The Heart Healthy Lenoir project--an intervention to reduce disparities in hypertension control: study protocol.
Ontology highlight
ABSTRACT:
SUBMITTER: Halladay JR
PROVIDER: S-EPMC4015615 | biostudies-literature | 2013 Oct
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care.Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions.As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have incorporated stakeholder input and tailored components of the interventions to meet the specific needs of the involved clinics and communities. Results from this study will provide knowledge about how integrated multi-level interventions can improve hypertension care and reduce disparities.ClinicalTrials.gov NCT01566864.
| S-EPMC3680084 | biostudies-literature
Project description:Initiatives to improve hypertension control within academic medical centers and closed health systems have been extensively studied, but large community-wide quality improvement (QI) initiatives have been both less common and less successful in the United States. The authors examined a community-wide QI initiative across 226 843 patients from 198 practices in nine counties across upstate New York to improve hypertension control and reduce disparities. The QI initiative focused on (a) providing population and practice-level comparative data, (b) community engagement, especially in underserved communities, and (c) practice-level quality improvement assistance, but was not designed to examine causality of specific components. Across the nine counties, hypertension control rates improved from 61.9% in 2011 to 69.5% in 2016. Improvements were greatest among whites (73.7%-81.5%) and more modest among black patients (58.8%-64.7%). The authors noted a considerable improvement in BP within the group of patients with the highest risk (defined as a BP ≥ 160/100) and a decrease in disparities within this group. The quality collaborative identified five key lessons to help guide future community initiatives: (a) anticipate a plateauing of response; (b) distinguish the needs of disparate populations and create subpopulation-specific strategies to address and reduce disparities; (c) recognize the variation across low SES practices; (d) remain open to the refinement of outcome measures; and (e) continually seek best practices and barriers to success. Overall, a large community-wide QI initiative, involving multiple different stakeholders, was associated with improvements in BP control and modest reductions in some targeted disparities.
| S-EPMC8030610 | biostudies-literature
Project description:Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.This paper describes the protocol of a nested 2 x 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.Overall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.ClinicalTrials.gov identifier NCT00201136.
| S-EPMC2654882 | biostudies-literature
Project description:BackgroundThe Chronic Care Model (CCM) has been endorsed by experts to reduce disparities in chronic disease outcomes but benefits may be slow to appear in low-income populations.ObjectiveTo evaluate the effect of CCM implementation on systolic blood pressure (SBP) control in minority patients with diabetes mellitus (DM).DesignRetrospective study from 2012 to 2016 in two primary care clinics with primarily uninsured, Hispanic patients.PatientsFour 2-year cohorts of patients aged 18-75 with DM and SBP ≥ 140 mmHg on HTN drugs in year 1 and SBP measured 1 year later in year 2.InterventionImplementation of CCM for DM in January 2014 involved: electronic medical record revision, a DM registry, hypertension (HTN) treatment protocol, team education, performance feedback, and case management.Main measureSBP < 140 mmHg in year 2.Key resultsOf 2354 patients, the mean age was 56.2 (SD 9.5), baseline SBP 153.8 (SD 14.9) mmHg, and 79.8% Hispanic. Last SBP < 140 mmHg was 58.4% for cohort 1 (2012-2013) and 68.5% for cohort 4 (2015-2016). Adjusted odds ratios (AORs) for SBP control versus cohort 1 were 1.35 (95% CI 1.07, 1.69) for cohort 3 (2014-2015) and 2.13 (95% CI 1.60, 2.80) for cohort 4. AORs for SBP control were reduced by 15% per HTN drug at baseline (P = 0.001), 9% per HTN drug added at last SBP (P = 0.024), and 22% for multi-dose HTN drugs (P = 0.004). Among patients with persistent elevated SBP and represented in multiple cohorts, AORs for control were still over 2-fold higher for cohort 4 versus cohort 1.ConclusionsAfter adopting the CCM for primarily Hispanic patients with DM, SBP control increased significantly despite treatment with fewer HTN drugs. Yet improvement took 3-4 years, suggesting that financial rewards for using the CCM to achieve improved clinical outcomes for low-income, minority patients may be delayed.
