Predictors of Changes in Medication Adherence in Blacks with Hypertension: Moving Beyond Cross-Sectional Data.

BACKGROUND: Many studies have examined the multiple correlates of non-adherence in Blacks. However, they are largely cross-sectional; thus, these studies are unable to examine their predictive value on long-term medication adherence. PURPOSE: The purpose of this study is to examine the predictive role of key psychosocial and interpersonal factors on changes in medication adherence over a 1-year period. METHODS: Data were collected from 815 Black patients with hypertension followed in community health centers. Hypothesized predictor variables included self-efficacy, depressive symptoms, social support, and patient-provider communication measured at baseline, 6, and 12 months. The dependent variable, medication adherence was assessed at baseline, 6, and 12 months. Latent Growth Modeling was used to evaluate the pathways between the latent predictor variables and medication adherence. RESULTS: Participants were mostly female, low-income, with high school education or less, and mean age of 57 years. At baseline, high self-efficacy was associated with low depressive symptoms (ß = -0.22, p = 0.05), collaborative patient-provider communication (ß = 0.17, p = 0.006), and better medication adherence (ß = 1.04, p < 0.001). More social support and collaborative patient-provider communication were associated with low depressive symptoms (ß = -0.08, p = 0.02; ß = -0.18, p = 0.01). More social support was positively associated with collaborative patient-provider communication (ß = 0.32, p < 0.001). In the longitudinal model, increasing self-efficacy over time predicted improvements in medication adherence 1 year later (ß = 1.76, p < 0.001; CFI = 0.95; RMSEA = 0.04; SRMR = 0.04; Chi-Squared Index of Model Fit = 1128.54). CONCLUSIONS: Self-efficacy is a key predictor of medication adherence over time in Black patients with hypertension. Initial levels of self-efficacy are influenced by the presence of depressive symptoms as well as the perceived quality of patient-provider communication.

Rationale and design of Faith-based Approaches in the Treatment of Hypertension (FAITH), a lifestyle intervention targeting blood pressure control among black church members.

BACKGROUND: Uncontrolled hypertension (HTN) is a significant public health problem among blacks in the United States. Despite the proven efficacy of therapeutic lifestyle change (TLC) on blood pressure (BP) reduction in clinical trials, few studies have examined their effectiveness in church-based settings-an influential institution for health promotion in black communities. METHODS: Using a cluster-randomized, 2-arm trial design, this study evaluates the effectiveness of a faith-based TLC intervention vs health education (HE) control on BP reduction among hypertensive black adults. The intervention is delivered by trained lay health advisors through group TLC sessions plus motivational interviewing in 32 black churches. Participants in the intervention group receive 11 weekly TLC sessions targeting weight loss, increasing physical activity, fruit, vegetable and low-fat dairy intake, and decreasing fat and sodium intake, plus 3 monthly individual motivational interviewing sessions. Participants in the control group attend 11 weekly classes on HTN and other health topics delivered by health care experts. The primary outcome is change in BP from baseline to 6 months. Secondary outcomes include level of physical activity, percent change in weight, and fruit and vegetable consumption at 6 months, and BP control at 9 months. CONCLUSION: If successful, this trial will provide an alternative and culturally appropriate model for HTN control through evidence-based lifestyle modification delivered in churches by lay health advisors.

Construction of the Digital Health Equity-Focused Implementation Research Conceptual Model - Bridging the Divide Between Equity-focused Digital Health and Implementation Research.

