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Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop (2021)

Chapter: 5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH

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Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 45
Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 46
Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 47
Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 48
Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 49
Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 50
Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
×
Page 51
Suggested Citation:"5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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5 STRATEGIES FOR ENGAGING OLDER ADULTS IN CLINICAL RESEARCH Key Messages Highlighted by Individual Speakers • Using networks to conduct research can leverage existing relationships and improve recruitment, trust, and data collection. (Tobin) • Community-based interventions that are designed to directly address common barriers to engagement can increase minority participation. (Blyler) • Tailoring interventions to specific underrepresented groups can help improve engagement. (Blyler) • Involving patient advocates in the design of a trial can improve the trial, make it more patient-centric, and potentially save money. (Strong) • Caregivers play a critical role in engaging and recruiting older adults for research; there is a need for caregiver-specific outreach by researchers. (Pracht) • Researchers hoping to work in a community should “build relationships with the people who have relationships.” (Rothschild) People over 65 are an extremely heterogeneous group, said Deborah Collyar, president of Patient Advocates in Research. They range from marathon runners to those in nursing homes, and everywhere between them. Why, then, are people often excluded from research simply based on age? (Bourgeois et al., 2017; Helfand et al., 2020; Radziszewska, 2019). Collyar suggested that it is time to create a “healthy aging” program, in which research, pilot programs, communities, and people are connected to create better evidence and improve the quality of life for older populations. The objective for this session was to explore approaches to better engage adults across the older age span in clinical research and clinical trials and strategies to generate evidence-based information on how to best optimize treatment for older adults. One way to incorporate a “healthy aging” approach into clinical trials is to spend time thoughtfully planning trials in a way that meets patient needs, said Collyar. For example, include research questions and endpoints that are relevant and important to patients; expand eligibility criteria based on the specific needs of the trial; use Comprehensive Geriatric Assessments (Ward and Reuben, 2020) to assess characteristics such as functionality, mobility, and cognition; and PREPUBLICATION COPY: UNCORRECTED PROOFS 5-1

5-2 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN use recruitment plans and health care workers to engage potential trial participants. During the trial itself, said Collyar, there is a need to adapt trial settings to meet the needs of participants (e.g., telehealth, local procedures, home care), to train health care workers and research staff, and to ensure that trials have the appropriate level of health literacy to ensure participants understand the trial and their role. Furthermore, said Collyar, the language that is used in research matters. When patients are described as “failing” treatment or being “non-responders” to treatment, this can make patients feel as if it is their fault. In addition, this language is inaccurate—“patients don’t fail treatments, treatments fail patients.” There are other standard clinical research terms that can create barriers with patients, she said. For example, using the term “subject” to describe a research participant can convey the idea that he or she is being “subjected” to something. Most importantly, she said, stakeholders must remember that context matters. A research design may seem ideal from the perspective of the researchers, but it may look very different to the patient population. OUTREACH AND NETWORKING STRATEGIES FOR ENGAGING OLDER ADULTS Jonathan Tobin, president/chief executive officer of Clinical Directors Network (CDN) and senior epidemiologist at The Rockefeller University Center for Clinical & Translational Science, shared his perspective on engaging older adults in clinical research through the use of Practice Based Research Networks (PBRNs)—groups of ambulatory care practices that are joined together into a network structure that transcends any single research project. PBRNs link practicing clinicians with experienced clinical investigators, and are “committed to enhancing the research skills of the network clinician members.” While PBRNs are a framework for a learning health care system, the clinicians who are practicing in these settings are “committed to the delivery of health care services, and research is often a secondary priority.”1 The challenge for PBRNs, he said, it to align the service delivery mission with the research mission. Clinical Directors Network, Inc. (CDN) is a nonprofit PBRN that focuses on translating clinical research into clinical practice for improving health equity and public health.2 CDN works with Federally Qualified Health Centers (FQHCs)3 and other safety-net primary care practices across the country. FQHCs are a particularly good opportunity for conducting real-world studies, said Tobin, because there are nearly 13,000 delivery sites across the United States that serve more than 25 million patients, and about one in five patients are ages 55 and older. The patients served by FQHCs are primarily low income and medically underserved, and are often from minority or immigrant populations. These are particularly important communities to engage in clinical and translational research because their participation can enhance the diversity of studies and therefore, their generalizability, said Tobin (Brandt et al., 2015). Tobin mentioned several barriers to conducting research that engages older adults, including issues related to transportation, language, literacy, technology, convenience, and trust. For example, Tobin said that health systems are rapidly adopting technologies (e.g., telehealth 1 For more information on Practice Based Research Networks, see https://www.ahrq.gov/research/findings/factsheets/primary/pbrn/index.html (accessed November 11, 2020). 2 For more information on the Clinical Directors Network, Inc., see https://www.cdnetwork.org (accessed November 11, 2020). 3 For more information on Federally Qualified Health Centers, see https://www.hrsa.gov/opa/eligibility-and- registration/health-centers/fqhc/index.html (accessed December 17, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

