Participation In Research Studies Research Articles

Participant perspectives on management and communication of incidental findings identified on radiographic imaging performed during a clinical research trial: A single site pilot study

BackgroundIncidental findings (IFs) in radiographic imaging are unexpected discoveries unrelated to the purpose of the scan. While the protocol for communicating IFs is better defined for clinical providers, little formal guidance on communicating IFs identified on research scans to participants is available. This study explored participants’ experience with communication and management of IFs found on imaging identified in a clinical research trial. MethodsParticipants who completed the parent clinical trial, which included imaging, were invited to participate. A survey, developed by the study team, was administered telephonically, and consisted of multiple choice and open-ended questions. ResultsThirty participants enrolled in the survey study. Ninety-three percent of all participants (with and without IFs) reported they would participate in another research study to learn information that was important to their health. Seventeen participants reported being notified about an IF on their study scan(s). Ninety-four percent of those participants with an IF were satisfied with how the IF was communicated, and 71 % were grateful to find out about a health problem before it became an issue. Forty-one percent reported that learning about the IF led to improved health. Content analysis of the data from the open-ended questions revealed categories and themes which enriched the quantitative data. ConclusionParticipants generally wanted to know when an IF was discovered unexpectedly on their imaging scan, as they learned important information about their health. Findings underscore the importance of having a clear protocol for communicating IFs to research study participants that undergo evaluation with radiographic imaging.

How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration.

Research study participants can stop taking part early, in various circumstances. Sometimes this experience can be stressful. Providing participants with the information they want or need when they stop could improve participants' experiences, and may benefit individual studies' objectives and research in general. A group of public contributors and researchers at the Clinical Trials Research Unit, University of Leeds, aimed to develop a communication template and researcher guidance. This would address how to provide information sensitively around the time when participants stop or significantly reduce their level of participation. The project lead used scoping review methods to identify relevant prior evidence and derive a list of potential information topics to communicate to participants who stop taking part. The topic list was reviewed by research professionals and public contributors before finalisation. Further public contributors were identified from a range of networks. The contributors formed a 'development group', to work on the detail of the planned resources, and a larger 'review group' to review the draft output before finalisation. The involvement was planned so that the development group could shape the direction and pace of the work. The literature review identified 413 relevant reports, resulting in 94 information topics. The review suggested that this issue has not been well explored previously. Some evidence suggested early-stopping participants are sometimes excluded from important communications (such as study results) without clear justification. The development group agreed early to focus on guidance with reusable examples rather than a template. We took time to explore different perspectives and made decisions by informal consensus. Review group feedback was broadly positive but highlighted the need to improve resource navigability, leading to its final online form. We co-developed a resource to provide support to research participants who stop taking part. A strength of this work is that several of the public contributors have direct lived experience of stopping research participation. We encourage others to review the resource and consider how they support these participants in their studies. Our work highlights the value of researchers and participants working together, including on complex and ethically challenging topics.

