Dataset Information

Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial.

ABSTRACT: BACKGROUND:We investigated whether, in the emergency department (ED), educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. METHODS:We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups. RESULTS:A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention (72.57?±?16.21 (SD)) than in the control (61.67?±?18.39) group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores (coefficient: 7.646, 95% CI: 3.381-11.911). Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients' perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction. CONCLUSIONS:Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction. TRIAL REGISTRATION:The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

SUBMITTER: Lin YK

PROVIDER: S-EPMC5845218 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial.

Lin Yen-Ko YK Chen Chao-Wen CW Lee Wei-Che WC Cheng Yuan-Chia YC Lin Tsung-Ying TY Lin Chia-Ju CJ Shi Leiyu L Tien Yin-Chun YC Kuo Liang-Chi LC

BMC medical ethics 20180309 1

<h4>Background</h4>We investigated whether, in the emergency department (ED), educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care.<h4>Methods</h4>We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical ...[more]

PMID: 29523129

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Project description:Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients' knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process.A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery.The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department (ED) were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video.Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts' opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care.The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

Project description:Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member.In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4-20; neutral = 12) and willingness (range, 21-105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05).Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14-18) and demonstrated high willingness scores (median, 82; IQR, 76-88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14-18] vs. 16 [13-16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68-77] vs. 77 [70-85]; p = 0.03) or community members (median [IQR], 76 [70-84]; p = 0.01).Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families.Epidemiologic, level III.

Project description:BackgroundObtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients.MethodsWe conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed (1961-August 2018) that had experimental or observational study design and involved adult trauma patients. Studies involving informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach.ResultsA total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information.ConclusionsMany articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients.

Project description:ImportanceException From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive.ObjectiveTo describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests.Design, setting, and participantsThis survey study analyzed the CC and PD campaigns conducted for the TAP trial (Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival), an EFIC trial of the early administration of prothrombin complex concentrate in patients with trauma. The CC and PD campaigns consisted of social media advertisements, linked websites, community surveys, and online community forums. These activities were coordinated from a central site and approved by a central institutional review board. This study focused on the first 52 of 91 TAP trial sites (level I trauma centers) in the US to have completed their CC and PD campaigns. Community members in the catchment areas of the participating trauma centers were targeted. Data analysis was conducted between October 2023 and February 2024.ExposureSocial media advertisements, surveys, and online community meetings conducted as part of the CC and PD campaign for the TAP trial.Main outcomes and measuresSocial media campaign reach and engagement, web page views, survey results, online community forum attendance, and opt-out requests.ResultsFifty-two trial sites were approved for participant enrollment. Social media advertisements were displayed 92 million times, reaching 11.8 million individuals. The median (IQR) number of people reached in each location was 210 317 (172 068-276 968). Site-specific websites were viewed 144 197 times (median [IQR] viewings per site, 2984 [1267-4038]). A total of 17 206 fully or partly completed surveys were received, and survey respondents had a median (IQR) age of 40.1 (15-65) years and included 10 444 females (60.7%). Overall, 60.6% survey respondents said they would want to be entered into the trial even if they could not give consent, 87.7% agreed that emergency care research was necessary, and 88.0% agreed that the TAP trial should be conducted in their community. Online community forums were attended by a median (IQR) number of 38 (20-63) people. Four opt-out requests were received.Conclusions and relevanceThe interactive media-based approach to CC and PD for the ongoing TAP trial showed the feasibility and benefits of executing an efficient, coordinated, centrally run series of locally branded and geographically targeted CC and PD campaigns for a large EFIC study.

Dataset Information

Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial.

Publications

Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial.

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