STRATEGIES FOR ENGAGING OLDER ADULTS 5-3 platforms), but some older adults may have difficulty accessing or using these technologies due to physical challenges, visual impairment, or lack of familiarity and confidence with technology (Anderson, 2019; Anderson and Perrin, 2017). To address some of these barriers, CDN has carried out hybrid studies in real-world settings that examine not only whether an intervention is effective, but also how the intervention can be implemented in the target population (Curran et al., 2012). To illuminate the study strategies that CDN uses, Tobin shared examples of three current studies. The first is a set of PBRN studies that use electronic health (eHealth)4 and mobile health (mHealth)5 strategies to improve hypertension and diabetes control, funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, respectively (Fiscella et al., 2015; Mamykina et al., 2017). These studies use interactive text messaging to bring information and self-management messages to low health literacy and low-income populations (Fiscella, et al., 2020; Heitkemper et al., 2017; Williams et al., 2020). EHRs are used to identify and reach out to eligible patients, and capture baseline and outcome data. These data are combined with self-reported patient measures, as well as measures obtained from laboratory tests and self-monitoring devices such as home blood glucose monitors. Using mHealth and eHealth platforms, said Tobin, takes many of the clinical services that normally require a trip to the doctor’s office and “puts them back in the household, back under the control of the patient and their caregiver.” He suggested this approach may increase levels of health literacy and self-efficacy, which may in turn improve self-management and clinical outcomes. The second study that Tobin presented, funded by the Patient-Centered Outcomes Research Institute (PCORI), is examining the effect of adding a health coach for patients with multiple chronic conditions who receive their primary care in FQHCs that are designated patient- centered medical homes.6 This trial is set in health systems in New York and Chicago that primarily serve low-income African American and Latino patients. EHRs are used to identify patients with a Charlson Comorbidity index score of 4 or greater, and recruitment is done via outreach and introductions from the clinical staff at the FQHCs. A key aspect of this study, said Tobin, is that it brought together a number of networks and organizations, and leveraged existing long-term relationships. The involved research networks have a strong relationship with the FQHCs, clinicians, and staff because of previous long-term training and research development efforts. Those relationships have established trust between the research networks and the practices, and between the practices and the patients. Being able to leverage that trust and build on those relationships, said Tobin, enhanced the ability to capture information that is routinely collected as part of care. Finally, Tobin shared details on an implementation study funded by the Administration for Community Living in two senior centers in New York City. The study is assessing whether adapting the meals provided at these centers to be compatible with dietary approaches to stop hypertension can result in improved control of blood pressure (Challa et al., 2020).7 These types 4 eHealth, or electronic health, refers to health care services provided with the support of information and communication technology—such as computers, mobile phones, and satellite communications—for health services and information. For more information, see https://pubmed.ncbi.nlm.nih.gov/31157099 (accessed January 19, 2021). 5 mHealth, or mobile health, refers to the use of smart or portable devices for health services and information. For more information, see https://pubmed.ncbi.nlm.nih.gov/31157099 (accessed January 19, 2021). 6 For more information, see https://www.pcori.org/research-results/2018/what-effect-adding-health-coach-patient- centered-medical-homes-managing (accessed November 11, 2020). 7 For more information, see https://www.cdnetwork.org/CBN-DASH (accessed November 11, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

