Before we begin, this is a reminder to turn off all pagers, cell phones, and computers during this educational session. Please also note that you are required to participate in the group debriefing session at the end of this educational training where you will have the opportunity to reflect and evaluate the training that you participated in today. Please complete the “Pre-Program Self-Assessment: Confidence Level” form1 prior to the beginning of the lecture.
Why do we care about informed consent? Shared decision-making is a key aspect of patient-centered care; good information is needed to make good decisionsIt is an important to partner with patients to improve quality and safety. Patients share the responsibility for their care. There are important ethical and legal principles Are the residents at this stage familiar with shared decision-making?Uncomfortable situations. Physician providing too much information in an encounter…what to do. Providing options-where is the cut-off point for amounts of information. How should the options be presented? Physician awareness of own biases; counseling the patient-how much? Avoiding the paternalistic approach. Some patients prefer this way. Science is not always clear-cut, and what does this mean in the conversation? 1-5
In your SP encounter, you will obtain informed consent for placement of a central line. You’ll get some feedback from the SP who will also complete an evaluation. When all have completed the SP encounter, we will gather to debrief the experience as a group.
Let’s look at this ~4 minute video clip. [Click on the Green Box in Slide Show mode to play video clip.]
Open with a request for reactions from the group – what worked well? What might have been done differently? Did it reflect experiences that people in the group might have had?
This follows our effective communication strategy that we have already established and includes reminding us to perform our hand hygiene and to properly identify each patient, then providing privacy, sitting with the patient, being aware of body language and tone of voice, and introducing oneself (including role) to the patient and others.2 Determining who else should be present is also important in helping the patient feel supported in the conversation. If family is already present, and the patient wants them to be part of the conversation, then be welcoming and inclusive. If a third party e.g. a social worker, a nurse, etc. is present, ask the patient whether s/he would like this person to remain for the conversation and what role the patient would like this person to play. We are also reminded to provide adequate time with no interruptions for the conversation especially since this conversation is difficult and complex. So, turn off your pager, cell phone and computer, close the door to the room, and do not let anyone interrupt you and the patient. A comfortable, welcoming environment fosters better communication. Reminder to be friendly, caring, respectful, and helpful without berating the patient when providing information and asking questions. The important thing here is to have mutual respect. Be very aware of your own body language. Your words will not be heard if your body language conveys disrespect. 2
While this module is really about informed consent, the concept of shared decision-making is important to understand. The optional article on the OPTIONS scale provides references and more information about SDM. Key principles that we want to reinforce include the above. Below are the original sentences we put together from the OPTIONS scale in the article.Draws attention to an identified problem as one that requires a decision-making process. Indicates the need for a decision-making (or deferring) stage. Assesses the patient’s preferred approach to receiving information to assist decision-making (e.g. discussion, reading printed material, assessing graphical data, using videotape or other material). Elicits the patient’s preferred level of involvement in decision making.States that there is more than one way to deal with the identified problem. Lists options, which can include the choice of “no action”. Explains the pros and cons of options to the patient (taking “no action” is an option).Explores the patient’s expectations (or ideas) about how the problem(s) is to be managed. Explores the patient’s concerns (fears) about how the problem(s) is to be managed.Checks that the patient has understood the information. Offers the patient explicit opportunities to ask questions during the decision-making process. Indicates the need to review the decision (or deferment). [OPTION scale steps listed above are from p. 1015 in Pellerin et al article. 1]
We’ll now focus more on the specific issue of informed consent. This slide reviews the DHMC policy. 3 There are two important aspects to consider: the conversation & the documentation – getting informed consent is NOT just getting a paper signed. . We will begin with the conversation part.Verify patient’s identity using 2 patient identifiers.Be sure to ask the patient how s/he wants to be addressed. What types of information regarding risks & benefits is important? What are participants’ practices – how do they quantify risk? How do they describe alternatives? How is the information customized for a particular patient?How do we know when we are slipping into the use of medical jargon?How do they check for understanding? How could teach back be used?
This slide covers the required documentation, which should include BOTH a signed/timed/dated consent form as well as a note in the chart that summarizes the conversation and the patient’s decision. Ask about participants’ documentation practices..
