Transforming Clinical Trial Training for Enhanced Patient Trust

• October 17, 2024
• Blog

Patient trust is critical for ensuring adequate enrollment and retention of clinical trial participants. If patients lack trust in the capabilities of the investigators, nurses and other staff conducting a clinical trial, they are less likely to enroll in a study, and even if they do, they are more likely to drop out if their confidence is shaken by poor performance of trial procedures.

The way that clinical researchers are trained can play a key role in building necessary trust. When patients are confident in the knowledge and abilities of the research staff, they feel more comfortable with the trial process. This increased confidence makes them more likely to enroll and, most importantly, stay enrolled throughout the trial.

Adaptive learning, such as that provided by Pro-ficiency, can play a crucial role in increasing patient comfort levels with clinical trial participation. By providing realistic scenarios, this type of training allows clinical research professionals to sharpen their skills in a risk-free environment. This immersive approach based on realistic scenarios bolsters their qualification and competence, so researchers are better equipped to conduct trial procedures smoothly and effectively, leading to a more comfortable experience for patients.

Most trial participants are unaware of how sponsors conduct training on protocols or that the traditional approach relies on slide decks, a method that most patients would likely view as worrying. Additionally, the pharma industry in general faces challenges related to mistrust. In clinical research, any uncertainty displayed in describing or performing protocol procedures can exacerbate any reservations a potential study participant may feel. And this can drive both low enrollment and participant drop-out after a study begins.

Patients need to feel confident that the research team has the skills and tools necessary to execute the trial correctly, from administering the correct dose to maintaining protocol accuracy. This need places a burden on research teams to demonstrate to patients that they have sufficient knowledge, skill and understanding to overcome that underlying suspicion-a burden that is difficult to overcome without comprehensive training.

A 2021 blog post from Medidata emphasizes the foundation of trust in clinical trials. It highlights the needs for clear communication to ensure that participants comprehend study procedures early in the process. This then sets the stage for more impactful communications throughout the trial, which further fosters trust between the patient and the research team.

Medidata writes, "To build trust with clinical trial participants, it's important they understand precisely what is being done and why, early in the process. With that established, the communications that follow will have more impact and help establish trust throughout the trial experience."

And sometimes, a simple solution is the most effective. In this case, multimedia training that successfully ensures consistent follow through of all clinical trial procedures would play a key role in building and retaining patient confidence and trust.

Proven performance results

Adaptive Learning provides research teams with the chance to practice simulated scenarios before acting them out in the real world. Immediate feedback helps to guide research staff to develop better decision-making skills. And the associated performance management dashboard tracks all individual, site, and study performance to inform leadership decision making.

This training approach immerses coordinators, investigators and other research staff in realistic scenarios, which helps to ensure that they are well-prepared to both describe and perform procedures accurately, giving participants more confidence in a trial. By providing a risk-free environment to practice and gain skill and understanding, a simulation-based training platform enables research staff to confidently interact with patients, conveying accurate information and addressing any concerns they may have. This ensures that patients receive clear and consistent communication throughout their participation in the trial, enhancing their overall experience and likelihood of enrollment.

Real-time performance analytics of sites allows sponsors to see where gaps or weak areas may exist and to focus on the areas where training is most needed.

This type of training has proven over time to be extremely effective in improving performance. For instance, Elio Mazzone et al. noted in a paper in the August 2021 Annals of Surgery that proficiency-based progression simulation training was more effective than traditional training in reducing procedural errors and increasing the number of correct steps taken. A key, the paper said, lies in continuous feedback and the ability to repeat tasks until they are done correctly.

Why? Virtual simulations of realistic, protocol-specific scenarios provide the opportunity to replicate real-world situations, providing an environment that invites engagement and builds accessible professional knowledge, rather than providing just abstract learning of content from static materials. At its heart, simulation technology achieves a complex, meaningful interactivity, allowing users to construct and test hypotheses and receive feedback in response to their actions in a risk-free, persistent environment. Learners can actively and rigorously develop needed skills by facing simulated challenges.

And the proof is in the pudding. In 2010, an analysis was conducted of data from a country-wide deployment in East Africa for the CDC. Every healthcare professional in the country was trained on a rigorous HIV treatment protocol.

