Antoinette M. Schoenthaler, Ed.D. - US grants

DESCRIPTION (provided by applicant): African Americans have the highest prevalence of hypertension, making it a major contributor to the racial/ethnic health disparities. Numerous studies have sought to understand the reasons for the disproportionate rates of premature hypertension-related mortality. Many have concluded that much of the variance related to differential health outcomes cannot entirely be attributed to differences in access to and quality of health care. Patient-physician relationship has emerged as a potential mechanism in the racial disparities in health care. However, little is known about the effect of the patient-physician relationship on hypertension-related outcomes in African Americans. This study will evaluate the impact of patient-physician relationship on medication adherence and blood pressure control among hypertensive African Americans followed in primary care practices. Specifically, the impact of patients' perceptions of physician communication styles as well as the effect of racial/ethnic composition of the patient-physician relationship on medication adherence and blood pressure control will be investigated. Physician communication style will also be tested as a mediating variable between racial/ethnic composition and medication adherence.

DESCRIPTION (provided by applicant): The goal of this career development award is to develop theoretical and methodological expertise in patient-provider communication to facilitate the candidate's development into a leader in research to improve patient-provider communication with an emphasis on its relation to health disparities in patients with chronic disease. Building on her training and experience in cardiovascular behavioral medicine and minority health, the candidate has identified four core-training areas to further develop the skills needed to become an independent investigator: 1) interaction with a multidisciplinary mentorship team in cardiovascular disease, health disparities research, patient-provider communication, and behavioral medicine;2) coursework and didactic training to develop expertise in methodological and analytical principles of minority and cardiovascular health research;3) rigorous hands-on training in the use of qualitative analysis and an objective interaction analysis system to elucidate how patient-provider communication relates to patient outcomes, and;4) participation in seminars/workshops to gain the fundamental knowledge needed to develop an intervention to improve patient-provider communication. Despite the mounting evidence that racial differences in patient- provider communication affects patient care, many of these studies have examined processes of care such as patient satisfaction with little attention to intermediate outcomes such as medication adherence. Further, studies examining racial differences in patient-provider communication have not adequately captured the mutual influence the patient and provider may have on one another during the interaction. Thus, the potential pathways through which patient-provider communication contribute to hypertension-related disparities is not clearly understood. This proposed two-phase, mixed-methods study, provides a unique opportunity to address these gaps by elucidating the effect of patient's race on patient-provider communication and medication adherence among 120 hypertensive black and white patients receiving care at the Bellevue Ambulatory Care Practice in New York City. Specifically, findings from a qualitative analysis of patient-provider communication (Phase 1) will inform the development of a conceptual model that will be used to quantitatively evaluate the relationship between patient's race, patient-provider communication and medication adherence (Phase 2). In addition, patient-, provider-, and clinic-level characteristics will be evaluated as covariates to examine potential confounders of the relationship between patient-provider communication and medication adherence. The proposed career development plan and research project, along with the support of an established mentorship team and access to a well-resourced institution, will be instrumental in launching the candidate's academic research trajectory into an independent investigator with a focus in behavioral medicine and cardiovascular health disparities. The knowledge gained from this award will provide invaluable information for developing interventions to reduce the disparate rates of cardiovascular mortality and morbidity in high-risk populations. PUBLIC HEALTH RELEVANCE: According to the Institute of Medicine report Unequal Treatment, patient-provider communication may play a vital role in disparate health outcomes between blacks and whites. With increasing evidence that provider communication behaviors are potentially modifiable, and enduring, it is critical to understand the effect of patient-provider communication on intermediate patient outcomes such as medication adherence. Identifying the potential pathways through which interpersonal processes in the patient-provider relationship differentially affect medication adherence in black patients compared to whites will provide needed information for developing targeted interventions to improve patient-provider communication, thus reducing the racial disparities in cardiovascular mortality and morbidity.