110 Answering the Call for Greater LGBTQ+ Research Inclusivity by Co-Developing A Workshop for Researchers

OBJECTIVES/GOALS: The objectives of this workshop were to: (1) provide learners with a space to become aware of and discuss the history of the LGBTQ+ community in medical and public health research; (2) apply frameworks for LGBTQ+ inclusivity in research, inspired by lived experience and multimedia; and (3) assess LGBTQ+ research inclusivity best practices. METHODS/STUDY POPULATION: The CTSC provided the LGBT Community Center of Greater Cleveland (Center) with access to academic resources via an affiliate account and insights on the clinical and translational science research process. Members of the CTSC Research Equity, Accessibility, Diversity, and Inclusion team met regularly with the education and programming team at the Center to review research findings for workshop segments, ideate and provide feedback on activities, and strategize to ensure a psychologically safe virtual environment for learners. Zoom registration was used for workshop registration. An evaluation survey, created by the LGBT Community Center of Greater Cleveland (Center), was deployed by the CTSC to learners after the workshop. Respondents reported that the LGBTQ+ terminology focus was most valuable. RESULTS/ANTICIPATED RESULTS: To maximize investment in and scale theLGBTQ+ Inclusivity For Researchers workshop, the LGBT Community Center of Greater Cleveland offered a shortened version to their Youth Participatory Action Research group and will continue to offer the workshop in their suite of program/educational offerings. The CTSC plans to offer opportunities to co-host the workshop at its hospital system partner institutions, with room to tailor content based on internal LGBT resources (e.g., gender care offered at the institution). We hope to see a remarkable increase in LGBTQ+ identifying researchers, LGBTQ+ participation in research studies and clinical trials, and LGBTQ+ research topics/ideas/questions in response to CTSC pilots, local, national, and global funding opportunities. DISCUSSION/SIGNIFICANCE: LGBTQ+ people are less likely to have a regular health care provider—impeding screening, diagnosis, and treatment. This is reflected in health research where clinical research participation may follow a diagnosis. By providing tools for LGBTQ+ research inclusion, we will catalyze more research with LGBTQ+ people—as researchers and participants.

Comparison of recruitment methodologies for clinical trials: Results from the time for living and caring (TLC) intervention study

BackgroundRecruiting participants for research studies is a critical yet challenging task. Community-engaged recruitment strategies have gained prominence as effective means to engage diverse populations and ensure the representativeness of study samples. This case study aims to investigate the cost and effectiveness of various recruitment methods in enhancing research participation. MethodsA comparative approach was employed to assess the outcomes of five different recruitment strategies used in the Time for Living & Caring (TLC) research study. Data on recruitment success, participant demographics, and retention rates were collected and analyzed using descriptive statistics, including ANOVA and Chi-squares, to statistically compare the outcomes associated with 5 different recruitment methodologies. The recruitment methodologies included two community-engaged strategies (community partner referral and community-based recruiters), a clinical database, social media, and word-of-mouth referral. ConclusionThe meta-data used to build this methodological case study describe different recruitment methodologies that may be used for clinical trials. This data-driven evaluation provides examples and considerations for researchers when developing budgets and proposals for future clinical trials. The primary finding is that there are tradeoffs in terms of cost, time, labor, and ultimately the representativeness of the sample, based on the type of recruitment methodology chosen.

Abstract 3469: Exploring the impact of a giant inflatable colon on the level of awareness, knowledge, and intent for colorectal cancer screening among men attending two state fairs in the Midwest

Abstract Purpose: This study aimed to evaluate the influence of an interactive inflatable colon as an effective educational tool to increase colorectal cancer (CRC) awareness, knowledge, and screening intention among men attending the Wisconsin (WI) and Minnesota (MN) state fairs. Methods: Eligible study participants were self-identified men aged 18-75 who spoke English, were residents of WI or MN, and able to read in English. The study was employed during the final operating weekend of both the 2023 WI State Fair (August 11-13) and the MN State Fair (September 1-3). Eligible participants completed: (1) a pre-survey, (2) an unguided tour of the inflatable “Super Colon”, and then (3) a post-survey. The primary outcomes of interest were change in awareness (two items), knowledge (four items), and behavioral intent to obtain CRC screening (one item) from pre- to post-survey. Chi-square tests were used to examine study site differences and to explore the association between demographics and behaviors (awareness, knowledge, intentions) before entry to the Super Colon. McNemar’s test were employed to test if there were significant differences in the distributions from pre- to post-survey. Results: A total of 940 eligible participants were included in the study sample. The men self-identified their race/ethnicity as Non-Hispanic (NH) White (72%), followed by NH other (12%), NH Black (9%), and Hispanic (8%). Race and ethnicity significantly varied by study site (<.0001) with participants from WI more likely being members of racial/ethnic groups that are often medically underserved (33% vs. 24% in MN). Only 13% of participants had walked through an inflatable colon before. Of those who were screening-age appropriate (age 45 or older), 89% had been screened for CRC previously. With the exception of one question, baseline CRC knowledge was relatively high among our study sample. Interestingly, having higher confidence of their awareness level was inversely associated with higher knowledge. As a result of touring the Super Colon, a significant improvement in confidence in individuals’ knowledge of CRC (<.0001), knowledge regarding a colon polyp (<.0001), and intentions to be screened in the future (<.0001) were observed. Most participants (95%) agreed that the Super Colon is an effective educational tool to teach people about CRC. Conclusion: Since both encouraging CRC screening uptake and increasing research study participation among men can be a difficult task, these findings emphasize the crucial role of community-based educational initiatives in achieving these goals. Our findings affirm how the three-dimensional interior of the Super Colon is as an effective educational tool for promoting CRC early detection screening behaviors among men and increasing their awareness. Citation Format: Ami E. Sedani, Kelly K. Rifelj, Malcolm S. Bevel, Cordero L. McCall, Mckenzi Rogalla, Lisa Laliberte, Kiara Ellis, Rebekah J. Pratt, Charles R. Rogers. Exploring the impact of a giant inflatable colon on the level of awareness, knowledge, and intent for colorectal cancer screening among men attending two state fairs in the Midwest [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3469.