5-4 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN of centers provide meals to more than a quarter of a million adults, said Tobin, and the existing infrastructure provides access to older adults and opportunities to engage in clinical research. Like the second study, this study brings together networks of providers, including an academic research center, a PBRN, and a network of community-based meals and educational providers. Integrating these providers enhances the ability to recruit participants, leverages trusting relationships, and increases availability of data, said Tobin. Networks can play a significant role in reducing barriers to engaging older adults in research, observed Tobin. Networks can: • Increase access in real-world settings; • Increase heterogeneity of both patient-level and organization-level variables; • Provide adequately powered sample sizes for subgroup analyses; • Allow greater statistical power to examine heterogeneity of treatment effects; • Enhance participation through trust (staff, participants, researchers); • Capture more comprehensive, integrated longitudinal data about experiences, services, and outcomes across a broader set of community-based providers; • Be deployed both to generate new evidence and to disseminate and implement new evidence into practice that will enhance public health for these underserved populations; and • Provide an existing and well-tested infrastructure that is effective at engaging a broad range of underserved populations, including older adults. Tobin closed with a number of recommendations for how to more effectively engage older adults in clinical trials: • Increase the use of telehealth and home visits to reduce barriers to enrollment and retention; • Use a trusted organization as a “middle man” for recruitment, for example, printing outreach letters on institutional letterhead with the signature of the primary care clinician; • Leverage existing partnerships and relationships with community-based organizations that serve older adults and include clinicians and other service providers in the investigator team; • Focus on pragmatic designs in real-world settings that test both the intervention effectiveness and the implementation of the intervention; and • Develop heterogeneous populations that are large enough in number to provide adequately powered sample sizes and broaden eligibility criteria to include those with multiple comorbidities and polypharmacy. LOS ANGELES BARBERSHOP BLOOD PRESSURE STUDY Minorities are underrepresented in most clinical trials, said Ciantel Adair Blyler, clinical research pharmacist at Cedars-Sinai Medical Center. Even legislative action—for example, the PREPUBLICATION COPY: UNCORRECTED PROOFS

STRATEGIES FOR ENGAGING OLDER ADULTS 5-5 NIH Revitalization Act of 1993, Public Law 103-438–—has failed to have a lasting impact on minority recruitment for clinical trials. Underrepresentation of minorities in trials is especially troubling for diseases that disproportionally affect marginalized racial and ethnic groups, Blyler added. She discussed three barriers to minority engagement: • Approachability, such as awareness and knowledge of disease stage and its associated risks; • Acceptability, such as mistrust of medical establishment and lack of cultural competence; and • Accessibility, such as transportation, time, and financial constraints. When thoughtfully designed, community-based research initiatives are uniquely positioned to directly address these barriers, said Blyler. These initiatives traditionally take place in large, visible venues such as churches, community centers, and fairs; this visibility can increase awareness among community members and increase the approachability of research. Community-based initiatives “meet people where they are,” increasing accessibility. Community members themselves are often called on to deliver the intervention, improving acceptability for others. Blyler shared the details of the Los Angeles Barbershop Blood Pressure Study (LABBPS), a community-based initiative that was set in barbershops to address racial disparities in hypertension (Victor et al., 2018). Barbershops are an obvious venue for this type of intervention for several reasons, said Blyler. First, barbershops have a connection with medicine dating back to the Middle Ages, when barbers performed procedures such as bloodletting and tooth extractions (Pillay, 2020). Second, barbers are regarded as trusted, respected members of the Black community (Balls-Berry et al., 2015); Blyler said some study participants reported that they confide in their barber more than their religious adviser. Third, the relationship between barber and client is long-lasting, with frequent face-to-face interaction. Most men in the study visited their barber weekly or every other week. Fourth, the barbershop has a laid-back and comfortable environment that facilitates sharing information and experiences (Victor et al., 2018; Victor et al., 2019). For these reasons, there has been a history of barbershop-based health outreach and promotion in the United States since the 1980s, Blyler said (Releford et al., 2010). LABBPS was a community-based, pharmacist-led hypertension trial with the aim of developing an “effective and convenient intervention for Black men which links health promotion by barbers to drug therapy by pharmacists.” Black men have the highest rates of hypertension-related disability and death in the United States, said Blyler (Benjamin et al., 2017). The prevalence of hypertension is around 55 percent among Blacks, and Black men have less physician interaction than Black women, and thus lower rates of treatment and control. The trial identified non-Hispanic Black male barbershop patrons with uncontrolled hypertension, ages 35 to 79, and randomized them into an intervention group and a control group. Recruitment took place over the course of about 2 years; research staff spent between 4 and 6 weeks in each barbershop and offered free blood pressure screening to all patrons, regardless of eligibility for the study. Approximately 4,500 patrons were screened in 50 barbershops, and 310 were enrolled. At 6 months, cohort retention was 95 percent, and at 12 months, 90 percent were still participating (Victor et al., 2019). The mean age of participants was 8 For more information on the NIH Revitalization Act of 1993, see https://www.ncbi.nlm.nih.gov/books/NBK236531 (accessed December 15, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

