The Hopkins/Michigan DECIPHeR Alliance study, Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies, is led by Dr. Gail Daumit and Dr. Amy Kilbourne. The Hopkins/Michigan DECIPHeR study will focus on cardiovascular disease (CVD) risk factors in adults with serious mental illness (SMI). People with SMI comprise 5% of the US population and experience one of the largest CVD-related mortality disparities of any group with rates 2 times higher, and dying 10-20 years earlier, than the overall US population. Underpinning this wide disparity is marked elevation in prevalence of all CVD risk factors in persons with SMI, with low rates of risk factor control.

The overarching goal of this study is to partner with communities in Michigan and Maryland serving persons with SMI to refine, tailor and test provision of different implementation strategies to improve uptake of these evidenced-based practices for reducing CVD risk in SMI in behavioral health homes. The complementary evidence-based interventions that will be scaled up are IDEAL and Life Goals.

The Hopkins DECIPHeR team will engage a variety of stakeholders including community mental health programs, community-based organizations, study participants and/or caregivers, health care system, governmental agencies and advocacy groups. The Replicating Effective Programs (REP) implementation framework will be used. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE- AIM) evaluation framework will be used to evaluate the implementation strategies.

The Hopkins/Michigan specific aims are:

Aim 1 (UG3 phase): Establish a highly collaborative and productive partnership with 24 Michigan and Maryland community mental health program sites to tailor IDEAL/Life Goals evidence-based practices and implementation strategies to fit site needs,

Aim 2 (UG3 phase primary): Determine effectiveness of two implementation strategy augmentations to REP, Coaching and Facilitation, on a) uptake and delivery of IDEAL/Life Goals at 18-months (primary outcome), and b) quality of care for CVD risk factors and CVD risk factors among persons with SMI, (secondary outcomes).

Aim 3 (UG3 phase secondary).

Aim 3a: To determine the effect of the implementation strategies on: (1) quality of care for CVD risk factors and (2) CVD risk factors and behaviors among persons with SMI in community health programs.

Aim 3b: To assess mechanisms (e.g., provider self-efficacy), moderators (e.g., implementation climate), and other relevant measures (e.g., fidelity, costs) to inform an adaptive implementation intervention to further scale up IDEAL/Life Goals in the behavioral health home setting.

Principal Investigators:

Gail L. Daumit, MD, MHS
Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Amy M. Kilbourne, PhD, MPH
Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA.

Grant number: UG3 HL154280

The New York DECIPHeR Alliance study, Actions to Decrease Disparities In Risk and Engage In Shared Support For Blood Pressure Control (ADRESS-BP) In Blacks, is led by Dr. Gbenga Ogedegbe, Dr. Antoinette Schoenthaler, and Dr. Nadia Islam. The NYU DECIPHeR Team will focus on uncontrolled hypertension (<140/90 mmHg) in New York City, NY.

Black Americans have the highest rate of hypertension in the United States, (42% prevalence compared to 27% in Whites) and greater rates of fatal stroke (1.8X) and CVD mortality (1.5X). The most common reason for the mortality gap between Black and White communities is uncontrolled hypertension.

The ADDRESS-BP Project uses practice facilitation (PF) to implement three evidence-based interventions (EBIs) designed to improve hypertension control among Black patients in primary care practices in New York, NY. The study integrates: 1) Nurse case management (NCM); 2) Home blood pressure monitoring (HBPM); and 3) community health workers (CHWs) into routine care. These EBIs will be delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE)] to address patient-, physician-, health system-, and community-level barriers to hypertension control in Blacks. While NCM and HBPM improve HTN provider- and self-management, 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 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.

UG3 Phase

Aim 1: Develop processes for decision-making, communication, and coordination across sites and partners.

Aim 2: Use CBPR principles and CFIR to assess community needs and assets impacting HTN control in Black communities; and use the findings to develop a context-specific PF strategy for implementation of PACE.

Aim 3: Build infrastructure to support training and data monitoring processes across an integrated EHR system; and develop and refine implementation protocols.

Aim 4: Recruit study sites; train practice facilitators, nurses and CHWs; pilot test the PF strategy and the PACE intervention.

