Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

BACKGROUND: Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. METHODS: A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project's duration. RESULTS: The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. CONCLUSIONS: Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Clinical research should involve patient and community stakeholder perspectives to make sure the study addresses questions important to the studied population. One way to do this is by creating a group of stakeholders who can advise on the conduct of a study. We assembled a Study Advisory Committee (SAC) for the Emergency Medicine Palliative Care Access (EMPallA) trial. The purpose of this clinical trial is to compare the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. This paper describes how the SACs involvement translated into direct impacts on the EMPallA trial. The trial research team held regular meetings with the SAC throughout the trial process. Their involvement led to many significant changes in the trial, such as  expanding recruitment inclusion criteria (Spanish-speaking patients), and including survey instruments to measure lonelines and caregiver burden. The SAC also devised strategies to overcome patient and caregiver recruitment and retention challenges, including the creation of patient-friendly materials and training for research coordinators. This study provides a successful example of how actively engaging patient and community stakeholders, through committee engagement, can promote patient priorities in all phases of a trial while facilitating patient recruitment and retention.

What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research.

Study advisory committees (SACs) provide critical value to clinical trials by providing unique perspectives that pull from personal and professional experiences related to the trial's healthcare topic. The Emergency Medicine Palliative Care Access (EMPallA) study had the privilege of convening a 16-person SAC from the project's inception to completion. The study team wanted to understand the impact this project had on the SAC members. In this narrative, we use reflective dialogue to share SAC members' lived experiences and the impact the EMPallA study has had on members both personally and professionally. We detail the (1) benefits SAC members, specifically patients, and caregivers, have had through working on this project. (2) The importance of recruiting diverse SAC members with different lived experiences and leveraging their feedback in clinical research. (3) Value of community capacity building to ensure the common vision of the clinical trial is promoted.

Using Community-Partnered Participatory Research to Value the "Community Lens" and Promote Equity in Community-Academic Partnerships.

Background: Community input is crucial for identifying characteristics necessary for equitable, sustainable community-academic partnerships (CAPs). A November 2021 conference, honoring the late Dr. Loretta Jones and the Community-Partnered Participatory Research (CPPR) model, was held to gather input for designing a learning institute for community members as co-equal partners with academics in research, program, and policy initiatives. This created an opportunity to explore attendees' perspectives on challenges and opportunities related to CAPs with special focus on promoting equity. Methods: Institutional Review Board approval was obtained. Five break-out discussion group sessions were conducted in November 2021 co-facilitated by both an academic and a community leader. After consent, discussions were recorded and transcribed. An iterative procedure for collaborative-group-thematic-analysis was developed. The six-phase process included rigorous coding, discussion, comparison of data with data, and development and refinement of themes and subthemes. Results: A total of 38 racial-ethnically diverse participants volunteered from the total conference audience of 62 community and academic partners from various sectors including community-based organizations, health care, social services, academia, or policy within Los Angeles County. Analysis led to development of three themes: Being cautious with the extractive tendency of academia and the need for anti-racism within CAPs; Leveraging community power to resist the top-down lens of academia; and bridging two worlds through an equitably structured table. Discussion: Participants described optimism about the future uses of CPPR to enhance CAPs, and the need to address barriers to equitable partnerships owing to unequal social contexts and entrenched power dynamics. Implications include addressing racism, evaluating financial equity in partnerships to promote accountability, and mentoring community leaders to promote equity. Conclusion: Use of a "community lens" for developing sustainable, equitable CAPs is crucial to promote accountability and to responsibly implement authentic CPPR.

Parental Education and Adolescents' Asthma: The Role of Ethnicity.

