The Importance of e-Consent to Improving Patient Care and Compliance
Patient consent is extremely important in providing the right care and treatment to people. A healthcare center or primary care provider is legally and ethically required to discuss everything with their patients. They’re also asked to sign consent forms to ensure that the patient understands everything that has anything to do with their treatment. Failure to secure consent forms is one of the main reasons why medical practitioners are sued for medical malpractice.
In addition to getting a patient to sign an informed consent on paper, these documents still have to be secured and organized which takes a lot of work for the hospital staff. About 10% of surgeries often get delayed because of the missing paper-based signed consent on the day of the surgery.
Electronic consent forms prevent such accidents from happening by storing the signed form on a server or online. They also help improve patient care since the staff focuses on the patient’s treatment instead of worrying about where the consent form and other medical records are.
Patients also have fewer chances of damaging or losing their copy of the digital consent form. The e-Consent also comes with patient education materials that make it easier for them to learn more about their treatment. Patients with high health literacy are more likely to comply with the doctor’s instructions, making the treatment even more effective.
What is an Electronic Consent Form?
Electronic consent forms are more than just the digital version of informed consent. It’s an informed consent discussion between patients and healthcare providers about the recommended procedure. Electronic consent forms usually function as three things: a legal requirement, a gatekeeper, and an audit trail.
- e-Consent as a Legal Record – The digital record of the patient’s consent counts as evidence if there’s a legal dispute between the patient and provider. Clinics and hospitals are legally and ethically required to obtain the consent of a patient before a procedure.
- e-Consent as a Gatekeeper – Only the individuals who signed the consent are permitted to access specific patient health information written in the consent. It protects the patient’s privacy and prevents the unlawful distribution of the patient’s records. The e-Consent system also verifies the qualifications of an individual before access is granted to them.
- e-Consent as an Audit Trail – Authorized clinicians who gain access to the patient records using their e-Consent should signify that they fully understand the specifics of the signed consent. They should acknowledge that the patient has specific wishes regarding how the accessed information is used.
Using Paper-based vs. Digital Consent Forms
Technology is an important part of any industry, including health care and medical practices. Most of the patient records in clinics and hospitals are stored in web-based or server-based systems that make them accessible for the staff who need them at any given time.
But aside from storing patient records digitally, more health care organizations have started adopting electronic consent forms for their patients. Keeping digital consent forms is a lot more convenient than paper consent forms because they don’t take up a lot of physical space. They’re also less vulnerable to getting lost or stolen since cloud-based software often comes with advanced cybersecurity and a reliable backup system.
Electronic consent forms also contain more updated and accurate information than paper-based consent forms. Hospital consent forms are always subject to lots of changes, which is why it’s difficult to update paper consent forms every time new changes are made. Electronic consents are easy to update after just a few clicks, which decreases the chances of accidentally letting a patient sign an outdated consent form.
4 Types of e-Consent Forms
Consent systems have the potential to be complex, which is why many people prefer to use the terms “opt-in” and “opt-out.” An opt-in consent system means that the patient allows the healthcare organization to access their health information for all future requests, while an opt-out model denies the use of patient information for future treatments. The opt out system requires patients to sign a new informed consent document every time their records need to be accessed.
The problem with these two types of e-Consent is that they’re two extreme ends of a spectrum. There’s still a wide range of possibilities in between these two models in which patients have more control over what they permit the medical centers to access. Here are the four main types of e-Consent Forms:
1. General Consent
This type of e-Consent is generally known as the “opt-in” model as it gives blanket consent to healthcare professionals working in a specified health context. General consent gives access to all of the patient’s health information needed to give the customer the right care and treatment for their condition. This consent is used for all future information requests unless the consent is suddenly revoked by the patient.
2. General Consent with Specific Denial(s)
Patients who signed this type of e-Consent give a general consent to the healthcare provider, except for a few things, such as:
- Disclosure of specific information
- Disclosure of information to specific part or type of parties
- Disclosure of information to be used for a specific purpose
The blanket access for all future requests is slightly modified based on specific conditions decided by the patient. For example, a patient may sign a general consent but chooses to exclude the disclosure of a gynecologic procedure, disclosure to their family members, or disclosure for purposes that don’t have anything to do with treating a cardiovascular condition.