? DESCRIPTION (provided by applicant): Corrosive couple conflict (CCC) and coercive parent-child conflict constitute a ubiquitous, potent, and destructive (but modifiable) interpersonal poison to a wide range of adult and children's health outcomes. Such patterns are also linked with poor parent-child relationships and with more harsh punishment, which is associated with disturbed responses to environmental stresses (e.g., disruption in sympathetic nervous system and hypothalamic-pituitary-adrenocortical responses), a wide variety of adverse health outcomes in childhood, including dental caries, obesity, and diabetes related metabolic markers. This phase of NIH's Science of Behavior Change program emphasizes an experimental medicine approach to behavior change necessitating identification of central interpersonal/social targets for maximal impact on far-reaching panoply of health outcomes. This project will focus on factors associated diabetes and oral health (though the processes affect many other disease outcomes). Both are associated with pain, distress, expense, loss of productivity, and even mortality. They share overlapping medical regimens, are driven by overlapping proximal health behaviors, and affect a wide developmental span, from early childhood to late adulthood. As requested by the RFA, we will isolate three proximal health behaviors: (a) medical regimen adherence; (b) eating and drinking high sugar/calorie items; and (c) self-care behaviors. CCC/coercive parent-child conflicts are marked by an interrelated set of affective, behavioral, and physiological signatures. In the UH2 phase, we will identify/develop/validate assays. We will also identify/develop, and test interventions to reduce CCC/coercion targets. In the UH3 phase, we expect to conduct at least 2 studies to test whether reduction in targets results in improvement in adherence and other health behaviors of interest. One study will focus on parents and children, the other on adults in intimate relationships. Health behaviors related to diabetes and oral health problems will serve as dependent variables as will self-care behaviors in both diabetes and oral health. To place these health behaviors in the context of disease conditions and medical regimen adherence, we expect to focus one study on a sample of children with early childhood caries and the other study on an adult sample with diabetes.

Project Summary: Uncontrolled type 2 diabetes (T2D) is a major health problem in the US that constitutes a significant cause of morbidity and mortality, particularly in vulnerable populations who continue to suffer disproportionately higher rates of complications. Despite the significant physical and psychosocial impact T2D has on patients' behavioral, functional and clinical outcomes; much of clinical practice continues to neglect patients' perspective of their T2D giving preference to the physiological aspects of the disease. However, without incorporation of patients' perspective of their health and functional status into diabetes care, achievement of the outcomes desired by patients and primary care providers (PCP) will be unattainable. To address this gap, we will use the Technology Acceptance Model and Capability-Opportunity-Motivation Model of Behavior to evaluate the efficacy of a technology-based patient-reported outcome (PRO) system, the Modern Journal System, for management of T2D [MJS DIABETES]. MJS is an innovative mobile platform that utilizes text-messaging to capture PRO data in real-time, enhance patient engagement through data-driven feedback and motivational messages, and creates dynamic data visualizations of the PRO data that can be shared through printed reports, and integrated into the electronic health record (EHR). Using a mixed-methods design, we will conduct this study in two phases: 1) A formative phase, using the evidence-based user- centered design approach; and 2) a clinical-efficacy phase. The formative phase will use qualitative methods to: a) adapt MJS DIABETES to the needs of PCP and patients with T2D; b) integrate MJS DIABETES into the EHR system, primary care practice as well as the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and PCPs in order to optimize the tool's performance and workflow integration. For the clinical efficacy phase, we will evaluate in a randomized control trial, the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices. Patients randomized to the intervention arm will be enrolled in MJS DIABETES where they will receive and respond to PROs via text message, receive data-driven feedback and motivational messages based on patterns of their PROs, and journal reports over the 12-month study. PCPs will have access to reports of patients' PRO data through the MJS-EHR interface, which can be viewed during visits with the patient or asynchronously to track patient PROs between visits. Patients randomized to the UC arm will receive standard T2D treatment recommendations, as determined by their PCP. The primary outcome will be mean reduction in HbA1c from baseline to 12 months. Secondary outcomes will include changes in: a) patient adherence to self-care behaviors (e.g., lifestyle and medication recommendations); and b) theoretical mediators of diabetes knowledge, self-efficacy, outcomes expectations, and patient-provider communication. Regardless of group assignment, all outcome data will be assessed at baseline, 3- 6-, 9- and 12-months.

