Making the Jump from Paper Informed Consent Forms to an Electronic Consent Form
An Overview of the Current Informed Consent Form and Electronic Consent Form Process in Healthcare
The concept of informed consent has a relatively short history. If you take USA for example, the case for true patient autonomy only began at the turn of the 20th Century where landmark cases established the legal precedent of patient autonomy in females at a time when women did not have the right to vote. Since then, great strides regarding the informed consent form have been made in terms of informing patients, but the manner in which this is done is still antiquated – a largely paper form driven process.
Securing patient consent just before medical procedures using a paper form harbors various drawbacks including auditing difficulties, lack of version control, incomplete informed consent form, error prone processes, limited representation of diverse populations, incompatibility with today’s digital-first world, tracking storage and cost-related issues.
In fact, a study of paper consent forms determined that they resulted in missing a signed informed consent form at surgery for two-thirds of patients, which in turn delayed surgery in 14% of total cases. A different study found that eICFs improved numerous issues with paper surgical ICFs, including missing patient information (10%), missing procedure details in (30%) and patient sign-off issues in (27%).
This has some serious cost implications – according to an article citing a study from JAMA Surgery, missing forms are estimated to delay 10 percent of surgeries and can cost hospitals $580,000 each year.
So, why do healthcare organizations persist with a paper-based informed consent form and not make the shift to an electronic consent form?
Despite these challenges, many healthcare organizations remain tethered to a paper-based informed consent form – or a paper form in general. The reluctance to transition to an electronic consent form is rooted in various impediments: fear of change, comfort with established processes, cost misconceptions, administrative hurdles in approving a replacement digital system, and an underestimation of the benefits offered by digital systems.
A 2020 academic paper talks about replacing a paper informed consent form with an electronic consent form and the barriers to adoption. It identified the four biggest barriers to be:
- ethical, legal and social issues
- interface/user experience considerations
- scalability and,
- changes to consent elections
The prevalent belief that people are habituated to paper-based processes further impedes progress.
The Transition from a Paper-Based Informed Consent Form to an Electronic Consent Form is Largely Due to Changing Demographics
There is an urgent need for healthcare organizations to embrace digital solutions. While the reasons related to enhancing patient care, operational efficiencies, and overall advancement are important, the biggest reason is that of shifting demographics.
Newer generations are becoming the primary users of healthcare services, and this has had an impact on the demand for digital interactions and technology-driven solutions to significantly increase. Now is the time to make that transition. Almost every other industry has adopted digital – Airlines, Banking, Newpaper, Legal Contracts – because they are seeing the ill-effects of a dependency on paper forms firsthand. USPS, for example, a government powerhouse, has been reporting losses for the last decade as the reliance on paper-based mail is now practically non-existent.
According to an article in the Percifient, Millennials are now the largest adult generation in the U.S. And the GWI USA study which cross-examined 250 million people across America annually, revealed that in 2021, 36% of baby boomers said they felt confident in using new technology – a 10% increase YOY. The results with regard to Gen X are much higher.
Embracing digital tools ensures healthcare institutions remain relevant AND accessible to this diverse patient population.
Considerations when Implementing a Digital System or Electronic Consent Form in Healthcare:
Now, while technological advancements promise streamlined processes and improved efficiency, the successful adoption of electronic consent form or digital systems in healthcare necessitates a comprehensive approach, one that extends beyond mere technological implementation. Significant points to consider are:
A. Patient education emerging as a linchpin
Patient education emerging as a linchpin in the successful transition from traditional paper-based processes to digital. Interactive sessions, informational materials, and user-friendly guides play a pivotal role in empowering patients to navigate digital platforms confidently, make better decisions about their own health, leading to better outcomes.
B. Moreover, patient education aligns with the ethical principle of informed decision-making.
Moreover, patient education aligns with the ethical principle of informed decision-making. It enables patients to comprehend the significance of their consent, understand the implications of their choices, and actively participate in their healthcare journey.
C. Staffing challenges, including shortages and turnover
Staffing challenges, including shortages and turnover, present a critical consideration when transitioning to digital systems in healthcare. The time saved through streamlined digital processes may not necessarily translate into increased revenue due to the strain caused by staffing shortages. Moreover, these challenges can significantly impact patient care as healthcare professionals may face increased workloads, potentially affecting the quality and timeliness of care delivery.
D. Patients may harbor concerns about the security of their data
Patients may harbor concerns about the security of their data, the authenticity of electronic signatures on an electronic consent form, or their ability to adapt to new technologies. Healthcare solution providers play a crucial role in addressing these concerns, ensuring that patients comprehend the mechanisms and safeguards integrated into an electronic consent form system.
Addressing staffing challenges becomes pivotal in ensuring that the implementation of digital systems not only aims for operational efficiency but also takes into account the need for adequate support and resources for healthcare staff. Effective training, support systems, and strategies to mitigate the impact of staffing shortages are crucial to prevent potential revenue loss and uphold the standard of patient care during the transition to digital healthcare systems.
So, while resistance prevails and training is needed on both sides of the provider-patient fence, there exists a compelling case for an electronic consent form or system. One that emphasizes compliance, streamlined processes, enhanced patient satisfaction, and alleviating staff burdens that have been associated with traditional paper forms.