5-6 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN 54 years old, and 18 percent of the cohort was 65 years or older (Victor et al., 2018). Blyler noted that the average barbershop in the study was in business for around 18 years, and that the average man in the study went to the same barber every 2 weeks for about a decade. This “really drives home the point” that the barbershop is an excellent place for this type of intervention. In response to a participant question about whether barbershop-based research can reach the oldest cohort of older adults, Blyler said that although LABBPS cut off recruitment at age 79, she believed that men over this age were still frequent visitors of barbershops. She noted that many men who frequent the barbershop are not there for a haircut, but rather to play dominos, watch television, and play cards. It is a common place for socializing, particularly for older adults, she said. In the intervention group, the pharmacists had monthly check-ins with participants at the barbershop, where they checked blood pressure, monitored electrolytes, and prescribed medication under a collaborative practice agreement with the participant’s primary care physician. The primary endpoint of the trial was changes to systolic blood pressure; efficacy was measured at 6 months, and sustainability was evaluated at 12 months. In the end, intervention participants saw a 21 mm greater fall in systolic blood pressure, compared with the control group (Victor et al., 2018, 2019). Blyler shared the personal success stories of two participants (see Box 5-1). It was an “enormously successful” trial in terms of both retention and outcomes, Blyler said. Blyler offered some “lessons learned” from LABBPS. First, barbershops can be convenient and effective hubs for the recruitment/retainment of Black men in clinical research. A broader lesson, however, is that community-based interventions that are designed to directly address common barriers to engagement can increase minority participation. LABBPS was an accessible model that “met people where they were,” said Blyler. For older adults, who are often less mobile, this may be particularly important. The endorsement and participation of the barbers, trusted members of the Black community, helped to overcome issues of mistrust of the medical community. In addition, the fact that patrons came to the barbershop very frequently helped facilitate follow-up. Finally, Blyler said that tailoring interventions to specific underrepresented groups can improve engagement in clinical research. LABBPS did not just happen to enroll Black men; rather, it was tailor-made for Black men. Blyler encouraged workshop participants to consider venues and approaches for engaging other groups—such as Black women and Hispanic men—in research. BOX 5-1 Personal Stories from the Los Angeles Barbershop Blood Pressure Study “I am 72 years old. I’ve been a customer at Long Beach Finest for over 15 years. I thought I had my blood pressure under control because I’ve been taking my medication faithfully for a long time now. I was surprised to find out it was still high when I got it checked at the shop. My barber encouraged me to work with the pharmacist to figure out the right regimen for me. I was only taking one medication when we started. Now I take two medications and my pressure is right where I want it to be. I had a stroke 10 years ago so I’m going to do whatever it takes to make sure it doesn’t happen again.” “I’m 77 and I’ve been coming to Gaines barbershop for 3 years. I found out I had high blood pressure 4 years ago. At the time I really didn’t feel anything and had never had any trouble from it. They just told me I had high blood pressure so I accepted it. My doctor put me PREPUBLICATION COPY: UNCORRECTED PROOFS

