Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.

Importance: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN's challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support. Observations: The TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN's impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic. Conclusions and Relevance: The TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.

The RIC Recruitment & Retention Materials Toolkit - a resource for developing community-informed study materials.

Clinical trials face many challenges with meeting projected enrollment and retention goals. A study's recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit.

Research Bronchoscopies in Critically Ill Research Participants: An Official American Thoracic Society Workshop Report.

Bronchoscopy for research purposes is a valuable tool to understand lung-specific biology in human participants. Despite published reports and active research protocols using this procedure in critically ill patients, no recent document encapsulates the important safety considerations and downstream applications of this procedure in this setting. The objectives were to identify safe practices for patient selection and protection of hospital staff, provide recommendations for sample procurement to standardize studies, and give guidance on sample preparation for novel research technologies. Seventeen international experts in the management of critically ill patients, bronchoscopy in clinical and research settings, and experience in patient-oriented clinical or translational research convened for a workshop. Review of relevant literature, expert presentations, and discussion generated the findings presented herein. The committee concludes that research bronchoscopy with bronchoalveolar lavage in critically ill patients on mechanical ventilation is valuable and safe in appropriately selected patients. This report includes recommendations on standardization of this procedure and prioritizes the reporting of sample management to produce more reproducible results between laboratories. This document serves as a resource to the community of researchers who endeavor to include bronchoscopy as part of their research protocols and highlights key considerations for the inclusion and safety of research participants.

Differences in Caregiving Intensity Among Distinct Sociodemographic Subgroups of Informal Caregivers: Joint Effects of Race/Ethnicity, Gender, and Employment.

More than 40 million informal caregivers in the United States provide essential care to older adults. Recent research has identified substantial differences in caregiving intensity by gender, race/ethnicity, and employment status. Using intersectionality theory, the current study extends the existing literature by exploring the relationship between caregiving intensity and the unique experiences of individuals with different intersections of gender, ethnicity, and employment. We used generalized linear models to estimate multivariate associations between caregiving intensity assessed by three different measures (hours of caregiving per month and number of activities of daily living and instrumental activities of daily living [IADLs] assisted with) and the three sociodemographic factors of interest (race/ethnicity, gender, and employment status). Unemployed White males provided, on average, 77 fewer hours per month of care (p < 0.001) and assisted with 1.9 fewer IADLs (p = 0.004) than unemployed Black males. Employed White females provided 42.6 fewer hours per month of care (p = 0.002) than employed Black females and 49.2 fewer hours per month (p = 0.036) than employed females of other races. Study findings suggest that examining racial/ethnic or gender differences in isolation does not provide a true picture of differences in caregiving intensity. There is a critical need to understand how the intersections of race/ethnicity, gender, employment, and other sociodemographic factors shape the experiences of caregiver subgroups. [Journal of Gerontological Nursing, 47(7), 23-32.].

Engaging smokers in research: Utility of Facebook in facilitating recruitment to a smoking cessation study.

INTRODUCTION: Social media, including Facebook outreach, is increasingly being used as a participant recruitment tool, and may be particularly useful in tobacco and smoking cessation studies. The Recruitment Innovation Center at Vanderbilt University Medical Center partnered with Project LUNA, a smoking cessation study, to conduct a pilot social media campaign aimed at increasing study recruitment. METHODS: Two posts encouraging study participation were developed and promoted on Facebook to users with an interest in smoking-related topics, with a link to a study-specific webpage. Facebook and website analytics were collected, including impressions, clicks, click-through rates, website traffic, and clicks to the study screening form. Study screening and enrollment data were also collected. RESULTS: The Facebook campaign ran in June 2019 in the greater Houston area. In total, the Facebook posts logged 1,179,844 impressions, 6490 clicks, and an overall click-through rate of 0.55%. There were no differences in response to the two different promotional posts. Approximately 3812 unique individuals visited an intermediary study page, with 473 expressing interest in the study. Forty-three potential participants contacted the study team, resulting in study enrollment and randomization of 23 participants, with an estimated cost per enrolled participant of $441. CONCLUSIONS: The social media campaign was successful at increasing outreach and interest in the LUNA study. However, the price-per-participant enrolled was higher than in comparable tobacco cessation studies. These results and lessons learned may be beneficial to others considering social media as a recruitment method for their clinical research trial.

