Dialogues In Healthcare STRATEGIES FOR EFFECTIVE COMMUNICATION Volume 6, Number 8 August 2012 The Translated Consent Form A Publication of The Rozovsky Group, Inc./RMS Fay A. Rozovsky, JD, MPH Editor The diversity of cultures is a hallmark of American society. Perhaps it is more noticeable in larger cities or in areas of the country where ethic groups have formed large communities. The result is a neighborhood, a town, a city or a county enriched with a range of ideas, foods, literature, religions, and languages. The healthcare needs of a multicultural group can pose challenges for care providers, hospitals, clinics, physician practices and more. Cultural competency training can assist care providers appreciate important considerations that can facilitate the delivery of care. The use of language interpreters can help bridge a communication gap between care providers and patients, too. Following recognized guidelines, healthcare organizations and physician practices can develop effective patient information sheets, brochures, and post-treatment discharge instructions that meet health literacy criteria. Notwithstanding efforts to address language considerations, issues persist when care providers encounter a patient who requires assistance with communication in a language other than English. As seen in a hypothetical case, language interpretation services may be eclipsed by the translated consent form. The Marial Consent Case Example. Suzette Marial arrived in the United States a few months after the devastating earthquake that destroyed large parts of Port-Au-Prince, Haiti. Ms. Marial s home had collapsed as did her modest business establishment.
2 Family living in the United States worked with an international social relief agency to secure Ms. Marial s entry into the country. In Haiti, Ms. Marial had completed four years of school in a rural village before she was forced to go to work to help support her family. As a young person she had worked as a seamstress for others. Ultimately, she was able to open up her own one-person business as a seamstress. When she arrived in the United States, Ms. Marial was welcomed into a large Haitian community. During the earthquake, Ms. Marial had been trapped under debris that had fallen on top of her. She had sustained a broken left arm, three broken ribs, and what she understood to be a bruise inside her abdomen. Although the broken arm and ribs had healed, from time to time Ms. Marial noticed pains in her abdomen. Ms. Marial lived with her cousin and her children. She was able to get a part-time job as a seamstress. The rest of her time was taken up with English language training. Speaking in Creole, Ms. Marial told her cousin Anne-Marie that she was experiencing terrible pain in her abdomen. Seeing that her cousin was doubled-over and clasping her stomach, Anne-Marie took Ms. Marial to a nearby hospital emergency department. Ms. Marial was triaged and taken immediately to an examination room. In the treatment area, Ms. Marial was perspiring. She had an elevated temperature. When a physician assistant attempted to palpate the patient s abdomen, she rebounded pushed her away and in a loud voice said, Non, non! A nurse showed Ms. Marial a language board with the flags and names of various countries and various languages. She pointed to Haiti and Creole on the board and Ms. Marial nodded and said, Oui, yes. The nurse contacted the language interpreter telecommunication service and a Creole-speaking interpreter came on line promptly. With the assistance of the language interpreter, the nurse introduced the emergency physician. The doctor, in turn, asked Ms. Marial a series of questions. Based on the patient s information and brief physical examination, the doctor said, We are going to run some tests to see why you are having so much pain in your abdomen. We are going to take some images of your abdomen. After we get the results, we shall discuss what can be done to help you. The diagnostic work-up revealed that the patient had acute appendicitis. The emergency room doctor, using the telecommunications language
