INFORMED CONSENT FOR TRAUMA PATIENTS: AN EXPERIMENT TO IMPROVE TAIWANESE PATIENT KNOWLEDGE AND SATISFACTION AFTER INFORMED CONSENT FOR DEBRIDEMENT OF COMPLICATED WOUNDS
Background: Valid informed consent is an ethical fundamental element and a prerequisite of law and regulation for clinical treatment. Trauma patients with physical pain and emotional stress under an environment of time constraint in emergency settings usually have difficulty in understanding the information presented to them. It is vital that physicians convey any complicated treatment information to patients, and patients need to have adequate knowledge about the treatment to facilitate individual choice.
Aims: The study has three aims. The first aim is to explore what the current state of art for informed consent is, and how we can improve the quality of the informed consent process for trauma patients in the emergency department. The second aim is to develop an audiovisual video containing the information for the informed consent process in trauma patients undergoing the surgery, and to develop and validate a knowledge measure instrument to quantify the understanding of trauma patients for informed consent to surgery. The third aim is to compare the understanding and satisfaction of trauma patients between video and routine informed consent groups.
Methods: To address the first aim, a systematic review is conducted to identify relevant articles. To address the second aim, an audiovisual video including information about the surgical procedure, benefits, risks, and alternatives is developed. One panel of experts is invited to develop the script for the video based upon the consensus from the modified Delphi technique. Furthermore, the development of the knowledge measure instrument is based on the literature and the consensus of experts. To address the third aim, a prospective randomized controlled trial is conducted in the emergency department, and a convenience sample of targeted trauma patients is enrolled.
Findings: From the literature, it is found that trauma patients have poor recall of risks and complications, while written information, pamphlets or video have positive effect on patients’ understanding and satisfaction. Modified Delphi technique is a useful method to collect and reach experts’ consensus to develop the contents of informed consent. Moreover, the audiovisual video containing information about informed consent to surgery for trauma patients was developed and pilot-tested as well as the knowledge measure instrument for evaluating the understanding of trauma patients. Furthermore, by using the educational video, patients were found to have better information, more understanding and higher satisfaction. The video-assisted method is, accordingly, a good vehicle for improving the informed consent process for trauma patients in the emergency department.
Conclusion: The content of informed consent should be developed by integrating a variety of experts’ opinions, especially patients. Using educational videos is a good tool for improving informed consent process for the surgery in trauma patients. Future studies should be conducted to develop a structured and standardized informed consent process and evaluate the effectiveness in combination with healthcare providers, patients, and informed consent experts. Institutions should give top priority to ensure patient-centered health care and improved quality of care for trauma patients