Abstract P446: Community-Engaged Strategies for Recruitment of Black Men at Risk for Hypertension: The CLIP Study

Background: Recruitment of Black participants in research studies is challenging. Mistrust of academic and medical institutions due to historic mistreatment, medical racism, and lack of culturally tailored strategies to engage Black communities as partners, has led to under-representation of Black participants in studies. Black men have higher prevalence of hypertension (HTN) and worse outcomes than other groups. Yet, Black men are underrepresented in HTN clinical trials. The Community-to-Clinic Linkage Program to Prevent Hypertension (CLIP) is a community-engaged cluster randomized trial to test barbershop facilitation to prevent HTN among Black men residing in Staten Island (SI), New York City. Objective: To describe recruitment strategies to engage Black men in CLIP via an academic-community partnership. Methods and Results: Approximately 10% of SI residents identify as Black, of which ~ 90% live in 3 census tracts with the highest prevalence of HTN in the borough. The study team collaborates with Community Health Action of Staten Island (CHASI), a grassroots health organization with > 30 years of community focus on addressing the root causes of health disparities on SI, the Director of Health in SI, a community advisory council (CAC) comprised of local leaders and residents, and the New York American Heart Association providing HTN education materials in an academic-community partnership to implement CLIP. Our recruitment goal is to enroll 84 men across 4-5 Black-owned barbershops over 5 cycles (12 weeks each), total N=418. We did not meet recruitment goals for cycles 1 and 2, (~60% enrolled). In consultation with CHASI and the CAC we adjusted our recruitment strategies to: 1) host bi-monthly community events in or around participating barbershops; 2) offer study incentives at the time of enrollment; 3) leverage existing relationships with faith-based organizations and other stakeholders to promote CLIP; and 4) distribute co-branded promotional flyers with CHASI and other stakeholders to publicize events. Subsequently we exceeded recruitment goals in our last cycle (113% enrolled); current cycle recruitment is ongoing. Several strategies have been successful in improving recruitment of Black men for CLIP: 1) deep community ties of our community health partner; 2) enlisting local community health workers representative of the study population; 3) flexibility and open communication between academic and community staff; 4) trust in the competence of each partner; 5) mutual commitment to the mission of the study. Conclusion: Partnering with engaged and trusted community partners, stakeholders, and local leaders positively impacts recruitment of Black men participants in HTN research studies. Organizations with deep community ties are crucial for establishing trust and identifying flexible solutions to recruitment challenges.

Advancing Aging Research through a Health Disparities Perspective.