3 interpretive service said, Ms. Marial, the tests tell us that you must have your appendix removed. You will be admitted to the hospital shortly, and a surgeon will come to see you and discuss the operation with you. Good luck. Dr. Johannes, a general surgeon, met with Ms. Marial and using the telecommunications language interpreter service, he discussed the need for a laparoscopic appendectomy. Dr. Johannes described how he would perform the procedure. He told her that if she did not have the operation and the appendix burst, it could cause her great harm. Dr. Johannes told Ms. Marial that while he expected it to be a routine he cautioned her that complications could arise especially with a patient who had experienced abdominal trauma or surgery in the past. He continued, If I encounter any problems, I will modify the procedure and do it a different way that may require a larger surgical opening. Do you understand, Ms. Marial? Do you have any questions of me? Through the language interpreter Ms. Marial said she wanted the operation. A nurse gave Ms. Marial a surgical consent form printed in Creole. She appeared to read it and then through the telecommunications language interpreter the nurse said, Do you have any questions? If not, please sign the document so that we can get you into the operation as quickly as possible. Ms. Marial signed the form. The procedure was started as a laparoscopic appendectomy. However, complications occurred and the surgeon had to switch to an open appendectomy. It was evident that the appendix had ruptured, too. Ms. Marial was placed on a course of IV antibiotic therapy. She remained in the hospital for three days. Shortly before the planned discharge, Ms. Marial spiked a temperature and developed significant abdominal pain. The surgeon ordered some tests and came to Ms. Marial. Through a telecommunications language interpreter he explained that she had developed an abscess in abdomen and that the antibiotics alone would not resolve it. He explained that he would have to insert a drain into the abscess to remove the contents. He continued, the drain will be there for several days and possibly a few weeks. If this procedure is not successful you may require additional surgery. Ms. Marial was quite upset. Through the language interpreter she said, The document that the nurse gave to me never explained that this could happen. I do not understand why this happened. I do not think I can trust you or this hospital. I want to see another surgeon! Dr. Johannes was quite surprised by the patient s reaction. He decided to contact patient relations and he explained the situation. After the patient
4 relations representative spoke with Ms. Marial, she did receive a second opinion from another surgeon. Satisfied that the treatment plan was as Dr. Johannes had explained it to her, Ms. Marial had a drain placement. She spent several days in the hospital before being discharged home with the drain. It was removed two weeks later. The patient relations representative was troubled by something Ms. Marial had said about the consent form. She looked at the English language version of the consent document. It contained a description of possible complications should the appendix rupture, including an infection in the abdominal cavity that might require intravenous antibiotic therapy and the use of a drain. With the assistance of a Creole-language interpreter she reviewed the translated consent form. She learned that the health literacy level for the translated form was set for those with a far higher reading comprehension skill set than was the case in the English version of the consent document. Moreover, the translation of surgical complications was not consistent with the content in the English language consent form. The patient relations representative met with the Director of Performance Improvement and showed her the results of her evaluation. You really did your homework. This is a real problem. I am going to bring this matter to the Performance Improvement Committee tomorrow. If this form is out-of-line how many others have the same problem? And, I think we need to alert Dr. Johannes and explain what happened to the patient, too. By her speaking up, she helped us identify an important flaw in our consent communication process. Observations on the Marial Case Example. The healthcare facility appeared to take all the right steps for Ms. Marial. From the outset, compassionate care providers made certain that the patient received language-appropriate translation services. Looking at the facts more closely, however, there are some issues in the case. The surgeon never discussed with the patient what he meant by doing the procedure in a different way that may require a larger surgical opening. Further he asked her if she understood, but he never completed a teach-back process to determine if she understood what he had shared with her. From the information provided, it is apparent that no one evaluated the patient s health literacy skills. This was a serious communication issue.
