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Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial.

ABSTRACT: Importance:Community health worker (CHW) intervention is a promising approach to address type 2 diabetes among Latinos. However, evidence from randomized clinical studies is limited. Objective:To compare a CHW intervention with enhanced usual care. Design, Setting, and Participants:This 52-week, single-blind, randomized clinical trial included 300 Latino adults aged 18 to 65 years who were treated in 2 public hospital outpatient clinics in Miami-Dade County, Florida, from July 1, 2010, through October 31, 2013. Eligible participants had a hemoglobin A1c (HbA1c) level of 8.0 or greater. Follow-up was completed January 31, 2015, and data were analyzed from March 10, 2015, to June 6, 2016. Interventions:A 1-year CHW intervention consisted of home visits, telephone calls, and group-level activities. Main Outcomes and Measures:Primary outcomes included systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDLC) levels, and HbA1c levels. Secondary outcomes included body mass index, medication regimen intensification, and self-reported measures of diet, physical activity, and medication regimen adherence. Results:Of the 300 participants randomized (135 men [45%] and 165 women [55%]; mean [SD] age, 55.2 [7.0] years), we obtained follow-up data on 215 (71.7%). Participants in the CHW group received a median of 4 home visits and 20 telephone calls. After adjusting for baseline values and covariates, participants in the CHW group had an HbA1c level that was 0.51% lower (95% CI, -0.94% to -0.08%) than that of participants in the enhanced usual care group. The reduction in SBP of 4.62 mm Hg (95% CI, -9.01 to -0.24 mm Hg) did not meet the preplanned target of 8 mm Hg and was not statistically significant in unadjusted models. No significant differences in LDLC levels (mean difference, -8.2 mg/dL; 95% CI, -18.8 to 2.3 mg/dL) or any of the preplanned secondary outcomes were observed. Post hoc analyses suggest that the intervention may be more beneficial among those with worse control of their type 2 diabetes at baseline. Conclusions and Relevance:Among Latinos with poorly controlled type 2 diabetes, a 12-month CHW intervention lowered HbA1c levels by 0.51%. The intervention did not lead to improvements in LDLC levels, and the findings with respect to SBP were variable and half of what was targeted. Future studies should examine whether CHW interventions affect other measures, such as access to health care or social determinants of health. Trial Registration:clinicaltrials.gov Identifier: NCT01152957.

SUBMITTER: Carrasquillo O

PROVIDER: S-EPMC5818804 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial.

Carrasquillo Olveen O Lebron Cynthia C Alonzo Yisel Y Li Hua H Chang Aileen A Kenya Sonjia S

JAMA internal medicine 20170701 7

<h4>Importance</h4>Community health worker (CHW) intervention is a promising approach to address type 2 diabetes among Latinos. However, evidence from randomized clinical studies is limited.<h4>Objective</h4>To compare a CHW intervention with enhanced usual care.<h4>Design, setting, and participants</h4>This 52-week, single-blind, randomized clinical trial included 300 Latino adults aged 18 to 65 years who were treated in 2 public hospital outpatient clinics in Miami-Dade County, Florida, from J ...[more]

PMID: 28459925

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Project description:IntroductionLatinos are the largest minority group in the United States and diabetes or pre-diabetes affects more than 70% of Latinos aged 45 years and older. Miami-Dade County is home to one of the highest populations of diverse Latinos. In this descriptive manuscript, we present baseline characteristics of participants enrolled in the Miami Healthy Heart Initiative (MHHI). This was a study conducted to determine the effects of a community health worker (CHW) intervention among Latinos with poorly controlled diabetes in South Florida.MethodsWe recruited 300 diverse Latino adults with suboptimal diabetes outcomes (HbA1c≥8) into MHHI. This randomized control trial examined the impact of a 1-year CHW-led intervention on glycemic control, blood pressure, and cholesterol levels. At baseline, physiologic measures, including HbA1c, LDL, blood pressure, and BMI, were assessed. Data on socio-demographic characteristics and additional determinants of health such as depression status, provider communication, diet, exercise, cigarette smoking, readiness to change diabetes management behaviors (stages of change), and confidence in ability to improve diabetes self-care (self-efficacy) were collected.ResultsParticipants came from 20 different countries, with Cuban Americans representing 38% of the sample. Most had lived in the US for more than 10 years, had completed at least 12 years of school, and had high levels of health literacy, yet 48% had very low acculturation. Nearly 80% had poor self-efficacy, 80% met the criteria for depression, and 83% were not adherent to their medications. More than half the population was not at their target for blood pressure, 50% were above the recommended LDL goal, and most were obese.ConclusionIn a diverse population of Latinos with poorly controlled diabetes in Miami, we found high rates of depression, obesity, medication non-adherence, poor self-efficacy, and provider communication. These may contribute to poor diabetes control, high blood pressure, and elevated cholesterol.