While high parental education is associated with better health, this association may be weaker for ethnic minority than for ethnic majority families. It is unknown whether the association between parental education and adolescents' asthma also varies by ethnicity. AIM: To study the association between parental education and adolescents' asthma overall and by ethnicity. METHODS: The current study used data from the Population Assessment of Tobacco and Health (PATH)-Adolescents study. All participants were 12 to 17-year-old non-smokers (n = 8652). The outcome of interest was adolescents' asthma. The predictor of interest was baseline parental education, the covariates were age, sex, and number of parents present at baseline, and the moderator was ethnicity. RESULTS: According to logistic regression analyses, higher parental education was predictive of adolescents' asthma; however, this association was weaker for Latino than non-Latino adolescents (OR 1.771; CI 1.282-2.446). We did not find a significant difference in the effect of parental education on asthma of White and African American adolescents. Our stratified models also showed that higher parental education was associated with lower asthma for non-Latino but not for Latino adolescents. CONCLUSION: The effect of high parental education on adolescents' asthma prevalence differs between Latino and non-Latino families, with Latino families showing weaker protective effects of parental education on adolescents' asthma. Future research should test the role of exposure to environmental pollutants, neighborhood quality, and prevalence of smoking in social network members as well as other contextual factors at home, in school, and in the neighborhood that may increase prevalence of asthma in Latino adolescents regardless of their parental education. Given that these potential causes are multi-level, potential causes of such disparities should be tested in future multi-level research.

Association between School Achievement and Tobacco Susceptibility among US Adolescents: Ethnic Differences.

BACKGROUND: Although risky behaviors such as educational problems and tobacco use tend to co-occur, these associations may vary across diverse ethnic groups, in part because ethnic minorities tend to reside in worse neighborhoods and tend to attend worse schools than Non-Latino White adolescents. AIM: To compare the association between baseline school achievement (student grades) and subsequent tobacco use susceptibility (openness to smoke in future) by ethnicity, we compared African American, Latino, and Non-Latino White adolescents in the US over a four-year period. METHODS: This longitudinal study followed 3636 adolescents who were never smokers at baseline for a period of four years. Baseline and four-year data of the Population Assessment of Tobacco and Health (PATH) study were used for this analysis. All participants were 12 to 17 years old at baseline and were either Non-Latino White (Majority), African American (Minority), or Latino (Minority). The outcome was a tobacco use susceptibility score at wave 4 which was defined as openness to use tobacco in the future, measured at year four. The predictor was school achievement at wave 1, measured as grades from F to A+. The moderator was ethnicity (African American, Latino, Non-Latino White), and covariates were age, gender, parental education, and family structure. RESULTS: Our linear regressions in the pooled sample showed an inverse association between baseline school achievement and subsequent tobacco use susceptibility four years later. However, this inverse association was weaker for ethnic minorities than for Non-Latino White adolescents, as documented by interaction effects between ethnic minority status and baseline school grades. CONCLUSION: Higher educational success better correlates with lower tobacco use susceptibility of non-Latino White than African American and Latino adolescents, which may reflect some tobacco use susceptibility of Latino and African American adolescents with highly educated parents. Future research should investigate how social context such as high-risk school environment, neighborhood risk, peer risk, and other mechanisms increase behavioral risk of educationally successful African American and Latino adolescents.

Race and Ethnic Differences in the Protective Effect of Parental Educational Attainment on Subsequent Perceived Tobacco Norms among US Youth.

BACKGROUND: Although parental educational attainment is known to be associated with a lower prevalence of behaviors such as tobacco use, these effects are shown to be weaker for Black than White youth. It is important to study whether this difference is due to higher perceived tobacco use norms for Black youth. AIM: To study the association between parental educational attainment and perceived tobacco use norms overall and by race/ethnicity among youth in the US. METHODS: The current study used four years of follow-up data from the Population Assessment of Tobacco and Health (PATH-Youth) study conducted between 2013 and 2017. All participants were 12- to 17-year-old non-smokers at baseline and were successfully followed for four years (n = 4329). The outcome of interest was perceived tobacco use norms risk at year four. The predictor of interest was baseline parental educational attainment, the moderator was race/ethnicity, and the covariates were age, sex, and parental marital status at baseline. RESULTS: Our linear regressions in the pooled sample showed that higher parental educational attainment at baseline was predictive of perceived disapproval of tobacco use at year four; however, this association was weaker for Latino than non-Latino youth. Our stratified models also showed that higher parental educational attainment was associated with perceived tobacco use norms for non-Latino but not for Latino youth. CONCLUSION: The effect of high parental educational attainment on anti-tobacco norms differs between Latino and non-Latino youth. Latino youth with highly educated parents remain at risk of tobacco use, while non-Latino youth with highly educated parents show low susceptibility to tobacco use.

Pragmatic Considerations in Incorporating Stakeholder Engagement Into a Palliative Care Transitions Study.