5 Remember that this patient had a limited formal education. The nurse assumed that the patient did not have any questions because she signed the consent form. However, the patient was never asked questions to evaluate her comprehensive of the document. As it was learned later on, the consent form itself was flawed because the information it contained was not consistent with the English version. Furthermore, the anticipated comprehension level was set higher than for English-speaking patients. Notwithstanding the use of a language interpreter, the consent form created a situation in which important information was lost in translation. Coupled with a lack of health literacy, it may well explain why the patient was so upset and said that she did not trust the hospital or the surgeon. Communication Strategies for Translating Consent Forms. There are a several strategies to consider in developing consent forms that do not lose meaning when translated into languages other than English. Consider the following: 1. Implement Health Literacy Requirements for Consent Forms. Work with clinical leadership and patient education professionals in crafting requirements for health literacy in consent forms. Recognizing that one size may not fit all, anticipate that a contingency process should be available for illiterate or very low health literacy patients. [See sample tool]. 2. Set Translation Requirements for Non-English Language Consent Forms. Make certain that qualified personnel translate English language content properly so that there is no incongruity in other languages. Reinforce that the translation must also meet health literacy requirements. 3. Field Test Translated Consent Forms. Evaluate the accuracy and health literacy of draft versions of non- English language consent forms. Make modifications based on the results of field tests. 4. Build in Teach-Back For All Consent Forms. Confirm patient understanding of information provided in the consent document. Use the teach-back communication with both English and non-english speaking patients. Include in the consent
6 process the need to reconcile patient misunderstandings, as identified through the teach-back communication. 5. Utilize Language Interpreters for Non-English Consent Form Teach-Back Process. Make effective use of language interpreters to complete the teachback communication process with non-english speaking patients. Make certain that language interpreters follow the same teach-back questions or script as do care providers when dealing with Englishspeaking patients. 6. Provide Staff Education on Effective Use of Consent Documentation. Encourage clinical professionals to participate in orientation and inservice programs on the proper use of consent documentation. Reinforce that the consent form is not a substitute for the consent communication process. Explain the reason for and the proper effective of teach-back as part of the consent communication and documentation process. 7. Retain Consent Documentation in the Patient Medical Record. Work with legal counsel to identify the retention plan for consent forms in the patient record. Recognizing that with electronic medical records, consent forms should be part of the patient record, include the document in the language used with non- English speaking patients. Conclusion. Central to an understanding of consent is the fundamental concept that consent is a communication process, not a form. With that being said, there is a need to memorialize the discussion in a consent document. Such documentation is needed for continuity of care, billing, and legal defense. It is also a patient safety tool. Health literacy is a key aspect of effective consent communication and documentation. The risk of information being lost in translation should not be minimized. It is imperative to including the need for consistent information being incorporated into both English and non-english consent documentation. Coupled with staff who are prepared to use consent documentation properly, the risk of such miscommunication can be minimized.
7 DIALOGUES IN HEALTHCARE is a publication of The Rozovsky Group, Inc./RMS. This publication is not intended to be and should not be used as a substitute for specific legal advice. Readers should obtain specific legal advice in translated consent processes and other patient communications. Contact Information: The Rozovsky Group, Inc./RMS, 272 Duncaster Road, Bloomfield, CT 06002. Tel: (860) 242-1302.
8 Sample Tool Checklist for Health Literacy Consent Forms Development Recognizing that consent policy and procedures are found in most healthcare organizations and physician practices, the fundamentals should be in place to reinforce the concept that consent is first and foremost a communication process. Having in place solid consent documentation is essential as it is evidence that can be helpful in litigation. Moreover, it is the basis for continuity of care, billing, and regulatory compliance let alone patient safety. Consent documentation should meet recognized guidelines for health literacy. This includes translated forms. For this purpose, consider the following checklist items to guide development of health literacy-based consent forms, including those that are translated into other languages. Establish reading comprehension level for consent forms, taking into consider national guidelines and recommendations. Use a tool to field-test draft consent forms for health literacy. Make certain that the field test incorporates a teach-back process. Follow process improvement methods to refine tools that reflect inconsistencies with health literacy guidelines. Develop an alternate method for managing consent documentation for those patients with very low or non-existent literacy skills. Consider for this purpose the use of interactive pictures or computer games that are designed to evaluate patient understanding. Develop a teach-back communication process that will be used consistently with all patients. Provide the teach-back communication process or script to language interpreters. Offer health literacy and teach-back orientation and training for clinical care professionals. Incorporate a copy of the signed consent form in the patient record and for non-english language patients, include both the foreignlanguage and the English based version of the consent form used in the care of the patient. Establish a version number system for identifying the current consent forms used in the health organization. Retain copies of English consent forms and foreign language consent documents in accordance with healthcare facility document retention protocol.