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Effectiveness of Telehealth Versus In-Person Informed Consent: Randomized Study of Comprehension and Decision-Making.
Saif Khairat1,2,3,4, Paige Ottmar1, Prabal Chourasia1
1Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Journal of Medical Internet Research
|March 7, 2025
Summary
Teleconsent is as effective as in-person informed consent (IC) for participant understanding and engagement. This digital approach overcomes barriers, improving research recruitment and accessibility.
Area of Science:
- Clinical Research
- Health Informatics
- Patient Recruitment
Background:
- Traditional in-person informed consent (IC) faces barriers like geography and literacy, impacting research enrollment.
- Telehealth, specifically teleconsent, presents a digital solution to overcome these obstacles.
- Concerns exist regarding teleconsent's equivalence to in-person IC in participant understanding and engagement.
Purpose of the Study:
- To evaluate participant comprehension and decision-making in teleconsent versus traditional in-person IC.
- To determine if teleconsent is a viable alternative maintaining participant understanding and decision-making abilities.
Main Methods:
- A randomized comparative study comparing teleconsent (using Doxy.me) and in-person IC.
- Validated assessments included the Decision-Making Control Instrument (DMCI) and Quality of Informed Consent (QuIC).
- Health literacy was measured using the Short Assessment of Health Literacy-English (SAHL-E) tool.
Main Results:
- No significant differences in QuIC or DMCI scores between teleconsent and in-person groups.
- Teleconsent group showed a statistically significant difference in SAHL-E scores compared to the in-person group (P=.03).
- No significant differences in understanding or decision-making were found across demographic subgroups.
Conclusions:
- Telehealth-based informed consent (teleconsent) demonstrates comparable participant understanding and engagement to in-person methods.
- Teleconsent effectively addresses geographic and accessibility barriers, enhancing clinical research recruitment and retention.
- Integrating telehealth practices into regulations can improve access and health outcomes.
Keywords:
comprehensionconsentcross-sectioncross-sectional studydecision-makingeHealtheffectivenessfeasibilityhealth care servicesinformedinformed consentmHealthstatistical analysistelehealthtelemedicineMore Related Videos
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