Project description:OBJECTIVES:There is emerging interest and data supporting the effectiveness of community health workers (CHWs) in non-communicable diseases (NCDs) in low/middle-income countries (LMICs). This study aimed to determine whether a CHW-led intervention targeting diabetes and hypertension could improve markers of clinical disease control in rural Mexico. DESIGN AND SETTING:A prospective observational stepped-wedge study was conducted across seven communities in rural Chiapas, Mexico from March 2014 to April 2018. PARTICIPANTS:149 adults with hypertension and/or diabetes. INTERVENTION:This study was conducted in the context of the programmatic roll-out of an accompaniment-based CHW-led intervention designed to complement comprehensive primary care for adults with diabetes and/or hypertension. Implementation occurred sequentially at 3-month intervals with point-of-care data collected at baseline and every 3?months thereafter for 12 months following roll-out in all communities. OUTCOME MEASURES:Primary outcomes were glycated haemoglobin (HbA1c) and systolic blood pressure (SBP), overall and stratified by baseline disease control. We conducted an individual-level analysis using mixed effects regression, adjusting for time, cohort and clustering at the individual and community levels. RESULTS:Among patients with diabetes, the CHW-led intervention was associated with a decrease in HbA1c of 0.35%; however, CIs were wide (95%?CI -0.90% to 0.20%). In patients with hypertension, there was a 4.7?mm Hg decrease in SBP (95%?CI -8.9 to -0.6). In diabetic patients with HbA1c ?9%, HbA1c decreased by 0.96% (95% CI -1.69% to -0.23%), and in patients with uncontrolled hypertension, SBP decreased by 10.2?mm Hg (95%?CI -17.7 to -2.8). CONCLUSIONS:We found that a CHW-led intervention resulted in clinically meaningful improvement in disease markers for patients with diabetes and hypertension, most apparent among patients with hypertension and patients with uncontrolled disease at baseline. These findings suggest that CHWs can play a valuable role in supporting NCD management in LMICs. TRIAL REGISTRATION NUMBER:NCT02549495.

Project description:BackgroundOne third of U.S. children and two thirds of adults are overweight or obese. Interventions to prevent obesity and thus avert threats to public health are needed. This paper describes the design and methods of the Healthy Kids & Families study, which tested the effect of a parent-focused community health worker (CHW)-delivered lifestyle intervention to prevent childhood obesity.MethodsParticipants were English or Spanish-speaking parent-child dyads (n = 247) from nine elementary schools (grades K-6) located in racial/ethnically diverse low-income communities in Worcester, Massachusetts. Using a quasi-experimental design with the school as the level of allocation, the study compared the lifestyle intervention vs. an attention-control comparison condition. The lifestyle intervention was guided by social cognitive theory and social ecological principles. It targeted the child's social and physical home environment by intervening with parental weight-related knowledge, beliefs, and skills for managing child obesogenic behaviors; and addressed families' needs for community resources supportive of a healthy lifestyle. The two-year CHW-delivered intervention was structured based on the 5As model (Agenda, Assess, Advise, Assist, Arrange follow up) and included two in person sessions and two telephone follow-ups per year with the parent, with a personalized letter and print materials sent after each contact. Parents also received quarterly newsletters, Facebook messages, and invitations to community events. The attention-control comparison condition used the same format and contact time as the intervention condition, but targeted positive parenting skills. Measurements occurred at baseline, and at 6-, 12-, 18- and 24-month follow-up. Assessments included anthropometrics, accelerometry, global positioning system (GPS), and self-report surveys. The primary outcome was child body mass index (BMI) z score. Secondary outcomes were parent BMI; and parent and child diet, physical activity, sedentariness, and utilization of community resources supportive of a healthy lifestyle.DiscussionA CHW-delivered parent-focused lifestyle intervention may provide a translatable model for targeting the high priority public health problem of childhood obesity among low-income diverse communities. If demonstrated effective, this intervention has potential for high impact.Trial registrationClinicalTrials NCT03028233. Registered January 23,2017. The trial was retrospectively registered.