UH3 Phase

Aim 1: To evaluate, in a stepped-wedge cluster RCT of 20 primary care practices in 500 Black patients with uncontrolled HTN, the effect of a tailored PF strategy on BP control

Aim 2: To evaluate the cost-effectiveness of the tailored strategy at 18 months.

Aim 3: To examine adoption and implementation fidelity as potential mechanisms that may explain the impact of PF on BP control.

Aim 4. Develop and disseminate toolkits to sustain PACE in primary care practices and support its replication by public health agencies, insurers, and health systems.

The study's findings will provide a practical and sustainable system that harnesses existing clinical and community resources to build capacity for primary care practices to manage HTN control in minority populations.

Principal Investigators:

Gbenga Ogedegbe, MD, MPH, FACP

Department of Population Health, Center for Healthful Behavior Change, NYU Grossman School of Medicine, New York, NY, USA.

Antoinette Schoenthaler, EdD

Department of Population Health, Center for Healthful Behavior Change, NYU Grossman School of Medicine, New York, NY, USA.

Nadia Islam, PhD

Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA.

Grant number: UG3 HL151310

The Northwestern DECIPHeR Alliance study, Community Intervention to Reduce CardiovascuLar Disease in Chicago (CIRCL-Chicago)-Northwestern University, is led by Dr. Abel Kho, Dr. Justin Smith, and Dr. Paris Davis. The Northwestern DECIPHeR study will focus on hypertension control in the South Side Chicago, Illinois. Hypertension affects 1 in every 3 adults in the US and contributes to 410,000 deaths annually. Hypertension and its associated complications disproportionately affect minority populations living in urban areas. In Chicago, health status indicators show worsening disparities between black and white residents, with the highest rates of hypertension, heart disease, and stroke clustering in the predominantly black South and West Sides.

Kaiser Permanente demonstrated that a bundle of evidence-based interventions implemented within a large, integrated health system in Northern California significantly increased blood pressure control rates. However, it is unclear whether a health system centered intervention can be adapted to other settings, particularly under-resourced urban communities.

The Northwestern DECIPHeR Team will adapt a health care system evidence-based intervention (e.g. Kaiser bundle) to be centered within a community setting (e.g. churches) in the South Side of Chicago. The Kaiser bundle interventions are registry/audit and feedback, simplified treatment regimens, accurate Blood Pressure measurement). The Northwestern DECIPHeR study will follow the Exploration, Preparation, Implementation and Sustainment (EPIS) process model and implementation is rigorously evaluated using a multimethod approach to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework. They are engaging variety of stakeholders including churches, community agencies, health care system, community health workers, advocacy organizations, large non-profit organizations.

The Northwestern DECIPHeR specific aims are:

Aim 1: Convene community stakeholders in order to adapt implementation strategies using the Dynamic Adaptation Process model.

Aim 2: Design, implement, and evaluate pilot projects in order to optimize implementation strategies within our community.

Aim 3: Implement, test and evaluate an adapted implementation strategy to control hypertension through faith-based organizations in the South Side of Chicago. Our overall implementation is a hybrid Type 2 effectiveness–implementation design based within one primary community area (South Side Chicago) and in two settings (church and clinic). The overall study outcome is the Public Health Impact metric (reach * effect size of the intervention).

Aim 4: Disseminate findings internally to community stakeholders and externally through creation of community implementation toolkits.

Principal Investigators:

Abel N Kho, MD Division of General Internal Medicine and Geriatrics, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.

Justin D Smith, PhD Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah, USA.

Paris Davis, PHD, MBA Total Resource CDO and Pastors4PCOR, Triedstone Full Gospel Baptist Church, Chicago, IL, USA

Grant number: UG3 HL154297

The Tulane DECIPHeR Alliance study, Community Health Worker-Led Church-Based Intervention for Eliminating Cardiovascular Health Disparities in African Americans, is led by Dr. Jiang He and Dr. Keith Ferdinand. The Tulane DECIPHeR study will focus on atherosclerotic cardiovascular disease (ASCVD) in New Orleans and Bogalusa, Louisiana. Louisiana residents, especially African Americans, bear a disproportionately high burden of atherosclerotic cardiovascular disease (ASCVD).

The Tulane DECIPHeR Alliance is creating the CHERISH (Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health) trial based on the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease that will be delivered in 42 black churches in New Orleans and Bogalusa, Louisiana.