Digital health implementations and investments continue to expand. As the reliance on digital health increases, it is imperative to implement technologies with inclusive and accessible approaches. A conceptual model can be used to guide equity-focused digital health implementations to improve suitability and uptake in diverse populations. The objective of this study is expand an implementation model with recommendations on the equitable implementation of new digital health technologies. The Digital Health Equity-Focused Implementation Research (DH-EquIR) conceptual model was developed based on a rigorous review of digital health implementation and health equity literature. The Equity-Focused Implementation Research for Health Programs (EquIR) model was used as a starting point and merged with digital equity and digital health implementation models. Existing theoretical frameworks and models were appraised as well as individual equity-sensitive implementation studies. Patient and program-related concepts related to digital equity, digital health implementation, and assessment of social/digital determinants of health were included. Sixty-two articles were analyzed to inform the adaption of the EquIR model for digital health. These articles included digital health equity models and frameworks, digital health implementation models and frameworks, research articles, guidelines, and concept analyses. Concepts were organized into EquIR conceptual groupings, including population health status, planning the program, designing the program, implementing the program, and equity-focused implementation outcomes. The adapted DH-EquIR conceptual model diagram was created as well as detailed tables displaying related equity concepts, evidence gaps in source articles, and analysis of existing equity-related models and tools. The DH-EquIR model serves to guide digital health developers and implementation specialists to promote the inclusion of health-equity planning in every phase of implementation. In addition, it can assist researchers and product developers to avoid repeating the mistakes that have led to inequities in the implementation of digital health across populations.

Frequency and nature of discussing social influences on health in urban safety-net clinics: A qualitative analysis.

OBJECTIVE: Chronic social isolation is a risk factor for all-cause mortality and disease progression, but is not routinely screened for in clinical settings. This study analyzed provider-patient communication patterns about social influences during primary care encounters, to identify opportunities to screen for objective or perceived social isolation. METHODS: Content analysis was conducted on transcripts of 97 audiotaped, English-speaking patient encounters with 27 primary care providers at 3 safety-net primary care centers in New York City. Conversations were first coded for specific social isolation screening, then more broadly to quantify and qualify how social influences were discussed in relation to health. RESULTS: Transcripts included no explicit examples of social isolation screening. Social influences on health were discussed meaningfully in only 28 % of transcripts, compared to medication adherence (93 %) and diet (64 %). Patients initiated conversations about social influences on health twice as often as providers, however providers did not acknowledge 67% of these prompts. CONCLUSION: Social influences on health, including social isolation, were uncommonly discussed in this sample of primary care visits. When social influences were discussed meaningfully, providers utilized relationship-centered communication strategies. PRACTICE IMPLICATIONS: Strategic conversations about social influences, even when brief and informal, can effectively screen patients for social isolation.

Self-reported adherence and reasons for nonadherence among patients with low proportion of days covered for antihypertension medications.

BACKGROUND: Incorporation of pharmacy fill data into the electronic health record has enabled calculations of medication adherence, as measured by proportion of days covered (PDC), to be displayed to clinicians. Although PDC values help identify patients who may be nonadherent to their medications, it does not provide information on the reasons for medication-taking behaviors. OBJECTIVE: To characterize self-reported adherence status to antihypertensive medications among patients with low refill medication adherence. Our secondary objective was to identify the most common reasons for nonadherence and examine the patient sociodemographic characteristics associated with these barriers. METHODS: Participants were adult patients seen in primary care clinics of a large, urban health system and on antihypertensive therapy with a PDC of less than 80% based on 6-month linked electronic health record-pharmacy fill data. We administered a validated medication adherence screener and a survey assessing reasons for antihypertensive medication nonadherence. We used descriptive statistics to characterize these data and logistic and Poisson regression models to assess the relationship between sociodemographic characteristics and adherence barriers. RESULTS: The survey was completed by 242 patients (57% female; 61.2% White; 79.8% not Latino/a or Hispanic). Of these patients, 45% reported missing doses of their medications in the last 7 days. In addition, 48% endorsed having at least 1 barrier to adherence and 38.4% endorsed 2 or more barriers. The most common barriers were being busy and having difficulty remembering to take medications. Compared with White participants, Black participants (incident rate ratio = 2.49; 95% CI = 1.93-3.22) and participants of other races (incident rate ratio = 2.16; 95% CI = 1.62-2.89) experienced a greater number of barriers. CONCLUSIONS: Nearly half of patients with low PDC reported nonadherence in the prior week, suggesting PDC can be used as a screening tool. Augmenting PDC with brief self-report tools can provide insights into the reasons for nonadherence. DISCLOSURES: Dr Kharmats, Ms Martinez, Dr Belli, Ms Zhao, Dr Mann, Dr Schoenthaler, and Dr Blecker received grants from the National Institute of Health/National Heart, Lung, Blood Institute. Dr Voils holds a license by Duke University for the DOSE-Nonadherence measure and is a consultant for New York University Grossman School of Medicine. This research was supported by the NIH (R01HL156355). Dr Kharmats received a postdoctoral training grant from the National Institutes of Health (5T32HL129953-04). Dr Voils was supported by a Research Career Scientist award from the Health Services Research & Development Service of the Department of Veterans Affairs (RCS 14-443). The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the United States Government.