STRATEGIES FOR ENGAGING OLDER ADULTS 5-7 on blood pressure medication, but I eventually stopped taking it. I thought everything was fine until one day I got my blood pressure checked at the barbershop and it was running high again. I learned that good pressure is important if you want to live a long life and that people (like me) often don’t know they have it because they don’t feel differently. Now I come to the shop regularly to get my hair cut, my blood pressure checked and under control.” SOURCE: As presented by Ciantel Blyler, August 6, 2020. A PATIENT PERSPECTIVE “There is more than one way to be 65-plus,” said Susan Strong, director of patient engagement for Heart Valve Voice US. Some older adults are working, while some are retired; some are fit, others experience failing health; and some have social support and others are isolated. They can have different skin colors, economic status, and native languages. Clinical trials should aim to include as many of these types of older adults as possible, she said. Strong gave a brief summary of her own history as a patient. In 1983, at age 17, she was diagnosed with Hodgkin’s lymphoma. In 2014, she underwent transcatheter aortic valve replacement due to severe aortic stenosis, and in 2017, she was diagnosed with HER2-positive, invasive breast cancer. Today she works as an educator and an advocate. In addition to her work at Heart Valve Voice U.S., she serves as an American Heart Association Heart Valve Ambassador, a PCORI Ambassador, and a research advocate, and she provides patient support through her own organization, Strong Heart Now.9 Strong shared the stories of two older men who also underwent transcatheter aortic valve replacement (TAVR) as part of clinical research. Jim, 65, bounced back after the minimally invasive procedure and sat in his hospital bed asking when he could get back to the gym. Simon, 84, had noticed he was having difficulty chopping wood. After researching treatment options, he found a clinical trial on TAVR on his own, and was back to chopping wood a few months after the procedure. For patients to have positive experiences with clinical research like Jim and Simon, said Strong, studies must be “patient-centric.” A patient-centric study puts patients at the heart of the study, measures what matters to patients, communicates clearly, aims for inclusivity and cultural humility, and does not put undue burdens on patients (Sharma, 2015). Involving patient advocates from the beginning of trial design can make this happen, said Strong. From the beginning of trial design, investigators should be talking to patients, asking them what matters, and incorporating their feedback. These steps “can end up saving a sponsor hundreds of thousands of dollars by avoiding a costly protocol amendment,” she said. For example, a colleague of Strong’s was working on a clinical trial on medication for hot flashes in older women. The sponsor had developed the screening design, which involved conducting many tests in one clinic visit, including an invasive endometrial biopsy. Patient advocates looked at this design and let the sponsor know that this was “too big of an ask for patients” because it was possible for some potential participants to undergo all of this testing and then be found ineligible 9 Available at https://www.strongheartnow.com (accessed October 30, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

5-8 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN for the trial. The protocol was redesigned based on this feedback, which saved the sponsor money and saved potential participants from unnecessary invasive testing, Strong explained. Finding patient advocates to help with trial design can be done a number of ways, said Strong. The PCORI Ambassador Program10 brings a variety of stakeholders—including patients, caregivers, and researchers—together to advance patient-centered research. Savvy Cooperative11 is a patient-owned co-op that allows patients to share their experiences, and others to seek out patient insights. WEGO Health12 is a network that connects more than 100,000 patient advocates with health care companies to incorporate the patient experience. Disease-specific patient organizations, community groups, and social media pages with patients and advocates can also provide insight. A CAREGIVER PERSPECTIVE Caregivers can play a critical role in engaging and communicating with prospective research participants, said Laurel Pracht, a research patient advocate and caregiver. While the role of a caregiver varies depending on the abilities of the patient, caregivers may assist patients with understanding information, making decisions, transportation, and logistics of participating in a trial. Researchers need to engage with these caregivers and communicate more clearly with them, she said. For example, researchers could develop shared decision-making materials for patient and caregiver, written in plain language, to share information about potential trials. Caregivers need more information about the history of clinical trials, and the advantages and disadvantages of participating. Pracht noted that when a patient talks with a provider or researcher about a clinical trial, the caregiver is a “second set of ears” and is the one to answer the patient’s questions after they leave the office. Caregiver-specific material would be useful to help answer questions of both caregivers and patients. Questions that patients frequently ask about clinical trials include • What is this research and why should I participate? • Will this benefit me and what are the costs to participate? • Does this mean there is nothing else to treat my condition? • I am 87 years old with a caregiver and limited resources; are study expenses covered? • I want to discuss this with my family and caregiver before deciding to participate; is that possible? To answer these types of questions, said Pracht, providers could make available a one- page plain language13 brochure about clinical trials (Warde et al., 2018). A “community champion” could be used to provide information about clinical trials in a community setting, and answer patient and caregiver questions. There is a need for more back-and-forth among providers, researchers, patients, and caregivers, and time should be made for asking questions and having a robust discussion. Caregivers cannot help patients with the decision to enroll in a 10 For more information on the PCORI Ambassador Program, see https://www.pcori.org/engagement/engage- us/pcori-ambassador-program (accessed December 15, 2020). 11 For more information on Savvy Cooperative, see https://www.savvy.coop (accessed December 15, 2020). 12 For more information on WEGO Health, see https://www.wegohealth.com (accessed December 15, 2020). 13 For more information on Plain Language Materials & Resources, see https://www.cdc.gov/healthliteracy/developmaterials/plainlanguage.html (accessed November 11, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