The Tulane DECIPHeR Team is using the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation framework. They are engaging variety of stakeholders including faith-based organizations, community-based organizations, governmental agencies, and community health workers. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE- AIM) evaluation framework will be used guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; church-based exercise and weight loss programs; self-monitoring of physical activity, blood pressure (BP), and glucose; and provider education and engagement.

The Tulane DECIPHeR specific aims are:

Aim 1 (UG3 phase): Establish a community advisory board (CAB) including representative community members, church leaders, local public health agencies, CHWs, and healthcare providers and work with them to ensure the multifaceted implementation strategy is responsive to the needs of local African American communities and is culturally and socioeconomically tailored;

Aim 2 (UG3 phase): Develop partnerships with local churches, healthcare systems, public health agencies, and CHWs for continuous feedback on planning, conduct, dissemination, and scale-up of the proposed research;

Aim 3 (UG3 phase): Select 42 churches that primarily serve African American communities in New Orleans and Bogalusa, LA and are willing to be research partners;

Aim 4 (UG3 phase): Conduct a health needs assessment among church leaders, church members, other community members, CHWs, and providers on views about CHMs, healthcare access, and readiness for change;

Aim 5 (UG3 phase): Develop an implementation and sustainability plan that addresses RE-AIM elements, and develop and pilot test the study protocol, manual of procedures (MOP), and study forms;

Aim 6 (UG3 phase): Obtain approval of the study protocol from the NIH, Data and Safety Monitoring Board (DSMB), and IRB; and

Aim 7 (UG3 phase): Adapt implementation strategies to meet participants' needs and the context of each church, and recruit and train CHWs from local churches.

Aim 1 (UH3 phase): Recruit 1,050 African American participants (25 per church) aged ≥40 years who have <4 ideal CHMs from 42 churches and randomly assign 21 churches to the multifaceted intervention and 21 churches to the enhanced usual care stratified by New Orleans vs. Bogalusa;

Aim 2 (UH3 phase):.Implement the multifaceted intervention program in the intervention group and provide CVH education materials and health promotion sessions to the control group;

Aim 3 (UH3 phase): Keep a high retention and follow-up rate among all study participants;

Aim 4 (UH3 phase): Collect data on study outcomes (i.e., clinical outcome CHMs, implementation process measures, and costs) at baseline and follow-up visits at 6, 12, and 18 months from all participants;

Aim 5 (UH3 phase): Conduct a post-intervention 6-month follow-up study to evaluate the sustainability of the multifaceted implementation strategy from both participant and organizational perspectives;

Aim 6 (UH3 phase): Perform intention-to-treat analyses on the primary study outcomes and cost-effectiveness analysis; and

Aim 7 (UH3 phase): Comprehensively, effectively, and timely disseminate the study findings to influence public health policy and practice and plan to scale up the proven-effective implementation strategy in community settings in Louisiana and beyond.

Principal Investigator:

Jiang He, MD, PhD
Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, and Tulane University Translational Science Institute, New Orleans, LA, USA

Co-Principal Investigator:

Keith C. Ferdinand, MD, FACC, FAHA, FASPC, FNLA
Tulane University School of Medicine, New Orleans, LA, USA

Grant number: UG3 HL151309

The UCLA DECIPHeR Alliance study, Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in LA County, is led by Drs. Arleen Brown and Joseph Ladapo. The study will focus on the racial/ethnic gaps in evidence-based treatment that contribute to hypertension disparities in the Los Angeles County Department of Health Services (LAC DHS). 43% of LAC DHS patients have hypertension, of which 60% are uncontrolled. The study will focus on racial/ethnic populations within LAC DHS with high rates of hypertension, including Latinos (42%), African Americans (48%), Chinese (31%), Filipino (62%), and Koreans (34%).

The UCLA DECIPHeR Team is using the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation framework. They are engaging variety of stakeholders including community-based organizations, LAC DHS and other governmental agencies, health care providers, community health workers, and study participants. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE- AIM) evaluation framework will be used to evaluate the implementation strategies.