3. General Denial with Specific Consent(s)
This type of e-Consent denies the healthcare provider access to the patient’s health information except for specific conditions that are identified for specific consent, such as:
- Disclosure of specific information
- Disclosure of information to specific part or type of parties
- Disclosure of information to be used for a specific purpose
For example, a patient may authorize their primary physician to send a sample of different body fluids and other related information to a diagnostic laboratory for a series of tests. The lab results are then forwarded to the general practitioner to provide the right care and treatment for the patient’s health condition.
4. General Denial
This type of e-Consent is also known as the “opt-out” model. This means that the patient denies consent for the use of their medical record for future circumstances. Healthcare providers have to create a new consent for the patients every time they perform a new diagnosis, care, or treatment. This type of e-Consent decreases the ease of clinical access for future care and treatment but it’s a great way to protect the patient’s privacy.
Benefits of e-Consent Forms for Patient Care
Like other industries, technology is also reshaping the standard of providing medical care. Health care providers need to be well-versed in health information technology and the utilization of different digital and interactive tools.
Electronic consent forms easily surpass paper consent forms in providing better physician-patient communication. This allows doctors to give better patient care to their clients while offering additional benefits like:
1. Enhanced Workflow
Electronic consent forms on websites and smartphones are easy to integrate with existing Electronic Health Records (EHRs) or Electronic Medical Records (EMRs). Patients only need to sign the necessary documents through their device and the information is already streamlined into the informed consent process. They only need to read the consent on their tablet or phone anytime, then sign the form using their finger or stylus. This saves them and the staff additional time that may be used for other important tasks.
2. Risk Mitigation
Although printing and storing a single patient consent form might not seem much at first, these additional costs easily pile up. Healthcare providers allocate hundreds of thousands of dollars every year on creating and storing these paper-based consent forms, yet they’re still highly vulnerable to damages, loss, and stealing.
Electronic consent forms minimize these potential risks since there isn’t a physical copy that might get lost or damaged. Most e-Consent solutions come with excellent cybersecurity solutions that protect the stored patient information from hackers.
3. User-Friendly
The digital consent process and forms are easily accessible for patients anytime and anywhere, as long as they have an internet connection. This allows them to review the contents of the consent and sign it with just a few taps. Patients also have fewer chances of accidentally losing or damaging their copy of the electronic consent form compared to a paper-based one.
4. Enhanced Data Integrity
Since consent forms always update and change, it’s easy for paper-based forms to have decreased data integrity. Patients might sign the wrong or outdated consent, which affects their treatment and medical record.
Electronic consent forms have built-in security features that help preserve data integrity. Some systems come with GPS, timestamps, and a single sign-on that allows the healthcare staff to check when and where the consent was signed by whom. These details are especially helpful for authorities who need to see the audit trail.
5. Immediate and Organized Archival of Digital Consent
Finishing the informed consent process is immediate because everything is digital. This eliminates the concern for improperly filled out or lost forms. It also ensures that all processed e-Consent Forms are archived for compliance with the US Department of Health and Human Service regulatory requirements.
6. Quick Knowledge Acquisition and Better Patient Engagement
All kinds of consent forms have standardized and detailed information according to the patient’s needs. Paper-based consent forms are usually several pages long and full of complicated terms that might be difficult to understand for most patients.
Electronic consent forms accompanied by visuals and additional links help patients understand what they are consenting to better. This results in higher health literacy and engagement among patients since they have a good understanding of the study protocol.
7. Patient-Centered Care
Although informed consent is a legal and ethical requirement, e-Consent also helps empower patients. They should always be considered as partners in creating important healthcare decisions, which is why it’s important to give them control and access to their own health data. This also allows them to comfortably talk to the physician about their needs and preferences, which leads to better patient care by healthcare organizations.
How to Choose the Right e-Consent Solution
Electronic consent forms transform the experience for patients and providers since there are fewer administrative tasks to deal with. Patients also have the option to accomplish the forms at home whenever they want to. All of these potential benefits make e-Consent systems a must-have for healthcare providers.
Looking for a reliable e-Consent solution to help manage patient consent efficiently? Here are five things and basic elements to consider when selecting an e-Consent solution for the healthcare organization:
- Choose a system that has an educational informed consent process and patient-friendly interface for easy navigation.
- It should be usable for all studies to enable standardization. This allows great site efficiency and enhanced clinical study quality.
- Make sure that the system is validated according to national and global compliance standards.
- Find a solution that’s easy to integrate into the existing system and workflow.