key: cord-1038040-2ln7f3di
authors: Kho, Abel; Daumit, Gail L.; Truesdale, Kimberly P.; Brown, Arleen; Kilbourne, Amy M.; Ladapo, Joseph; Wali, Soma; Cicutto, Lisa; Matthews, Alicia K.; Smith, Justin D.; Davis, Paris D.; Schoenthaler, Antoinette; Ogedegbe, Gbenga; Islam, Nadia; Mills, Katherine T.; He, Jiang; Watson, Karriem S.; Winn, Robert A.; Stevens, June; Huebschmann, Amy G.; Szefler, Stanley J.
title: The National Heart Lung and Blood Institute Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Alliance
date: 2022-05-15
journal: Health Serv Res
DOI: 10.1111/1475-6773.13983
sha: 1839e03f9bdabe0f844850a8b32fc28f31d95efe
doc_id: 1038040
cord_uid: 2ln7f3di

OBJECTIVE: To describe the National Heart Lung and Blood Institute (NHLBI) sponsored Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease (DECIPHeR) Alliance to support late‐stage implementation research aimed at reducing disparities in communities with high burdens of cardiovascular and/or pulmonary disease. STUDY SETTING: NHBLI funded seven DECIPHeR studies and a Coordinating Center. Projects target high‐risk diverse populations including racial and ethnic minorities, urban, rural, and low‐income communities, disadvantaged children, and persons with serious mental illness. Two projects address multiple cardiovascular risk factors, three focus on hypertension, one on tobacco use, and one on pediatric asthma. STUDY DESIGN: The initial phase supports planning activities for sustainable uptake of evidence‐based interventions in targeted communities. The second phase tests late‐stage evidence‐based implementation strategies. DATA COLLECTION/EXTRACTION METHODS: Not applicable. PRINCIPAL FINDINGS: We provide an overview of the DECIPHeR Alliance and individual study designs, populations, and settings, implementation strategies, interventions, and outcomes. We describe the Alliance's organizational structure, designed to promote cross‐center partnership and collaboration. CONCLUSIONS: The DECIPHeR Alliance represents an ambitious national effort to develop sustainable implementation of interventions to achieve cardiovascular and pulmonary health equity.

tions, and outcomes. We describe the Alliance's organizational structure, designed to promote cross-center partnership and collaboration.

Conclusions: The DECIPHeR Alliance represents an ambitious national effort to develop sustainable implementation of interventions to achieve cardiovascular and pulmonary health equity. What is known on this topic • Marked disparities in heart and lung health exist and persist in the United States across race, ethnicity, sex and/or gender, geography, socioeconomic status, and disability status.

• To narrow these gaps and achieve health equity for heart and lung diseases, we need to understand barriers and facilitators to interventions that work and how to implement and sustain them in the community.

• The National Heart Lung and Blood Institute sponsored the creation of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease (DECIPHeR) Alliance to support research to reduce disparities in communities with high burdens of heart and/or lung disease.

• We describe the DECIPHeR Alliance including the seven research projects and a coordinating center to bring the project teams together for the highest impact to narrow health disparities.

Despite substantial improvements in cardiovascular and pulmonary health in the United States over recent decades, marked disparities persist. 1, 2 Significant cardiopulmonary health inequities endure by race, ethnicity, sex and/or gender, geography, socioeconomic status, and disability status, and contribute to the disproportionate burden of preventable mortality in these groups. 3, 4 Evidence supporting these disparities is compelling and consistent and includes research based on epidemiologic cohorts, and spatial analyses illustrating geographic variation in rates and outcomes for cardiovascular and pulmonary diseases. [5] [6] [7] [8] [9] [10] [11] [12] [13] To achieve health equity, there is a pressing need to understand how to implement evidence-based interventions. 14 Dissemination and implementation research methods can tailor programs to address needs at multiple levels as health disparities develop due to complex determinants across the individual, interpersonal, community, and environmental levels. [15] [16] [17] [18] [19] Late-stage (T4) implementation research identifies strategies to achieve sustainable uptake of proveneffective interventions into routine clinical practice and communitybased settings and maximizes impact on population health. 20 In 2020, the National Heart Lung and Blood Institute (NHLBI) created and funded the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance to support late-stage T4 implementation research strategies for optimal implementation and sustainment of evidence-based multi-level interventions to reduce disparities in communities with a high burden of cardiovascular and/or pulmonary risk factors. DECIPHeR is funded as a cooperative agreement using the UG3/UH3 administrative mechanism. During an initial 3-year UG3 planning phase, project teams engage partner communities to identify programs and health areas of most importance for implementation strategies and to identify strategies most appropriate and effective in the community. If milestones for the initial UG3 phase are achieved, a subsequent 4-year UH3 phase will conduct a prospective study of implementation strategies refined and adapted through the UG3 phase. Here we describe the DECIPHeR Alliance with an overview of study designs, disparities populations, evidencebased interventions, planned implementation strategies, and outcomes as well as the organizational structure promoting cross-center partnership and collaboration. At this early stage of the project, the approach to the research planned for the UH3 phase remains flexible and will likely change as information from our communities and their barriers and facilitators expands.

