Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent:A parallel-group pilot study among Danish citizens

BACKGROUND: Teleconsent via video conferencing enables decentralized trials with remote consent and has the additional benefit of allowing a real-time reaction to potential misunderstandings. However, participant acceptance of and satisfaction with teleconsent versus in-person consent processes are unknown. METHODS: We conducted a parallel-group pilot study to evaluate participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent among Danish citizens for a hypothetical research study. RESULTS: There were no statistically significant differences in perceptions of security or satisfaction between teleconsent and in-person consent arms. However, participants viewed teleconsent as more convenient than in-person consent, as no transportation was needed and the process was less time-consuming. Recruitment was also faster in the teleconsent arm, and more people dropped out of the in-person arm, citing difficulties with transportation and time. CONCLUSION: Decentralized clinical trials have been demonstrated to increase recruitment and enrollment rates, improve trial efficiency, and decrease dropout rates and trial delays. We add to this literature by suggesting that patients perceive teleconsent as similar to in-person consent, suggesting this is a feasible and acceptable substitution for in-person consent in multisite, decentralized trials. Future work should include patient perspectives from a larger, more diverse group of participants

Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives.

The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information – an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study participation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and advertisement, to participate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of participants (38.6%) were not able to discuss the study with research staff. While the majority of participants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that reporting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the reporting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most important motivation for participation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to participate.Significance:• Navigation of the electronic consent process for participation in a COVID-19 vaccine implementation trial is not a challenge for educated healthcare professionals with access to electronic devices and data. However, technical skills and access to technology may impact the integrity of the informed consent process for lay research participants.• Motivation to join research studies for access to scarce resources impacts negatively on the authenticity of the consent processes, as participation may be informed but not truly voluntary, and is an issue that ethics committees and researchers should address

Front-Line Physicians' Satisfaction with Information Systems in Hospitals

Day-to-day operations management in hospital units is difficult due to continuously varying situations, several actors involved and a vast number of information systems in use. The aim of this study was to describe front-line physicians' satisfaction with existing information systems needed to support the day-to-day operations management in hospitals. A cross-sectional survey was used and data chosen with stratified random sampling were collected in nine hospitals. Data were analyzed with descriptive and inferential statistical methods. The response rate was 65 % (n = 111). The physicians reported that information systems support their decision making to some extent, but they do not improve access to information nor are they tailored for physicians. The respondents also reported that they need to use several information systems to support decision making and that they would prefer one information system to access important information. Improved information access would better support physicians' decision making and has the potential to improve the quality of decisions and speed up the decision making process.Peer reviewe

mHealth for Mental Health: Culturally-tailored Interventions for Managing Anxiety and Depression in African American Women

The rates of mental illness among African American women are comparable to the general population, however, they significantly underutilize mental health services compared to their white counterparts. Previous studies revealed that mHealth interventions increase access to mental health services and resources, and are effective in reducing anxiety and depression. Approximately 80% of African American women own smartphones. This presents a great opportunity to use mobile technology to help reduce the disparity in mental health service utilization and improve health outcomes. The purpose of this dissertation study is to examine the attitudes and perceptions of African American women towards using mental health services, and the feasibility of using mobile technology to deliver mental health services and resources. Eligible participants were African American women (≥ 18 years of age). Participants were recruited through convenience sampling methods (e.g., social media) to complete a web-based survey (n=395), participate in a focus group (4 groups of 5 participants), or test and evaluate a mental health app developed to help African American women manage anxiety and depression (n=15). Results from the study revealed that African American women have favorable views toward seeking mental health services. However, respondents identified many barriers to seeking treatment. Most of the barriers were related to cost, not knowing where to get services, lack of time, and concern of stigma. Findings from the study showed that respondents were more comfortable with using voice call or video call when compared with text messaging or use of a mobile app to communicate with mental health professionals for help in managing anxiety and depression. User-centered recommendations focused on the type of content (e.g., information to find a Black female therapist) and features (e.g., group chat rooms) that should be included in an app culturally-tailored for African American women. Suggestions to increase app usage (e.g., ability to learn coping techniques) and establish trust (e.g., transparency on how user data is protected) were also discussed. The findings of this study demonstrated the need for additional research into the use of mobile technology to provide African American women with more accessible and convenient options for mental health care.Doctor of Philosoph

Human Factors Considerations in a Telemedicine-Integrated Ambulance-Based Caregiving Environment for Stroke Care

Telemedicine, the use of communications technology to connect patients to medical professionals remotely, can be applied to a variety of settings, for example connecting older adults with their physicians from home, specialists to rural county hospitals or patients to physicians for emergency care. This dissertation focuses on the use of telemedicine for ambulance-based care for stroke patients, including how the design of this system impacts caregivers. The initial study investigated both the usability of a telemedicine system implemented in ambulances for stroke care as well as the possibility of human error when using it. The heuristic evaluation of usability violations found several issues that needed to be addressed, including the lack of clarity in the tab structure and the lack of suggestions for correct data inputs. Similarly, the analysis of possible errors also determined several issues with this system, with the two most common being miscommunication and difficulty in locating data input or selecting an incorrect option. Several remediations strategies were recommended based on this study: improvement of the labelling of the tab structure, consistent formatting, rigid or suggested formatting for data input, automation of task structure and camera movement, and audio/visual improvements to support communication. The second study investigated the experience of caregivers with the ambulance-based stroke telemedicine system, focusing on the support of the distributed cognition of the caregiving teams. Teams comprised of a neurologist, nurse, and paramedic were observed conducting 13 simulated stroke consults, after which each caregiver completed a survey on the perceived workload, usability, and teamwork during the session and an interview about their experience with the telemedicine system. In total, thirty-nine caregivers were interviewed, and the data collected were analyzed for themes. The themes that emerged identified such barriers to and facilitators for using telemedicine for ambulance-based stroke caregiving as training and experience, technical difficulty barriers, and patient care and efficiency improvement facilitators. The findings from this study resulted in design recommendations for supporting healthcare professionals during caregiving, especially ones that support their distributed cognition when using ambulance-based telemedicine for stroke care. The final study evaluated the effect of design recommendations implemented in a new telemedicine system on the neurologist’s workload, situation awareness, and task performance in addition to evaluating the perceived usability of this new design and its support of distributed cognition. For this study based on a within-subjects experimental design, 20 neurologists completed simulated stroke assessments using both the new design and the design investigated in the two previous studies and evaluated each system. Overall, the results found that the neurologists experienced a lower workload, performed better in their task, exhibited higher situation awareness, and rated usability highly in the new design. In addition, most participants thought that the new design better supported distributed cognition principles and preferred the new system for ambulance-based stroke consults

Assessing the Satisfaction of Citizens Using Teleconsent in Clinical Research

Researchers tested the functionality, and evaluated the feasibility of a telemedicine software, Doxy.me, to complete informed teleconsent sessions remotely with prospective research participants. Twenty healthy volunteers completed a teleconsent session, and web survey assessing overall experience and satisfaction with the Doxy.me software. There was a statistically significant correlation found between age and mean response for the overall reaction category (r = 0.398, p = 0.091) and the systems capabilities category (r = 0.380, p = 0.099). Results suggested that younger users are more satisfied than older users with using teleconsent as a modality for informed consenting. This information will be used to improve the software design and functionality of the Doxy.me software to make the teleconsent experience as simple and intuitive as possible