Dataset Information

A randomized, controlled trial of video supplementation on the cataract surgery informed consent process.

ABSTRACT:

Purpose

To assess the effects of the American Academy of Ophthalmology's 2015 patient education video on patient information retention and anxiety preoperatively, on the day of surgery and postoperatively.

Methods

This is a prospective, surgeon-blinded randomized controlled trial at the University of Chicago Medical Center. Ninety-one patients with a diagnosis of first-eye cataract were randomized into either a video or control group. Subjects in both groups received face-to-face discussion with the surgeon and an informational brochure at the preoperative evaluation. Participants in the video group then viewed a four-minute educational video at the preoperative evaluation and on the day of surgery. Both groups completed an information retention quiz and a state anxiety assessment at the preoperative visit, on the day of surgery, and on the postoperative week one visit. Subject understanding of cataract surgery was measured using a twelve-question multiple choice quiz. State anxiety was measured by State Trait Anxiety Inventory-Y1 survey score.

Results

Participants in the video group did not score significantly higher on the information retention quiz compared with the control group at the preoperative evaluation (8.7?±?2.4 vs 7.7?±?2.5, P?=?0.07), but did so on the day of surgery (11.2?±?0.8 vs 8.4?±?1.7, P?ConclusionsVideo supplementation to the traditional informed consent process demonstrated an improvement in patient understanding of cataract surgery at multiple timepoints and decreased anxiety on the day of surgery.

SUBMITTER: Zhang MH

PROVIDER: S-EPMC7846231 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

A randomized, controlled trial of video supplementation on the cataract surgery informed consent process.

Zhang Michael H MH Haq Zeeshan U ZU Braithwaite Evan M EM Simon Noah C NC Riaz Kamran M KM

Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie 20190530 8

<h4>Purpose</h4>To assess the effects of the American Academy of Ophthalmology's 2015 patient education video on patient information retention and anxiety preoperatively, on the day of surgery and postoperatively.<h4>Methods</h4>This is a prospective, surgeon-blinded randomized controlled trial at the University of Chicago Medical Center. Ninety-one patients with a diagnosis of first-eye cataract were randomized into either a video or control group. Subjects in both groups received face-to-face ...[more]

PMID: 31144057

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Project description:BackgroundWe 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.MethodsWe 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.ResultsA 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.ConclusionsBoth 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 registrationThe ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

Project description:ObjectiveTelemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent.MethodsA prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes.ResultsA total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar.ConclusionTelemedicine is noninferior to F2F consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials.

Project description:BackgroundThe traditional informed consent (IC) process rarely emphasizes research participants' comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies.ObjectiveThis paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC.MethodsUsing digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer's cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires.ResultsA total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process.ConclusionsThe use of dynamic, interactive audiovisual elements in VIC may improve participants' satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC's potential to improve research participants' comprehension and the overall process of IC.Trial registrationClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

Project description:BackgroundEthical principles obligate researchers to maximize study participants' comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts.MethodsStudy staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed.ResultsICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24-42). Median ICAT scores were 80% (IQR: 67-93) for comprehension and 89% (IQR: 78-100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials.ConclusionsParticipants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.

Project description:ImportanceCataract surgery is the most commonly performed intraocular surgery. Academic centers have mandates to train the next surgeon generation, but resident roles are often hidden in the consent process.ObjectiveTo investigate associations of full preoperative disclosure of the resident role with patient consent rates and subjective experience of the consent process.Design, setting, and participantsFull scripted disclosure of residents' roles in cataract surgery was delivered by the attending surgeon. Qualitative analysis was conducted from recorded interviews of patients postoperatively regarding consent process experience and choice of whether to allow resident participation. Associations were sought regarding demographic characteristics and consent rates. Patients were recruited though a private community office. Surgery was performed at a single hospital where resident training was routinely conducted. The study included systemically well patients older than 18 years with surgical cataract. They had no previous eye surgery, English fluency, and ability to engage in informed consent decision-making and postsurgery interview. Patients were ineligible if they had monocular cataracts, required additional simultaneous procedures, had history of ocular trauma, or had cataracts that were surgically technically challenging beyond the usual resident skill level.InterventionsEligible patients received an informed consent conversation by the attending physician in accordance with a script describing projected resident involvement in their cataract surgery. Postoperatively, patients were interviewed and responses were analyzed with a quantitative and thematic qualitative approach.Main outcomes and measuresConsent rates to resident participation and qualitative experience of full disclosure process.ResultsNinety-six patients participated. Participants were between ages 50 and 88 years, 53 were men (55.2%), and 75 were white (85.2%). A total of 54 of 96 participants (56.3%; 95% CI, 45.7%-66.4%) agreed to resident involvement. There were no associations between baseline characteristics and consent to resident involvement identified with any confidence, including race/ethnicity (60% [45 of 75] in white patients vs 30.8% [4 of 13] in nonwhite patients; difference, 29.2%; 95% CI, -0.7% to 57.3%; Fisher exact P = .07). Thematically, those who agreed to resident involvement listed trust in the attending surgeon, contributing to education, and supervision as contributing factors. Patients who declined stated fear and perceived risk as reasons.Conclusions and relevanceOur results suggest 45.7% to 66.4% of community private practice patients would consent to resident surgery. Consent rates were not associated with demographic factors. Because residents are less often offered the opportunity to do surgery on private practice patients vs academic center patients, this may represent a resource for resident education.

Dataset Information

A randomized, controlled trial of video supplementation on the cataract surgery informed consent process.

Purpose

Methods

Results

Publications

A randomized, controlled trial of video supplementation on the cataract surgery informed consent process.

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