The DECIPHeR Alliance brings together seven Implementation Research Centers (IRCs) and a research coordinating center (RCC). Figure 1 summarizes DECIPHeR Alliance projected outputs and distal outcomes. An advantage of the Alliance is the close collaboration between Alliance members and community partners to improve the quality of the studies and strengthen partnerships.

Given the focus on translational research, implementation science, and community engagement, the teams are both multi-disciplinary and multi-stakeholder, bringing together academic researchers with leaders from the study communities. Table 1 provides an overview   of the seven DECIPHeR IRCs, and we describe the individual projects below. 2.2 | Multi-ethnic multi-level strategies and behavioral economics to eliminate hypertension disparities in Los Angeles County-University of California Los Angeles

In Los Angeles County (LAC), the second largest US municipal health system, patient, clinician, health system, and community factors contribute to disparities in hypertension prevalence, control, and outcomes. In the LAC Department of Health Services (DHS) 43% of patients have hypertension, of which 60% are inadequately controlled. The study will focus on racial/ethnic populations within LAC DHS with high rates of hypertension, including Latino (42%), African Americans (48%), Chinese (31%), Filipino (62%), and Korean (34%) populations. Population differences in healthy eating, physical activity, obesity, and antihypertensive pharmacotherapy use, medication adherence, community awareness of hypertension, and communitylevel physical and social resources contribute to disparities in blood pressure (BP) control. In partnership with 51 adult primary care clinics in LAC DHS, we plan to significantly reduce hypertension disparities by leveraging our team's expertise in multi-ethnic, multi-level evidence-based strategies, community/stakeholder engagement, public-private partnerships, implementation science, and behavioral economics. Using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, we are planning a multi-level intervention for hypertension control that will complete Exploration/ Preparation stages in the UG3 phase and the Implementation/ Sustainment stages in the UH3 phase. 21 Through patient and stakeholder interviews, we will first assess multi-level (patient, clinician, health system leadership, and community) barriers to, facilitators of, and preferences for a menu of culturally tailored evidencebased practices and sustainable implementation strategies with established efficacy for hypertension control (Aim 1; UG3). Our initial focus will be on medication therapy management, home BP monitoring, and cultural adaptation of lifestyle modification with support from community health workers. We will then link preferred multilevel (patient-, clinician-, or community-directed) implementation strategies to behavioral science approaches, for example, patient incentives to attend initial pharmacy visits or clinician peer comparisons for patient BP control. (Aim 2; UG3) To test the effectiveness of these behavioral-science linked implementation strategies, we plan a stepped-wedge cluster randomized trial design using RE-AIM to guide assessment of uncontrolled hypertension, and BP disparities in comparison to non-minority LAC populations, and evidence-based practices. 22 The effectiveness outcomes are BP control in the electronic health record (primary), medication adherence, and costs. The implementation outcomes are acceptability of the intervention components and sustainment of the intervention strategies and BP control.

