Project Details - Ended
- Grant Number:R21 HS023987
- Funding Mechanism:
- AHRQ Funded Amount:$299,850
- Principal Investigator:
- Project Dates:5/1/2015 to 4/30/2018
- Care Setting:
- Medical Condition:
- Type of Care:
- Health Care Theme:
Informed consent (IC) for medical treatment is the process by which providers educate patients about the proposed treatment plan to obtain their consent to proceed. For patients to fully understand the content of the IC process, it should clearly explain the purpose, process, risks, benefits, and alternatives to medical procedures or clinical research. To minimize cost and risks, many providers opt for electronic IC that replicates the paper-based process. However, studies have revealed that many patients do not fully comprehend the information in IC forms. The deficiencies in provider-patient communication in explaining the IC process, in addition to health literacy issues, place the patient at greater risk for not understanding their care plan. Having patients participate in virtual interviews during the IC process has the potential to enhance patient comprehension.
This project developed and evaluated a mobile health (mHealth) tool called the Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC). The tool enables the informed consent process to be performed on a tablet device, utilizing virtual coaching and interactive multimedia libraries including video clips and animations that are designed to enhance patient comprehension.
The specific aims of the project were as follows:
- To develop, test, and refine the mHealth tool VIC to enhance patient comprehension while improving the efficiency of obtaining patient consent.
- To evaluate the feasibility of VIC compared to a standard consent in a real-world clinical research study.
Researchers conducted a mixed methods study to develop and evaluate VIC. They used a user-centered design approach including: requirement gathering and analysis, conceptual design, focus groups, design and development of a mockup screen and prototype, and usability evaluation of the prototype. To assess the feasibility of VIC, investigators conducted a randomized controlled trial with 50 asthma patients randomized to receive either standard paper consent or consent via VIC on a tablet device at the Yale Center for Asthma and Airway Disease. Patients using VIC had access to virtual coaching on the IC process through video demonstrations and audio explanations, in addition to the ability to ask questions and receive answers.
Researchers found that VIC reduced the time spent for initial patient instruction, including protocol explanations and questions and answers. Patients who used VIC were more satisfied with the IC completion process compared to patients who used paper consents. Feasibility testing found that patients using VIC answered surveys based on the information they received at a higher percentage. In the intervention arm, 96 percent of patients were able to correctly identify what would happen to their personal health information while they participated in the research study, as compared to 77 percent of control patients. Also, 96 percent of intervention patients were able to identify how to withdraw from the study, versus 81 percent of control patients. Possible future research includes assessing the VIC tool capabilities for other chronic conditions.