Hear the award-winning community engagement strategy of Ascension St. John Clinical Research Institute as Stacie Merritt and Dr. Jane Bryce share insights on their successful approach to diversity, equity, and inclusion in clinical research. Discover how their innovative BRIDGE framework, commitment to health literacy, and continuous presence have led to meaningful results within their community. Tune in for valuable advice on overcoming diversity recruitment challenges and fostering collaboration with industry partners for more inclusive clinical trials.
Hear the award-winning community engagement strategy of Ascension St. John Clinical Research Institute as Stacie Merritt and Dr. Jane Bryce share insights on their successful approach to diversity, equity, and inclusion in clinical research. Discover how their innovative BRIDGE framework, commitment to health literacy, and continuous presence have led to meaningful results within their community. Tune in for valuable advice on overcoming diversity recruitment challenges and fostering collaboration with industry partners for more inclusive clinical trials.
Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks is a program that allows our partners and those that we work closely with to take a few minutes to address issues of industry concern share exciting achievements and to learn more about our extensive community. Today we have Stacie Merritt, the director at Ascension St. John Clinical Research Institute and Dr. Jane Bryce, a clinical research nurse with the Institute here with us to talk about their recent recipiency of the inaugural SCRS Diversity Award. Jane, Stacie. It's great to have you with us today. I'd love to start things off and learn a little bit more about each of you and maybe a little bit about Ascension St. John.
Stacie Merritt:Thank you for inviting us today. I'm glad that we are here to share with you a little bit about our organization and the fantastic work that our team has done with regard to diversity, equity and inclusion.
Jane Bryce:And yes, I'm Jane and I would just wanted to tell you a few things about Ascension St. John. We're part of a nationwide Ascension Health Network and our local ministry includes five hospitals in northeast Oklahoma. Our main location is in Tulsa and in 2021 Tulsa was designated as a majority minority city. So our catchment area accounts for about 35 percent of the whole state's population. And because of our geographical location, we're also able to draw patients from Kansas, Missouri and Arkansas. So we're quite regional. We are a decentralized unit in that we work with in multiple different service lines throughout the hospital. So Ascension St. John Clinical Research itself is a 7000 square foot facility and it's attached to the main hospital in Tulsa and our physical space includes examination rooms, an investigational product pharmacy, a processing lab for biospecimens, and we're fully electronic. We have eReg,eSource, and CTMS. Within our department, we employ dedicated clinical research nurses and non RN coordinators. We have regulatory specialists, billing and contracting specialists, and pretty much everything that's needed to ensure a clinical trial runs smoothly and successfully as possible with Stacie at our lead.
Jimmy Bechtel:Well, great. That's wonderful. And again, thank you so much for being here with us today and really excited to talk a little bit about your your program and the award. So again, congratulations to Ascension St. John for receiving the inaugural Global Excellence in Diversity Award. So maybe start us off. Stacie, can you tell us a little bit more about your winning community engagement strategy?
Stacie Merritt:Yes, I want to first start by saying how proud I am of my team and the work that we do every single day to promote diversity engagement in our clinical trials. Winning the Global Site Excellence and Diversity Award, honestly, isn't the end of our journey, it's the beginning. We started talking about diversity in 2019. We had a particular study that our team at Ascension St. John helped to participate in that required involvement of a specific group within our community. I pulled the demographic information as a part of our feasibility assessment, and as a group we reviewed the data. We realized at that point that we were falling short of where we thought we were and definitely where we wanted to be. And this was truly the catalyst for the project that led to our Bridging Diversity Together or BRIDGE framework for community engagement.
Jane Bryce:And I want to continue by saying we really started by brainstorming. We were using a whiteboard where all ideas were welcome, and we quickly discovered that there were many to tackle. We found some common themes, though, that are all centered around equity. We had to start by identifying the different barriers to diversity enrollment before we could even begin the work of dismantling them. So we conducted a thorough evaluation of our site practices and found we had some quite significant barriers to diversity enrollments. And as one example, we had a standard operating procedure that, that stated English had to be the primary language of the study subject. So we engaged in an introspective review looking for self bias that could be impacting minority engagement as well. As a team, we participated in sensitivity training really to foster a deeper understanding of diversity and the health care needs of various community groups. These activities really propelled Ascension St. John's Research Department forward with a desire for greater community representation in our trials. And then the COVID pandemic hit and really reshaped our priorities by emphasizing the need to connect with every single person, every single group within our community. And in general in clinical trials it had been a practice really to focus on enrolling individuals, but we shifted our priority instead to how our research can better serve the community, our community and our strategy. Simple. It was focused. On establishing a rapport of trust with people in our community who belong to different groups. And that's it. I mean, that's how we started. And that's something that we still maintain. It's in the execution that things become a little more challenging. And we chose to focus on a few areas we thought were key for the BRIDGE framework. And Stacie is going to tell you about the first one.