Opening doors to clinical trial participation among Hispanics: Lessons learned from the Spanish translation of ResearchMatch.

INTRODUCTION: Clinical trial participation among US Hispanics remains low, despite a significant effort by research institutions nationwide. ResearchMatch, a national online platform, has matched 113,372 individuals interested in participating in research with studies conducted by 8778 researchers. To increase accessibility to Spanish speakers, we translated the ResearchMatch platform into Spanish by implementing tenets of health literacy and respecting linguistic and cultural diversity across the US Hispanic population. We describe this multiphase process, preliminary results, and lessons learned. METHODS: Translation of the ResearchMatch site consisted of several activities including: (1) improving the English language site's reading level, removing jargon, and using plain language; (2) obtaining a professional Spanish translation of the site and incorporating iterative revisions by a panel of bilingual community members from diverse Hispanic backgrounds; (3) technical development and launch; and (4) initial promotion. RESULTS: The Spanish language version was launched in August 2018, after 11 months of development. Community input improved the initial translation, and early registration and use by researchers demonstrate the utility of Spanish ResearchMatch in engaging Hispanics. Over 12,500 volunteers in ResearchMatch self-identify as Hispanic (8.5%). From August 2018 to March 2020, 162 volunteers registered through the Spanish language version of ResearchMatch, and over 500 new and existing volunteers have registered a preference to receive messages about studies in Spanish. CONCLUSION: By applying the principles of health literacy and cultural competence, we developed a Spanish language translation of ResearchMatch. Our multiphase approach to translation included key principles of community engagement that should prove informative to other multilingual web-based platforms.

Differences within Differences: Gender Inequalities in Caregiving Intensity Vary by Race and Ethnicity in Informal Caregivers.

Among the 50+ million informal caregivers in the US, substantial gender, racial/ethnic, and socioeconomic disparities in caregiving intensity are well-documented. However, those disparities may be more nuanced: gender disparities in caregiving intensity may vary by race/ethnicity (White, Black, and Hispanic) and socioeconomic status (SES). We used data from the 2011 National Study of Caregiving and applied generalized linear models to estimate associations between three measures of caregiver intensity (ADLs, IADLs, and hours caregiving/month) and the three sociodemographic factors with their interaction terms. Black female caregivers provided significantly higher levels of care than White females and males for both IADL caregiving and hours/month spent caregiving. Black caregivers spent an average of 28.5 more hours/month (95%CI 1.7-45.2) caregiving than White caregivers. These findings highlight the need to understand the complex disparities within population subgroups and how intersections between gender, race/ethnicity, and SES can be used to develop effective policies to reduce disparities and improve caregiver quality-of-life.

Sociodemographic Disparities in Adult Child Informal Caregiving Intensity in the United States: Results from the New National Study of Caregiving.

The objective of the current study was to assess socioeconomic and demographic disparities in caregiving intensity among informal caregivers. Using a randomized, nationally representative sample of 1,014 adult child informal caregivers from Medicare enrollment databases, the associations between informal caregiving intensity and age, race/ethnicity, and income were examined using binary and ordinal logistic regression. Caregiving intensity varied by demographics. Activities of daily living (ADL) caregiving was highest among Black, non-Hispanic caregivers. Instrumental ADL caregiving and number of hours spent caregiving was highest in female and non-White caregivers. Although the overall association between caregiving intensity and income was not significant, when stratified by race/ethnicity, this association was positive for White caregivers and negative for non-White caregivers. Health care providers frequently interact with informal caregivers and should be aware of trends in caregiving and the needs and supports available to ameliorate caregiver burden. To protect caregivers, policies and programs should be designed to promote well-being and mitigate the potential harms of caregiving to health. [Journal of Gerontological Nursing, 44(9), 15-20.].

Socioeconomic and demographic factors modify observed relationship between caregiving intensity and three dimensions of quality of life in informal adult children caregivers.