Build on participants’ experiences in obtaining consents. It is likely that topics of language barrier, incapacitation, or refusal may come up; however there may be other challenges that arise. It will be important to tie the discussion back to the principles of informed consent.
Talking points include:The incapacitated / incompetent patient in a procedural / surgical situationThe first question should be, Does the patient have an advance directive (formal proxy; a durable power of attorney (DPOA) for healthcare)?If no advance directive / DPOA, which family member do you go to (Who is the legal next of kin)? Look at spouse and adult children.Is there an assigned guardian?If the procedure is urgent and no one can legally sign for the patient, need two physicians in agreement that procedure is medically necessary (the right thing to do for the patient) and needed now.If there is time, can go through guardianship process. Takes at least 2 weeks in NH; uicker in VT (judge talks with MD).Care Management can help Remember: This is not always a black & white situation. You want to always do what is in the best interest of the patient!
Talking points include:Treatment Refusal:Does the patient have the capacity to understand what s/he has been told including risks and benefits?If there is any question about whether the patient can understand, get another MD involved to ascertain patient’s capacity to understand. The patient also has the right to ask for a consult! If there is still question as to capacity to understand, you may wish to ask for a psychiatric consult for the patient. Remember: Ultimately, the competent patient has the right to refuse interventions! Document the refusal. You want to make sure all the information is provided to the patient without sounding coercive. Education points only! Medical staff should stick to medical factors and can ask for help from discharge planning (Care Management) with any issues around insurance paying (or not) for expenses should patient refuse treatment / procedure.
We are obligated to offer an interpreter.If the patient refuses an interpreter, s/he can request having a family member interpretPhysician can request an interpreter if not comfortable that the family member is interpreting the information adequately / correctlyThe DHMC Care Management office has an Interpreter Coordinator who may be reached at extension 5-5792
The bottom line is that informed consent is legally up to the parents of the child. It is possible that an adolescent may not assent to a treatment or procedure s/he is facing even though the parents have signed the consent form. There can be many situations that can occur regarding legal consent and children, but the purpose of this slide to remind you that informed consent also involves parents and children.
Refer to DHMC Patient Safety Initiatives and Goals (Part 1. shown, verbatim, below)DHMC Patient Safety Initiatives & Goals (National Patient Safety Goals). Accessed November 29, 2011 at http://intranet.hitchcock.org/hc-upload/file_collection/DHMC%20Safety%20Initiatives-07.docNPSG 1 - Improve Accuracy of Patient IdentificationA. NPSG 1A - Patient IdentificationTwo patient identifiers used when:administering medications or blood productsproviding treatments or procedurescollecting blood samples and other specimens for clinical testingWhat are the identifiers:Inpatient: name and MRNOutpatient: name and DOBContainers used for blood and other specimens are labeled in presence of patientPolicy: Patient Identification Policy B. NPSG 1B- Universal Protocol/Time outMechanism to prevent wrong patient, wrong procedure, wrong site/side procedure errorsSpecific Guidelines: “Prior to start of any invasive procedure, conduct a final verification process (e.g., such as a “time out,”) to confirm the correct patient, procedure and site using active—not passive—communication techniques”The Joint Commission requires 3 safety checks before all invasive procedures. These safety checks - now referred to as the Joint Commission Universal Protocol (UP) - include: pre-procedure verification procedural site marking conducting a 'time out' Forms:Policy: Protocol for Prevention of Wrong Patient, Wrong Procedure, Wrong Site/Side Errors
What’s next? 6 Explain what will happen next and discuss expectations regarding the OSCEs portion of the training. This is an opportunity to explain that the conversation about informed consent is the priority of this encounter, NOT the documentation. Expectations and Reminders: Each learner will complete the “Multi Source Evaluation”7 right after the encounter, then participate in the group debriefing session. Learners will complete the “Post-Program Self-Assessment: Confidence Level” form before leaving the PSTC.
