By: Faisal Latif, MD, FSCAI

Think about it for a minute: When we (as physicians) consent patients for invasive cardiovascular procedures, we typically hand them a few pieces of paper with a signature line at the end. We aim to explain the procedure benefits, risks, and alternatives in terms that we think the patient understands. We know that patients differ widely in their risks, thereby making generic information inadequate. We know that some patients may not read or fully understand this long, wordy document. Yet, almost all patients sign these documents to consent for the procedure. While we provide patients additional education about these procedures, how confident are you that we have successfully incorporated both the patient values and their preferences while the decision is made?
 
In the current format, informed consents are not very well understood by patients¹. Typical informed consents are long and formulated at 12th grade level English, while an average American reads at an 8th grade level¹. Using numerical risk description in percentages is not well understood by patients. Patients seem to understand absolute risk better than relative risk². Finally, explanation of informed consent by physicians is often suboptimal especially with respect to a discussion of alternative treatment modalities, including their pros and cons³.

Key Tips for Effective Informed Consent²

1. Quote absolute risk reduction, rather than relative risk
2. Focus on quoting incremental risk/benefit of any therapy above baseline (in the absence of therapy)
3. Utilize Patient Decision Aids (PDAs) (including pictographs) in standardized education/consent documents

Creating the Framework for Shared Decision Making

Shared Decision Making (SDM) is especially important in treatments where there are complex considerations on the benefits, harms, indications, and existing equally effective treatments.  This SDM interaction is a bi-lateral process where the patient first communicates his/her values, preferences, and life goals. After taking into consideration the patient’s wishes, we share our knowledge regarding the benefits, potential risks, alternatives (sharing both pros and cons) before arriving at a final decision².  The goal is for the physician and the patient (and occasionally their family) exchange information to achieve a better understanding of the relevant factors and also shares responsibility in the decision about how to proceed.

It is beneficial to have these SDM interactions in the clinic setting where a decision is made rather than on the day of the procedure. Use Patient Decision Aids (PDAs) in the form of audiovisual materials or simplified written documents with use of pictographs to help simplify information for patient’s understanding of invasive procedures. The Ottawa Hospital Research Institute is one source of available PDAs^5, 6. In the case of patients who prefer a more passive role in decision-making, it may be helpful to include another physician (such as their primary care physician or a non-interventional cardiologist) as well as patient’s family members in the SDM interaction to help alleviate any bias or misunderstanding of the patient values, preferences, and life goals.

Creating the Framework for Shared Decision Making

1. Discuss with patient  his/her active role in the process, including patient favored style of decision making
2. Explain the indication for the diagnostic/therapeutic procedure and nature of the decision
3. Elaborate on alternative approaches along with pros/cons of alternatives
4. Discuss the uncertainties of potential benefit associated with any decision
5. Considering patient-specific situations, present realistic expectations of impact on lifestyle and mortality from the proposed therapy
6. Exercise caution in the “ad hoc” intervention situation, and consider whether all options have been discussed
7. In revascularization procedures, always present the likelihood of need for repeat revascularization
8. Ensure an environment in which the patient feels comfortable asking questions
9. Explore all patient preferences
10. Frequently assess patient’s understanding of the above during the discussion

SDM aims to promote the realistic expectations of benefits and harms. Incorporation of SDM is one of the goals of the Institute of Medicine toward patient-centered care^6, 7. Understanding and application of SDM is particularly relevant to the field of interventional cardiology. In spite of occasional conflicting opinions, SDM could become standard of care, as there is increasing body of literature supporting its use. While value-based payments are being progressively implemented, they do not take into account patient values and goals. SDM could ultimately lead to reduced cost of care⁸.

SCAI QI Committee is a resource for SCAI Members to help implement all SCAI QIT Tips-of-the-Month into your daily practice. Forward your questions or comments to Joel C. Harder, SCAI Director for Quality and Clinical Documents, at [email protected].

References:

1. Terranova G, Ferro M, Carpeggiani C, et al. Low quality and lack of clarity of current informed consent forms in cardiology: how to improve them. JACC Cardiovasc Imaging. 2012 Jun;5(6):649-55.
2. Lin GA, Fagerlin A. Shared decision making: state of the science. Circ Cardiovasc Qual Outcomes 2014; 7(2):328-34.
3. Rothberg MB, Sivalingam SK, Kleppel R, et al. Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease. JAMA Intern Med. 2015 Jul; 175(7):1199-206.
4. http://ipdas.ohri.ca/
5. https://decisionaid.ohri.ca/decguide.html
6. Institute of Medicine Committee on Quality of Health Care in America.  Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.
7. Krumholz HM. Informed Consent to Promote Patient-Centered Care. JAMA. 2010;303(12):1190-1191.
8. Lynn J, McKethan A, Jha AK. Value-Based Payments Require Valuing What Matters to Patients. JAMA. 2015 Sep 17:1003-1004.