We found that participants who received a video-assisted informed consent intervention showed greater knowledge of pediatric procedural sedation. Referring to the multimedia principle, a theory of multimedia learning, Mayer proposed that “people learn more deeply from words and pictures than from words alone.” Participants in the video intervention group showed greater satisfaction with the informed consent process than those in the conventional discussion control group. To our knowledge, this is the first study to use educational videos to improve the informed consent process for pediatric procedural sedation in the ED.
The informed consent process advocates the two core principles of patient well-being and patient autonomy,[14, 16] and physicians must respect and promote these principles. Informed consent comprises several essential components, including competence, disclosure, and voluntariness.[32, 33] A competent patient must receive adequate information from healthcare providers, understand the risks and benefits, and make decisions voluntarily based on his/her own values. In addition to the ethical aspects of informed consent, its legal requirements require physicians to provide information about medical procedures, risks and complications, benefits, and available alternatives.[14, 34]
Obtaining valid consent in the ED is a challenging and time-consuming process. It is often difficult for patients and their families to understand and absorb sufficient information to provide valid consent owing to time constraints, stress, and distress caused by acute symptoms or pain in the ED.[14–16, 18] Parents of children in the ED are generally considered the legal surrogates and decision makers. It is presumed that parents will make decisions according to the best interests of their child, maximizing benefits and minimizing possible risks and suffering. Therefore, healthcare providers must work hard to convey the necessary information in an effective way to help patients and parents make effective decisions under demanding conditions.
Research on the decision-making framework for informed consent has identified many factors that affect patients’ understanding of the process. Patient factors (e.g., age, education level, previous experience), physician factors (e.g., years in practice, communication skill, use of information aids), disease context (e.g., disease type, disease severity), and environmental factors (e.g., ordinary or emergency settings, time of visit) may affect information exchange, patient deliberation, and voluntarism regarding treatment decisions and consent.[36, 37] Our findings indicate that, after controlling for several factors, baseline knowledge scores and the use of the educational video influenced parents’ knowledge and understanding. Future studies are needed to explore whether and how these factors affect the informed consent process in the ED for pediatric patients and their parents.
A previous study reported that parental educational level and sex of parent affect risk counseling recall; maternal parents showed better risk recall than paternal parents. However, another study revealed that demographics were not related to parental recall rates during informed consent for emergency surgery for their children. In our study, maternal parents and parents with education equal to or above college level in the intervention group showed a significantly greater difference in knowledge scores. Although the difference was not statistically significant in the multivariable analysis, sex of parent and education level seemed to have a greater impact on parental understanding after the video education. Future studies are needed to confirm these results.
The importance of the entire consent process should be emphasized: a good consent process may improve patient satisfaction and foster a good patient–physician relationship. Several strategies have been proposed to improve the consent process in the emergency setting.[40, 15] One study reported that using information aids may improve parental satisfaction with surgical informed consent in children. Another study revealed that visual aids may improve communication about surgery between pediatric surgeons and surrogates. During shared decision making, the physician may act as the parent’s partner, providing information about diagnosis, treatment options, prognosis, and possible risks and complications. Physicians may communicate with parents about their perspectives and preferences, help them to discuss their values, and help them to make the best decisions for their children. A range of strategies have been used to improve patients’ and parents’ comprehension, including illustrative materials, leaflets and pamphlets, video descriptions, interactive computer programs,[3, 44–52] and “repeat back to me” or testing with feedback strategies.[53–55]
We found that baseline knowledge score and the use of an educational video were significant predictors of parental knowledge and understanding. Previous findings indicate that the use of video to educate adult patients and facilitate informed consent in the ED is effective.[44, 56–58] However, the effectiveness of preoperative education for pediatric patients and parents in the ED has not attracted much research interest. One study reported that standardized portable computer presentation was an effective way to improve education and facilitate the informed consent process in parents of children undergoing emergency surgery. Traditionally, information about medical treatments or procedures is presented in written and/or verbal formats. However, research suggests that this standard approach often yields poor participant understanding of the information provided. Possible reasons for poor understanding and memory retention include participants’ lack of ability to read and understand material written above the suggested reading level, rushed and incomplete disclosure from information providers, use of unfamiliar medical terminology, and variability in the clarity and amount of information. One systematic review of informed consent in trauma patients reported that risk recall and comprehension were greater for written or video information than for only verbal information. Patients who received video information were more satisfied than patients who received written or verbal information. The present results show that the video-assisted informed consent intervention resulted in improved understanding compared with the conventional informed consent discussion.
Recent advances in portable and tablet computer technology have provided good opportunities to improve parent preoperative education for pediatric emergency surgery. The latest portable and tablet computers have larger screen displays, larger memory storage, and good image resolution, so can more easily deliver educational information and good quality videos. Consequently, the use of innovative portable computer technology may help to produce timely and effective preoperative education in the ED. In this study, we used a laptop with a preloaded video to educate parents and facilitate informed consent at the bedside in the ED. The results are promising, but additional studies are needed to further explore these findings.
We did not measure how much time was spent on the informed consent process for pediatric procedural sedation in both groups. Time spent on the informed consent process may affect participant comprehension and satisfaction.[38, 42, 54] However, we believe that participants in both groups had sufficient time to obtain satisfactory information and similar opportunities to clarify their questions with their physicians to make medical decisions during the informed consent process. Therefore, it is unlikely that time affected the results.
It is essential that institutions establish an ethical environment for patient-centered healthcare. One study recommended it is essential to define universal standards for informed consent. We found that the video improved parental knowledge and satisfaction for the informed consent process in the ED. However, we believe that the main improvement was a result of the institution’s efforts to improve patient safety and quality of care. The improvement in outcomes reflected these achievements. Institutions must both emphasize patient-centered healthcare as a top priority and attach importance to improved quality of care in the ED. ED staff need to share these values with other staff and healthcare personnel to provide appropriate care during all parts of the care process.
Furthermore, the importance of adequate education and training for healthcare providers to deliver structured and comprehensive information in a timely manner in the ED should not be underestimated. Effective communication of complicated information helps patients to understand the relevant information and make decisions. A good informed consent process can also promote good patient–physician relationships and build trust.
Our study had several limitations. First, this was one intervention for a particular population at one institution and thus the findings may not be generalizable to other situations or populations. Second, although the video-assisted informed consent intervention improved information understanding, it remains unclear how it influenced the decision to accept the procedure. No participants refused consent for the procedure after being informed by either the conventional process or the video. However, the choice of study design and population may have made it likely that participants were already aware of the procedure’s necessity and had made an initial decision to accept it prior to recruitment. Further studies are needed to examine the effect of video-assisted informed consent intervention on decision making. Moreover, there are no reliable and valid measures of participant understanding of the benefits, risks, and alternatives of pediatric procedural sedation. In this study, the video and the knowledge test developed by a panel of experts demonstrated face validity and included information that we believed participants should know before providing consent for the procedure. The knowledge test focused on the purpose, risks, and benefits of the procedure and participants showed substantial improvement in their understanding of these aspects. However, knowledge about alternative treatments was not measured. It would have been useful to assess this and to determine whether the intervention improved participants’ understanding of alternatives. Furthermore, we did not evaluate the effect of video education on parents’ anxiety. A previous study reported that a multimedia intervention significantly reduced anxiety and increased knowledge in parents. Further studies are needed to confirm these findings in the ED.