| S-EPMC6108988 | biostudies-literature
Project description:The purpose of this study was to assess the effectiveness of a quality improvement (QI) plan aimed at primary healthcare teams (PHCTs) to optimise hypertension control and to compare it with standard clinical care.Design Multicentric, non-randomised, quasi-experimental controlled intervention study. Setting 5 PHCTs in the intervention and 13 in the standard care group in the province of Barcelona, Catalonia, Spain. Participants This is a population-based study in which all patients over 18 years of age with a diagnosis of hypertension before 1 January 2006 were included (n=9877 in the intervention group and n=21?704 in the control group). Intervention A QI plan that targeted primary care professionals. The plan included training sessions, implementation of recommended clinical practice guidelines for the management of hypertensive patients and audit and feedback to health professionals. Main outcome measure Prevalence of hypertensive patients with an adequate blood pressure (BP) control.The adjusted difference between intervention and standard care groups in the odds of BP control was 1.3 (95% CI 1.1 to 1.6, p=0.003). Results of the mixed model on repeated measures showed that, on average, an individual in the intervention group had an increase of 92% in the odds of BP control (OR 1.9, 95% CI 1.7 to 2.1).The implementation of a QI plan can improve BP control. This strategy is potentially feasible for up-scaling within the existing PHCTs.ClinicalTrials.gov MS: 1998275938244441.
| S-EPMC3332244 | biostudies-literature
Project description:BackgroundThe HIV epidemic continues to disproportionately burden marginalized populations despite the availability of effective preventive and therapeutic interventions. Transgender women are severely affected by HIV worldwide including in Brazil and other low- and middle-income countries, with evidence of increasing new infections among young people. There is an urgent need for youth-specific HIV prevention and care interventions for young transgender women in Brazil.ObjectiveThis study aims to (1) address stigma in the Brazilian public health system and (2) reduce barriers to HIV care and prevention with systems navigation among young transgender women aged 18-24 years in Rio de Janeiro, Brazil.MethodsThe Brilhar e Transcender (BeT) study is a status-neutral, peer-led, single-arm digital intervention study enrolling 150 young transgender women in Rio de Janeiro, Brazil. The intervention was pilot tested and refined using data from a formative phase. The BeT intervention takes place over 3 months, is delivered remotely via mobile phone and in person by peers, and comprises three components: (1) BeT sessions, (2) digital interactions, and (3) automated messages. Eligibility criteria include identifying as transgender women, being aged 18-24 years, speaking in Portuguese, and living in the Rio de Janeiro metropolitan area in Brazil. The primary outcomes are HIV incidence, pre-exposure prophylaxis uptake, linkage to HIV care, and viral suppression. Primary outcomes were assessed at baseline and quarterly for 12 months. Participants respond to interviewer-based surveys and receive tests for HIV and sexually transmitted infections.ResultsThe study has been approved by the Brazilian and the US local institutional review boards in accordance with all applicable regulations. Study recruitment began in February 2022 and was completed in early July 2022. Plans are to complete the follow-up assessment of study participants on July 2023, analyze the study data, and disseminate intervention results by December 2023.ConclusionsInterventions to engage a new generation of transgender women in HIV prevention and care are needed to curb the epidemic. The BeT study will evaluate a digital peer-led intervention for young transgender women in Brazil, which builds on ways young people engage in systems and uses peer-led support to empower transgender youth in self-care and health promotion. A promising evaluation of the BeT intervention may lead to the availability of this rapidly scalable status-neutral HIV intervention that can be translated throughout Brazil and other low- and middle-income countries for young transgender women at high risk of or living with HIV.Trial registrationClinicalTrials.gov NCT05299645; https://clinicaltrials.gov/ct2/show/NCT05299645.International registered report identifier (irrid)DERR1-10.2196/44157.
| S-EPMC9938440 | biostudies-literature
Project description:BackgroundTobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics.DesignCluster-randomized controlled trial with village as the unit of assignment. Sixteen villages in rural southwest Alaska were stratified on village size and randomized to a multicomponent intervention (n = 8 villages) or usual care (n = 8 villages).MethodsPregnant AN women from the study villages were enrolled. All participants receive the usual care provided to pregnant women in this region. Participants from intervention villages additionally receive individual phone counseling on healthy pregnancies plus a social marketing campaign targeting the entire community delivered by local AN "Native Sisters." Baseline measurements for all enrolled pregnant women have been completed. Follow-up assessments are ongoing at delivery, and at 2 and 6 months postpartum. The primary outcome is biochemically verified tobacco use status at 6 months postpartum.ResultsRecruitment was feasible with 73% of eligible women screened enrolled. The program reached more than half (56%) of AN pregnant women from the study villages during the recruitment period. Participants are N = 352 pregnant AN women, 188 enrolled from intervention villages and 164 from control villages. At baseline, participants' mean (SD) age was 25.8 (5.0) years, they were at 26.8 (9.8) weeks gestation, and 66.5% were current tobacco users.DiscussionProcesses and products from this project may have relevance to other Native American populations aiming to focus on healthy pregnancies in their communities.
