Dataset Information

Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults.

ABSTRACT:

Objective

Hispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics.

Methods and analysis

The Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised controlled trial to be performed as a community-based participatory research study performed in a Primary Care Setting in Northern Manhattan (New York City). 360 Hispanic adults with poorly controlled type 2 diabetes mellitus (haemoglobin A1c >8%), aged 35-70 years, will be randomised at a 1:1 ratio, within Primary Care Provider clusters. The two study arms are (1) a 12-month CHW intervention and (2) enhanced usual care (educational materials mailed at 4-month intervals, preceded by phone calls). The end points, assessed after 12 months, are primary = haemoglobin A1c and secondary = blood pressure and low-density lipoprotein-cholesterol levels. In addition, the study will describe the CHW intervention in terms of components and intensity and will assess its effects on (1) medication adherence, (2) medication intensification, (3) diet and (4) physical activity.

Ethics and dissemination

All participants will provide informed consent; the study protocol has been approved by the Institutional Review Board of Columbia University Medical Center. CHW interventions hold great promise in improving the well-being of minority populations who suffer from diabetes mellitus. The NOCHOP study will provide valuable information about the efficacy of those interventions vis-à-vis clinically relevant end points and will inform policy makers through a detailed characterisation of the programme and its effects.

Clinical trial registration number

NCT00787475 at clinicaltrials.gov.

SUBMITTER: Palmas W

PROVIDER: S-EPMC3330252 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Publications

Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults.

Palmas Walter W Teresi Jeanne A JA Findley Sally S Mejia Miriam M Batista Milagros M Kong Jian J Silver Stephanie S Luchsinger Jose A JA Carrasquillo Olveen O

BMJ open 20120326 2

<h4>Objective</h4>Hispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics.<h4>Methods and analysis</h4>The Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised contr ...[more]

PMID: 22454189

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Project description:BACKGROUND:Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. METHODS:The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~?2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. DISCUSSION:This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language-based eligibility and the use of HbA1c as a measure of DM risk. It will measure both clinical and implementation outcomes and potentially broaden the evidence base for CHWs and patient-centered medical home implementation. Further, the intervention's unique features, notably patient-level personalization and referral to existing programs, may offer a scalable model to benefit patients at-risk of DM. TRIAL REGISTRATION:Clinicaltrials.gov NCT03006666 (Received 12/27/2016).

Project description:Dementia prevalence and its burden on families are increasing. Caregivers of persons with dementia have more depression and stress than the general population. Several interventions have proven efficacy in decreasing depression and stress in selected populations of caregivers. Hispanics in New York City tend to have a higher burden of dementia caregiving compared to non-Hispanic whites (NHW) because Hispanics have a higher prevalence of dementia, tend to have high family involvement, and tend to have higher psychosocial and economic stressors. Thus, we chose to test the effectiveness of a dementia caregiving intervention, the New York University Caregiver Intervention (NYUCI), with demonstrated efficacy in spouse caregivers in Hispanic relative caregivers of persons with dementia. Including the community health worker (CHW) intervention in both arms alleviates general psychosocial stressors and allows the assessment of the effectiveness of the intervention. Compared to two original efficacy studies of the NYUCI, which included only spouse caregivers, our study includes all relative caregivers, including common law spouses, children, siblings, a nephew and nieces. This study will be the first randomised trial to test the effectiveness of the NYUCI in Hispanic caregivers including non-spouses. The design of the study is a randomised controlled trial (RCT). Participants are randomised to two arms: case management by a CHW and an intervention arm including the NYUCI in addition to case management by the CHW. The duration of intervention is 6 months. The main outcomes in the trial are changes in the Geriatric Depression Scale (GDS) and the Zarit Caregiver Burden Scale (ZCBS) from baseline to 6 months. This trial is approved by the Columbia University Medical Center Institutional Review Board (AAAI0022), and funded by the National Institute on Minority Health and Health Disparities. The funding agency has no role in dissemination. www.ClinicalTrials.gov NCT01306695.

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.

Project description:IntroductionThe prevalence of dementia is increasing without a known cure, resulting in an increasing number of informal caregivers. Caring for a person with dementia results in increased stress and depressive symptoms. There are several behavioural interventions designed to alleviate stress and depressive symptoms in caregivers of persons with dementia with evidence of efficacy. Two of the best-known interventions are the New York University Caregiver Intervention (NYUCI) and the Resources for Enhancing Alzheimer's Caregivers Health (REACH). The effectiveness of the NYUCI and REACH has never been compared. There is also a paucity of data on which interventions are more effective in Hispanics in New York City. Thus, we proposed the Northern Manhattan Hispanic Caregiver intervention Effectiveness Study (NHiCE), a pragmatic clinical trial designed to compare the effectiveness of adaptations of the NYUCI and the REACH in informal Hispanic caregivers of persons with dementia in New York City.Methods and analysisNHiCE is a 6-month randomised controlled trial comparing the effectiveness of adaptations of the NYUCI and REACH among 200 Hispanic informal adult caregivers of persons with dementia. The planned number of sessions of the NYUCI and REACH are similar. The primary outcome measures are changes from baseline to 6 months in the Zarit Caregiver Burden Scale and Geriatric Depression Scale. Our primary approach to analyses will be intent-to-treat. The primary analyses will use mixed random effects models, and a full information maximum likelihood approach, with sensitivity analyses using generalised estimating equation.Ethics and disseminationNHiCE is approved by the Institutional Review Board of Columbia University Medical Center (protocol AAAM5150). A Data Safety Monitoring Board monitors the progress of the study. Dissemination will include reports of the characteristics of the study participants, as well as a report of the results of the clinical trial.Trial registration numberNCT02092987, Pre-results.

Project description:Background:Community Health Workers (CHWs) are considered to be a cost-effective and inclusive solution to address the persistent health workforce shortage in many low and middle-income countries. In recent years, microfinance institutions (MFIs) got increasingly engaged in providing health services delivered by CHWs. Despite their growing importance, little is known about the impacts and implementation barriers of these mostly small-scale initiatives. This paper evaluates an MFI-led CHW program in the Philippines and studies the role of microfinance group networks in influencing program outreach and impact. The intervention aims at disseminating information in poor communities, improving health monitoring through increased check-ups and raising social support. Methods:Clustered randomized controlled trial in 70 communities in the greater area of Metro Manila, the Philippines. The main data was collected in a baseline and follow-up survey and is complemented with extensive sociometric network and geographical data. The main outcome variable is a composite health index based on 10 indicators. The role of the health worker's embeddedness and connectedness in the community for program success is tested using tools of social network analysis. Results:The intervention led to a 3.8% (95% confidence interval (CI)?=?1.3, 6.4) improvement in the composite health outcome. Effects across indicators are mixed and mainly driven by changes in immediate health monitoring behavior: The probability for routine examinations increased in the treatment group by 10.6% (95% CI?=?3.2, 18.1), for regular blood pressure checks by 9.6% (95% CI?=?3.3, 15.9), and for having access to a health care provider by 7.2% (95% CI?=?0.93, 13.5). No statistical effects on general knowledge and social support are observable. Social networks are a key driver of program outreach and impact. Close friends and acquaintances of health workers used and benefited substantially more from the program than more distant ties. Conclusions:Despite the promising immediate behavioral impacts, it remains questionable to what extent such small-scale MFI initiatives can bring transformative and sustainable changes without external support. Microfinance group networks played an important role for the success of the health intervention and further research is needed to better understand how these affect the health care utilization decisions of the clients.

Dataset Information

Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults.

Objective

Methods and analysis

Ethics and dissemination

Clinical trial registration number

Publications

Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults.

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