Louisiana residents, especially African Americans, bear a disproportionately high burden of atherosclerotic cardiovascular disease. Ageadjusted cardiovascular disease (CVD) mortality was 274.0 per 100,000 (the fourth highest in the United States) and stroke mortality was 46.7 per 100,000 (the second highest in the United States) in Louisiana residents in 2016-2018. 23 Church-based health intervention to eliminate racial inequalities in cardiovascular health (CHERISH) is a cluster randomized trial that aims to test whether a multifaceted strategy for implementing the 2019 American College of Cardiology/ American Heart Association primary prevention guideline will reduce cardiovascular health (CVH) disparities in Black populations in Louisiana. 24 CHERISH utilizes an effectiveness-implementation hybrid design to: (1) test the effectiveness of a community health worker (CHW)-led church-based multifaceted implementation strategy for improving CVH over 18 months among Black participants at high risk for CVD, and (2) assess implementation outcomes. The EPIS is used for developing intervention program and implementation strategies and the RE-AIM for evaluating study outcomes. 25, 26 Implementation strategies include CHW-led health coaching on lifestyle changes and medication adherence; church-based exercise and weight loss programs; self-monitoring of physical activity, BP, and glucose; and provider education and engagement. The primary effectiveness outcome is the difference in proportion of participants having ≥4 ideal or improved CVH metrics, 27 defined as a healthy diet score of 4-5 components or increase of 2 components from baseline; 150 min/week moderate-or 75 min/week vigorous-intensity physical activity or a combination; never smoking or quitting ≥6 months ago; BMI <25 kg/m 2 or weight loss ≥10 pounds; A1c <7.0% (or <8.0% with complications); use of statin therapy as appropriate; and BP <130/80 mmHg or systolic BP reduced by ≥10 mmHg. CHERISH will recruit 1050 Black participants F I G U R E 1 The inputs, outputs, and distal outcomes for the DECIPHeR Alliance. The inner circle lists the inputs, the middle circle lists the outputs, and the outer circle lists the distal outcomes. The DECIPHeR Alliance's organizational structure promotes cross-center partnership and collaboration and the project's study designs, populations, evidence-based interventions, planned implementation strategies, and outcomes as currently planned. The DECIPHeR Alliance represents an ambitious national effort to develop and support sustainable implementation of interventions to achieve cardiovascular and pulmonary health equity [Color figure can be viewed at wileyonlinelibrary.com] 34 The Colorado program seeks broad-scale implementation of our effective school-based asthma program (Col-SBAP) to improve asthma disparities for children aged 5-12 years in five regional asthma "hot spots" across the state of Colorado. We define asthma "hot spots" as regions with both high rates of uncontrolled asthma and high levels of socioeconomic need. Using community-based participatory methods with stakeholders representing schools, clinics, families and public health in each region, we will adapt our Col-SBAP that reduces asthma exacerbations and missed school days to meet the needs, priorities, practices, and resources of these diverse communities. 32, [35] [36] [37] The EPIS framework is being applied during our Planning phase of the UG3 award with community stakeholders to iteratively adapt our current implementation guide into a set of common implementation strategies that meet local community and school setting needs. 26 During the exploration phase, we are conducting meetings with stakeholders in our five targeted regions of Colorado to understand the needs, resources, and outcomes of success. We are using this information in the Preparation Phase to develop implementation strategies for each region tailored for their abilities to conduct the Col-SBAP as well as access and manage SDOH for their school children with asthma who suffer health disparities. We will use this information to design and conduct a cluster-randomized trial in participating regions in the Implementation Phase, using a randomized stepped-wedge study design to compare two interventional elements with a control population: (1) our original evidence-based Col-SBAP that addresses a targeted subset of SDOH that limit health care access, and (2) a comprehensive assessment and case management approach to SDOH. This complex, combined program is termed Stop Asthma Attacks (SAA). Meanwhile, for the Sustainment Phase, we intend that the interventional elements will be designed for T A B L E 1 (Continued) sustainable delivery by school nurses, in partnership with trained asthma navigators who provide "high-touch" care coordination with students/families, primary care and community SDOH resources. 38 We will also work with the community stakeholders to identify the appropriate support to sustain the program (Table A1 ). We will have to determine what capacity each region has for sustaining the Col-SBAP and/or the SAA Program. The central hypothesis is that SAA will have broad and equitable Reach (primary outcome) and yield important benefits in reducing asthma attacks and symptoms, as compared to schools that have not yet implemented SAA. Cost effectiveness of each program will also be assessed.