A framework for digital health equity.

We present a comprehensive Framework for Digital Health Equity, detailing key digital determinants of health (DDoH), to support the work of digital health tool creators in industry, health systems operations, and academia. The rapid digitization of healthcare may widen health disparities if solutions are not developed with these determinants in mind. Our framework builds on the leading health disparities framework, incorporating a digital environment domain. We examine DDoHs at the individual, interpersonal, community, and societal levels, discuss the importance of a root cause, multi-level approach, and offer a pragmatic case study that applies our framework.

From Screening to the Receipt of Services: A Qualitative Examination.

INTRODUCTION: Research has focused on developing methods to facilitate screening and tracking data on social risk factors in healthcare settings. Less is known about the multiple factors that shape patients' acceptance of healthcare-based social risk programs. This qualitative study sought to elucidate the multilevel (individual, interpersonal, family/community, system, policy) factors that influence patients' acceptance of a healthcare-based social risk program within a Federally Qualified Health Center in New York City. METHODS: Participants included 5 patients receiving care at the Federally Qualified Health Center who screened positive for social risks, 4 nurses who are responsible for conducting social risk screenings, and 5 Family Support Services counselors who conduct outreach to patients who screened positive. Interviews were conducted from March to June 2021 and analyzed from July to September 2021 using the constant comparative method. RESULTS: Analyses of the transcripts identified the following 3 themes: (1) Patients appreciated being asked about social risk factors, but there was a mismatch between their understanding of the screening process, their desire for assistance, and the support received. Although nurses and counselors described relationship-centered approaches to involve patients in the process, patients reported feeling initial discomfort and confusion; (2) Multilevel barriers inhibit patients' acceptance of assistance; and (3) Patient trust in the physician and healthcare organization serves as facilitators to acceptance. CONCLUSIONS: Patients' views about the purpose of a healthcare-based social risk program differed from nurses' and counselors' perspectives of the process. Although patients face multilevel challenges, strong trust in the physician and Family Health Centers served as facilitators to accepting healthcare-based assistance.

Validation of EHR medication fill data obtained through electronic linkage with pharmacies.

BACKGROUND: Recent linkages between electronic health records (EHRs) and pharmacy data hold opportunity for up-to-date assessment of medication adherence at the point of care. OBJECTIVE: To validate linked EHR-pharmacy data, which can be used for point-of-care interventions for concordance with insurance claims data for patients in a large health care delivery system. METHODS: We performed a retrospective cohort study of adult patients with an active antihypertensive medication order and seen as outpatients between August 25, 2019, and August 31, 2019. Pharmacy fill information was obtained from the EHR via linkages with Surescripts pharmacy and pharmacy benefit manager data, as well as from insurance claims available at our institution. We matched antihypertensive medication fills observed in the linked EHR-pharmacy database with available fills in the insurance claims database and calculated the percentage of medication fills that were available in each database. We estimated medication adherence using proportion of days covered in the linked EHR-pharmacy database and in the insurance claims database. RESULTS: Of 26,679 patients with hypertension, 23,348 (87.5%) had at least 1 antihypertensive medication fill recorded in the linked EHR-pharmacy database. Of 1,501 patients matched with the insurance database and with a documented medication fill, a fill was present for 1,484 (98.9%) and 1,259 (83.9%) patients in the linked EHR-pharmacy and insurance databases, respectively. Of 12,109 medication fills recorded in the insurance data, we found an overlap of 11,060 (91.3%) fills with the linked EHR-pharmacy database. The linked EHR-pharmacy database also contained 18,232 of 19,281 (94.6%) medication fills present in either database. Measured medication adherence was higher for patients when based on linked EHR-pharmacy data compared with insurance claims data (42% vs 30%, P < 0.001). CONCLUSIONS: Linked EHR-pharmacy data captured medication fills for the vast majority of patients and resulted in higher estimates of adherence than insurance claims. Our results suggest that pharmacy fill data available in the EHR have sufficient reliability to be used for point-of-care assessment of medication adherence. DISCLOSURES: This study was supported by grant R01HL155149 from the National Heart, Lung, and Blood Institute. Allen Thorpe provided funding for the NYU Langone Health Learning Health System Program, which helped fund this project. The authors have nothing to disclose.