BACKGROUND: Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings. OBJECTIVES: This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement. METHODS: Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation. RESULTS: The trial's SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges. CONCLUSIONS: Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.

Families and the Juvenile Justice System: Considerations for Family-Based Interventions.

We conducted focus groups with defense lawyers, clinicians, and education advocates to gather their perspectives on families' experiences with the juvenile justice system. Our quantitative descriptive analysis identified a range of themes such as discussions about the poor treatment of families as well as recommendations for a shifting of power to families. These perspectives may provide insights about the context in which families are expected to participate in interventions, meet probationary demands, and provide for their youth's well-being. The results support evidence gathered from families about the impact of youth incarceration on their lives and has implications for practitioners and researchers working with families whose youth have been incarcerated.

Shared Decision Making in the Emergency Department Among Patients With Limited Health Literacy: Beyond Slower and Louder.

Although studies suggest that patients with limited health literacy and/or low numeracy skills may stand to gain the most from shared decision making (SDM), the impact of these conditions on the effective implementation of SDM in the emergency department (ED) is not well understood. In this article from the proceedings of the 2016 Academic Emergency Medicine Consensus Conference on Shared Decision Making in the Emergency Department we discuss knowledge gaps identified and propose consensus-driven research priorities to help guide future work to improve SDM for this patient population in the ED.

Adapting Conceptual Frameworks for Patient Engagement in Emergency Department Research.

For many people the emergency department (ED) is the first point of access to healthcare for acute needs and a recurring location for many with chronic healthcare needs. While the ED is well placed to identify unmet needs it can also be a net that people slip through when faced with uncoordinated and expensive healthcare challenges. Thus the ED has a responsibility to set patients on a safe and meaningful care trajectory, which can only be done in consultation and partnership with the patients themselves. The purpose of this article is to present crucial aspects of patient engagement that are essential for future research to foster an environment of colearning and respect that encourages ongoing involvement by patients, families, and staff.

The Impact of Community Engagement on Health, Social, and Utilization Outcomes in Depressed, Impoverished Populations: Secondary Findings from a Randomized Trial.

BACKGROUND: Disparities in depression care exist among the poor. Community Partners in Care (CPIC) compared a community coalition model with technical assistance to improve depression services in under-resourced communities. We examine effects on health, social, and utilization outcomes among the poor and, non-poor depressed, and poor subgroups. METHODS: This study analyzed clients living above (n = 268) and below (n = 750) the federal-poverty level and, among the poor, 3 nonoverlapping subgroups: justice-involved (n = 158), homeless and not justice-involved (n = 298), and other poor (n = 294). Matched programs (n = 93) from health and community sectors were randomly assigned to community engagement and planning (CEP) or resources for services (RS). Primary outcomes were poor mental health-related quality of life and 8-item Patient Health Questionnaire scores, whereas community-prioritized and utilization outcomes were secondary. Effects were scrutinized using false discovery rate-adjusted P values to account for multiple comparisons. RESULTS: In the impoverished group, CEP and RS clients of participating study programs did not differ in primary outcomes, but CEP more than RS improved mental wellness among the depressed poor (unadjusted P = .004) while providing suggestive evidence for other secondary outcomes. Within the poor subgroups, evidence favoring CEP was only suggestive but was strongest among justice-involved clients. CONCLUSIONS: A coalition approach to improving outcomes for low-income clients with depression, particularly those involved in the justice system, may offer additional benefits over standard technical assistance programs.

Work through the valley: plan.

This first of three chapters on the Valley stage, or main work of a Community-Partnered Participatory Research (CPPR) initiative, concerns the planning phase of the work cycle. The main goal of this phase is to develop an action plan, which clarifies the goals, methods, responsible individuals, and timeline for doing the work. Further, this chapter reviews approaches, such as creativity and use of humor, that help level the playing field and assure community co-leadership with academic partners in developing effective action plans.

Work through the valley: do.

Much of the work for a community-partnered participatory research (CPPR) initiative is done in committees that operate under the principles of CPPR and the vision of the partnership, while implementing the action plans of the initiative. Action plans are developed in work group meetings and sponsored events that engage the community in discussion about programs or new policy directions. This article provides detailed recommendations for conducting meetings, completing assignments, and running events as the main body of work.