Reminders Turn off all pagers, cell phones, and computers during this educational session. You are required to participate in the group debriefing session when you have completed the Standardized Patient (SP) encounter. Please complete the “Pre-Program Self Assessment: Confidence Level” form
Informed Consent Module development supported by a grant from thePicker Institute / Gold Foundation 2010 Challenge Grant
Learning Objectives Describe the basic principles of shared decision- making Demonstrate key elements of the informed consent conversation Identify some potential challenges in the informed consent conversation 3
Expected Outcome Obtain informed consent consistent with professional standards and shared decision-making principles 4
Setting the Environment Provide privacy Introduce self Determine who else should be present Ensure no interruptions Provide comfortable space Create welcoming environment. 7
Shared Decision-making Overview Identify that problem requires a shared decision- making process. Assess the patient’s information preferences and level of involvement in decision-making. Discuss management options and patient’s wishes. Confirm patient’s understanding and choice. 8
D-H Informed Consent Policy Overview Remember to perform hand hygiene Conversation Introduce yourself & explain why you are there Verify patient’s identity Use plain language & avoid medical jargon Discuss: nature & purpose of procedure risks, expected benefits possible alternatives, right to refuse treatment & possible consequences of refusal Check for understanding 9
D-H Informed Consent Policy Overview Documentation includes both: Consent Form: Provider’s signature signifies that the conversation took place Patient’s signature indicates consent & questions were solicited & answered Must be dated & timed Valid for 90 days Recurring procedures-valid for one year Note in record: Summary of the conversation Risks & benefits Alternatives Special circumstances or concerns Patient decision regarding procedure / intervention 10
Challenges What are some challenges you have seen in obtaining informed consent? 11
Common Challenges: Incapacitated or Incompetent Patient Is there an Advance Directive? If not, who is legal next of kin? Is there time to go through guardianship process? Is the procedure urgent? Care Management can help! ALWAYS do what is in best interest of the patient! 12
Common Challenges: Treatment Refusal Competent patients have right to refuse interventions Confirm patient’s capacity to understand Get help from another physician Consider psychiatry consult Consider ethics committee consult Medical staff provides medical information Involve Care Management as needed Financial assistance 13
Common Challenges: Language Barrier Use an Interpreter unless patient refuses Interpreter Coordinator may be reached at ext. 5-5792 during daytime hours (8am-5pm) Call on-call Care Management staff during nights and weekends If patient refuses an interpreter, a family member may be used Physician may request interpreter if uncomfortable 14
Consents for Minors Parents must legally consent for their children under 18 years of age Important to have assent from the adolescent patient 15
Partnering with Patients to Improve Safety Hand hygiene Two patient identifiers Inpatient Outpatient Verify Procedure Site Time out 16
References1. Pellerin M, Elwyn G, Rousseau M, Stacey D, Robitaille H, Legare F. Toward Shared Decision Making: Using the OPTION Scale to Analyze Resident-Patient Consultations in Family Medicine. Acad Med. 2011;86(8):1010-1018.2. Weiss BD. Removing Barriers to Better, Safer Care, Health Literacy and Patient Safety: Help Patients Understand, Manual for Clinicians. 2nd ed. American Medical Association Foundation and American Medical Association. 2007; http://www.ama-assn.org/ama1/pub/upload/mm/367/healthlitclinicians.pdf. Accessed December 15, 2009.3. Dartmouth Hitchcock Medical Center (DHMC). Informed Consent (Policy No. OCA.0007). DHMC Clinical Operations Policy Library. 2011; http://policy.hitchcock.org/PolicyStore/193/193_83639.pdf. Accessed November 18, 2011.4. Henry Ford Health System Department of Medical Education. Informed Consent. [DVD]. Detroit, MI: Henry Ford Health System; 2009.5. Henry Ford Health System Department of Medical Education. Sharing Bad News. [DVD]. Detroit, MI: Henry Ford Health System; 2009.6. Mahmud A. File: Serious Discussion image by Ashfaq.JPG. Dhaka University Institute of Fine Arts; 2008. Wikimedia Commons. http://commons.wikimedia.org/wiki/File:Serious_Discussion_image_by_Ashfaq.JPG. Accessed December 6, 2010.7. Wind LA, Van Dalen J, Muijtjens AMM, Rethans JJ. Assessing Simulated Patients in an Educational Setting: The MaSP (Maastricht Assessment of Simulated Patients). Medical Education, 39-44; 2004. 18