Adaptation and Evaluation of a Symptom-Monitoring Digital Health Intervention for Patients With Relapsed and Refractory Multiple Myeloma: Pilot Mixed-Methods Implementation Study.

BACKGROUND: Relapsed and refractory multiple myeloma (RRMM) is a bone marrow cancer that requires systemic treatment, which often results in severe symptom burden. Recent studies have found that electronic patient-reported outcome (ePRO) interventions implemented in the clinic setting have had positive outcomes for other oncology populations. Evidence of the efficacy of a similar approach is lacking for patients with RRMM. OBJECTIVE: Recent recommendations for digital health interventions call for the publication of descriptions of iterative development processes in order to improve reproducibility and comparability. This study is an implementation pilot aiming to evaluate the acceptability and appropriateness of an ePRO intervention for patients with RRMM and to explore its impact on clinic workflow. METHODS: A total of 11 patients with RRMM were recruited from the John Theurer Cancer Center in Hackensack, New Jersey. Patients used a mobile app to report on 17 symptoms at 4 sessions, each a week apart. Patients could also report symptoms ad hoc. When reports met predefined thresholds, the clinic was alerted and patients received automated guidance. Study end points were assessed using qualitative and quantitative methods. RESULTS: A total of 9 patients (mean age 69.7 years) completed the study. Overall, 83% (30/36) of weekly sessions were completed. Patients found the frequency and time required to complete reporting acceptable. All patients agreed that the app was easy to use and understand. Providers felt the alerts they received required refinement. Patients and providers agreed it would be beneficial for patients to report for longer than 4 weeks. Patients felt that the training they received was adequate but contained too much information for a single session. All patients found the symptoms tracked to be appropriate; providers suggested shortening the list. All patients understood how to use the app for weekly reporting but had confusion about using it ad hoc. Providers felt the ad hoc feature could be removed. Neither patients nor providers viewed the in-app data reports but agreed on their potential value. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. Clinic staff reported that app alerts were too numerous and redundant. They had difficulty responding to alerts within their existing workflow, partially because the data were not integrated into the electronic medical record system. CONCLUSIONS: Overall, the intervention was found to be acceptable and appropriate for patients with RRMM. Points of friction integrating the intervention into the clinic workflow were identified. Clinic staff provided recommendations for addressing these issues. Once such modifications are implemented, ePRO data from patients with RRMM could be used to inform and improve clinical research and care. This study underlines the importance of an iterative approach to implementation that includes all stakeholders in order to ensure successful adoption.

Cluster Randomized Clinical Trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in Blacks.

