Electronic research consents for complex early-phase I-II clinical trials integrated with telemedicine visits compared with in-person encounters.

Abstract

1514 Background: Based on our previous research with patient satisfaction for electronic consenting (95% of 940 respondents would recommend it another patient), we hypothesized that telemedicine (telemed) would be received as well as or better than in-person clinical research (CR) consent encounters for complex early-phase clinical trial (Phase I-II) and clinical genetic consent discussions by patients. Oncologist experiences to date have shown that telemed works well for uncomplicated clinical scenarios, but its performance alongside increased care complexity is less clear from the patient perspective. Methods: We conducted a one-time survey of adult patients having a telemed consent visit between 8/31/21 and 2/13/22 and an in-person clinic visit. Nine CR specific questions covered visit preference and empowerment across 6 high value consent agency domains. Results: 513 patients completed the survey and consented across 96 Clinical trials (CT), including genetic, therapeutic, diagnostic, and quality of life. Consent discussions were performed by 75 clinicians and 41 non-clinicians, with the majority (64%) for clinical genetic and Phase I-II CTs. Most patients (52%) preferred telemed over in-person clinic visits (19%) when all visit related factors (time, cost, convenience, quality of care, healthcare team interaction) were considered ( P<.05) (Table). Comparing their last in-person visit with telemed, patients reported feeling either less stressed/overwhelmed (16%) for their consent discussion or about the same (39%) using telemed, and 6% were more stressed ( P<.05). Patients expressed equal comfort taking agency-supported action across 6 domains regardless of consent setting. Conclusions: Electronic consenting via telemed is the preferred method for consent in complex early-phase clinical trials when all visit factors are considered and performs as well across 6 key agency domains when compared with in-person visits. Telemed does not contribute additional stress to consent appointments for most patients and performs well across complex clinical genetic and Phase I-II clinical trial discussions. Our findings suggest telemed and electronic consent should be offered as an option for patients throughout their treatment continuum. Beyond MSK, our data support a broader call for organizations to offer telemed platforms for CT discussions to increase overall patient satisfaction and potentially increase participation. [Table: see text]

Electronic consent in clinical care: an international scoping review

“…Almost uniformly, e-consenting was acceptable to patients and did not result in a loss of comprehension. These encouraging findings are consistent with results from the literature on research e-consent, in which patients similarly find electronic consenting systems comparable, or even preferable, to paper-based ones 18 19. A notable exception among the articles we examined was a study of consent for health information exchange, where an attempt to communicate risks and benefits entirely via computer (as opposed to paper plus human interaction) resulted in a decreased comprehension by some patients.…”