The proportion of older adults in the U.S. is growing, and the older adult population is also becoming increasingly diverse. However, there are limited data on the aging process and older adults in underserved populations. Equitable participation in research studies on aging, the research workforce, and the healthcare workforce is critical to improve health outcomes for the entire U.S. population. Health disparities frameworks offer researchers and healthcare professionals the tools to develop and evaluate aging research that addresses all levels of analysis and domains of influence. Although there have been efforts to diversify the healthcare and research workforce, significant disparities in representation remain. In this perspective, we discuss existing aging health disparities, health disparities frameworks to use as tools to better conduct aging research, methods to enhance the proportion of underrepresented populations in aging research, and the current gaps in as well as efforts to enhance the diversity of the healthcare and research workforces.

Algorithms for Liver Segmentation in Computed Tomography Scans: A Historical Perspective.

Oncology has emerged as a crucial field of study in the domain of medicine. Computed tomography has gained widespread adoption as a radiological modality for the identification and characterisation of pathologies, particularly in oncology, enabling precise identification of affected organs and tissues. However, achieving accurate liver segmentation in computed tomography scans remains a challenge due to the presence of artefacts and the varying densities of soft tissues and adjacent organs. This paper compares artificial intelligence algorithms and traditional medical image processing techniques to assist radiologists in liver segmentation in computed tomography scans and evaluates their accuracy and efficiency. Despite notable progress in the field, the limited availability of public datasets remains a significant barrier to broad participation in research studies and replication of methodologies. Future directions should focus on increasing the accessibility of public datasets, establishing standardised evaluation metrics, and advancing the development of three-dimensional segmentation techniques. In addition, maintaining a collaborative relationship between technological advances and medical expertise is essential to ensure that these innovations not only achieve technical accuracy, but also remain aligned with clinical needs and realities. This synergy ensures their applicability and effectiveness in real-world healthcare environments.

INviting Veterans InTo Enrollment in Alzheimer's Disease Research Centers (INVITE-ADRC): An NIA and VA-sponsored initiative to increase veteran participation in aging and dementia research.

Older military veterans often present with unique and complex risk factors for Alzheimer's disease (AD) and related dementias. Increasing veteran participation in research studies offers one avenue to advance the field and improve health outcomes. To this end, the National Institute on Aging (NIA) and Department of Veterans Affairs (VA) partnered to build infrastructure, improve collaboration, and intensify targeted recruitment of veterans. This initiative, INviting Veterans InTo Enrollment in Alzheimer's Disease Research Centers (INVITE-ADRC), provided funding for five sites and cross-site organizing structure. Diverse and innovative recruitment strategies were used. Across five sites, 172 veterans entered registries, and 99 were enrolled into ADRC studies. Of the enrolled, 39 were veterans from historically underrepresented racial and ethnic groups. This initiative laid the groundwork to establish sustainable relationships between the VA and ADRCs. The partnership between both federal agencies demonstrates how mutual interests can accelerate progress. In turn, efforts can help our aging veterans.

A Noninvasive Method to Sample Immune Cells in the Lower Female Genital Tract Using Menstrual Discs.

T cells in the human female genital tract (FGT) are key mediators of susceptibility to and protection from infection, including HIV and other sexually transmitted infections. There is a critical need for increased understanding of the distribution and activation of T cell populations in the FGT, but current sampling methods require a healthcare provider and are expensive, limiting the ability to study these populations longitudinally. To address these challenges, we have developed a method to sample immune cells from the FGT utilizing disposable menstrual discs which are noninvasive, self-applied, and low in cost. To demonstrate reproducibility, we sampled the cervicovaginal fluid of healthy, reproductive-aged individuals using menstrual discs across 3 sequential days. Cervicovaginal fluid was processed for cervicovaginal cells, and high-parameter flow cytometry was used to characterize immune populations. We identified large numbers of live, CD45+ leukocytes, as well as distinct populations of T cells and B cells. Within the T cell compartment, activation and suppression status of T cell subsets were consistent with previous studies of the FGT utilizing current approaches, including identification of both tissue-resident and migratory populations. In addition, the T cell population structure was highly conserved across days within individuals but divergent across individuals. Our approach to sample immune cells in the FGT with menstrual discs will decrease barriers to participation and empower longitudinal sampling in future research studies.