The population in the South Side of Chicago is primarily Non-Hispanic Black and suffers from hypertension rates that are significantly higher (37%) than the estimated rate of hypertension (28%) of the adult population in Chicago. 39 The community intervention to 40, 43 In addition to our community engagement and community-academic partnership development strategies, other implementation strategies include implementer training, patient engagement, and practice facilitation. 44 Partnering with FQHCs that are part of practice-based research networks with shared health information technology infrastructures will facilitate implementation of the Kaiser Bundle components (e.g., patient registry) and the evaluation of our implementation efforts and intervention effectiveness. [45] [46] [47] Guided by RE-AIM, 25 the primary implementation outcomes are to reach into the population, delivery costs, and sustainability of the intervention.

Tobacco use is the leading preventable cause of pulmonary health morbidity and mortality in the United States. 48 Despite a decline in the prevalence of smoking, 14.1% of adults-more than 34 million people-continue to smoke. 49 Low-income populations are disproportionately burdened by tobacco use and carry a greater burden of smoking-related pulmonary health morbidity. 50 Public Health Service guidelines recommend the 5 A's framework (ask patients about their smoking status, advise smokers to quit, assess their readiness to make a quit attempt, assist with accessing treatment, and arrange a follow-up appointment to monitor progress) for smoking cessation. 53 Although effective, the 5 A's model is timeconsuming and challenging to implement in high-volume clinical settings, and a simplified version of the framework (Ask-Advise-Refer

[AAR]) was subsequently developed. 54, 55 Our multi-disciplinary team proposes Mile Square QUIT Community-Access-Referral-Expansion (MI QUIT CARE), an innovative strategy for using the patient portal to deliver evidence-based tobacco treatment (AAR) within an urban FQHC system, Mile Square Health Center. Patient portals are secure online tools linked to an individual's electronic health record designed to help patients access and manage their health information and are increasingly used to deliver educational and health promotion content and interventions. 56 The intervention components include using the patient portal to send a provider message advising current smokers to quit, proactively linking smokers interested in quitting smoking or cutting down to the Illinois Tobacco Quitline, and using patient navigation to address barriers to treatment engagement. The EPIS framework is being used to guide the study. During the exploration phase, we will use clinic data to examine smoking prevalence rates in the patient population and identify patients and clinic sites disproportionately impacted by smoking.

In the Planning Phase, we will conduct in-depth interviews with clinic patients and providers to identify barriers and facilitators to smoking cessation, attitudes regarding the intervention components (patient portal, proactive linkage to the quitline, and patient navigation), and finalize outreach and education materials. In the Implementation Phase, we will conduct a randomized clinical trial comparing the treatment engagement (the receipt of counseling from the tobacco quitline) and smoking cessation outcomes (biochemically verified smoking status at 6 months). The intervention is being developed to maximize sustainability by using low-touch (sending mass mailings to portal message boxes), automated and population-based strategies (opt-in and proactive linkage), and a cost-effective approach (use of the state-run quitline). In the Sustainment Phase, we will work with all key stakeholders (patients, providers, patient navigators, and the Illinois Tobacco Quitline) to identify potential barriers to sustainability.

The final step of the project will be to translate all materials to Spanish to increase inclusivity and evaluate the program's cost effectiveness. CHWs to be part of the care team, and to assist patients in navigating complex health systems and facilitate access to community resources is one such strategy. 61 While NCM and HBPM improve HTN provider-and selfmanagement, these strategies do not address community-level barriers to hypertension control which CHWs are well-suited to address.