| S-EPMC6407629 | biostudies-literature
Project description:BackgroundThe proportion of patients with controlled hypertension (< 140/90 mmHg) is very low in India. Thus, there is a need to improve blood pressure management among patients with uncontrolled hypertension through innovative strategies directed at health system strengthening.MethodsWe designed an intervention consisting of two important components - an electronic decision support system (EDSS) used by a trained nurse care coordinator (NCC). Based on preliminary data, we hypothesized that this intervention will be able to reduce mean systolic blood pressure by 6.5 mmHg among those with uncontrolled blood pressure in the intervention arm compared to the standard treatment arm (paper-based hypertension treatment guidelines). The study will adopt a cluster randomized trial design with the community health center (CHC) as the unit of randomization. The trial will be conducted in Visakhapatnam district (southern India). A total of 1876 participants aged ≥30 years with high blood pressure - systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg will be enrolled from 12 CHCs. The intervention consists of trained NCCs equipped with an evidence-based hypertension treatment algorithm in the form of the EDSS with regular SMSs to patients with hypertension to promote hypertension treatment and blood pressure control for 12 months. The primary outcome will be difference in the mean change of SBP, from baseline to 12 months, between the intervention and the standard treatment arm. The secondary outcomes are the difference in mean change of DBP; difference in the proportion of patients with controlled blood pressure (< 140/90 mmHg); difference in mean change of fasting blood sugar, HbA1C, eGFR, and albumin to creatinine ratio; difference in the proportion of patients visiting the CHC regularly (number of actual visits to the CHC/number of visits suggested by the EDSS > 80%); difference in proportion of patients compliant to anti-hypertensive medication/s; cost-effectiveness of intervention versus enhanced care. All the outcomes will be assessed at 12 months.DiscussionThe study is expected to provide evidence on the effectiveness of NCC-led, EDSS-based hypertension management in India and can likely offer an exemplar for improving cardiovascular disease (CVD) management in India within the resource-constrained public healthcare system.Trial registrationClinicalTrials.gov, ID: NCT03164317 ). Registered retrospectively on 23 May 2017 (first patient enrolled on 6 April 2017) because the authors did not receive a response to their original registration submission (5 January 2017) to the Clinical Trial Registry - India (CTRI).
| S-EPMC6081824 | biostudies-literature
Project description:BACKGROUND:The shortage of organs for kidney transplantation for patients with end-stage renal disease (ESRD) is magnified in Hispanics/Latin Americans in the United States. Living donor kidney transplantation (LDKT) is the treatment of choice for ESRD. However, compared to their representation on the transplant waitlist, fewer Hispanics receive a LDKT than non-Hispanic whites. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and language barriers. Few interventions have been designed to reduce LDKT disparities. This study aims to reduce Hispanic disparities in LDKT through a culturally targeted intervention. METHODS/DESIGN:Using a prospective effectiveness-implementation hybrid design involving pre-post intervention evaluation with matched controls, we will implement a complex culturally targeted intervention at two transplant centers in Dallas, TX and Phoenix, AZ. The goal of the study is to evaluate the effect of Northwestern Medicine's® Hispanic Kidney Transplant Program's (HKTP) key culturally targeted components (outreach, communication, education) on Hispanic LDKT rates over five years. The main hypothesis is that exposure to the HKTP will reduce disparities by increasing the ratio of Hispanic to non-Hispanic white LDKTs and the number of Hispanic LDKTs. We will also examine other process and outcome measures including: dialysis patient outreach, education session attendance, marketing efforts, Hispanic patients added to the waitlist, Hispanic potential donors per potential recipient, and satisfaction with culturally competent care. We will use mixed methods based on the Promoting Action on Research Implementation in Health Services (revised PARIHS) and the Consolidated Framework for Implementation Research (CFIR) frameworks to formatively evaluate the fidelity and innovative adaptations to HKTP's components at both study sites, to identify moderating factors that most affect implementation fidelity, and to identify adaptations that positively and negatively affect outcomes for patients. DISCUSSION:Our study will provide new knowledge about implementing culturally targeted interventions and their impact on reducing health disparities. Moreover, the study of a complex organizational-level intervention's implementation over five years is rare in implementation science; as such, this study is poised to contribute new knowledge to the factors influencing how organizational-level interventions are sustained over time. TRIAL REGISTRATION:(ClinicalTrials.gov registration # NCT03276390 , date of registration: 9-7-17, retrospectively registered).
| S-EPMC5956564 | biostudies-literature
Project description:Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.MethodsRICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, "Standard of Care Plus" (SCP), to a multi-level intervention, "Collaborative Care/Stepped Care" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.DiscussionThis study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.Trial registrationClinicaltrials.govNCT02674464.
| S-EPMC7481013 | biostudies-literature