TY - JOUR
T1 - Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices
AU - Gupta, Avni
AU - Hu, Jiyuan
AU - Huang, Shengnan
AU - Diaz, Laura
AU - Gore, Radhika
AU - Levy, Natalie
AU - Bergman, Michael
AU - Tanner, Michael
AU - Sherman, Scott E.
AU - Islam, Nadia
AU - Schwartz, Mark D.
N1 - Funding Information:
This study has undergone peer-review by and is supported by the National Institutes of Health—National Institute of Diabetes and Digestive and Kidney Diseases under award number R18DK110740. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding agency has not influenced the design of this study or the writing of this manuscript and will not influence the study’s implementation, data collection and analysis, and the writing of future manuscripts.
Funding Information:
Presented in part at Society of General Internal Medicine (SGIM) 2021 conference and Academy Health ARM 2021 conference. We thank Dr. Erin Rogers, Assistant Professor at the Department of Population Health, NYU Grossman School of Medicine, for her valuable review of the manuscript.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - Background: It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY). Methods: We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure. Results: Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA). Conclusions: The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions. Trial registration: The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666.
AB - Background: It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY). Methods: We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure. Results: Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA). Conclusions: The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions. Trial registration: The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666.
KW - Community health workers
KW - Diabetes Prevention
KW - Implementation fidelity
KW - Lifestyle intervention
KW - Process evaluation
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U2 - 10.1186/s12889-023-15477-2
DO - 10.1186/s12889-023-15477-2
M3 - Article
C2 - 36978071
AN - SCOPUS:85151112869
SN - 1471-2458
VL - 23
JO - BMC public health
JF - BMC public health
IS - 1
M1 - 575
ER -