Project Summary: Despite advances in treatments for hypertension (HTN) over the past three decades, poorly controlled blood pressure (BP) remains a significant public health problem in the United States. Evidence-based care of patients with uncontrolled HTN requires collaboration of healthcare providers, patients, and the healthcare system within which the care occurs?in order for patients to achieve a full understanding of their disease, and to be adherent to medications that are needed to reduce elevated BP. While studies have consistently documented the beneficial effects of collaborative patient?physician relationships on improvements in medication adherence and attainment of disease control among patients with chronic diseases such as HTN, 40% of primary care visits do not include discussions about medication adherence, irrespective of patients' disease control status. When these conversations do occur, primary care physicians spend an average of 5% of the interaction discussing medications. As the largest segment of the healthcare workforce, nurses are integral members of the care team and thus, well poised to assist with critical tasks such as counseling for medication adherence. While interventions have targeted nurses' communication skills for patient adherence, they have not consistently led to improvements in nurse or patient-level outcomes. A major limitation has been the use of brief workshop-based interventions that include limited opportunity for nurses to practice the newly learned skills and the failure to integrate the new role into their daily work. The proposed study provides an opportunity to address this gap in the literature, and is a logical extension of Dr. Schoenthaler's excellent research trajectory focused on patient-provider communication and medication adherence, and builds on pilot data from Dr. Schoenthaler's K23 Career Development Award. Based on her findings, the current application will partner with clinic nurses as the primary target for a communication intervention in order to support primary care physicians in assessing and addressing barriers to medication adherence. Specifically, this proposal will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2) develop a virtual communication simulation designed to improve the quality of adherence counseling by allowing nurses repeated opportunities to practice discussing medication adherence with virtual patients; and 3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy of the simulation on changes in: a) nurses' collaborative communication skills, b) medication adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled HTN who are non-adherent to their medications.

Project Summary: Despite increasing awareness and treatment of hypertension (HTN) across all racial/ethnic groups, Latinos have the lowest blood pressure (BP) control rates in the US (Latino adults: 34% vs. 43% and 53% in non-Hispanic black and white adults). These statistics may be explained by the disproportionately poorer adherence to antihypertensive medications among Latinos compared to blacks and whites. Systems- level interventions conducted in primary care settings have improved medication adherence in minority populations. Our Ayudando a Latinos Hipertensos Para Mejorar Adherencia a sus Medicamentos (ALMA) trial, which informs this proposal significantly improved both BP control (51 vs. 29%, p=.04) and medication adherence (78 vs. 72%, p=.02) compared to enhanced usual care in a sample of 119 Latino patients followed in a safety-net practice. Despite their efficacy, evidence-based interventions like ALMA often take up to 17 years to be translated into clinical practice. Implementation strategies are sorely needed to accelerate the translation of evidence-based interventions into routine ?real world? safety-net practices, in order to reduce disparities in BP control in vulnerable populations. Practice facilitation (PF) is one method to accelerate the implementation of evidence-based interventions into healthcare settings. Through PF, a facilitator works with healthcare teams to develop the skills to adapt and implement evidence-based system changes and promotes a tailored approach to integrating those changes into the clinic workflow. Although evidence supports the effect of PF for preventive screenings (e.g., breast examination), its impact on implementing evidence-based systems approaches to support HTN management in safety-net practices remains largely untested. This proposal provides an opportunity to fill this evidence-to-practice gap by evaluating the effectiveness of PF as a practical and replicable strategy for implementing ALMA in a network of 12 safety-net Family Health Centers (FHCs) in New York City. Using a mixed-methods design, we will conduct this study in two phases: (1) A pre- implementation phase where we will refine the PF strategy, informed by our prior work, based on the Consolidated Framework for Implementation Research to facilitate the implementation of ALMA at the FHCs. (2) An implementation phase, during which we will evaluate, in a pragmatic cluster-randomized controlled trial, the effect of the PF strategy compared to a self-directed condition (i.e., receipt of information for implementing ALMA but no facilitation) on implementation fidelity (primary outcome) of ALMA and on clinical outcomes (secondary outcome) at 12 months among a sample of 650 Latinos with uncontrolled HTN cared for at the FHCs. Implementation fidelity will be assessed using a mixed methods approach based on the five core dimensions of implementation fidelity, as defined by Proctor?s Implementation Outcomes Framework. Clinical outcome measures include BP control (defined as <140/90 mmHg) and medication adherence (assessed using the proportion of days covered via pharmacy records).

