Deciphering Disparities: The NHLBI Program on Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR)

The elimination of health disparities has been an overarching national health objective in the United States for more than 3 decades.^1-4  In Healthy People 2030, the current and the fifth decennial iteration of the Healthy People initiative, eliminating health disparities and achieving health equity remain overarching goals as well as foundational principles.⁴  Prior to the Healthy People effort, several national health promotion and disease prevention efforts also highlighted the importance of addressing health disparities. For example, in 1985, the US Department of Health and Human Services Secretary’s Task Force on Black and Minority Health (The Heckler Report) called for immediate action to address the nation’s health disparities and recommended comprehensive, multidisciplinary, and multisectoral approaches involving government agencies, health care providers, communities, and individuals.⁵  Despite these efforts, health disparities remain pervasive in the United States, and in many settings, these disparities are widening.^6-10 

In examining progress made toward the elimination of racial and ethnic health disparities in the Healthy People 2020 initiative, Huang et al¹¹  reported, using the Centers for Disease Control and Prevention data, that there had been little or no change in overall disparities for most of the initiative’s objectives, regardless of which of 3 objective metrics of overall disparity were analyzed. They further demonstrated that the highest percentage of objectives showing a narrowing (improvement in disparities) was only 14.2%, whereas 8.9% showed widening or worsening disparities. In that analysis, the percentage of objectives in the “little or no detectable change” category was 76.9%, 83.3%, and 92.1% for the 3 objective metrics used.¹¹ 

Similarly, assessment of progress made 30 years after The Heckler Report showed that disparities were improving in 2 priority areas (care for cancer and care for diabetes); however, there had been no change in disparities for the remaining 4 priority areas (care for cardiovascular diseases, care for substance use disorders, suicide prevention and mental health care, and infant mortality and maternity care).¹²  In fact, analysis of the most recent disparity trends for African Americans at that time in 2015 showed a 50% worsening for cancer care, 33% worsening for cardiovascular disease care, 78% worsening for diabetes care, and 75% worsening for suicide prevention and mental health care, while no disparity was seen for the care of substance use and a 33% improvement was observed in infant mortality and maternity care.¹²  Taken together, these findings show that while some progress has been made in reducing health disparities, much more work remains to be done. Collectively, the findings also highlight the urgent need for new, innovative, transformative approaches for reducing health disparities and achieving health equity through rigorous dissemination and implementation research and meaningful engagement of racial and ethnic minority populations and communities disproportionately impacted by health disparities.^13-17 

In March 2019, the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) issued a funding opportunity on Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) following opportunities identified in an NHLBI workshop report.^18,19  Seven implementation research centers (IRCs) and a research coordinating center (RCC) were funded in September 2020 to undertake a biphasic endeavor to develop and test effective implementation strategies for eliminating disparities in heart and lung disease risk (Figure 1).^20,21  In phase 1 of the research (UG3 phase, 2020-2023), the IRCs focused on (1) identifying communities disproportionately impacted by disparities in heart and lung diseases and risks; (2) using principles of meaningful community engagement to work with diverse community partners to identify community needs and priorities; and (3) using validated theoretical or conceptual implementation research frameworks to identify and design appropriate implementation strategies to be conducted in phase 2 of the research (UH3 phase, 2023-2027).^20,21  In this issue of Ethnicity & Disease, we present the DECIPHeR Alliance articles and reflect on the insights, lessons learned, and key aspects of the evidence-based interventions used and implementation strategies developed at the completion of the UG3 phase of the DECIPHeR program.

Ensuring scientific rigor in clinical trial design is a core principle of the NHLBI clinical trial enterprise. To advance this principle in the DECIPHeR program, Murray et al²¹  share examples and highlights from the methodologic and study design challenges they surfaced during the technical assistance workgroup discussions during the planning phase of the DECIPHeR program. These workgroup discussions were designed to support the DECIPHeR Alliance awardees as they refined their study aims and strengthened their research designs, as part of NHLBI’s normative process for awards made under a cooperative agreement funding mechanism. Among key challenges identified during the sessions were the need to clearly distinguish evidence-based interventions from implementation strategies in the protocol, and the need for greater emphasis on implementation research outcomes. The sessions also surfaced cross-classification challenges, especially in cluster-randomized trial designs, when intervention agents work across multiple units of randomization in the same arm. In the studies that used a stepped-wedge design, the sessions also highlighted the need to accommodate time-varying intervention effects. In all 7 DECIPHeR IRC study designs, important attention was paid to the need for data-based estimates of the parameters required for sample size estimation and power determination.

Smith et al²²  provide details on the multiyear process of developing their study protocol beginning with engaging community partners with in-depth local knowledge and lived experiences as well as academic health center collaborators with expertise in implementation science, community-engaged research, and health disparities research. In a second example, Matthews et al²³  share details on a protocol informed by 2 validated implementation science frameworks and designed to compare 3 implementation strategies and the impact of facilitated referrals to link low-income smokers to state-based tobacco quit lines. The 5 remaining IRCs completed their protocol development but did not have adequate time to present their process papers as part of the Ethnicity & Disease collection of articles. However, they share various formative activities or development of process or other measures in other papers. For example, Yuan et al²⁴  describe their novel, theory-informed process of gathering community input to adapt an intervention for improving cardiovascular disease risk factors in persons with serious mental illness. The NIH’s Office of Disease Prevention and the NHLBI Office of Biostatics Research played crucial roles in working with the DECIPHeR Alliance’s IRCs and RCC during these technical assistance sessions.