The UCLA DECIPHeR specific aims are:

Aim 1 (UG3 phase): Assess multilevel (patient, clinician, health system leadership, and community) barriers to, facilitators of, and preferences for a menu of culturally tailored evidence-based practices (EBPs) and implementation strategies with established efficacy for hypertension control.

Aim 2 (UG3 phase): Select and systematically apply behavioral economics to the design of our patient-, clinician-, and community-directed implementation strategies to maximize acceptability, uptake, and effectiveness.

Aim 3 (UH3 phase): Test the effectiveness of our implementation strategies in a stepped-wedge cluster randomized trial design using RE-AIM to guide assessment of uncontrolled hypertension, disparities in comparison to non-minority LAC populations, and evidence-based practices.

Principal Investigators:

Arleen F. Brown, MD, PhD
Division of General Internal Medicine and Health Services Research at UCLA, Los Angeles, CA, USA.

Grant number: UG3 HL154302

The Colorado DECIPHeR Alliance study, Reducing Asthma Attacks in Disadvantaged School Children with Asthma, is led by Dr. Stanley Szefler and Dr. Lisa Cicutto. The Colorado DECIPHeR study will focus on asthma in children in Colorado. Asthma is a leading cause of children's hospitalizations, missed school days and caregivers' missed workdays that has a significant impact on low-income families.

This study seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children in low-income communities (ages 5 to 12 years). Using community-based participatory methods with high-risk populations and communities, the Colorado DECIPHeR Team will contextualize dissemination and implementation (D&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health (SDOH) which our pilot identified as major drivers of asthma disparities. This two-step level of intervention, called Stop Asthma Attacks (SAA), will be designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. 

The Colorado DECIPHeR team is engaging a variety of stakeholders including the Colorado Public School System, community agencies, primary care staff, government officials, school health staff, health insurers, and study participants and/or caregivers. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE- AIM) evaluation framework will be used to evaluate the implementation strategies.   

The Colorado DECIPHeR specific aims are:

Aim 1 (UG3 phase): Using community-engaged research principles and the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, we will work with our multi-sectoral stakeholders to:

Aim 1a: identify school site-specific implementation needs, priorities, and resources for SAA (EPIS phase 1).

Aim 1b: co-develop site-specific implementation strategies for SAA targeted to Aim 1a data (EPIS phase 2).

Aim 1c: identify metrics for success relevant to stakeholders (process and health outcomes) to test in Aim 2.

Aim 2 (UH3 phase): Measure the equity of reach and implementation of SAA across diverse "hot spot" schools with poor asthma control in 5 regions of Colorado, by using a Type III Hybrid implementation-effectiveness trial design with a stepped-wedge randomization approach to assess:

Aim 2a: Implementation outcomes of Reach (primary outcome), and secondary outcomes of Adoption, Implementation, and Maintenance (EPIS Phase 3)

Aim 2b: Effectiveness outcomes of asthma exacerbations (primary effectiveness outcome) and secondary outcomes of reduced SDOH and reduced asthma symptoms (EPIS phase 3)

Aim 2c: Based on the evaluation of Aims 2a-2b, adapt the current Col-SBAP implementation guide into a multi-media "SAA dissemination playbook" to guide the future national dissemination of SAA (EPIS phase 4)

IMPACT:

By engaging multiple key stakeholders as guided by the EPIS framework, this project will test the effects of implementing an evidence-based program to reduce asthma disparities in five geopolitically diverse areas. The trial will also inform a "dissemination playbook" that will accelerate future dissemination of SAA nationally to communities experiencing health inequities related to asthma care.

Principal Investigators:

Stanley J Szefler, MD
Department of Pediatrics, Breathing Institute, Children's Hospital Colorado, University of Colorado, School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.

Lisa Cicutto, PhD, RN
Community Outreach and Research, National Jewish Health, Denver, CO, USA.

Grant number: UG3 HL151297

The University of Illinois Chicago (UIC) DECIPHeR Alliance study, Mi Quit CARE (Mile Square Quit Community-Access-Referral-Expansion), is led by Dr. Phoenix Matthews, Dr. Karriem Watson and Dr. Robert Winn. The UIC DECIPHeR study will focus on tobacco cessation in low-income populations in Chicago, Illinois. Nationally,14.1% of adults continue to smoke. Low-income populations are disproportionately burdened by tobacco use and carry a greater burden of smoking-related pulmonary health morbidity. Federally Qualified Health Care Centers (FQHCs) represent an important yet under-utilized model for reducing smoking-related health inequalities. Nationally, 25.8% of all patients receiving care at FHQCs are current smokers.