BACKGROUND: The relationship between informal caregiving intensity and caregiver health is well-established, though research suggests this may vary by caregiver demographics. The aim of this exploratory study is to assess the association between caregiving intensity and three dimensions of quality of life outcomes, and determine how caregiver sociodemographics change the nature of this relationship among informal adult children caregivers. METHODS: Using the 2011 National Study of Caregiving, associations between caregiving intensity and quality of life were examined in caregivers providing care to an aging parent (n = 1014). Logistic regression was used to model caregiver quality of life on caregiving intensity using an ordinal composite measure of caregiving activities, including Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL), hours per month, and length of caregiving, stratified by race/ethnicity, gender, age, and family income. Odds ratios and corresponding 95% confidence intervals were calculated. RESULTS: Associations between caregiving intensity and quality of life varied substantially by race/ethnicity, gender, age, and annual family income. White caregivers were significantly more likely to experience negative emotional burden when providing high intensity care (ADL: 1.92, Hours: 3.23). Black caregivers were more likely to experience positive emotions of caregiving (ADL: 2.68, Hours: 2.60) as well as younger caregivers (Hours: 8.49). Older caregivers were more likely to experience social burden when providing high ADL, IADL, and monthly hours of care. CONCLUSIONS: These findings demonstrate the complex and multi-dimensional nature of caregiving, and emphasize the need to develop approaches that are tailored to the specific health needs of subpopulations of informal caregivers.

What Aspects of Rural Life Contribute to Rural-Urban Health Disparities in Older Adults? Evidence From a National Survey.

PURPOSE: Rural-urban health disparities are well-documented and particularly problematic for older adults. However, determining which specific aspects of rural or urban living initiate these disparities remains unclear. The purpose of this study was to assess associations between place-based characteristics of rural-urban status and health among adults age 65+. METHODS: Data from the 2012 Behavioral Risk Factor Surveillance System were geographically linked to place-based characteristics from the American Community Survey. Self-reported health (SRH), obesity, and health checkup within the last year were modeled against rural-urban status (distance to nearest metropolitan area, population size, population density, percent urban, Urban Influence Codes [UIC], Rural-Urban Continuum Codes [RUCC], and Rural-Urban Commuting Area [RUCA]) using generalized linear models, accounting for covariates and complex sampling, overall, and stratified by area-level income. FINDINGS: In general, increasing urbanicity was associated with a reduction in negative SRH for all 7 measures of rural-urban status. For low-income counties, this association held for all measures and characteristics of rural-urban status except population density. However, for high-income counties, the association was reversed-respondents living in areas of increasing urbanicity were more likely to report negative SRH for 4 of the 7 measures (RUCC, UIC, RUCA, and percent urban). Findings were mixed for the outcome of obesity, where rural areas had higher levels, except in low-income counties, where the association between rurality and obesity was reversed (OR 1.033, 95%CI: 1.002-1.064). CONCLUSION: These results suggest that rural-urban status is both a continuum and multidimensional. Distinct elements of rural-urban status may influence health in nuanced ways that require additional exploration in future studies.

Socioeconomic and Demographic Disparities in Caregiving Intensity and Quality of Life in Informal Caregivers: A First Look at the National Study of Caregiving.

Informal caregiving is an integral component of the health care system, saving the national economy more than $522 billion annually. The current study examined how the association between caregiving intensity and caregiver quality of life varies by sociodemographic factors through a secondary analysis of the National Study of Caregiving. Generalized linear models assessed the associations among four aspects of caregiving intensity, three aspects of caregiver quality of life, and key sociodemographic factors. Compared to White individuals, Black individuals had higher levels of overall caregiving intensity (ß = 0.293, 95% confidence interval [CI] [0.140, 0.447]), number of instrumental activities of daily living performed (ß = 0.060, 95% CI [0.030, 0.090]), and hours spent caregiving per month (ß = 0.025, 95% CI [0.002, 0.049]), yet experienced significantly fewer negative impacts on quality of life. Understanding how informal caregiving affects caregiver quality of life is critical to inform public health policies and programs designed to support caregivers and protect this critical component of the U.S. health care system. [Journal of Gerontological Nursing, 43(6), 17-24.].

A Patient and Provider Research Agenda on Diabetes and Hypertension Management.