Project Summary Abstract This diversity supplement will provide Ms. Deborah Onakomaiya with invaluable mentorship, training, and advanced research experience via the recently funded Actions to Decrease Disparities in Risk and Engage in Shared Support for BP Control (ADDRESS-BP) grant (#HL151310). The research portion of this supplement aims to conduct an environmental scan of primary care facilities (PCFs) utilizing a mixed-mixed methods approach to evaluate barriers, facilitators, and readiness of these practices to participate in the parent study?s (ADDRESS-BP) intervention across 20 New York City-based PCFs. The first step needed to successfully implement an evidence-based intervention (EBI) is examining the context of the implementation site i.e. understanding factors that might hinder or facilitate the implementation of the EBIs within the context of a clinic, primary care facilities, or community organization, in which the EBI will be implemented. One way to achieve this is by using an environmental scan. An environmental scan is a structured practice capacity assessment that combines qualitative (observations, key informant interviews) and quantitative (surveys) data collection methodologies to develop a robust understanding of the internal conditions and external factors that affect an organization. The proposed diversity supplement will utilize an environmental scan toolkit guided by the Consolidated Framework for Implementation Research (CFIR) to assess and document factors related to the inner and outer setting domains of CFIR that might influence PCFs capacity to implement evidence-based interventions for hypertension control among Black patients. Findings from the environmental scan will be useful for understanding the implementation setting?s readiness to receive the intervention, providing key areas of modification for the intervention before it is delivered at PCFs, building key relationships with medical staff and workers at PCFs, and finally developing a shared understanding of project roles and responsibilities, before intervention delivery. In this diversity supplement, Ms. Onakomaiya aims to: 1) evaluate through an environmental scan the practice factors and characteristics, which may influence the feasibility and acceptability of implementing ADDRESS-BP in the PCFs. 2) assess culture, attitudes, and beliefs among PCF staff regarding the Implementation of ADDRESS-BP. The combinations of findings from both aims will determine the best approach for adapting and tailoring the intervention and the practice facilitation Implementation strategy at participating PCFs before the UH3 Implementation Phase of the parent study.

Project Summary Medication nonadherence is common among patients with hypertension and is associated with increased cardiovascular morbidity and mortality. Nonetheless, medications adherence is often not addressed in clinical practice due to a number of factors, including lack of readily available assessment tools and provider competing demands. Recent uptake of electronic prescribing from the electronic health record (EHR) to pharmacies offers the opportunity for scalable, real-time measurement of medication adherence that can be used for interventions at the point of care. In addition, we have demonstrated that an intervention utilizing medical assistants (MAs) trained as health coaches can improve medication adherence among patients with hypertension. The objective of this application is to implement a multicomponent intervention that utilizes linked EHR-pharmacy data and teamlets, consisting of primary care providers (PCPs) and MAs who will receive brief training in health coaching, to pragmatically address medication adherence in a real-world, primary care setting. The intervention consists of four components: 1) patients with hypertension will be automatically screened for low medication adherence using linked EHR?pharmacy data at the time of a PCP encounter; 2) MAs will deliver a validated, rapid, 12-item survey of common causes of non-adherence; 3) MAs will address specific barriers to adherence tailored to survey response, including delivery of brief health coaching based on motivational interviewing; and 4) PCPs will address specific barriers to adherence based on survey response. The central hypothesis is that this multicomponent intervention will improve medication adherence and blood pressure for patients with hypertension. We will test this hypothesis in a hybrid type I effectiveness- implementation pragmatic, cluster-randomized trial in 22 diverse primary care clinics. We will also evaluate the implementation of the intervention, including adoption, acceptability, fidelity, cost-effectiveness, and sustainability. The project is innovative because it proposes to: 1) measure adherence using pharmacy fill data available in the EHR for use in real-time clinical interventions; 2) utilize teamlets in which MAs will be given the tools to assess reasons for non-adherence and deliver tailored health coaching in a pragmatic, scalable way; and 3) incorporate user centered design principles to maximize incorporation of the intervention into both PCP and MA workflows. The proposed project is significant because it is expected to provide a scalable implementation model that utilizes linked EHR-pharmacy fill data, clinical decision support, and teamlets to improve anti-hypertensive medication adherence. If shown to be successful, this multicomponent, clinic-based intervention can be scaled to ultimately improve cardiovascular outcomes for millions of patients with hypertension.