Obtaining informed consent is one of the most important tasks that a surgeon completes, and yet a number of factors can complicate this process—especially miscommunication between patients and health care providers. In an effort to help surgeons and hospital administrators feel confident that they are obtaining true informed consent, the Agency for Healthcare Research and Quality (AHRQ) and The Joint Commission have developed new informed consent resources, which are described in this month’s column.
Communication and informed consent
Informed consent is much more than a signed form. It entails a thorough discussion of the rationale, potential benefits, and risks associated with the proposed procedure. Appropriate communication between the physician and the patient and family is at the heart of informed consent, and with this in mind, this information should be presented in a humble and patient-centered way. Communication errors in the course of obtaining informed consent are among the most frequent root causes of serious adverse events reported to The Joint Commission.
Communication starts with intent, but as it moves through the phases of creating and delivering the message, as well as the reception and interpretation by the other party, the message is influenced by the way it is formulated and delivered, as well as by the receiving party’s health care literacy, personal values, and beliefs. Through the process of communication, a message may metamorphose into a meaning that is far different from the one intended.* Indeed, communication is affected by a number of factors, such as the nature of the patient’s disease; the family and social environment; the cultural context around the patient, family, and physician; and their overall level of information about the problem at hand.*
Failure to adequately communicate with the patient induces mistrust and can potentially lead to complications and other unfortunate circumstances, which makes the need for a more effective exchange of information between providers and patients imperative. Effective communication depends on clinicians’ and patients’ individual capacity to communicate in a competent manner, and on each party’s ability to adapt behavior and to align perspectives to accomplish shared goals.*
Processes for obtaining informed consent vary from state to state, although national standards are in place to guide health care providers. In essence, informed consent processes typically emphasize the patient’s need to understand the proposed course of treatment. To be successful, informed consent processes should factor in any potential barriers to effective communication between the provider and the patient, such as health literacy, language, or cultural differences.
The process culminates with a signed consent form or document that serves as an attestation from the patient that he or she has received and understands what the provider has communicated to them regarding a treatment or procedure.
Two new e-learning modules offered by the AHRQ can help hospital leaders and clinicians improve the informed consent process. The first module, Making Informed Consent an Informed Choice: Training for Health Care Leaders, is geared toward hospital administrators and provides guidance on developing policies and ensuring organizational support. The other module, Making Informed Consent an Informed Choice: Training for Health Care Professionals, provides clinicians with strategies to communicate clearly and offers to tools to assist in the proper documentation of informed consent. The modules, which are free, are available through The Joint Commission’s learning management system for continuing medical education credit. The AHRQ also has created the Informed Consent and Authorization Toolkit for Minimal Risk Research, which helps facilitate the process of obtaining informed consent and Health Insurance Portability and Accountability Act authorization from potential research subjects. This toolkit is available online.
The Joint Commission also published an issue of Quick Safety in February 2016, outlining best practices for obtaining effective informed consent, including the following:†
- Promote informed consent as a process of effective communication between a provider and patient, rather than the act of simply obtaining a patient’s signature
- Develop a written policy on informed consent and provide formal training for physicians
- Use everyday language instead of medical jargon when communicating with patients
The thoughts and opinions expressed in this column are solely those of Dr. Pellegrini and do not necessarily reflect those of The Joint Commission or the American College of Surgeons.
*Pellegrini CA. Trust: The keystone of the patient-physician relationship. Bull Am Coll Surg. 2017;102(1):58-61. Available at: bulletin.facs.org/2017/01/trust-the-keystone-of-the-physician-patient-relationship/. Accessed March 14, 2017.
†The Joint Commission. Informed consent: More than getting a signature. Quick Safety. Issue 21. February 2016. Available at: www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdf. Accessed February 23, 2017.