BACKGROUND: Therapeutic lifestyle change (TLC) is a recommended treatment for patients with hypertension, but its effectiveness in community-based settings remains untested, particularly in black churches-an influential institution for health promotion in black communities. METHODS AND RESULTS: The FAITH study (Faith-Based Approaches in the Treatment of Hypertension) evaluated the comparative effectiveness of a TLC intervention plus motivational interviewing (MINT) sessions versus health education (HE) alone, on blood pressure (BP) reduction among blacks with uncontrolled hypertension. Data were collected on 373 participants meeting eligibility criteria (self-identification as black, age ≥18 years, self-reported diagnosis of hypertension, and uncontrolled BP [BP ≥140/90 or ≥130/80 mm Hg with diabetes mellitus or chronic kidney disease]) from 32 New York City churches. The MINT-TLC intervention plus motivational interviewing treatment comprised 11 weekly group sessions on TLC plus 3 MINT sessions delivered monthly by lay health advisors. The HE control group received 1 TLC session plus 10 sessions on health topics delivered by local experts. The outcomes were BP reduction at 6 months (primary) and BP control and BP reduction at 9 months (secondary). The sample mean age was 63 years; 76% women, with mean BP of 153/87 mm Hg. Using linear mixed-effects regression models, the MINT-TLC intervention plus motivational interviewing group had a significantly greater systolic BP reduction of 5.79 mm Hg compared with the HE group at 6 months ( P=0.029). The treatment effect on systolic BP persisted at 9 months but had reduced significance (5.21 mm Hg; P=0.068). The between-group differences in diastolic BP reduction (0.41 mm Hg) and mean arterial pressure (2.24 mm Hg) at 6 months were not significant. Although the MINT-TLC intervention plus motivational interviewing group had greater BP control than the HE group at 9 months, the difference was not statistically significant (57.0% versus 48.8%; odds ratio, 1.43; 95% CI, 0.90-2.28). CONCLUSIONS: A community-based lifestyle intervention delivered in churches led to significantly greater reduction in systolic BP in hypertensive blacks compared with HE alone. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01065831.

Patient factors, but not provider and health care system factors, predict medication adherence in hypertensive black men.

The problem of medication adherence is pronounced in hypertensive black men. However, factors influencing their adherence are not well understood. This secondary analysis of the ongoing Counseling African Americans to Control Hypertension (CAATCH) randomized clinical trial investigated the patient, provider, and health care system factors associated with medication adherence among hypertensive black men. Participants (N=253) were aged 56.6±11.6 years, earned <$20,000 yearly (72.7%), and almost one half were on Medicaid (44%). Mean systolic blood pressure was 148.7±15.8 mm Hg and mean diastolic blood pressure was 92.7±9.8 mm Hg. Over one half of participants (54.9%) were nonadherent. In a hierarchical regression analysis, the patient factors that predicted medication adherence were age, self-efficacy, and depression. The final model accounted for 32.1% of the variance (F=7.80, df 10, 165, P<.001). In conclusion, age, self-efficacy, and depression were associated with antihypertensive medication adherence in black men followed in Community/Migrant Health Centers. Age is a characteristic that may allow clinicians to predict who may be at risk for poor medication adherence. Depression can be screened for and treated. Self-efficacy is modifiable and its implications for practice would be the development of interventions to increase self-efficacy in black men with hypertension.

Patient and physician factors associated with adherence to diabetes medications.

PURPOSE: The purpose of this study was to examine the influence of patient and physician psychosocial, sociodemographic, and disease-related factors on diabetes medication adherence. These factors were also examined as effect modifiers of the association between quality of the patient-physician relationship and medication adherence. METHODS: Data were collected from 41 Geisinger Clinic primary care physicians and 608 of their patients with type 2 diabetes. Adherence to oral hypoglycemic medications was calculated using a medication possession ratio based on physician orders in electronic health records (MPR(EHR)). MPR(EHR) was defined as the proportion of total time in the 2 years prior to study enrollment that the patient was in possession of oral hypoglycemic medications. Linear regression was used to examine the influence of patient- and physician-level factors on adherence. Effect modification of the patient-physician relationship-adherence association was evaluated by adding the main effects of the individual-level factors and their cross-products to the models. RESULTS: In adjusted analyses, satisfaction with the physician's patient education skills, patient beliefs about the need for their medications, and lower diabetes-related knowledge were associated with better adherence to oral hypoglycemic medications. Shorter duration of time with diabetes and taking only oral hypoglycemic medications were also associated with better adherence. Finally, the association between shared decision making and medication adherence was significantly modified by patients' level of social support. CONCLUSIONS: This study identified several patient-, physician-, and disease-related factors that should be targeted to maximize the potential for developing tailored adherence-enhancing interventions within the context of a collaborative patient-physician relationship.

Daily interpersonal conflict predicts masked hypertension in an urban sample.