Hispanics’ Perceptions of Participation in Research Studies and Solutions for Improvement in Participation

In 2022, the Hispanic population in the United States reached 63.6 million, accounting for 19% of the total population. Despite this growth, Hispanics are significantly underrepresented in research studies. The purpose of this mixed-methods study was to evaluate perceived research burden, explore perceptions towards participation in research studies, and solicit strategies to increase research participation in Hispanics. We recruited 25 Hispanic participants’ ages 18-65 years from the community. Data were collected using a demographic data sheet, the Perceived Research Burden Assessment (PeRBA), and face-to- face interviews. It took about 10 minutes to collect the quantitative data. Interviews lasted 20 to 60 minutes. Audio-recorded interviews were transcribed and translated from Spanish to English by certified translators. Data analyses involved descriptive statistics, the Wilcoxon Rank Sum Test, and thematic analysis. Eighty (n =20) of the participants were female, 80% (n = 20) spoke a Spanish dialect as their primary language, 43.3% (n = 13) had an annual income of less than $20,000, 56% (n = 17) had no health insurance, and 49.9% (n = 15) had less than a 12th-grade education. The PeRBA revealed three main areas of research participation burden: 1) second thoughts about participating, 2) participation regret, and 3) participation costs. Five major themes emerged from the interviews: 1) lack of knowledge, 2) immigration status, 3) social isolation, 4) language and literacy, and 5) transportation. Two additional themes were academic and community partnerships, and community engagement via social media platforms.

Cultural, Linguistic, and Geographical Diversity of Participants in Australian Physical Activity Research Studies: A Systematic Review.

The Australian population is highly diverse in terms of cultural heritage, languages spoken, and geographical dispersion. Health outcomes are often worse among these culturally, linguistically, and geographically diverse populations, and this is reflected in rates of physical activity participation, with people from these groups often engaging in insufficient physical activity for health benefits. This research aimed to investigate if physical activity intervention studies conducted in Australia were (1) designed to recruit culturally, linguistically, and geographically diverse participantsand (2) recruiting culturally, linguistically, and geographically diverse participants. We conducted a systematic review of physical activity intervention studies conducted in adults in Australia between 2015 and November 2022. Information relevant to inclusivity in study recruitment methods and diversity of recruited participants was extracted. We identified and extracted data from 371 studies, of which 98 were protocol papers for which no follow-up data was available. Only 26 studies (7%) included methods to recruit culturally or linguistically diverse participants. Most studies (189, 51%) recruited participants from major city locations, with few studies recruiting from more remote locations. No studies included recruitment from very remote regions. Information on cultural, linguistic, or geographic diversity of participants recruited to physical activity studies was provided by 109 studies (40% of studies including results) with the majority recruiting White, English-speakers from major cities. Few Australian physical activity studies are designed to recruit culturally, linguistically, and geographically diverse participants. Due to limited reporting of the diversity of participants, comparisons with population-representative data are unreliable.

Reaching Communities Through Food Allergy Advocacy, Research, and Education: A Comprehensive Analysis