STRATEGIES FOR ENGAGING OLDER ADULTS 5-9 trial if they do not have the necessary information themselves, she said. When older adults are not included in trials, the trials do not represent a real-world population, said Pracht. To improve enrollment of older adults, engaging caregivers in the process is critical. A COMMUNITY PROVIDER PERSPECTIVE Steven K. Rothschild, professor and chair of the Department of Family Medicine at the Rush University Medical Center, wore “three hats” for his presentation: behavioral investigator for several clinical trials, an administrator of a primary care service line, and a primary care physician still in practice. Rothschild began by reflecting on the other presentations and drawing out two themes that resonated with his experiences. First, it is critical for investigators to build relationships and plan for engagement at the beginning of the study. Oftentimes, he said, a trial protocol is made based on the science, and recruitment is an afterthought. Second, he argued that the target population for a study should be a “primary driver” and not an afterthought. He pointed to a nearly 30-year-old paper (Dresser, 1992) that called attention to the fact that young white males are the default population for research studies, and noted that this is still an issue today. Widening the scope of participants in clinical trials is essential, he said, for providers to know if a new intervention will be beneficial for an older patient with comorbidities and/or polypharmacy. These two themes—building relationships and designing with a particular population in mind—were evident in the design of the Neighborhood Family Practice of Pilsen.14 Pilsen is a medically underserved LatinX community in Chicago. Thirty years ago, Rothschild and others spent nearly a year “walking the streets” interviewing community members, school principals, medical providers, and others, to understand the community and the barriers to medical care. Surveys, focus groups, community meetings, and public health data were used to complete the picture. The end result was a practice that was built entirely with the community in mind, including the lighting, colors, graphics, art, community space, and staff. Although the practice sought to be accessible to older adults with features such as easy physical access and materials in large-font Spanish, older adults in the community were not fully using the practice. Rothschild collaborated with other physicians in the community, reviewed the literature, and interviewed patients, and concluded that this population relied heavily on peer relationships. Consequently, the practice recruited community health workers (CHWs) from the community to help reach out to older adults and connect them to care. Now, the practice has robust programming for older adults, including social determinants screening, physical activity classes, caregiver support, extended hours, and support for telehealth access. The practice has implemented the 4M Model for an age-friendly health system (Fulmer et al., 2018). The model focuses on four “Ms”: knowing what matters to patients; using medications appropriately; understanding a patient’s mentation, including cognition, depression, and anxiety; and facilitating a patient’s mobility goals. Ultimately, Rothschild said, the practice is about relationships. CHWs are essential to building and maintaining strong relationships. He characterized CHWs as “trusted, knowledgeable frontline health personnel who typically come from communities that they serve. They can bridge cultural and linguistic barriers, expand access to coverage and care, and improve health outcomes.” Both CHWs and primary care clinicians have long-term relationships with the 14 For more information, see https://www.johnahartford.org/ar2007/Model4_virtual_integrated_practice_p5.html (accessed November 11, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

5-10 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN communities they serve, they have built trust over the years, and they can recognize and leverage the assets that exist within the community. Rothschild noted that these relationships are critical to practice, but also to research. He urged researchers to “build relationships with the people who have relationships.” That is, if researchers first build relationships with CHWs, clinicians, and other providers in the community, they will be in a position to engage with the community and to leverage the trust and communication that already exists. Rothschild had several suggestions for researchers hoping to successfully build relationships with those already working in a community. First, he said, “shut up and listen.” This is not easy to do, but it is important to hear things—especially “things you don’t always want to hear.” For example, when Rothschild was originally setting up his clinic in Pilsen, community members “saved [him] from the mistake” of putting the practice in the location that he, as an outsider, thought was best. Second, he encouraged researchers and providers to continuously collaborate to focus on the participant experience. It is critical to understand what matters to the community, and what outcomes they care about, he said. Third, researchers need to understand that providers serve their communities first, not the needs of the study. Finally, said Rothschild, the goal should not just be to get recruitment done for one study. The goal should be to build longstanding relationships with providers and with the community, so that researchers can continue to come back year after year to work together on issues that matter to the community. DISCUSSION Noting that Blyler had discussed the “3 As” of community-based research initiatives, and Rothschild presented the “4 Ms” of an age-friendly health system, Collyar offered her own idea of the “4 Cs” for what researchers need to give to people and providers: “Clear Communication of Content in Context.” After this insight, the panelists answered questions from workshop participants. Using EHRs for Recruitment A workshop participant asked panelists for clarification about how outreach and recruitment for trials are conducted using EHRs. Tobin replied that EHRs can be used to identify eligible patients based on the inclusion and exclusion criteria. Eligible patients can then be contacted through online patient portals, although Tobin noted that this strategy may not be as effective in lower income or older populations. He emphasized, however, that the most “powerful ingredient” of the PBRN research model is trust. Patients trust their clinicians and the practice where they receive care, and the practices have trusting relationships with the PBRNs and researchers. Whether the EHR is used solely for identification, or also for recruitment, this “trust by proxy” enables a “warm handoff” from provider to researcher. Communication with Patients About Research A participant asked how patients in a clinical practice are initially approached about potentially being involved in research. She wondered if it might be useful to discuss the idea of clinical research when a patient initially joins a practice. Rothschild responded that his practice seeks to build a culture where research is part of what they do to improve the care of their PREPUBLICATION COPY: UNCORRECTED PROOFS