The Role of 5thPort’s Patient Engagement and Electronic Consent Form Solution
In the quest to digitize healthcare practices and improve patient experiences, the adoption of an electronic informed consent form (eICF) or eConsent, stands as a pivotal advancement. 5thPort introduces a distinct approach to patient engagement and informed consent. Departing from traditional paper-based methods, it offers a modernized digital or electronic consent form for truly informed decision-making.
Through interactive elements, video modules, quizzes, teach-back sessions, and pre-appointment preparations, 5thPort’s electronic consent form solution facilitates a holistic and comprehensive understanding for patients, empowering them to make informed decisions. 5thPort also provides vital feedback to staff on what they need to address with their patients when they come in for their appointment.
Benefits of Implementing an Electronic Consent Form Over a Paper Form
By leveraging the power of technology, eConsent not only streamlines administrative tasks but also revolutionizes the very essence of patient engagement and diversity/inclusivity within healthcare systems.
In this section, we explore the multifaceted advantages offered by eConsent – particularly 5thPort – ranging from cost savings and enhanced compliance to fostering diversity, patient engagement, and comprehensive informed consent.
1. Elimination of Paper-Related Costs and Storage Issues
Transitioning to an electronic informed consent form mitigates the burden of paper costs and storage limitations, optimizing resource allocation within healthcare organizations. Research from CynergisTek (now part of Clearwater) shows that the average 1,500-bed hospital prints a staggering 8 million pages per month. With the average cost of four cents per printed page, it equates to a $3.8 million spend per year. This doesn’t include costs related to printers, scanners or even storage facilities.
One cannot speak about paper without mentioning sustainability. In 5thPort’s October 2023 webinar, Jeanie Magdalena Gatewood, Principal of Gatewood Consulting mentioned, “…at the end of the day, clinical trials are a business and we must manage it (and the unsustainability of paper forms) as an important factor when switching to digital”.
B. Clear Audit Trail for Compliance and Accountability
An electronic consent form offers a transparent and traceable audit trail, ensuring accountability and compliance with regulatory standards.
At 5thPort, our One Touch Compliance™ report provides organizations with a simple way to comply with audit compliance in totality, while providing ‘evidence’ for audit queries, should the need arise. This comprehensive report lets healthcare providers and/or clinical researchers see actions taken on patient encounters by their staff and patients in real time. Each action is logged as a separate date and time-stamped event, with details on the specific action taken as well as the location of the action. For your convenience, you have the option to download and/or print the One Touch Compliance™ report.
C. Recruiting Patients Across Regions – A Demand in Decentralized Clinical Trials (DCTs)
A 2022 research paper highlights the use of an electronic consent form in recruiting study participants during a COVID lockdown. Before face-to-face recruitment was suspended, the study recruited an average of 9 participants/month. After the implementation of an electronic consent form solution, “63 new patients (4/month) were enrolled despite a second lockdown – none of whom would have been recruited using the old methods given restrictions on face-to-face consultations.”
5thPort facilitates the recruitment of patients across diverse regions, beyond borders and jurisdictions, supporting the demand for DCTs.
D. Promoting Diversity, Equity and Inclusion (DEI) – An Imperative in Healthcare Equity
It’s hard to reach the right participants for a clinical trial. But as Basia Coulter wrote in her article ‘Reinventing eConsent to Drive Diversity and Inclusion in Clinical Trials’: electronic consent form systems may “…indirectly contribute to improved clinical trial outcomes by increasing access to a more diverse patient population.” This can be especially achieved by providing multilingual solutions.
By transcending geographical and language barriers, electronic consent form systems like 5thPort contribute to fostering diversity and inclusion in healthcare.
E. Enhanced Patient Engagement Through Multimedia in an Electronic Consent Form System
There are many cases to be made for the use of multimedia in an electronic consent form system and patient engagement. The most compelling of which was a study in 2011, where Schenker, Fernandez, Sudore and Schillinger reported that participants in a study who received an ICF via video, standard text and an interactive quiz scored 23% higher in a test than those who received the ICF in paper form alone.
5thPort is based on Mayer’s Multimedia Cognitive Learning Model. By enhancing routine engagements with audio-video content we educate patients using bi-channel information acquisition (audio & video) leading to 65% content retention at 72 hours (verses text content at 10% at 72 hours).
The challenges embedded within a paper form necessitate a paradigm shift towards electronic consent form solutions within healthcare organizations. Embracing eConsent or electronic informed consent form, offers a plethora of advantages, ranging from cost efficiency and compliance to enhanced patient engagement and inclusivity. Healthcare institutions should explore and adopt electronic consent systems, recognizing the pivotal role they play in fostering informed decision-making and improving patient outcomes.
There will be hurdles in recommending the implementation of an electronic consent form. We recommend handling these by taking a two-pronged approach:
- Strategize collaborative efforts involving healthcare providers, patient advocates, and technology experts to design comprehensive educational programs. These programs should encompass both the technical aspects of electronic consent and the implications for patients’ rights and responsibilities.
- Continuous support and accessible resources are essential post-implementation. Offering helplines, FAQs, and user-friendly interfaces ensures ongoing support for patients navigating electronic consent platforms.
- 5thPort’s no username/password feature makes it especially easy for principal investigators, clinical research coordinators and assistants to access patients’ engagement and electronic consent form documents, while still in a HIPAA-secured environment.
In this paper-to-eConsent journey, the unique features and advantages of 5thPort’s solution are revolutionizing patient engagement and ensuring true informed consent.
Chat with us today and find out how.