The image below illustrates the results of that training. The acceptable level of clinical variance from a simulated patient encounter is represented in the green center in the circles below. Red circles indicate an action within an unacceptable level of clinical variance. The graphic on the left shows a pass rate of 69%. The graphic on the right shows that the pass rate increased to 97% after simulation training.

These factors become especially important for larger, international studies. With more research sites involved, there can be greater variation among capabilities, which can lead to protocol deviations. And when international sites are involved, complications related to language and culture can challenge research sponsors to provide training that meets all the different needs at myriad sites.

Pro-ficiency's Performance Management platform serves as a central hub for all training resources and metrics, providing real-time performance analytics to address challenges. This dashboard tracks every decision made by learners, with the ability to categorize errors by individual, site, geographic region, or preferred language. This dashboard functionality simplifies identifying where language or cultural barriers may exist, allowing for the agile development of custom resources to address those challenges.

Another benefit of adaptive learning is that the knowledge gained tends to stick with learners better than lecture-based methods. The ability to practice tasks and procedures virtually in a risk-free environment allows employees to develop accurate muscle memory that helps them perform optimally in real-world situations.

This is especially important when it comes to developing skill and competency in procedures that differ from the standard of care. The ability to smoothly perform and explain novel techniques or procedures to patients is critical to ensuring patients are comfortable with trial participation.

Pro-ficiency's platform, for instance, reduces the likelihood of errors or complications during a trial that involves novel treatments by immersing learners in lifelike scenarios. Knowing that the healthcare providers treating them during a clinical trial are well-qualified and competent in protocol-specific procedures goes a long way toward instilling trust and reassurance in patients.

Proactive problem-solving

Adaptive learning allows for proactive addressing of problems in a consequence-free environment before a trial even begins. When problems are only addressed after they occur in a live clinical trial, patient trust can erode. Identifying and addressing issues up front, on the other hand, can boost patient trust in the trial and the team implementing it.

A lot of distrust in the pharma industry and in the clinical trials it sponsors can be linked to the industry's tendency to address problems only after they occur.

But Pro-ficiency's training packages, for instance, include analytics that are just as important as the training itself. This information can help managers track not only progress in completing the protocol-specific training, but also provide invaluable information about how well individuals and sites perform as they move through the training.

The immediate feedback and analytics offer extra support and guidance to individuals or sites struggling with any aspect of a clinical protocol. This real-time assessment allows for timely intervention and remediation, ensuring that research staff are adequately prepared to conduct the trial procedures and interact with patients effectively. By addressing areas of difficulty promptly, Pro-ficiency contributes to the overall success of the trial and improves patient satisfaction and retention.

In other words, if staff can complete the simulated activities successfully, the training itself proves their competency. For instance, if 70% of a cohort failed in the first attempt at a simulated procedure, the organization would know that was a problem area in the protocol that needed to be addressed.

The design of the training modules allows high achievers to move easily through the material at which they already excel, while learning new procedures or practices at a suitable rate. Meanwhile, those with less knowledge or experience are carefully guided to making the correct decisions.

Investigator meetings can then be used to address any remaining pain points, using the performance analytics to guide those conversations. This will help ensure that training remains focused on crucial issues without wasting investigators' time.

This level of training helps to ensure that investigators, coordinators, research nurses and other staff thoroughly understand the study and its procedures before they speak with patients. Not only does this help them execute the study without error, it also gives them the in-depth understanding necessary to confidently explain a trial to potential enrollees and to answer their questions easily and correctly.

With this deep understanding, research teams can focus on building relationships with patients, rather than on remembering details of the clinical trial protocol.

In conclusion, the pivotal question emerges: If patients were aware of how their HCPs were trained for trials, would they still enroll? Transparency about site performance, completion reports, and the success of top sites could potentially influence patient enrollment decisions. These considerations prompt a reevaluation of our current practices, urging us to embrace transformative approaches to clinical trial training for the benefit of all stakeholders.

Simulation-based training has a well-documented track record of producing competence among healthcare professionals. Pro-ficiency's platform leverages this proven effectiveness, providing research staff with the skills and confidence necessary to conduct clinical trials successfully. By offering realistic simulations and comprehensive training modules, Pro-ficiency equips research staff with the tools they need to navigate protocol procedures and patient interactions with proficiency and professionalism.

Visit our website to learn more about our adaptive learning solution.