This article explores the multifaceted approach of food allergy (FA) advocacy, research, and education to address the diverse challenges associated with FA, such as disparities in socioeconomic status, food security, quality of life, and the overall burden of the disease. Advocacy initiatives are instrumental in driving policy changes, raising public awareness, and directing substantial research funding, with a focus on reducing disparities. They have influenced allergen labeling regulations and improved access to epinephrine, emphasizing the importance of school-based management plans, especially in underserved communities. Research in FA informs medical practices and offers them hope for improved treatments. Recent breakthroughs in peanut allergy prevention and oral immunotherapy trials exemplify the potential for advancements while highlighting the need to address disparities in health care access. Education is a critical tool for prevention, raising awareness, and reducing the risk of allergic reactions. Efforts should be tailored to reach marginalized communities, particularly in schools where education on FA management is essential. Collaborating directly with communities is imperative to ensure inclusivity and address disparities. Barriers such as mistrust, language and cultural differences, and lack of diversity among researchers must be overcome to encourage diverse participation in research studies. This article concludes by emphasizing the significance of a comprehensive approach to FA research that prioritizes equity and inclusivity. The call to action highlights the need for global initiatives to reshape the landscape of FA care and address disparities in health care access and outcomes.

ARE YOU A REAL PARTICIPANT? EXPERIENCES WITH FRAUDULENT PARTICIPATION ACROSS TWO FUNDED STUDIES

Abstract While offering financial incentives for participation in research studies is common, less discussed is the potential impact of fraudulent participation for financial gain. Survey and data management software provide safeguards for fraud detection but enabling detection does not automatically weed out fraudulent responses. Few resources provide guidelines for identifying or managing fraudulent participation. Thoughtful processes are important, while also being mindful of normal research behaviors which might get flagged as suspicious, for example due to low literacy skills. This presentation discusses experiences across two studies with adults living with serious illness and/or their family members and two different types of fraudulent participation: online surveys and studies requiring personal interaction. Study one is a pilot instrument validation study collecting online survey data. Recruitment occurred locally through listservs and a research participation database from a large university hospital. Study two is a mixed-methods longitudinal design where survey and interview data are collected via phone or video calls. Participants for this study were recruited nationwide using multiple strategies, including social media. Both offer time-saving insights for dealing with fraudulent participation in research. For example, study one provides tips for planning how to manage spam/bots prior to data collection, including setting up filters to automatically weed out identified spam, creating automatic messaging included in the survey in the event it needs to be paused, and identifying potential problematic patterns in data that bypasses fraud detection. Study 2 emphasizes the importance of creating strong verification procedures for study eligibility when relying on participant reporting.

EXAMINING THE IMPACT OF BURNOUT ON RESEARCH PARTICIPATION IN CLINICIANS TREATING DEMENTIA

Abstract Clinicians treating people living with dementia (PLWD) are likely to face burnout due to 1) the significant emotional burden of the job and 2) the increasing number of patients requiring dementia care. While much research has been conducted on the impact of clinician burnout on patient care and outcomes, more research is needed on its effects on clinician participation in research studies. This study will analyze qualitative data to examine the effect of clinician burnout on participation and intervention uptake in a dementia care research study.

INCLUDING PEOPLE WITH COGNITIVE IMPAIRMENT IN HEALTH SERVICES RESEARCH: PROMISING PRACTICES AND LESSONS LEARNED

Abstract Engaging impacted populations, including consumers, in the design of health policies and services is increasingly recognized and prioritized in the United States. However, people with dementia and other forms of cognitive impairment are underrepresented and have often been excluded from health services research. As the number of people worldwide who are living with some form of cognitive impairment is expected to rise dramatically in the coming years, it is critical that researchers across all areas of health services research consider including this population in their work and ensure decisions for exclusion are fully justified. That said, individuals with cognitive impairment constitute a vulnerable population and additional precautions and safeguards are warranted to ensure they are protected throughout and beyond their participation in research studies. The inclusion of people with cognitive impairment also adds complexity to studies, and appropriate research protocols are often challenging to design and implement. This poster will describe two studies conducted by researchers at Georgia State University that included populations with cognitive impairment. The content will cover background about the study populations, which varied in diagnosis and disease progression; methods for recruitment, screening, and consent; and helpful communication strategies to employ throughout the research process. The poster will also share lessons learned and promising practices identified for both studies.

