TY - JOUR
T1 - Implementation of a multi-level community-clinical linkage intervention to improve glycemic control among south Asian patients with uncontrolled diabetes
T2 - study protocol of the DREAM initiative
AU - Lim, Sahnah
AU - Wyatt, Laura C.
AU - Mammen, Shinu
AU - Zanowiak, Jennifer M.
AU - Mohaimin, Sadia
AU - Troxel, Andrea B.
AU - Lindau, Stacy Tessler
AU - Gold, Heather T.
AU - Shelley, Donna
AU - Trinh-Shevrin, Chau
AU - Islam, Nadia S.
N1 - Funding Information:
We acknowledge our dedicated team of community health workers. Specifically, we would like to thank Haroon Zafar, Sidra Zafar, MD Jalal Uddin, Mamnunul Haq, Gulnahar Alam, Mursheda Ahmed, and Sabiha Sultana. We would also like to acknowledge our CAB members from the following organizations: UNITED SIKHS, South Asian Council for Social Services, Bangladeshi American Community Development & Youth Service, India Home, and Council of Peoples Organization. Protocol version: Protocol dated 1/15/2019. Trial registration: ClinicalTrials.gov Registration number: NCT 03188094. Date of trial registration: November 6, 2017. Was this trial prospectively registered? Yes. Date recruitment began: July 2019. Recruitment is ongoing. Anticipated end date: April 2022.
Funding Information:
This study is supported by the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases Grant R01DK11048. The organization has played no role in the study, other than reviewing the protocol for the purpose of awarding funding. NI’s time is partially supported by the National Institutes of Health National Institute on Minority Health and Health Disparities Grant U54MD000538; Centers for Disease Control and Prevention Grant U48DP001904; National Institutes of Health National Institute of Diabetes and Digestive Kidney Diseases Grant R18DK110740; National Heart Lung and Blood Institute Grant 1UG3HL15310; and the National Center for Advancing Translational Science Grant UL1TR001445. The views expressed are those of the authors and do not necessarily represent the official position of the funding organizations.
Funding Information:
STL is founder and co-owner of NowPow, LLC. Under the terms of grant number 1C1CMS330997–01-00 (STL, PI), from the Department of Health and Human Services, Centers for Medicare & Medicaid Services, awardees were expected to develop a sustainable business model to continue to support the model that was tested after award funding ended. Neither the University of Chicago nor the University of Chicago Medicine is endorsing or promoting NowPow or its business, products or services.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. Methods: The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. Discussion: Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. Trial registration: This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.
AB - Background: A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. Methods: The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. Discussion: Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. Trial registration: This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.
KW - Community health workers
KW - Community-based participatory research
KW - Diabetes management
KW - Electronic health records
KW - Health disparities
KW - South Asian
KW - Structural determinants of health
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U2 - 10.1186/s12902-021-00885-5
DO - 10.1186/s12902-021-00885-5
M3 - Article
C2 - 34814899
AN - SCOPUS:85119828929
VL - 21
JO - BMC Endocrine Disorders
JF - BMC Endocrine Disorders
SN - 1472-6823
IS - 1
M1 - 233
ER -