Background/Purpose: Participating in clinical research can be burdensome for subjects due to time and travel barriers, particularly among underserved, rural, and/or chronic disease bearing populations such as systemic lupus erythematosus (SLE). Telemedicine offers one way to overcome these barriers by providing tele-research visits. Doxy.me is a platform which facilitates these types of visits with its tele-consent functionality. However, diverging from the traditional in-person informed consent methodology could unduly influence subjects’ willingness to participate, reduce their comprehension of their study and associated risks or benefits. This poses an ethical concern that warrants exploration prior to widespread implementation. In this study, we examined the impact of tele-consent on measures of consent quality as compared to in-person consenting procedures. 

Methods: Assessments of perceived decision-making control (Decision Making Control Index, DMCI), consent quality (Quality of Informed Consent, QuIC), and health literacy (Short Assessment of Health Literacy – English Version) were integrated into an ongoing observational study. This study enrolls African American patients with SLE and healthy controls over the age of 18, many of whom are of Gullah Geechee heritage. Subjects were invited to participate in tele-consent and associated assessments at their in-person observational study visit. Willing subjects were randomized to tele-consent or standard in-person consent, followed by consent assessments. An independent samples t-test was used to compare mean outcome scores and age, whereas the chi-squared test was used for categorical demographic variables.

Results: Twenty-five subjects have completed the study, 12 of whom were randomized to tele-consent. There were no significant differences in age (mean 49 ± 15.39), sex (96% female), or health literacy scores (mean 16.7 ± 2.14, out of 18). The study sample is entirely African American, possesses health insurance, and 52% are diagnosed with SLE. Two tele-consent subjects were unable to complete their tele-consent encounters. One failure was due to a software issue while the other failed due to subject usability problems. Outcome measures did not vary significantly between groups; for tele-consent and standard consent the QuIC part A scores were 95.0 and 92.9 respectively (p = 6.83) out of 100, whereas the Part B scores were 4.9 and 4.8 respectively (p = 0.851) out of 5. Similarly, scores on the DMCI were 51.2 and 50.8 (p = 0.974) out of 54. 

Conclusion: The lack of statistically significant differences in outcome measures is promising for the validity of tele-consent. However, two tele-consent failures, one of which was due to the software, were encountered. A larger sample size will provide greater surety in these results and determine if failures may be a significant barrier to implementation. Tele-consenting is a novel methodology to increase recruitment and retention of under-served and hard to reach populations in minimally invasive studies. Trials may benefit from partnering with external laboratories or satellite clinics to facilitate more complex research visits while maintaining a reduction in travel burden for participants.

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/expanding-access-to-research-using-tele-health-lupus-and-informatics-feasibility-study/