Retention of American Indian and Alaska Native participants in the National Alzheimer's Coordinating Center Uniform Data Set.

The number of American Indian and Alaska Native (AI/AN) elders is expected to double by 2060. Thus it is imperative to retain AI/AN participants in longitudinal research studies to identify novel risk factors and potential targets for intervention for Alzheimer's disease and related dementias in these communities. The National Alzheimer's Coordinating Center houses uniformly collected longitudinal data from the network of National Institute on Aging (NIA)-funded Alzheimer's Disease Research Centers (ADRCs). We used logistic regression to quantify participant retention at 43 ADRCs, comparing self-identified AI/AN participants to non-Hispanic White (NHW) participants, adjusting for potential confounding factors including baseline diagnosis, age, sex, education, and smoking. The odds of AI/AN participant retention at the first follow-up visit were significantly lower than those for NHW participants (adjusted odds ratio [aOR]: 0.599; 95%: 0.46-0.78; p<0.001). These results suggest the need for improved strategies to retain AI/AN participants, perhaps including improved researcher-community relationships and community engagement and education. American Indian and Alaska Native (AI/AN) research participants were retained to the first follow-up appointment at lower rates than non-Hispanic White (NHW) participants. AI/AN participants are retained at lower rates than NHW participants for long-term follow-up. The majority of AI/AN participants were not retained to the second follow-up visit.

Abstract A052: Perspectives of African immigrants on community health needs and clinical trials

Abstract INTRODUCTION In the past decade, Jacksonville, Florida has seen an increase in African immigrants. However, little is known about their health needs and perspectives related to community health and clinical trials. The Mayo Clinic Comprehensive Cancer Center (MCCCC) Community Outreach and Engagement (COE) Office and Programs partnered with multiple community-based organizations as part of the FL Community Engagement Alliance Against COVID-19 to hold a series of focus groups with African immigrants to better understand their perspectives surroudning these determinants. METHODS This was a qualitative study with African immigrants residing in Jacksonville, Florida. Data was collected by community partner, Jocelyn Turner Consulting, who has led multiple community-based studies in Florida. Recruitment was in partnership with African businesses and churches. Using a guide developed by MCCCC COE, three focus groups were held to explore African immigrants’ 1) general experiences, 2) access to social services, 3) perspective of community health and diseases, 4) access and use of healthcare services, 5) knowledge and participation in clinical trials, and 6) appropriate strategies for providing community education and enhancing participation in research studies. RESULTS 24 participants participated in the focus groups. 83% had recently immigrated from Africa (Democratic of the Congo, Benin, Ghana, Sudan, Mali, Nigeria, Ethiopia, and Nigeria). The remaining 17% recently immigrated from Haiti or came to the US as a baby. Participants reported suprise to the proliferation of chronic diseases, such as increased cancer diagnoses of those who immigrated to the United States. Most participants associated this with the Western sedentary lifestyle, dietary habits, and lack of access to fresh food. Participants connected to refugee organizations reported knowledge of the ability to access health education resources and mental/physical care services, but those not connected with similar organizations expressed limited knowledge about access. Similarly, participants with no connection to refugee organizations reported not knowing where to access healthcare services and not seeking services until home remedies had failed. Only 33% of participants reported knowledge of clinical trials and all reported mistrust of research. Many of the participants expressed a need for health-related information upon arrival in the United States. CONCLUSION There is currently little infrastructure in place to support African immigrants in Jacksonville, Florida, which can contribute to cancer health disparities in this population. Strong community engagement is needed to partner with African immigrant communities to address culturally specific needs identified of this underrepresented population. The needs expressed by participants include information on physical activity, nutrition, and healthcare/clinical trials. A strong partnership with African immigrant communities has the potential to address cancer disparities and increase both trust and participation in clinical trials. Citation Format: Jocelyn Turner, Laureen Husband, Jessica Otero, Opeyemi Bolajoko, Parisa Fathi, Jennifer Crook, Folakemi Odedina. Perspectives of African immigrants on community health needs and clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A052.