STRATEGIES FOR ENGAGING OLDER ADULTS 5-11 patients, and they communicate this culture to their patients. As part of this communication, they ask patients for permission to access their EHR to identify eligibility for any future trials that may be appropriate. He noted that in a large health system, it could make sense to gather information on whether a patient would be potentially interested in clinical research to build a registry of sorts. Pracht added that before even getting to a conversation with an individual patient, it is critical to have community education to raise awareness about clinical trials. Pracht suggested that this could be done through peer education in the community of older adults, and could include simple written materials about the basics of clinical research. Potential Conflict of Interest A participant asked about the potential for conflict of interest between the role of physician and the role of research advocate. She noted that there is a risk of patients interpreting research as part of clinical care, or of enrolling in a study out of a desire to please their physicians. Rothschild began by noting that this is a “critical ethical issue,” and that physicians should act as facilitators for research but not try to “sell the study.” All studies should begin with a place of equipoise, he said, meaning that “if we knew the answer to this question we shouldn’t be doing the trial in the first place.” This should be communicated to the patient and it should be made clear that the trial may or may not be helpful to the individual patient. However, Rothschild also conveys to patients the importance of research for answering questions—the treatment they are receiving today is due to “somebody else in a clinical trial a few years back.” Tobin added that patients participating in research is particularly important for comparative effectiveness studies. While the effectiveness may be similar between the two treatments being compared, there may be important differences that can help patients choose between them, he said. Tobin said that shared decision making is critical to avoid any potential conflict of interest; clinicians and patients should have open, honest conversation about benefits and risks of participating. Collyar said that there is a difference between a clinician communicating the benefits of research in general and advocating for participation in a specific study. Pracht agreed, and reiterated her earlier call for community education about clinical trials, and the need to involve caregivers in these discussions. Next Step Opportunities Collyar asked panelists to identify some concrete steps that can be taken to move forward with increasing older adult participation in research. Pracht responded that COVID-19 has highlighted the value of e-visits and the need for support for patients and caregivers to use this option (Monaghesh and Hajizadeh, 2020).15 Furthermore, said Rothschild, this new attention on telehealth “has lowered the burden of entry” for research. It has demonstrated what types of care can be provided at home, and opened doors to conducting research using these technologies. However, he said, we must remain aware of the electronic divide and how relying on technology may leave some populations behind. Another important step forward, said Rothschild, is focusing on outcomes that matter to patients. Studies often measure outcomes such as blood pressure or A1C levels, but older adults may care more about staying in their homes, playing with their grandchildren, or avoiding hip fractures. 15 For more information on using telehealth to expand access to essential health services during the COVID-19 pandemic, see https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html (accessed November 11, 2020). PREPUBLICATION COPY: UNCORRECTED PROOFS

5-12 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN Along these lines, said Tobin, there is a need for health researchers and health providers to view patients as whole persons, with a variety of health and non-health experiences. Many of the factors that affect health—such as education, housing, food insecurity, and homelessness— fall outside the purview of health care, but are likely the primary concerns of individuals. Health researchers should consider these issues not only as risk factors but also as intervention targets, he said. PREPUBLICATION COPY: UNCORRECTED PROOFS

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There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population.

On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.

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