Project description:BACKGROUND:Electronic health record (EHR)-based interventions that use registries and alerts can improve chronic disease care in primary care settings. Community health worker (CHW) interventions also have been shown to improve chronic disease outcomes, especially in minority communities. Despite their potential, these two approaches have not been tested together, including in small primary care practice (PCP) settings. This paper presents the protocol of Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, a 5-year randomized controlled trial integrating both EHR and CHW approaches into a network of PCPs in New York City (NYC) in order to support weight loss efforts among South Asian patients at risk for diabetes. METHODS/DESIGN:The DREAM Initiative was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health). A total of 480 individuals at risk for type 2 diabetes will be enrolled into the intervention group, and an equal number will be included in a matched control group. The EHR intervention components include the provision of technical assistance to participating PCPs regarding prediabetes-related registry reports, alerts, and order sets. The CHW intervention components entail group education sessions on diabetes prevention, including weight loss and nutrition. A mixed-methods approach will be used to evaluate the feasibility, adoption, and impact (??5% weight loss) of the integrated study components. Additionally, a cost effectiveness analysis will be conducted using outcomes, implementation costs, and healthcare claims data to determine the incremental cost per person achieving 5% weight loss. DISCUSSION:This study will be the first to test the efficacy of an integrated EHR-CHW intervention within an underserved, minority population and in a practical setting via a network of small PCPs in NYC. The study's implementation is enhanced through cross-sector partnerships, including the local health department, a healthcare payer, and EHR vendors. Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations. Study findings, including those resulting from cost-effectiveness analyses, will have important implications for translating similar strategies to other minority communities in sustainable ways. TRIAL REGISTRATION:This study protocol has been approved and is made available on ClinicalTrials.gov by NCT03188094 as of 15 June 2017.

Project description:BACKGROUND:Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support. OBJECTIVE:This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States. METHODS:Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ?140 mm Hg and/or diastolic blood pressure [DBP] ?90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention. RESULTS:Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls. CONCLUSION:We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact. TRIAL REGISTRATION:ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).

Project description:IntroductionU.S. Hispanic women suffer a disproportionate burden of cervical cancer, with incidence and mortality rates almost twice that of whites. Community health workers, or promotoras, are considered a potential strategy for eliminating such racial and ethnic health disparities. The current study is a randomized trial of a promotora-led educational intervention focused on cervical cancer in a local Hispanic community.MethodsFour promotoras led a series of two workshops with community members covering content related to cervical cancer. Sociodemographic characteristics, cervical cancer risk, previous screening history, cervical cancer knowledge, and self-efficacy were measured by a pre-intervention questionnaire. The post-intervention questionnaire measured the following outcomes: cervical cancer knowledge (on a 0-6 scale), self-efficacy (on a 0-5 scale), and receipt of Pap smear screening during the previous 6 months (dichotomous). Univariate analyses were performed using chi square, t-test, and the Mann-Whitney test. Multivariate logistic regression was used to model the association between explanatory variables and receipt of Pap smear screening.ResultsThere were no statistically significant differences between the two experimental groups at baseline. Follow-up data revealed significant improvements in all outcome measures: Pap smear screening (65% vs. 36%, p-value 0.02), cervical cancer knowledge (5.4 vs. 3.5, p-value<0.001), and self-efficacy (4.7 vs. 4.0, p-value 0.002). In multivariate analysis, cervical cancer knowledge (OR 1.68, 95% CI 1.10-2.81) and intervention group assignment (OR 6.74, 95% CI 1.77-25.66) were associated with receiving a Pap smear during the follow-up period.DiscussionOur randomized trial of a promotora-led educational intervention demonstrated improved Pap screening rates, in addition to increased knowledge about cervical cancer and self-efficacy. The observed association between cervical cancer knowledge and Pap smear receipt underscores the importance of educating vulnerable populations about the diseases that disproportionately affect them. Future research should evaluate such programs on a larger scale, and identify novel targets for intervention.

Dataset Information

Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial.

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Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial.

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