As the DECIPHeR funding opportunity required, all IRCs addressed a cardiovascular or pulmonary disease and related risk factors including asthma,^25,26  tobacco use and cessation,²³  hypertension, diabetes, and other cardiometabolic, lifestyle, and behavioral risks.^22,23,27-31  Several articles address the importance of social determinants of health as well as pay attention to structural and systemic contexts of risks. Yuan et al²⁴  also addressed cardiovascular health interventions for persons with serious mental illness. All conditions tackled were in communities disproportionately impacted by the COVID-19 pandemic and had evidence of disproportionate burden of heart and lung diseases and risks. The clinical and public health settings included schools,^25,26  faith-based settings such as African American churches,^27,28,31  community mental health settings,^24,32  federally qualified health centers,^33,34  and other safety-net clinics.²⁹  An important part of this work is the creative engagement of community health workers, health systems navigators, social workers, and allied health professionals to advance the heath disparities research agenda.^24,34,35 

Meaningful community engagement, as defined by the Centers for Disease Control and Prevention³⁶  and National Academy of Medicine,³⁷  is a key component of all activities of the DECIPHeR Alliance.³⁸  In fact, the DECIPHeR Alliance created a specific Community Engagement Subcommittee to strengthen promising practices and core principles in community engagement across the Alliance. Cooper et al³⁵  share the subcommittee’s “Why We Engage Communities” statement that describes why community engagement is critical in the activities undertaken by the DECIPHeR Alliance. The article also provides concrete case examples of DECIPHeR Alliance community engagement activities.³⁵  Additionally, the 2 process papers in the collection of DECIPHeR articles provide details of communities, and partners were meaningfully engaged during the planning phase of their work.^22,23 

The diverse communities and partners engaged by the DECIPHeR Alliance include trusted voices and leaders from faith-based organizations, schools, community-based social services, health systems, payor organizations, state and local governmental health officials, community health workers, health systems navigators, large nonprofit organizations, and academic health center partners. The importance of nurturing these strategic partnerships and heeding partner perspectives in study design and execution is addressed in several articles.^22,34,39  In particular, Gleason et al³⁹  demonstrate the important role partner perspectives play in advancing and improving the equity focus of implementation science guides.

As the name of the funded IRCs suggest, implementation strategies that use evidence-based interventions and assess implementation research outcomes are crucial in the DECIPHeR research endeavor. Several articles address these themes,^21,30,35,39  and also address related barriers and facilitators of sustained uptake of evidence-based interventions and/or effective implementation strategies.^27,32  The importance of distinguishing between the concepts of evidence-based interventions and implementation strategies on one hand, and effectiveness and implementation outcomes on the other have been previously addressed.²¹  Schoenthaler et al³³  describe the key principles and promising practices that underpin “the development and sustainment of an equitable research-practice alignment” essential for supporting implementation research using multilevel systems intervention for improved hypertension care. All IRCs also address effectiveness and implementation research outcomes as appropriate for their study protocol. Implementation research outcomes of interest addressed by the IRCs include reach, acceptability, adoption, appropriateness, and other outcomes well recognized in the field of implementation science.⁴⁰ 

Several different implementation strategies are planned by the IRCs. Smith et al²²  and Schoenthaler et al³³  use different models of practice facilitation for hypertension control in persons receiving care in federally qualified health centers and community health centers. Mills et al²⁸  plan on using a community health worker–led strategy consisting of individualized health coaching and health care navigation combined with church-based nutrition education and exercise programs and self-monitoring of cardiometabolic risk factors. Matthews et al³⁴  also tackle patient navigation as an implementation strategy and share insights on training and lessons learned in the use of patient navigators to increase enrollment of low-income patients in a health system–supported and electronic health record–linked patient portal. Several articles in this issue of Ethnicity & Disease also address health education and training as implementation strategies in community-engaged research for addressing disparities.

The importance of meaningful community engagement in increasing the impact of implementation strategies in health disparities research is emphasized in the DECIPHeR Alliance’s Community Engagement Subcommittee statement in the article by Cooper et al.³⁵  That statement identifies 3 themes including the importance of (1) engaging local knowledge and expertise, (2) promoting authentic relationships, and (3) building community and researcher capacity.³⁵  This subcommittee’s work, coupled with the implementation science and community-engaged research expertise within the DECIPHeR Alliance, further strengthens the interventions planned as the Alliance begins the UH3 implementation research phase of the DECIPHeR program’s work.

The DECIPHeR program is an ambitious endeavor and a high priority for the NHLBI because it is designed to address a major strategic objective and several enduring principles crucial for sustaining the Institute’s legacy of excellence.⁴¹  We are very pleased with the diverse community of partners that the DECIPHeR Alliance has built and the scientific rigor of the implementation strategies planned. As Khan et al⁴²  point out, we have great expectations of the DECIPHeR Alliance as they enter the implementation phase of the research program. We are excited about the potential of charting the future together with the Alliance to ensure that the promising implementation strategies they identify can be reliably and sustainably scaled and spread to NHLBI mission areas beyond heart and lung diseases. In fact, we hope that the successful strategies they develop will have applicability and impactful, equitable implementation⁴³  beyond NHLBI and provide a road map for advancing health equity in thriving communities across the United States.

We thank the IRC and RCC awardees, their affiliated institutions, and especially the myriad community partners without whose engagement and commitment the work presented in this issue of Ethnicity & Disease would not have been possible. We also thank Dr Roland Thorpe, Jr., the Editor-in Chief of the Journal, the editorial staff, and the many peer reviewers who helped make publication of this journal issue possible. The authors are employees of the National Institutes of Health. No specific funding was allocated for this work.