Identification of Persons Living with Dementia Using the Electronic Health Record

AbstractBackgroundAlzheimer’s disease and related dementias (ADRD) are underdiagnosed in the primary care setting. Proactive screening for cognitive impairment and subsequent evaluation and diagnosis of patients who screen positive are not routinely and reliably performed. As a result, identification of persons living with dementia (PLWD) for enrollment in clinical programs, clinical trials, and research studies can be challenging. The electronic health record (EHR) represents a potentially viable tool to efficiently and accurate identify PLWD.MethodsIn a large academic health care system in the U.S., we performed an EPIC EHR search for PLWD with the intent of enrolling them in an outpatient dementia care management program. The EHR algorithm used the following criteria for dementia: (1) an ICD‐10 dementia diagnosis in the problem list or past medical history or (2) an FDA‐approved drug on their active medication list. We performed chart review for patients who were identified to have potential dementia using this algorithm to confirm dementia diagnosis is documented in clinical notes.ResultsA total of 985 patients were identified by EHR criteria as potentially having dementia. After chart review, 747 (75.8%) were confirmed to have dementia documented in their clinical history and progress notes. One hundred thirty (13.2%) did not have a confirmed dementia diagnosis, 58 (5.9%) had an incomplete dementia evaluation, and 50 (5.0%) had only mild cognitive impairment. In addition, 55 (5.6%) were deceased.ConclusionWe found that an EHR algorithm can identify patients with dementia in a health plan population. This model may be a useful tool for a focused recruitment of potential participants in clinical trials, research studies, and clinical programs.

The Australian Dementia Network Registry: A Nationwide Clinical Quality Registry to monitor and improve dementia diagnosis and care

AbstractBackgroundMany Australians live with dementia, yet limited evidence suggests there are unacceptable variations in clinical care. Until now there had been no systematic collection of high‐quality clinical data that benchmarks practice and helps drive improvements.MethodThe Australian Dementia Network (ADNeT) Registry, a clinical quality registry designed to close this gap, recruits sites involved in dementia diagnosis, such as memory clinics, and collects a minimum dataset from clinicians at the time of diagnosis of either dementia or mild cognitive impairment (MCI). The Registry later sends information to patients (and/or caregivers), including on how to withdraw if preferred, and collects co‐designed patient and/or caregiver outcome and experience measures by survey. The Registry oversees data analysis, generates clinical quality indicators (CQIs), and facilitates timely access for providers to this data.ResultCommencing in 2020, ADNeT Registry has so far collected data from 55 clinics, representing all Australian states, including from regional and rural areas, and public and private providers. Data on the 2250 participants to date, 1552 (69%) with dementia and 698 (31%) with MCI, indicates a median time from referral to diagnosis of 126 days. For dementia and MCI, respectively, mean ages (SD) at diagnosis are 78.7(8.7) and 76.8 (8.8) years, and mean MMSE scores are 20.7(5.3) and 26.1 (2.8). The most common dementia subtype diagnosed is Alzheimer’s Disease (76%), whilst the CQIs showing most substantial variation nationally are for cholinesterase prescription and appointment wait‐times. The Registry has an 11% opt‐out rate, receives 48% of patient/caregiver surveys sent, has published three site and one annual report, and continues to grow.ConclusionThe ADNeT Registry’s early experience is that a clinical quality registry for dementia in Australia is feasible to implement and provides value to participating clinicians. We anticipate that, over time, feedback to clinicians and benchmarking of their data compared to their colleagues’ will drive improvements in diagnostic practices and care. Additional Registry attributes, such as facility to enable research study participation, and expansion of dataset to enable uptake and outcome monitoring of new diagnostics and therapeutics, has made it attractive to governmental, regulatory, professional, consumer and pharmaceutical bodies.