The difference between telehealth and in-person informed consent

A recent study published in the Journal of Medical Internet Research explored this issue, comparing telehealth-based informed consent, known as teleconsent, with traditional in-person consent. According to their findings, “telehealth offers similar participant understanding and engagement while overcoming geographic and accessibility barriers.”

Understanding informed consent

Informed consent is a structured communication process. The study describes this, stating that “obtaining informed consent (IC) supports the successful recruitment of participants and the overall success of research studies.”

A researcher or healthcare professional meets with a participant, explains the purpose of the study, outlines potential risks and benefits, and answers questions. The study explains that “traditional methods of obtaining IC usually involve face-to-face interactions in which health care providers explain procedures, risks, benefits, and alternatives to patients, often using written consent forms.”

However, obtaining in-person consent has its own challenges related to accessibility and comprehension.

The limitations of in-person consent

In-person informed consent relies on physical presence, which could introduce logistical barriers. For many patients and research participants, factors like transportation and time constraints can interfere with participation.

The study specifically mentions “challenges related to the cost and time to travel to and from the study site, geographic barriers in rural or remote areas, and literacy barriers.” These barriers directly affect who can participate in the research or receive treatment. For example, those who live in rural areas may be excluded due to travel reasons, while others may avoid participation due to caregiving responsibilities.

Additionally, the study notes that “patients often have varying levels of health literacy, which can significantly impact their understanding of medical information and their ability to make informed decisions.” When consent forms include technical language or medical jargon, comprehension becomes even more difficult. As the researchers explain, “the use of complex medical jargon can confuse patients, making it difficult for them to grasp the details of their treatment options.”

Time pressure can also affect consent discussions, which may be shortened, leaving less opportunity for questions or clarification. The study emphasizes that “time constraints during consultations can further hinder thorough discussions, leaving patients with insufficient information.”

Ultimately, these factors might impede full understanding of IC or patient engagement.

What teleconsent changes in the consent process

The study describes teleconsent as involving “live video calls during which the researcher and participant can see and interact with each other in real-time.”

More specifically, documents can be reviewed together and signed electronically. The patient can join a session from home and complete the process in their digital appointment. This system removes logistical barriers and preserves patient-provider interaction.

How HIPAA compliant email can help informed consent workflows

The consent process begins with communication outside of the live session. HIPAA compliant emails can help providers and researchers contact participants during recruitment, eligibility screening, scheduling, and follow-up.

As evidenced by the research study, researchers can send links to surveys and instructions for participants. HIPAA compliant email solutions, like Paubox, use advanced security measures, such as encryption and access controls, so providers can securely send consent forms or discuss participation in clinical research.

With HIPAA compliant emails, participants and patients can review the consent documents asynchronously, before the video session. As such, participants arrive already familiar with the content and prepared with questions.

For example, a participant can receive a secure email containing the study overview and consent document two days before their scheduled teleconsent session. They may read through the risks section multiple times, consult family members, or write down questions. When the live session begins, the conversation becomes more efficient as the participant is already engaged with the material.

HIPAA compliant email also supports follow-up communication after consent has been obtained. Researchers can send reminders about upcoming study activities and provide clarification if participants have questions later. These emails can help improve patient understanding and support participant retention over time.

Improving the patient-centered consent experience

The ubiquity of emails makes HIPAA compliant emails great for supporting informed consent before, during, and after virtual appointments. Secure email systems help extend communication further than the live session to create a more organized and patient-centered consent experience.

The study notes that “time constraints during consultations can further hinder thorough discussions, leaving patients with insufficient information.” HIPAA compliant emails allow patients to study information and educational materials ahead of the appointment, so they are better prepared.

HIPAA compliant email can also improve accessibility for patients who may need additional time to process information. Some individuals prefer reading information multiple times before making decisions, particularly when medical terminology or research procedures are involved. The study explains that “patients often have varying levels of health literacy,” which can affect their understanding of consent materials.

Providers can use HIPAA compliant emails to send simplified educational resources, follow-up explanations, or additional documentation that patients can revisit whenever needed.

Another benefit is continued communication. HIPAA compliant email allows healthcare organizations to maintain secure communication after the initial consent session, as they can send appointment reminders, follow-up instructions, study updates, or clarification regarding procedures.

For instance, if a participant forgets part of the study timeline discussed during a telehealth appointment, a research coordinator can securely resend the information, reducing confusion throughout the participant’s involvement in the study.

Supporting accountability

HIPAA compliant email also supports documentation and accountability. Secure email systems often include audit trails and message tracking features that help healthcare organizations uphold privacy regulations.

Clinical researchers can use HIPAA compliant email to securely distribute revised consent forms if study procedures change. Participants can review updates electronically and ask questions before signing updated documents, so consent remains informed throughout the duration of the study.

Convenience

HIPAA compliant email can additionally improve patient convenience and reduce missed appointments. Providers can use Paubox email to automate secure reminders for teleconsent sessions, follow-up surveys, or study check-ins to help participants stay informed. This may be helpful for participants who have other responsibilities, like work or caregiving, helping them manage multiple in-person visits.

If a clinical trial is being conducted remotely, HIPAA compliant email can also facilitate secure communication between researchers and participants, so sensitive information is protected throughout the study.

Another example could be if a patient is unable to attend an in-person appointment, they can still receive important information through flexible email communication. Overall, using HIPAA compliant email in clinical trials can improve accessibility and convenience for participants, ultimately leading to better engagement and retention rates.

Improving patient trust

When healthcare organizations use encrypted email and explain how patient data is protected, participants are more confident sharing their information digitally. It also supports the study’s statement on maintaining “perceived voluntariness, trust, and decision self-efficacy” throughout the consent process.

Moreover, participants who trust their providers can help improve participation rates and more accurate data collection in clinical trials, leading to better results and potentially more effective treatments for patients in the future. It can also help build long-term relationships between healthcare providers and participants, improving collaboration and mutual respect in research endeavors.

FAQs

Are standard emails secure for discussing sensitive healthcare information?

No, standard emails do not provide the necessary encryption to protect sensitive healthcare information from potential breaches. So, providers must use a HIPAA compliant email platform, like Paubox, to safeguard patients' protected health information (PHI) during transmission and at rest.

Do providers need patient consent for HIPAA compliant emails?

Yes, a provider must get explicit patient consent before sharing their PHI through HIPAA compliant emails.

Learn more: A HIPAA consent form template that's easy to share

How can providers obtain patient consent?

Providers can email patients a consent form using Paubox Forms. The patient then explicitly agrees to receive HIPAA compliant emails through the secure form submission process. Patients who submit their information through Paubox Forms acknowledge and understand how their information will be handled in compliance with HIPAA regulations.