The UIC DECIPHeR Team will create Mi Quit CARE by combining three evidence-based interventions - (1) an electronically delivered brief smoking cessation intervention (Ask, Advise, Refer, AAR), (2) proactive linkage of smokers to the Illinois Tobacco Quit Line (ITQL), and (3) patient navigation to reduce barriers to care. They will be using the Practical, Robust Implementation and Sustainability Model (PRISM) implementation framework. They are engaging a variety of stakeholders, including community agencies, health systems, government agencies, large non-profit organizations and institutional partners. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework will be used to evaluate the implementation strategies.

The UIC DECIPHeR specific aims are:

Aim 1 (UG3 phase): Examine the burden of tobacco use and its influence on pulmonary health disparities (lung cancer, COPD, and asthma) in the patient population and the economically disadvantaged and racially segregated catchment areas of Mile Square Health Centers (MSHC).

Aim 2 (UG3 phase): Evaluate knowledge, attitudes, barriers, and facilitators to smoking cessation, engagement with the tobacco quit line, linkage to the tobacco quit line via a patient health portal, and receipt of patient navigation to facilitate access to the tobacco quit line among MSHC patients and health care providers.

Aim 3 (UG3 phase): Evaluate the use of community engagement strategies to increase uptake of the UI Health Patient Portal among low-income patients receiving care at MSHC.

Aim 4 (UG3 phase): Test the acceptability, feasibility, and capacity of MSHC to deliver Mi Quit CARE, an evidence-based and multi-level intervention to increase engagement with the quit line via the UI Health Portal.

Aim 1 (UH3 phase): Determine the effectiveness of Mi Quit CARE compared to standard of care in increasing patient engagement with the Illinois Tobacco Quit Line and subsequent smoking cessation outcomes.

Aim 2 (UH3 phase): Evaluate the scalability of Mi Quit CARE to multiple sites within the MSHC clinic network and by translating the intervention to Spanish.

Aim 3 (UG3 phase): Examine the cost effectiveness of Mi Quit CARE on smoking cessation outcomes compared to standard of care among a high risk FQHC population.

Demonstrating the feasibility, effectiveness, and cost-effectiveness of electronically delivered smoking cessation interventions via patient portals in FQHC settings has the potential for wide-spread dissemination and significant public health impact on patient populations with demonstrated high rates of smoking.

Principal Investigators:

Phoenix Matthews, PhD
College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.

Karriem Watson, DHSc, MS, MPH
University of Illinois at Chicago, School of Public Health, Division of Community Health Sciences, Chicago, IL, USA

Robert Winn, MD
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, USA

Grant number: UG3 HL151302

The DECIPHeR Research Coordinating Center (RCC) is led by Dr. June Stevens at the Gillings School of Public Health at the University of North Carolina in Chapel Hill. The RCC supports the work of the Implementation Research Centers in the conduct of outstanding research that will test implementation strategies with the ultimate goal of reducing or eliminating cardiovascular and/or pulmonary health disparities.

The DECIPHeR RCC specific aims are:

Aim 1: Provide organization and management

Aim 2: Supply cross-study research coordination and support data analysis

Aim 3: Facilitate research skills development and capacity building

Aim 4: Promote dissemination and initiate partnerships

To accomplish those aims the RCC manages in-person and virtual steering committee meetings and workshops and establishes a cross-study organization that promotes collaboration and communication among investigators. They arrange meetings of cross-study data safety and monitoring board (DSMB) and provide reports to them as requested. The RCC supports the creation of a consolidated database of common variables and assists in data transfer and cleaning as well as providing statistical and data analysis expertise. They also conduct regular site visits. The RCC promotes skills development in implementation science by providing webinars and workshops on timely topics. Dissemination is supported by tracking and archiving of scientific products, creation, and posting of public use data, and by inclusion of community partners in webinars and workshops.

Principal Investigator:

June Stevens, MS PhD

Departments of Nutrition and Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC,USA

Grant number: U24 HL151308