Secondary analysis of electronically monitored medication adherence data for a cohort of hypertensive African-Americans

BackgroundElectronic monitoring devices (EMDs) are regarded as the “gold standard” for assessing medication adherence in research. Although EMD data provide rich longitudinal information, they are typically not used to their maximum potential. Instead, EMD data are usually combined into summary measures, which lack sufficient detail for describing complex medication-taking patterns. This paper uses recently developed methods for analyzing EMD data that capitalize more fully on their richness.MethodsRecently developed adaptive statistical modeling methods were used to analyze EMD data collected with medication event monitoring system (MEMS™) caps in a clinical trial testing the effects of motivational interviewing on adherence to antihypertensive medications in a cohort of hypertensive African-Americans followed for 12 months in primary care practices. This was a secondary analysis of EMD data for 141 of the 190 patients from this study for whom MEMS data were available.ResultsNonlinear adherence patterns for 141 patients were generated, clustered into seven adherence types, categorized into acceptable (for example, high or improving) versus unacceptable (for example, low or deteriorating) adherence, and related to adherence self-efficacy and blood pressure. Mean adherence self-efficacy was higher across all time points for patients with acceptable adherence in the intervention group than for other patients. By 12 months, there was a greater drop in mean post-baseline blood pressure for patients in the intervention group, with higher baseline blood pressure values than those in the usual care group.ConclusionAdaptive statistical modeling methods can provide novel insights into patients’ medication-taking behavior, which can inform development of innovative approaches for tailored interventions to improve medication adherence

A Citizen Science Approach to Identifying Indoor Environmental Barriers to Optimal Health for Under 5s Experiencing Homelessness in Temporary Accommodation

The first five years of life are critical for optimal growth, health, and cognitive development. Adverse childhood experiences, including experiencing homelessness, can be a risk factor for multiple health issues and developmental challenges. There is a dearth of data collected with and by families with children under age five living in temporary accommodation due to experiencing homelessness (U5TA) describing indoor environmental barriers that prevent U5TA from achieving and maintaining optimal health. The aim of this study was to address this current gap using a citizen science approach. Fifteen participants, who were mothers of U5TA living in a deprived area of London, and the lead researcher collected data in late 2019/early 2020 using: (I) a housing survey conducted via a mobile app; (II) house visits; and (III) collaborative meetings. Data were analyzed using thematic analysis. Key themes included: overcrowding/shared facilities, dampness/mold growth, poor/inadequate kitchen/toilet facilities, infestations/vermin, structural problems/disrepair, unsafe electrics, excessively cold temperatures, and unsafe surfaces that risk causing trips/falls, with all participants experiencing multiple concurrent indoor environmental barriers. The citizen science approach was successfully used to collect meaningful data demonstrating the need for child-centered housing policies meeting the needs of current and future generations of families living in TA

A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial

BACKGROUND: Latinos experience disproportionately higher rates of uncontrolled hypertension as compared to Blacks and Whites. While poor adherence is a major contributor to disparities in blood pressure control, data in Latino patients are scant. More importantly, translation of interventions to improve medication adherence in community-based primary care practices, where the majority of Latino patients receive their care is non-existent. METHODS: Using a randomized controlled design, this study evaluates the effectiveness of a culturally tailored, practice-based intervention compared to usual care on medication adherence, among 148 Latino patients with uncontrolled hypertension who are non-adherent to their antihypertensive medications. Bilingual medical assistants trained as Health Coaches deliver the intervention using an electronic medical record system-embedded adherence script. Patients randomized to the intervention group receive patient-centered counseling with a Health Coach to develop individualized self-monitoring strategies to overcome barriers and improve adherence behaviors. Health Coach sessions are held biweekly for the first 3 months (6 sessions total) and then monthly for the remaining 3 months (3 sessions total). Patients randomized to the usual care group receive standard hypertension treatment recommendations as determined by their primary care providers. The primary outcome is the rate of medication adherence at 6 months. The secondary outcome is reduction in systolic and diastolic blood pressure at 6 months. DISCUSSION: If successful, findings from this study will provide salient information on the translation of culturally tailored, evidence-based interventions targeted at medication adherence and blood pressure control into practice-based settings for this high-risk population. TRIAL REGISTRATION: NCT01643473 on 16 July 2012

Community-Based Settings and Sampling Strategies: Implications for Reducing Racial Health Disparities Among Black Men, New York City, 2010–2013

