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Patient-centred medicine
Protocol
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
  1. Walter Palmas1,
  2. Jeanne A Teresi2,
  3. Sally Findley3,
  4. Miriam Mejia4,
  5. Milagros Batista4,
  6. Jian Kong2,
  7. Stephanie Silver2,
  8. Jose A Luchsinger1,
  9. Olveen Carrasquillo5
  1. 1Department of Medicine, Columbia University, New York, New York, USA
  2. 2Hebrew Home for the Aged, Riverdale, New York, USA
  3. 3Joseph Mailman School of Public Health, Columbia University, New York, New York, USA
  4. 4Alianza Dominicana, New York, New York, USA
  5. 5Department of Medicine, University of Miami, Miami, Florida, USA
  1. Correspondence to Dr Walter Palmas; wp56{at}columbia.edu

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.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

https://doi.org/10.1136/bmjopen-2012-001051

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    Supplementary materials

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    Footnotes

    • To cite: Palmas W, Teresi JA, Findley S, et al. 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. BMJ Open 2012;2:e001051. doi:10.1136/bmjopen-2012-001051

    • Contributors All authors edited the draft and contributed substantially to the manuscript; they all approved this submission. WP, JAT, SF, MM, MB and OC conceived of and designed the study. MM, JAT, JAL and SS participated in the design of the study. SF, MM and MB designed the community health workers intervention protocol, with input from WP, JAL and OC. MM and MB supervise the community health workers intervention, with assistance from WP and SF. JAT supervised the power analyses and wrote the data analyses section. SS and JK created the data entry system, under the supervision of JT; they will be responsible for performing the statistical analysis. JK programmed the Macros for power analyses. WP, OC and JAL designed and planned the evaluation visits. WP bears overall responsibility for the design, ethical conduct and publication of the study.

    • Funding This study was funded by the National Institute on Minority Health and Health Disparities and the National Institutes of Health, grant number P60 MD00020606.

    • Competing interests None.

    • Ethics approval Ethics approval was provided by the Columbia University Medical Center Institutional Review Board.

    • Provenance and peer review Not commissioned; internally peer reviewed.