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鼓励处方使用钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)和胰高血糖素样肽-1受体激动剂(GLP-1RA)药物以降低2型糖尿病患者的心血管和肾脏风险:一项随机对照试验的原理与设计

Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: Rationale and design of a randomized controlled trial.

作者信息

Haff Nancy, Horn Daniel M, Bhatkhande Gauri, Sung Meekang, Colling Caitlin, Wood Wendy, Robertson Ted, Gaposchkin Daniel, Simmons Leigh, Yang Judy, Yeh James, Crum Katherine L, Hanken Kaitlin E, Lauffenburger Julie C, Choudhry Niteesh K

机构信息

Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA.

Harvard Medical School, Boston, MA; Department of Medicine, Massachusetts General Hospital, Boston, MA; Medical Director of Devoted Health, Waltham, MA.

出版信息

Am Heart J. 2025 Jul;285:39-51. doi: 10.1016/j.ahj.2025.02.007. Epub 2025 Feb 20.

Abstract

BACKGROUND

Sodium-glucose cotransporter-2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1RA) medications reduce the risk of cardiovascular and renal complications among patients with type 2 diabetes but are underutilized. There are numerous barriers to prescribing including insurance coverage, medication availability, comfort with prescribing, and diffusion of responsibility of prescribing across specialists. Methods are needed to support prescribing in primary care.

METHODS

This was a pragmatic, randomized controlled trial testing interventions to increase appropriate SGLT2i and GLP-1RA prescribing. Primary care providers (PCPs) were randomized to 1 of 3 arms: (1) peer champion support (2) peer champion support and information on insurance coverage, or (3) usual care (no intervention). PCPs in both intervention arms received a welcome email and electronic health record (EHR) messages before visits with patients who had sub-optimally controlled diabetes and an indication for 1 of these medications. In the peer champion support only arm the EHR messages included prescribing tips. In the arm that provided peer champion support and information on insurance coverage, EHR messages contained information on medications in each class that would be most affordable for the patient based on their insurance coverage and offered support for prior authorizations if needed. The primary outcome was prescriptions for an SGLT2i or GLP-1RA medication, beginning 3 days before the targeted visit and continuing through 28 days, in each intervention arm compared to control.

RESULTS

191 primary care providers were included in the study. 1,389 patients had at least 1 visit scheduled with their PCP during the 6-month intervention period; of these 1,079 patients attended at least 1 of these visits and will be included in the primary outcome analysis. 66 providers (484 patients) received the peer champion intervention alone, 63 providers (446 patients) received the peer champion intervention and information on insurance coverage, and 62 providers (459 patients) received usual care. On average, patients were 66 years old, 46% were female, 61% were white, and 16% were Hispanic. There were small differences between groups with regards to patient sex, race, ethnicity, partner status, and percent with Medicare insurance.

CONCLUSIONS

These medication classes have the potential to reduce cardiovascular and kidney disease among patients with type 2 diabetes. This study tests interventions to support prescribing of these medications in primary care.

CLINICAL TRIAL

Clinicaltrials.gov. Unique identifier: (NCT, Registered: NCT05463705).

摘要

背景

钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)和胰高血糖素样肽-1受体激动剂(GLP-1RA)药物可降低2型糖尿病患者发生心血管和肾脏并发症的风险,但目前未得到充分利用。处方存在诸多障碍,包括保险覆盖范围、药物可及性、处方舒适度以及跨专科处方责任的分散。需要采取方法来支持基层医疗中的处方开具。

方法

这是一项实用的随机对照试验,测试旨在增加SGLT2i和GLP-1RA合理处方开具的干预措施。基层医疗服务提供者(PCP)被随机分为3组中的1组:(1)同伴支持者支持;(2)同伴支持者支持并提供保险覆盖范围信息;(3)常规护理(无干预)。两个干预组的PCP在对糖尿病控制不佳且有使用其中一种药物指征的患者进行就诊前,都会收到一封欢迎邮件和电子健康记录(EHR)信息。仅接受同伴支持者支持的组,EHR信息包括处方提示。在提供同伴支持者支持并提供保险覆盖范围信息的组中,EHR信息包含根据患者保险覆盖范围每种药物类别中最经济实惠的药物信息,并在需要时提供预先授权支持。主要结局是与对照组相比,每个干预组在目标就诊前3天开始并持续28天的SGLT2i或GLP-1RA药物处方。

结果

191名基层医疗服务提供者纳入研究。在6个月的干预期内,1389名患者至少安排了1次与他们的PCP的就诊;其中1079名患者至少参加了1次这些就诊,并将纳入主要结局分析。66名提供者(484名患者)仅接受同伴支持者干预,63名提供者(446名患者)接受同伴支持者干预并获得保险覆盖范围信息,62名提供者(459名患者)接受常规护理。患者平均年龄为66岁,46%为女性,61%为白人,16%为西班牙裔。各组在患者性别、种族、族裔、伴侣状况和医疗保险百分比方面存在细微差异。

结论

这些药物类别有可能降低2型糖尿病患者的心血管和肾脏疾病风险。本研究测试了支持在基层医疗中开具这些药物处方的干预措施。

临床试验

Clinicaltrials.gov。唯一标识符:(NCT,注册:NCT05463705)。

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