Introduction Rates of screening colonoscopies, an effective method of preventing colorectal cancer, have increased in New York City over the past decade, and racial disparities in screening have declined. However, vulnerable subsets of the population may not be reached by traditional surveillance and intervention efforts to improve colorectal cancer screening rates. Methods We compared rates of screening colonoscopies among black men aged 50 or older from a citywide random-digit–dial sample and a location-based sample focused on hard-to-reach populations to evaluate the representativeness of the random-digit–dial sample. The location-based sample (N = 5,568) was recruited from 2010 through 2013 from community-based organizations in New York City. Descriptive statistics were used to compare these data with data for all black men aged 50 or older from the 2011 cohort of the Community Health Survey (weighted, N = 334) and to compare rates by community-based setting. Results Significant differences in screening colonoscopy history were observed between the location-based and random-digit–dial samples (49.1% vs 62.8%, P \u3c .001). We observed significant differences between participants with and without a working telephone among the location-based sample and between community-based settings. Conclusions Vulnerable subsets of the population such as those with inconsistent telephone access are excluded from random-digit–dial samples. Practitioners and researchers should consider the target population of proposed interventions to address disparities, and whether the type of setting reaches those most in need of services

Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial

Background: Racial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), of two Community Transitions Interventions (CTIs). The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management. Methods/Design: This 3-arm trial will randomly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure (SBP) to one of three arms: UHC, UHC complemented by nurse practitioner-delivered transitional care (UHC + NP) or UHC complemented by an NP plus health coach (UHC + NP + HC). Both intervention arms emphasize: 1) linking patients to continuous, responsive preventive and primary care, 2) increasing patients’/caregivers’ ability to manage a culturally and individually tailored BP reduction plan, and 3) facilitating the patient’s reintegration into the community after home health care discharge. The primary hypothesis is that both NP-only and NP + HC transitional care will be more effective than UHC alone in achieving a SBP reduction. The primary outcome is change in SPB at 3 and 12 months. The study also will examine cost-effectiveness, quality of life and moderators (for example, race/ethnicity) and mediators (for example, changes in health behaviors) that may affect treatment outcomes. All outcome data are collected by staff blinded to group assignment. Discussion: This study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes. Trial registration: ClinicalTrials.gov NCT01918891; Registered 5 August 2013

Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices

BACKGROUND: Poor adherence to antihypertensive medications is a significant contributor to the racial gap in rates of blood pressure (BP) control among Latino adults, as compared to Black and White adults. While multi-level interventions (e.g., those aiming to influence practice, providers, and patients) have been efficacious in improving medication adherence in underserved patients with uncontrolled hypertension, the translation of these interventions into routine practice within real world safety-net primary care settings has been inadequate and slow. This study will fill this evidence-to-practice gap by evaluating the effectiveness of practice facilitation (PF) as a practical and tailored strategy for implementing Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA), a multi-level approach to improving medication adherence and BP control in 10 safety-net practices in New York that serve Latino patients. METHODS AND DESIGN: We will conduct this study in two phases: (1) a pre-implementation phase where we will refine the PF strategy, informed by the Consolidated Framework for Implementation Research, to facilitate the implementation of ALTA into routine care at the practices; and (2) an implementation phase during which we will evaluate, in a stepped-wedge cluster randomized controlled trial, the effect of the PF strategy on ALTA implementation fidelity (primary outcome), as well as on clinical outcomes (secondary outcomes) at 12 months. Implementation fidelity will be assessed using a mixed methods approach based on the five core dimensions outlined by Proctor\u27s Implementation Outcomes Framework. Clinical outcome measures include BP control (defined as BP \u3c 130/80 mmHg) and medication adherence (assessed using the proportion of days covered via pharmacy records). DISCUSSION: The study protocol applies rigorous research methods to identify how implementation strategies such as PF may work to expedite the translation process for implementing evidence-based approaches into routine care at safety-net practices to improve health outcomes in Latino patients with hypertension, who suffer disproportionately from poor BP control. By examining the barriers and facilitators that affect implementation, this study will contribute knowledge that will increase the generalizability of its findings to other safety-net practices and guide effective scale-up across primary care practices nationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT03713515, date of registration: October 19, 2018

Challenges and recommendations to improve institutional review boards’ review of community-engaged research proposals: A scoping review

Academic and community investigators conducting community-engaged research (CEnR) are often met with challenges when seeking Institutional Review Board (IRB) approval. This scoping review aims to identify challenges and recommendations for CEnR investigators and community partners working with IRBs. Peer-reviewed articles that reported on CEnR, specified study-related challenges, and lessons learned for working with IRBs and conducted in the United States were included for review. Fifteen studies met the criteria and were extracted for this review. Four challenges identified (1) Community partners not being recognized as research partners (2) Cultural competence, language of consent forms, and literacy level of partners; (3) IRBs apply formulaic approaches to CEnR; & (4) Extensive delays in IRB preparation and approval potentially stifle the relationships with community partners. Recommendations included (1) Training IRBs to understand CEnR principles to streamline and increase the flexibility of the IRB review process; (2) Identifying influential community stakeholders who can provide support for the study; and (3) Disseminating human subjects research training that is accessible to all community investigator to satisfy IRB concerns. Findings from our study suggest that IRBs can benefit from more training in CEnR requirements and methodologie

A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial

Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes. This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion. This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice. Trial Registration: Clinicaltrials.gov NCT0107005