Stacie Merritt:The first was being a true commitment to long term physical presence out in our community. Ascension St. John's Research Department participates in monthly outreach designed to meet a need of the community. We go to health fairs to perform blood pressure checks or provide stroke recognition education. We go to a local food bank to hand out food. It's really not a one and done kind of a thing. It's about consistently being out in your community time and time again, and we're not out there to promote research. We're there to provide a service. We may put up a sign or wear uniforms so that people know who we are, where we come from. We may even have brochures or flyers about different trial opportunities laying on a table that are next to us. And if someone asks, we'll provide information about the research we're doing. But that's not why we're there. We're there to meet a need in a way that can build a trusting relationship with our community members. This allows us an opportunity also to find out what the needs are in our community and opens the door for us to maybe find studies that will meet that need. We continually mind map new ways to connect with our community. We actively participate in Tulsa, in the Tulsa Health Department's Community Health Improvement Plan. We work hard to connect regularly with established community action and philanthropic groups that provide us entry into diverse populations.
Jane Bryce:We also focus a lot on health literacy. We don't think our industry is very good at this yet, so it's imperative to the concept of informed consent and self determination. So for example, we grade check the readability of every patient facing document we receive from our study sponsors. We found the average reading level for an informed consent was 10th grade. The NIH recommends a sixth to seventh grade reading level for health literacy. So we began returning the informed consent forms to the study sponsor if the reading level is too high and asking for corrections. Sometimes we use a companion document that incorporates pictures or icons or tables to help improve the understanding of the material for the participants. And we intentionally incorporate teach back, show back strategies into our conversation with potential, or actual study participants so we can better gauge their understanding. We also have a language line to communicate effectively with these individuals who are non English speaking or have English as a second language. And whenever possible, we make sure documents are provided in the native language of the participant. So we try to keep in mind how cultural differences may impact that communication also with body language and preferred communication style. So, for certain minority groups, it could be face to face encounters may be preferred over telephone calls. And knowing this can make a, a big difference for an individual, also for communities.
Stacie Merritt:And we also track diversity issues impacting equity excuse me, equal opportunity enrollments in the clinical trials. For example, it's not uncommon at all for multiple standard of care requirements to be written into a protocol. Does the subject have insurance to cover these billable events? Are subjects required to take off work in order to come into the facility for multiple visits? Do they have transportation available? If their protocol is written to allow for remote visits, do subjects have what they need to accomplish this? We tend to forget sometimes that not everyone has accesss to technology or the ability to to use it, even if it is provided. As an example, Oklahoma has a lot of rural space with very poor connection. Now this could impact somebody's ability to participate in a clinical trial. As a site, you have to be willing to think outside the box on how to combat disparity issues that might impact enrollment and act as an advocate by sharing these disparities with study sponsors so you can work together to solve the problems.
Jane Bryce:In fact, this is really a continual process that extends throughout the life of a trial. And we continue to track barriers once a trial is started and try to document any that occurred during the pre screening process. And that way we may discover a pattern of structural or subtle biases in participation that we may not have seen during feasibility. And start out.
Jimmy Bechtel:That's great and thank you for the detailed explanation of the program and how you came from one place to the next. I think what's really important and I know we'll probably dive into this a little bit more deeply here within the conversation, but. That first step, I think, is really important and something that a lot of other sites might consider that self reflection, taking time to look back and see what sort of policies do we have in place? What is the current state of our diversity, equity and inclusion capability as a site? And do we have any policies and procedures that might be sort of unintentionally preventing us from enabling a really good diverse culture at our organization? So let's talk a little bit more about that BRIDGE framework and how that transformed your approach to health equity and diversity in clinical research and, and a little bit share, I guess, some of the results that you might've observed as a result of that program.