BACKGROUND: Masked hypertension (MH) is a risk factor for cardiovascular and cerebrovascular diseases. However, little is known about the effect of psychosocial stressors on MH. METHODS: Daily interpersonal conflict was examined as a predictor of elevated ambulatory blood pressure (ABP) in a community sample of 240 unmedicated black and Latino(a) adults (63% women; mean age 36 years) who had optimal office blood pressure (BP) readings (≤120/80 mm Hg). Electronic diaries were used to assess daily interpersonal conflict (i.e., perceptions of being treated unfairly/harassed during social interactions). Participants rated the degree to which they experienced each interaction as unfair or harassing on a scale of 1-100. Systolic and diastolic ABP (SysABP and DiaABP, respectively) were collected using a validated 24-h ABP monitor. Participants were classified as having marked MH (MMH) if the average of all readings obtained yielded SysABP: ≥135 mm Hg or DiaABP: ≥85 mm Hg. Logistic regression was used to examine whether daily interpersonal conflict is an independent predictor of MMH. RESULTS: This form of MMH (i.e., optimal office BP plus elevated ABP) was present in 21% of participants (n = 50). Those with MMH (vs. without) were significantly more likely to be men (P < 0.001). Daily harassment and unfair treatment scores were significant predictors of MMH group status (P < 0.05). Participants with harassment scores >30 were significantly more likely to be in the MMH group. CONCLUSION: MH may be a concern, even for patients with optimal office BP. Evaluating exposure to psychosocial stressors, including routine levels of interpersonal conflict may help to identify those patients who might benefit from further clinical follow-up.

Revision and validation of the medication adherence self-efficacy scale (MASES) in hypertensive African Americans.

Study purpose was to revise and examine the validity of the Medication Adherence Self-Efficacy Scale (MASES) in an independent sample of 168 hypertensive African Americans: mean age 54 years (SD = 12.36); 86% female; 76% high school education or greater. Participants provided demographic information; completed the MASES, self-report and electronic measures of medication adherence at baseline and three months. Confirmatory (CFA), exploratory (EFA) factor analyses, and classical test theory (CTT) analyses suggested that MASES is unidimensional and internally reliable. Item response theory (IRT) analyses led to a revised 13-item version of the scale: MASES-R. EFA, CTT, and IRT results provide a foundation of support for MASES-R reliability and validity for African Americans with hypertension. Research examining MASES-R psychometric properties in other ethnic groups will improve generalizability of findings and utility of the scale across groups. The MASES-R is brief, quick to administer, and can capture useful data on adherence self-efficacy.

A senior center-based pilot trial of the effect of lifestyle intervention on blood pressure in minority elderly people with hypertension.

OBJECTIVES: To test the feasibility, acceptability, and effect of a senior center-based behavioral counseling lifestyle intervention on systolic blood pressure (BP). DESIGN: A pre-post design pilot trial of behavioral counseling for therapeutic lifestyle changes in minority elderly people with hypertension. Participants completed baseline visit, Visit 1 (approximately 6 weeks postbaseline), and a final study Visit 2 (approximately 14 weeks postbaseline) within 4 months. SETTING: The study took place in six community-based senior centers in New York City with 65 seniors (mean age 72.29+/-6.92; 53.8% female; 84.6% African American). PARTICIPANTS: Sixty-five minority elderly people. INTERVENTION: Six weekly and two monthly "booster" group sessions on lifestyle changes to improve BP (e.g., diet, exercise, adherence to prescribed antihypertensive medications). MEASUREMENTS: Primary outcome was systolic BP (SBP) measured using an automated BP monitor. Secondary outcomes were diastolic BP (DBP), physical activity, diet, and adherence to prescribed antihypertensive medications. RESULTS: There was a significant reduction in average SBP of 13.0+/-21.1 mmHg for the intervention group (t(25)=3.14, P=.004) and a nonsignificant reduction in mean SBP of 10.6+/-30.0 mmHg for the waitlist control group (t(29)=1.95, P=.06). For the intervention group, adherence improved 26% (t(23)=2.31, P=.03), and vegetable intake improved 23% (t(25)=2.29, P=.03). CONCLUSION: This senior center-based lifestyle intervention was associated with a significant reduction in SBP and adherence to prescribed antihypertensive medications and diet in the intervention group. Participant retention and group attendance rates suggest that implementing a group-counseling intervention in senior centers is feasible.