The study planning phase utilizes CFIR to examine barriers and facilitators to implementation of PACE through analysis of secondary data, as well surveys and interviews of practice leadership, providers and staff, and community-and faith-based groups. Using Proctor's Implementation Outcomes Framework, the implementation phase will evaluate the impact of PACE on BP control, adoption and fidelity at 18 months compared to usual care (UC) via a stepped-wedge cluster RCT of 20 NYU PCPs in 500 Black patients with uncontrolled hypertension. The project includes partnership with a payer (Healthfirst) to assess cost-effectiveness and inform the sustainability and scalability of integrated community-clinical linkage models. We hypothesize that rates of BP control and costeffectiveness will be higher during the PACE intervention period than during the UC period at 18 months and that rates of BP control will be higher in practices that exhibit higher levels of adoption and implementation fidelity of PACE at 18 months. Payer reimbursement mechanisms will be explored to sustain and scale the model across the NYU health system. 71 Life Goals is a self-management-focused intervention that aims to help individuals cope with mood symptoms and improve health by using healthy behavior changes such as physical activity and eating habits and also incorporates care coordination. 72 Replicating Effective Programs (REP) Framework components will lay the groundwork alongside Coaching and Facilitation implementation strategies, addressing provider and organizational barriers respectively. 72 In the first phase, we are partnering with community mental health programs in Maryland and Michigan to tailor IDEAL/Life Goals and implementation strategies to fit site needs. In the second phase, we plan to conduct a nonrestricted SMART with these community mental health programs to determine the effectiveness of Coaching and Facilitation augmentations to REP on IDEAL/Life Goals delivery, risk factor care quality and control, assessing mechanisms, moderators, and other implementation measures.

Uptake of IDEAL/Life Goals at 18 months is the primary outcome and will be measured by the number of evidence-based practice sessions delivered. This project will inform which combination of strategies lead to optimal uptake of effective cardiovascular risk reduction interventions for persons with serious mental illness, a critical step in reducing their cardiovascular health disparities. Table 2 describes the objectives of the subcommittees. Ad hoc working groups are formed as needed to provide in-depth collaboration and produce products in specific areas, for example, cost measurements and analysis, qualitative measurements and analysis, project coordinators, recruitment and retention, and adverse events.

The RCC also provides data-related and study monitoring functions, supports the convening and activities of a single consortium-wide Data Safety and Monitoring Board, provides reports to NHLBI, and participates as a scientific partner. The RCC has created a resource section on the DECIPHeR website, https://www.decipheralliance. org/resources with links to other implementation science resources.

As the RCC develops products and resources that would be beneficial to other researchers and the general public, they will be added.

In addition, at the end of the study the RCC will archive study materials and make them available to investigators outside the DECIPHeR study. They will also construct a de-identified public use data base that will be available to other investigators in accordance with NIH data sharing policies.

The mission of the DECIPHeR Alliance is to reduce or eliminate disparities in cardiovascular and pulmonary health, disease, and disease risk factors in high-burden communities in the US through the rigorous study of implementation strategies for proven effective interventions. 73 Implementation subcommittee Discuss all aspects of preparation, planning, and operationalization of implementation research with the goal of optimizing the research by the sharing of ideas including the identification of facilitators and barriers. In collaboration with the Measurement subcommittee select and plan implementation outcome measures with an emphasis on common measures (measurements used by more than one Implementation Research Center). Identify cross-center opportunities to advance implementation science.

Intervention subcommittee Discuss all aspects of preparation, planning, and operationalization of the evidence-based effectiveness intervention with the goal of optimizing the research by the sharing of ideas. Develop a list of common process evaluation measures across the studies, including a set of process components that each site will measure (i.e., reach, dose delivered, dose received, fidelity, and secular trends) and, if possible, a common way to measure each process component.

Community engagement subcommittee Support community and participant engagement and identify opportunities to strengthen (and potentially align) study approaches to engagement and community capacity building. Share plans for the development of partnerships and methods for engagement of stakeholders. Also, identify cross center opportunities to advance the science of how best to engage communities/partners/ stakeholders in research to implement the multilevel interventions needed to reduce disparities and promote equity in heart and lung disease.

Design and analysis subcommittee Review and enhance study designs and quantitative analytic plans.

In collaboration with other subcommittees, provide recommendations for standardization of common measures. This includes all types of measures-implementation, process variables, clinical/ effectiveness measures (intervention, outcome, mediators, and moderators), adverse events, recruitment, retention, engagement, and social determinants of health.

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The National Heart Lung and Blood Institute Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Alliance