The team at Shady Grove Fertility has begun a unique journey—creating a new standard for clinical research studies by leveraging EngagedMD's platform. As part of Alleviate, their recent in-house research study evaluating Toradol as a non-opioid option for pain relief after egg retrieval, Shady Grove Fertility is using EngagedMD's platform to streamline enrollment and consenting processes while maintaining the highest standards of patient care and regulatory compliance.
The motivation behind the unique use of EngagedMD
EngagedMD's application for clinical research emerged from Shady Grove Fertility's current use of the platform for patients undergoing fertility treatment and their desire to engage patients for research studies in a familiar manner. Dr. Marja Brolinson, a recent Reproductive Endocrinology and Infertility fellow at the National Institutes of Health, recognized EngagedMD's transformative impact on patient understanding and engagement in a clinical setting and was curious about how this could be used on the research side. The Shady Grove Fertility team hoped to emulate this success in their research study by offering patients video-based educational modules and consent forms on the EngagedMD platform.
In order to reach a broader audience, the clinical research team needed to implement a new process that would not only feel familiar to patients, who already used EngagedMD, but also make it easier for patients to communicate with them. Tasha Newsome, Clinical Research Supervisor at Shady Grove Fertility, notes that “It’s [EngagedMD] a great platform to keep us a little bit more organized in reaching out to patients and a great way to really utilize what the patients are doing anyway with EngagedMD, and keep it more familiar with how they do things."
The SGF team wanted to ensure that patients had adequate time to understand the research study, consider their participation, and ask more informed questions while simultaneously allowing for convenient tracking throughout the consent process while maintaining organization for study requirements and any future auditing.
“They [patients] can watch it more than once. They can also watch it, and then if they're interested, watch it with their partner and get their opinion about it. And then right on EngagedMD, they can review the consent form, read through it, page by page, and decide whether or not this is something that they're interested in." - Dr. Brolinson
Meeting research study consenting standards
In transitioning from conventional consent methods for research studies to EngagedMD's platform, there were a few challenges and hurdles to overcome. The consent process, a cornerstone of research ethics, had to be seamlessly integrated. Clear and concise communication was paramount, so Shady Grove Fertility worked closely with EngagedMD's experts, creating patient-friendly language and animations to convey complex information easily. Meeting regulatory demands and obtaining Institutional Review Board (IRB) approval was essential. EngagedMD's flexibility and customization allowed Shady Grove Fertility to tailor the video script and consent forms with patient verification to meet the IRB's stringent requirements.
Empowering patients and transforming research study outreach
Shady Grove Fertility's innovative approach reaped significant rewards. By using EngagedMD, they were able to introduce the clinical research study earlier in the patient journey, allowing them to reach a broader audience and improve the recruitment process. The previous method offered participation on the morning of or the night before the oocyte retrieval when patients' nerves were already high. Providing consistent and detailed information earlier in the patient journey fostered better decision-making.
"I think being able to introduce the study in more detail and allow for all of that time for them to review it, ask questions, think about it, and talk with their partner if they like—that is a big plus and something that we were excited about when we started working with EngagedMD,” said Dr. Zalles, an MD on the research team at Shady Grove Fertility.
In addition to improving the patient experience, this new process also streamlined the workflow for Shady Grove Fertility clinical research staff. The research team identified participants who qualified for the study, up to twenty a day and assigned them the module, which was linked to a sample consent form where patients could indicate their interest. After that, participants who declined were weeded out, and clinic staff refocused their efforts by only making phone calls to those who hadn't watched the module or agreed to participate in the study.
"Instead of having to call those 20 people, we're down to calling 15 or 10. So from the outreach in terms of numbers, it definitely helps with that workflow,” said Dr. Brolinson.
Using EngagedMD's platform has made reaching the goal of 400 participants easier and more efficient, creating consistency in messaging, expanding reach to more potential participants, and facilitating more meaningful conversations.
Meaningful insights and future implications
Insights gained from EngagedMD's platform helped Shady Grove Fertility engage patients and make better decisions. The platform's intuitive dashboard allowed the team to track patient interactions and adapt their outreach accordingly. The Shady Grove Fertility team leveraged these insights to enhance patient recruitment and engagement, ensuring the study's success.
This innovative use of EngagedMD extends beyond Shady Grove Fertility. A successful effort like this opens the door for rethinking research consent processes in the broader medical community. It showcases how EngagedMD's platform can enhance efficiency, boost patient engagement, and simplify regulatory compliance by offering streamlined consenting processes and consistent patient education at scale.=
Shady Grove Fertility's journey in using EngagedMD for clinical research illustrates the integration of innovation, patient empowerment, and research excellence. Adopting this new application of EngagedMD enabled Shady Grove to transform its research process, contributing to the advancement of technology implementation strategies that prioritize patient needs.