearlman RA, et. al., Arch Intern Med. 2005
21 What Matters Most to Patients? What matters most to patients is not the treatment BUT the outcome of treatment Not intubation, CPR, surgery, blood txn (the cart) BUT how their life will be after treatment (the horse). Fried TR, et. al., N Engl J Med. 2002; Quill TE. JAMA. 2000; McMahan. J of Pain & Symptom Manage. 2013, Lockhart LK, et. al., Death Stud & Pearlman RA, et. al., Arch Intern Med. 2005
22 Outcome of Treatment If go through all of this, how weak will I be? Will I be able to get myself up out of bed and take a bath, you know, or what will happen to me? Sudore RL et. al., J Pain and Symptom Management, 2012
23 The Treatment 77 yo frail woman presented to ER w/ a large abdominal aneurysm. She declined previous elective surgery, but now agreed (risk = death). After 8 hours, cardiac arrest in ICU & returned to OR for bleeding. Additional 6 hrs of surgery & 45 units of blood, she made it to ICU w/o vasopressors. The surgeons were happy. Schwarze ML, et al. J Palliat Med Oct;16(10):
24 The Outcome Values Her family was horrified; they asked to have all life sustaining treatments withdrawn. For years their mother voiced fears about the use of life support and spending her remaining life in a nursing home. Schwarze ML, et al. J Palliat Med Oct;16(10):
25 Best Case/Worst Case Best Case Best Case Most Likely Most Likely Worst Case Worst Case
26 Describing the Best Case Outcome SURGERY The Best Case is a 6-10 hour operation, followed by 5-7 days of IC with a breathing tube & maybe dialysis. Then, 2-3 weeks in the hospital followed by transition to a nursing home. After this surgery, it is unlikely that you would be able to return to living independently, & you will probably need to live the rest of your life in a nursing home. PALLIATIVE CARE The Best Case is that we admit you to our palliative care service, they will give you enough pain meds to stop the pain in your chest, & your family can come in to be with you. Unfortunately you may only live another hours, but your family can be at your bedside. You could possibly even go home with hospice if we can control your pain. c Schwarze ML, et al. J Palliat Med Oct;16(10):
27 Describing the Best Case Outcome SURGERY The Best Case is a long, 6-10 hour operation, followed by 5-7 days of IC with a breathing tube and maybe dialysis, and 2-3 weeks in the hospital followed by transition to a nursing home. After this surgery, it is unlikely that you would be able to return to living independently, & you will probably need to live the rest of your life in a nursing home. PALLIATIVE CARE The best case is that we admit you to our palliative care service, they will give you enough pain meds to stop the pain in your chest, your family will come in to see you, and you will live another hours with your family at your bedside. You could possibly even go home with hospice to die there if we can control your pain. I know this is hard, and I am sorry this is happening to you. I wish there were better options, but based on what we talked about, does one sound better to you? c Schwarze ML, et al. J Palliat Med Oct;16(10):
28 Lessons for Informed Consent Conversations Interactive teach to goal process may be necessary Literacy and language need to be addressed Elicit patients values 1 st & describe the outcome of treatment in real life terms
29 Outline Importance of discussions & confirmation Advance Care Planning Teach Back Conversation Considerations Patients values The use of stories Geriatric considerations
30 Stories Make an Impact Terri Schiavo: 92% English/Spanish speakers reached by the media and her story 70% clarified own goals > 60% were motivated to discuss wishes w/ family and wanted to complete an advance directive. Sudore RL, et. Al. J Gen Intern Med Nov;23(11):1854-7
31 Videos & Stories Can you dramatize the situation and put it on YouTube? Then they can say, Oh you know what, that could be me, you know. I mean reading is one thing, but sometimes when you visualize it. Wow, you know. I can see that Sudore RL et. al., J Pain and Symptom Management, 2012, unpublished quote
32 Video Images & Stories Improve understanding, increase engagement, decrease decisional conflict, help identify goals acpdecisions.org prepareforyourcare.org Volandes AE, Paasche-Orlow MK, et al. J Clin Oncol Jan 20;31(3):380-6; Volandes AE, et al. Health Expect Sep;16(3):e80-8; Volandes, Med. Dec Making, 2010; Sudore RL, et al. J Pain Symptom Manage Apr;47(4):674-86
33 Lessons for Informed Consent Conversations Interactive teach to goal process may be necessary Literacy and language need to be addressed Elicit patients values 1st & describe the outcome of treatment in real life terms Visual images & stories as powerful teaching tools
34 Outline Importance of discussions & confirmation Advance Care Planning Teach Back Conversation Considerations Patients values The use of stories Geriatric considerations
35 Age and Dementia Bias Does this man have capacity? Chronic illness Maximize hearing & alt. communication Dementia & caregivers
36 SLOW DOWN Chronic disease Neurocognitive processing disrupted from disease Medications = cognitive slowing -Anti-depressants -Muscle relaxants -Pain medications -Anti-cholinergics
37 Hearing Impairment Presbycusis: 63% age 70 & 80% age 85 Gradual, bilateral, high frequency loss Consonants: high frequency & make words distinct Speaking louder does NOT help Identification: Do you feel you have hearing loss? ( sens/spec) Requests to speak louder or leaning in Inappropriate responses or misinterpretation Bainbridge KE & Wallhagen MI. Annu Rev Public Health. 2014:35:139-52
38 Hearing Impairment Hearing aides & Pocket talker Communication Glasses to lip read FACE the patient at all times Speak slowly, clearly not loudly background noise, back to wall, sit close Bainbridge KE & Wallhagen MI. Annu Rev Public Health. 2014:35:139-52
39 Use All Alternate Forms of Communication
40 Dementia and Caregivers Dementia Teach back may not work (but it may!) May still be able to consent Caregiver Teach back needs to be w/ patient & caregiver Be aware of caregivers literacy (36% LHL) Lindquist L, et al. JGIM 2010 & Sudore RL, et al. JGIM, 2011
41 Lessons for Informed Consent Conversations Interactive teach to goal process may be necessary Literacy and language need to be addressed Elicit patients values 1 st & describe the outcome of treatment in real life terms Visual images & stories as powerful teaching tools Maximize hearing & all forms of communication Be aware of age/dementia bias & caregiver literacy
42 What Question Do You Have? PREPARE: prepareforyourcare.org
43 What We Already Know Essential info only & first Alternative # presentation Higher number = better Consider pictographs < 8 th grade reading level Use video and stories What questions do you have? hbrief_ pdf#page=166
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