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一项减少1型糖尿病患者技术使用不平等的最佳实践建议的实施与评估:一项混合方法、非随机对照试验的方案

Implementation and Evaluation of a Best Practice Advisory to Reduce Inequities in Technology Use for People With Type 1 Diabetes: Protocol for a Mixed Methods, Nonrandomized Controlled Trial.

作者信息

Mathioudakis Nestoras, Wolf Risa, Choudhary Abha, Davis Georgia, Gallagher Mary Pat, Gupta Meenal, Kamboj Manmohan, Rioles Nicole, Ospelt Emma, Thapa Susan, Weinstock Ruth S, Wright Trevon, Ebekozien Osagie

机构信息

Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.

Division of Pediatric Endocrinology, Department of Pediatrics, Johns Hopkins University, Baltimore, MD, United States.

出版信息

JMIR Res Protoc. 2025 May 28;14:e71038. doi: 10.2196/71038.

Abstract

BACKGROUND

Continuous advancements in diabetes technologies have improved self-management for people with type 1 diabetes. Continuous glucose monitoring and automated insulin delivery systems have enhanced the quality of life and glycemic outcomes while reducing severe hypoglycemia and diabetes ketoacidosis hospitalizations. Despite these benefits, racial inequities in the use of advanced diabetes technology (ADT) persist.

OBJECTIVE

This study aims to develop and evaluate a best practice advisory (BPA) within the electronic medical record (EMR) to reduce racial and ethnic disparities in ADT use. We hypothesize that an EMR-based BPA designed to standardize the prescribing of ADTs will minimize racial and ethnic disparities in ADT adoption or progression in use among pediatric and adult people with type 1 diabetes.

METHODS

The Best Practice Advisories to Reduce Inequities in Technology Use (BPA-TECH) study will use a nonrandomized matched pair intervention design. Phase 1 will use qualitative methods to develop and refine the BPA, including focus groups and surveys of health care providers and people with type 1 diabetes or their caregivers. Phase 2 will evaluate the effectiveness of the BPA through a controlled before-after study of people with type 1 diabetes seen at 7 T1D Exchange Quality Improvement Collaborative (T1DX-QI) centers, with control people with type 1 diabetes matched from nonintervention T1DX-QI centers. The baseline and postintervention periods will be the 12 months before and 12 months after deployment of the BPA at the intervention centers, respectively. Eligibility criteria include people with type 1 diabetes aged ≥2 years with an EMR diagnosis of T1D during the baseline period. The primary outcome is the progression in ADT use from the baseline to postintervention periods.

RESULTS

This 3-year study began in July 2024, with data collection from key stakeholders for phase 1 qualitative research beginning in August 2024. For phase 2, we estimate approximately 3000 eligible non-Hispanic Black and Hispanic people with type 1 diabetes at the intervention centers and 15,000 matched controls. Data on ADT use, glycated hemoglobin (HbA), severe hypoglycemic events, and diabetes ketoacidosis events will be collected via the T1DX-QI coordinating center. The study is powered to detect a between-group difference of 15% in the proportion of patients in the intervention and control groups in meeting the primary endpoint. We anticipate the completion of this study by May 2027.

CONCLUSIONS

The BPA-TECH study aims to leverage health IT to address racial and ethnic disparities in ADT use among people with type 1 diabetes. By standardizing the approach to ADT prescribing for people with type 1 diabetes, the BPA-TECH has the potential to promote equity in diabetes management and improve clinical outcomes. The outcomes of this study will inform future efforts to reduce health care disparities.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06931275; https://clinicaltrials.gov/search?term=NCT06931275.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71038.

摘要

背景

糖尿病技术的不断进步改善了1型糖尿病患者的自我管理。持续葡萄糖监测和自动胰岛素输送系统提高了生活质量和血糖控制效果,同时减少了严重低血糖和糖尿病酮症酸中毒的住院率。尽管有这些益处,但在先进糖尿病技术(ADT)的使用方面,种族不平等现象仍然存在。

目的

本研究旨在开发并评估电子病历(EMR)中的最佳实践建议(BPA),以减少ADT使用中的种族和民族差异。我们假设,旨在规范ADT处方的基于EMR的BPA将最大限度地减少1型糖尿病儿童和成人在ADT采用或使用进展方面的种族和民族差异。

方法

减少技术使用不平等的最佳实践建议(BPA-TECH)研究将采用非随机配对干预设计。第一阶段将使用定性方法来开发和完善BPA,包括焦点小组以及对医疗保健提供者、1型糖尿病患者或其护理人员的调查。第二阶段将通过对7个1型糖尿病交换质量改进协作中心(T1DX-QI)的1型糖尿病患者进行前后对照研究来评估BPA的有效性,对照组为从非干预T1DX-QI中心匹配的1型糖尿病患者。基线期和干预后期将分别为干预中心部署BPA前的12个月和之后的12个月。纳入标准包括年龄≥2岁、在基线期经EMR诊断为T1D的1型糖尿病患者。主要结局是从基线期到干预后期ADT使用的进展情况。

结果

这项为期3年的研究于2024年7月开始,2024年8月开始从关键利益相关者收集第一阶段定性研究的数据。对于第二阶段,我们估计干预中心约有3000名符合条件的非西班牙裔黑人和西班牙裔1型糖尿病患者以及15000名匹配的对照组。将通过T1DX-QI协调中心收集ADT使用、糖化血红蛋白(HbA)、严重低血糖事件和糖尿病酮症酸中毒事件的数据。该研究有能力检测干预组和对照组患者达到主要终点比例之间15%的组间差异。我们预计这项研究将于2027年5月完成。

结论

BPA-TECH研究旨在利用健康信息技术解决1型糖尿病患者在ADT使用方面的种族和民族差异。通过规范1型糖尿病患者ADT处方的方法,BPA-TECH有可能促进糖尿病管理的公平性并改善临床结局。本研究的结果将为未来减少医疗保健差异的努力提供参考。

试验注册

ClinicalTrials.gov NCT06931275;https://clinicaltrials.gov/search?term=NCT06931275。

国际注册报告识别码(IRRID):DERR1-10.2196/71038。

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