School of Global Public Health, New York University, 708 Broadway, New York, NY, 10003, USA.
Department of Population Health, NYU Grossman School of Medicine, 180 Madison Ave 2F Rm 222, New York, NY, 10016, USA.
BMC Public Health. 2023 Mar 28;23(1):575. doi: 10.1186/s12889-023-15477-2.
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).
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.
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).
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.
The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666 .
评估循证干预措施的实施保真度和调节保真度的因素对于了解其成功或失败的原因至关重要。然而，保真度和保真度调节剂很少被系统地报告。本研究的目的是进行并行实施保真度评估，并检查 CHORD（社区健康外展以减少糖尿病）的保真度调节剂，这是一项务实的、集群随机对照试验，旨在测试社区卫生工作者（CHW）领导的健康指导干预措施对预防纽约（NY）新发生的 2 型糖尿病的影响。
我们应用实施保真度概念框架来评估四个核心干预组件的实施保真度和调节因素：患者目标设定、教育主题指导、初级保健（PC）就诊和解决社会决定因素健康（SDH）的转诊，使用描述性统计和回归模型。从退伍军人事务部纽约港或贝尔维尤医院（BH）的患者中心医疗之家接受护理的患有前驱糖尿病的 PC 患者有资格随机分配到 CHW 领导的 CHORD 干预组或常规护理组。在 559 名随机分组并纳入干预组的患者中，79.4%完成了入组调查，并被纳入保真度评估分析样本。保真度衡量每个核心组件的覆盖范围、内容依从性和频率，评估的调节因素是实施地点和患者激活测量。
三个组件的内容依从性较高，近 80.0%的患者设定了≥1个目标，进行了≥1次 PC 就诊并接受了≥1次教育课程。只有 45.0%的患者接受了≥1次 SDH 转诊。在调整了患者的性别、语言、种族、族裔和年龄后，实施地点调节了目标设定的依从性（BH 为 77.4%，VA 为 87.7%）、教育指导（BH 为 78.9%，VA 为 88.3%）、CHW-患者成功接触的次数（BH 为 6 次，VA 为 4 次）和接受所有四个组件的患者百分比（BH 为 41.1%，VA 为 25.7%）。
两个实施地点之间 CHORD 干预措施的四个组成部分的保真度存在差异，这表明在不同环境中实施复杂的基于证据的干预措施具有挑战性。我们的研究结果强调了在对复杂的多地点行为干预措施进行随机试验的结果进行背景化时，测量实施保真度的重要性。
该试验于 2016 年 12 月 30 日在 ClinicalTrials.gov 上注册，注册号为 NCT03006666。