Stacie Merritt:To begin with, I think it really opened our eyes to disparity in our community and the barriers within our own organization. Regarding health equity, I think more about things like access to transportation or a subject's ability to obtain standard of care medications that could maybe impact the study. I pay attention to the impact of lost wages when subjects are required to complete multiple study visits. And as a team, we work to add coverage of these things into the study budgets and find resources in the community that might be able to help our subjects. Diversity engagement is something that we begin thinking about during the feasibility stage and continue to address throughout the life of the trial. I, I tend to include advertising dollars into every single budget that I have. Here's where I think our study sponsors could better partner with the sites. I still meet a lot of resistance when I ask for dollars to spread the news about a sponsor's clinical trial. To be honest, I, I would love to see those larger study sponsors kind of pull together and engage in a united advertising campaign to educate people about community, about clinical trials. At the SCRS Site Summit, I met a man who kind of likened it to the Got Milk campaign. It wasn't the individual farmers who advertised for their cows. It's the milk industry as a whole that advertised to use milk. Everybody knows Got Milk. A unified advertising campaign could increase study enrollments and impact diversity. So why not Got Research?
Jane Bryce:And we really believe that our community involvement has brought us into partnership with other stakeholders that promote community health. And that has been a very important factor for us. For example, we are part of the Tulsa Health Department's community health improvement plan. This has increased our visibility, approachability, our awareness and trust within the community, which we consider essential to making any changes or any headways into this. But you asked a little bit about results. We have I do have some numbers we can go over. I think that we believe that the framework has been quite successful. We were able to demonstrate a decrease in the proportion of white study participants from 85. percent down to 68. And that was by increasing diverse enrollments in the Black, American, Indian, Asian and Hispanic Latino communities. We still have a lot of work to do. For example, the Hispanic Latino community remains underrepresented in our trials compared to our population. We have 3. 9 percent enrollment. Yet this group makes up 17 percent of our community, so we're working to correct this through additional community outreach options programs designed to specifically connect with this demographic that we can do because we have these community partners and already a known presence within the community. We've seen an age disparity and underrepresentation of subjects of greater than 65 historically within clinical trials, and our site has experienced a dynamic increase of enrollments within this age category, and we move the needle from 27 percent to 51%. So we're monitoring this closely and being careful not to overcorrect, but it does show that our BRIDGE community outreach program is working, we believe. And our site continues to have a gender discrepancy that's consistent with the national average in the U. S. Our male participation outnumbers females by an average of 12. 9%. So we're attempting to combat this bias through the use of social media platforms and with some tailored advertising. Our current electronic medical record actually does not gather data related to gender non-binary persons. And our organization is actively involved in integrating this option for fostering an environment of equity as well. So we plan to monitor that data for in the future for trends within this field. So we really goes back to the cornerstone of our BRIDGE framework. There are many aspects to it, but it really is based on and focused on developing a genuine connections that will lead to a trusting relationships with the, with our community partners, our community members. Distinctive hallmark of our department's approach is a consistent hands on strategy, commitment to advocacy, to understand to the underserved populations. And within our community and we've made huge strides forward, but there's still work to do. And I think we're up for the challenge. I think Stacie believes that.
Jimmy Bechtel:I couldn't agree more. It totally sounds like you guys are up for the challenge and meeting that challenge head on, which is, which is really fantastic with programs like, like bridge. So are there any maybe notable challenges faced during the evolution of the community outreach plan and how might you have overcome some of those challenges? Every new program, every new project process comes with its own set of maybe foreseen or unforeseen challenges. So talk a little bit about maybe a couple of those that you saw, faced, and overcame.
Stacie Merritt:I think our biggest challenge initially was making community connections with groups who serve different demographics. One of the most useful tools that I use when I talk with community leaders that I speak with is to ask them, who do you think I should speak with? And then I can follow up and this technique has been very helpful in enlarging our circle of influence in the community. These connections have been key to our success. We reached out to the community because it's the right thing to do, but it does cost my institution money. Although our program benefits study sponsors, I have not been able to obtain funding to cover the cost of community outreach. As an example, we ask every study sponsor for patient facing materials that can be used to promote their studies. Sponsors usually provide us with a PDF of a flyer or a brochure that I can print off and use. With my paper and my ink and my staff to put everything together, the cost and man hours required to attend community events or for the materials we use comes from our pocket. This makes it difficult to sustain our efforts long term. In addition. In my experience, our study sponsors require a diverse patient population for their clinical trials, but they're unwilling to financially assist in making that happen. Every study budget, I ask for advertising knowledge and it's rarely approved. Financials, financially supporting community outreach is one of the ways that study sponsors and CROs could greatly help the sites. If the site is successful in diversity enrollments, the sponsor is successful as well.
