Comparing a Multimedia Digital Informed Consent Tool to Traditional Paper-based Methods Among GenEx Trial Participants: Randomized Control Trial (Preprint)

2020 ◽  
Author(s):  
Fuad Abujarad ◽  
Peter Peduzzi ◽  
Sophia Mun ◽  
Kristina Carlson ◽  
Siyuan Ma ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Cognitive Theory ◽  
Digital Health ◽  
Informed Consent Process ◽  
Ease Of Use ◽  
Consent Process ◽  
New Haven ◽  
Randomized Control ◽  
The Impact

BACKGROUND The traditional informed consent process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. OBJECTIVE This paper explores how we evaluated the feasibility of a digital health tool called ‘VIC’ for advancing the informed consent process and compared the results to traditional paper-based methods of informed consent. METHODS By utilizing Digital Health and virtual coaching, we developed the ‘Virtual multimedia interactive Informed Consent’ (VIC) tool that uses multimedia and other interactive digital features to improve the current informed consent process. Development of the tool was based on the user-centered design (UCD) process and on Mayer’s cognitive theory of multimedia learning. In a randomized control trial, we compared VIC’s feasibility against standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic (WCC) at Yale New Haven Hospital in New haven, CT, as well as from the community using fliers. The trial was coordinator-assisted, and participants were randomized to complete the informed consent process using VIC on the iPad or with traditional paper consent. The study was conducted at WCC and the outcomes were self-assessed through coordinator-administrated questionnaires. RESULTS Overall 50 participants were recruited in the study (VIC: n=25; Paper: n=25). Participant comprehension was high in both groups. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and a shorter perceived time for completing the consent process. CONCLUSIONS The use of dynamic, interactive audiovisual elements in VIC may improve participants satisfaction and facilitate the informed consent process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings which demonstrate VIC’s potential to improve research participant’s comprehension as well as the overall process of the informed consent. CLINICALTRIAL ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

2020 ◽  
Vol 15 (2) ◽  
pp. 75-83
Author(s):  
Rachel S Purvis ◽  
Leah R Eisenberg ◽  
Christopher R Trudeau ◽  
Christopher R Long ◽  
Pearl A McElfish
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Diabetes Management ◽  
Community Based Participatory Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Approach ◽  
Community Based ◽  
Randomized Control ◽  
Participatory Research Approach

Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial. Results Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process. Conclusion Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial

2015 ◽  
Vol 126 (6) ◽  
pp. 1273-1278 ◽  
Author(s):  
Jennifer M. Siu ◽  
Brian W. Rotenberg ◽  
Jason H. Franklin ◽  
Leigh J Sowerby
Keyword(s):  
Informed Consent ◽  
Endoscopic Sinus Surgery ◽  
Randomized Control Trial ◽  
Informed Consent Process ◽  
Sinus Surgery ◽  
Consent Process ◽  
Randomized Control

The Impact of the Informed Consent Process on the Anxiety Levels of Patients Undergoing Rhinoplasty

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Abdulhalim Aysel ◽  
Uzdan Uz ◽  
Berrak Karatan ◽  
Enes Aydin ◽  
Esin Erdoğan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Anxiety Levels ◽  
The Impact

scholarly journals An evaluation of the process of informed consent: views from research participants and staff

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lydia O’ Sullivan ◽  
Laura Feeney ◽  
Rachel K. Crowley ◽  
Prasanth Sukumar ◽  
Eilish McAuliffe ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Study ◽  
Contextual Factors ◽  
Informed Consent Process ◽  
Small Sample ◽  
Consent Process ◽  
Online Research ◽  
Research Staff ◽  
Research Participants ◽  
The Impact

Abstract Background The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process. Methods Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically. Results Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources. Conclusions Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques. Trial Registration Not applicable

The impact of disease severity on the informed consent process in clinical research

1996 ◽  
Vol 100 (3) ◽  
pp. 261-268 ◽  
Author(s):  
Monica H. Schaeffer ◽  
David S. Krantz ◽  
Alison Wichman ◽  
Henry Masur ◽  
Eddie Reed ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Disease Severity ◽  
Informed Consent Process ◽  
Consent Process ◽  
The Impact

Informed Consent in Clinical and Research Settings: What Do Patients and Families Need to Make Informed Decisions?

2015 ◽  
Vol 24 (4) ◽  
pp. 130-139 ◽  
Author(s):  
Helen M. Sharp
Keyword(s):  
Informed Consent ◽  
Family Members ◽  
Cognitive Disorders ◽  
Informed Consent Process ◽  
Consent Process ◽  
Clinical Settings ◽  
Risks And Benefits ◽  
Suboptimal Outcome ◽  
Research Environments ◽  
The Impact

Informed consent requires that patients in clinical settings and participants in research voluntarily agree to a proposed plan based on their understanding of a clear and thorough explanation of purpose, risks, benefits, and alternatives. Although the need to obtain informed consent is well understood in clinical and research environments, the evidence suggests that patients, family members, and participants in research are often unclear about options, risks, and benefits even after providing “informed” consent. Individuals with communication or cognitive disorders are at particular risk for a suboptimal outcome of the informed consent process. There are many barriers to achieving true informed consent, but the use of appropriate strategies can minimize the impact of these barriers and allow clinicians and researchers to improve the process of achieving true informed consent.

scholarly journals PO 8194 OPTIMISED INFORMED CONSENT FOR PARTICIPANTS IN A RANDOMISED CONTROLLED TRIAL IN RURAL UGANDA: A COMPARATIVE PROSPECTIVE COHORT STUDY

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A22.1-A22
Author(s):  
James Ditai ◽  
Jesca Kanyago ◽  
Rachael Nambozo ◽  
Nathan Kanyago ◽  
Julian Abeso ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
African Women ◽  
Consent Process ◽  
Research Information ◽  
Slide Show ◽  
Randomised Controlled ◽  
The Impact

BackgroundPoor participant understanding of research information can be a problem in community interventional studies in rural African women where levels of illiteracy, dependency and compliance are high. We assessed the impact of alternative consent models on participants’ understanding of the clinical trial information and its contribution to the informed consent process in rural Uganda.MethodsThis was a prospective comparative cohort, nested within a pilot study of community distribution of alcohol-based hand rub to prevent neonatal sepsis (BabyGel). As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information; a ‘slide show’ using illustrated text on a flip chart; and a video showing the patient information sheet (PIS) being read as if by a newsreader in either English or the local language. In addition, all women received a written PIS in their preferred language. Each information method was used for 1 week of recruitment. Two days after recruitment, women’s understanding of the clinical trial was evaluated.ResultsA total of 30 pregnant women from 13 villages in Mbale participated in this study. Majority 90% (27/30) were assessed for recall of trial information within planned 48 hours. The slide-show was the most popular, with a mean score not less than 4.2 highest [mean (sd) range: 4.8 (0.6) [4–5]] by women who had been recruited using any of the three models. The slide show was preferred by 63% of the women (19/30), compared with 17% (5/30) and 20% (6/30) who preferred the standard and video show message, respectively. Reasons given included the benefits of having pictures to aid understanding, and the logical progression of the information.ConclusionOur results suggest that a slide-show message is an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom had little or no literacy.

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