INTRODUCTION: A demonstration project in Richmond, Virginia involved patients and other stakeholders in the creation of a research agenda on dietary and behavioral management of diabetes and hypertension. Given the impact of these diseases on morbidity and mortality, considerable research has been directed at the challenges patients face in chronic disease management. The continuing need to understand disparities and find evidence-based interventions to improve outcomes has been fruitful, but disparities and unmet needs persist. METHODS: The Stakeholder Engagement in Question Development (SEED) method is a stakeholder engagement methodology that combines engagement with a review of available evidence to generate research questions that address current research gaps and are important to patients and other stakeholders. Using the SEED method, patients and other stakeholders participated in research question development through a combination of collaborative, participatory, and consultative engagement. Steps in the process included: (1) identifying the topic and recruiting participants; (2) conducting focus groups and interviews; (3) developing conceptual models; (4) developing research questions; and (5) prioritizing research questions. RESULTS: Stakeholders were involved in the SEED process from February to August 2015. Eighteen questions were prioritized for inclusion in the research agenda, covering diverse domains, from healthcare provision to social and environmental factors. Data analysis took place September to May 2016. During this time, researchers conducted a literature review to target research gaps. CONCLUSIONS: The stakeholder-prioritized, novel research questions developed through the SEED process can directly inform future research and guide the development of evidence that translates more directly to clinical practice.

A Closer Look at Rural-Urban Health Disparities: Associations Between Obesity and Rurality Vary by Geospatial and Sociodemographic Factors.

BACKGROUND: Obesity affects over one-third of older adults in the United States. Both aging and obesity contribute to an increased risk for chronic disease, early mortality, and additional health care utilization. Obesity rates are higher in rural areas than in urban areas, although findings are mixed. The objectives of this study are to assess potential nonlinearity in the association between rurality and obesity, and to evaluate the potential for socioeconomic status and geographic area to moderate the associations between rurality and obesity. METHODS: Using a representative sample of adults aged 65 and above from the Behavioral Risk Factor Surveillance System, obesity (BMI ≥ 30 kg/m2 ) was modeled against the primary exposure of rural-urban status, as measured by the Index of Relative Rurality. Binary logistic regression models were used to estimate the odds of obesity by rurality both as a continuous variable and by decile of rurality. Models were then stratified by per-capita income and state to assess potential moderation by these factors. RESULTS: The prevalence of obesity in older adults was highest in intermediate rurality areas (OR in rurality decile #5 1.134, 95% CI: 1.086-1.184) and lowest in the most rural and most urban areas. Obesity was highest in low- and middle-income areas, regardless of rural-urban status. In high-income areas, obesity among older adults was highest in areas of intermediate rurality and lowest in the most rural areas (OR 0.726, 95% CI: 0.606-0.870) and more urban areas, showing a J-shaped association. There were substantial differences in the associations between rurality and obesity in older adults among states. CONCLUSION: Associations between rurality and obesity varied by degree of rurality, socioeconomic status, and geography. Therefore, traditional "one-size-fits-all" approaches to reducing rural-urban health disparities in older adults may be more effective if tailored to the area-specific rural-urban gradients in health.

Challenges and barriers to health care and overall health in older residents of Alaska: evidence from a national survey.

BACKGROUND: From 1970 to 2010, the Alaskan population increased from 302,583 to 698,473. During that time, the growth rate of Alaskan seniors (65+) was 4 times higher than their national counterparts. Ageing in Alaska requires confronting unique environmental, sociodemographic and infrastructural challenges, including an extreme climate, geographical isolation and less developed health care infrastructure compared to the continental US. OBJECTIVE: The objective of this analysis is to compare the health needs of Alaskan seniors to those in the continental US. DESIGN: We abstracted 315,161 records of individuals age 65+ from the 2013 and 2014 Behavioral Risk Factor Surveillance System, of which 1,852 were residents of Alaska. To compare residents of Alaska to residents of the 48 contiguous states we used generalized linear models which allowed us to adjust for demographic differences and survey weighting procedures. We examined 3 primary outcomes - general health status, health care coverage status and length of time since last routine check-up. RESULTS: Alaskan seniors were 59% less likely to have had a routine check-up in the past year and 12% less likely to report excellent health status than comparable seniors in the contiguous US. CONCLUSIONS: Given the growth rate of Alaskan seniors and inherent health care challenges this vulnerable population faces, future research should examine the specific pathways through which these disparities occur and inform policies to ensure that all US seniors, regardless of geographical location, have access to high-quality health services.