Jimmy Bechtel:I couldn't agree more, Stacie, and we hear a lot from the sites. Your sentiment around needing the reimbursement, the budgetary related items to help support these programs is not rare or unique. It is one of the largest requests that we've received from the site community and passed back to our sponsor and CRO partner. So thank you for emphasizing and really tying the importance of that and what that means back to what is a successful strategy. And how the financial support can continue to go to build upon those strategies. So how then do you plan to sustain the progress that you've made with this really amazing community engagement program? And maybe putting the backing behind that so you can then measure that progress to ensure ongoing inclusivity.
Jane Bryce:Well, most importantly, we have to continue to acknowledge and then prioritize the needs of our community that first, not our research needs, but the needs of the community. It's not a one time event. You have to be seen in the community as meeting a need, a need that they have for the people in that community. And you need to do that time and time again. And honestly, it's not an easy task. There are many things that vie for our attention every day. And the department is dedicated to, at least one event every month to have a physical presence out in the community. We may do more than that, but we're committed to at least be there for one. The need is, is much greater than that. But where, when we go, we meet a need, whether it be health screening health promotion whatever it needs to be. It could also be providing food in a food insecure area. But in the process, what we are doing is building long lasting and trusting relationships with members of that community. And that is a continual process.
Stacie Merritt:Additional things that we'll focus on is you know, a continued emphasis on health literacy for all of our patient facing documents. It's really necessary to promote that self determination which is so important in clinical trials. We've also altered our policies and procedures within our facility to better support diversity inclusion in our clinical trials. I do take every opportunity I can to share the financial impact of our successful community outreach program with study sponsors and CROs, and I encourage other sites and the SCRS to do the same. We've built our diverse team here at our site, and we promote acceptance of one another, and we also understand that this is a continual process. By disseminating our experiences, procedures, and outcomes, we also hope to continue to grow our own processes toward diversity, equity, and inclusion and hopefully as a community, a research community, we can learn and grow from one another.
Jimmy Bechtel:I couldn't agree more, Stacie and Jane. That really is a lot of the spirit of what SCRS is all about and what we're here to do. And I appreciate very much, A, your willingness to share what you've done, but B, contribute to that ongoing sustainability of the industry as a whole. So it's a great message and one that I hope not only our sites are able to take back, but also our sponsors and CROs that are listening. To help reemphasize the point that we can't do this alone as sites that there's help that's needed in a variety of different ways. So thank you again for sharing that sentiment. And as we begin to wrap our conversation up here, I want to talk a little bit about and maybe end our conversation really around what advice that you might have for sites who are facing diversity recruitment challenges And maybe talk a little bit as well about how they can work with industry partners as you have to deploy innovative community outreach methods.
Stacie Merritt:I think first and foremost, you need to build diversity into your own team and learn from each other. It's important also to build DEI concepts into your orientation program for new hires and provide continuing education opportunities that cover DEI to your staff on a routine basis. Continue to look for biases within your own organization's processes and make changes that will promote diversity, equity, and inclusion. And again, provide that cultural sensitivity training for your staff.
Jane Bryce:It's also important that you track your metrics. You need to know where your strengths and weaknesses are and work on those. We found it was important to pick a project or 1 or more project champions among your team who are passionate about diversity, equity and inclusion to help lead these projects. You also need to provide some sort of form for brainstorming opportunities that focused on ways to improve diversity, equity and inclusion. It's an ongoing conversation and an ongoing a brainstorming event for the staff and that so that we can continually improve. It's important to disseminate and share your results and experiences within our community, within our research community And last but not least, be involved in the community you serve. I think we've said that multiple times in multiple ways, but that is, we believe that's the foundation of providing equity and equitable access to our trials.
Jimmy Bechtel:Well, I think that's a great summary and a really awesome place for us to conclude our conversation today. Stacie, Jane, thank you for being again here with us today. Congratulations again on your recipiency of the inaugural Excellence in Diversity Award, and thank you for being here and sharing your tips and a little bit of insight into what your program has done. I wish you the best and continued success. It will be exciting to see how this program continues to develop. So. Thank you for being here.
Stacie Merritt:Thank you so much.
Jane Bryce:Thank you. Thank you for inviting us.
Jimmy Bechtel:For those listening. Make sure that you register for upcoming summits being held throughout the year by visiting our summit page on our website. MySCRS.org. While you're on our website, be sure to check out other SCRS publications and resources built for our community. In the publications and members section of the same website. We appreciate your participation and listening to today's program and look forward to having you join us for more great content coming out soon. Thanks again for listening.