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百万心脏心血管疾病风险降低模型对起始和强化药物治疗的影响:一项随机临床试验的预设二次分析。

Effect of the Million Hearts Cardiovascular Disease Risk Reduction Model on Initiating and Intensifying Medications: A Prespecified Secondary Analysis of a Randomized Clinical Trial.

机构信息

Mathematica, Washington, DC.

Mathematica, San Francisco, California.

出版信息

JAMA Cardiol. 2021 Sep 1;6(9):1050-1059. doi: 10.1001/jamacardio.2021.1565.

DOI:10.1001/jamacardio.2021.1565
PMID:34076665
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8173467/
Abstract

IMPORTANCE

The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model pays provider organizations for measuring and reducing Medicare patients' cardiovascular risk.

OBJECTIVE

To assess whether the model increases the initiation or intensification of antihypertensive medications or statins among patients with blood pressure or low-density lipoprotein (LDL) cholesterol levels above guideline thresholds for treatment intensification.

DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of a cluster-randomized, pragmatic trial included primary care and cardiology practices, health care centers, and hospital-based outpatient departments across the US. Participants included Medicare patients who were enrolled into the model in 2017 by participating organizations and who were at high risk and at medium risk of a myocardial infarction or stroke in 10 years. Patient outcomes were analyzed for 1 year postenrollment (through December 2018) using an intent-to-treat design. Analysis began November 2019.

INTERVENTIONS

US Centers for Medicare & Medicaid Services paid organizations for risk stratifying Medicare patients and reducing CVD risk among high-risk patients through discussing risk scores, developing individualized risk reduction plans, and following up with patients twice yearly.

MAIN OUTCOMES AND MEASURES

Initiating or intensifying statin or antihypertensive therapy within 1 year of enrollment, measured in Medicare Part D claims, and LDL cholesterol and systolic blood pressure levels approximately 1 year after enrollment, measured in usual care and reported to Centers for Medicare & Medicaid Services via a data registry (data complete for 51% of high-risk enrollees). The study's primary outcome (incidence of first-time myocardial infarction and stroke) is not reported because the trial is ongoing.

RESULTS

A total of 330 primary care and cardiology practices, health care centers, and hospital-based outpatient departments and 125 436 Medicare patients were included in this analysis. High-risk patients in the intervention group had a mean (SD) age of 74 (4.1), 15 213 (63%) were male, 21 657 (90%) were receiving antihypertensive medication at baseline, and 16 558 (69%) were receiving statins. Almost all (21 791 [91%]) high-risk intervention group patients had above-threshold systolic blood pressure level (>130 mm Hg), LDL cholesterol level (>70 mg/dL), or both. Patients in the intervention group with these risk factors were more likely than control patients (8127 [37.3%] vs 4753 [32.4%]; adjusted difference in percentage points, 4.8; 95% CI, 2.9-6.7; P < .001) to initiate or intensify statins or antihypertensive medication. Centers for Medicare & Medicaid Services did not pay for CVD risk reduction for medium-risk enrollees, but initiation or intensification rates for these enrollees were also higher in the intervention vs control groups (12 668 [27.9%] vs 7544 [24.8%]; adjusted difference in percentage points, 3.1; 95% CI, 1.9-4.3; P < .001). Among high-risk enrollees with clinical data approximately 1 year after enrollment, LDL cholesterol level was slightly lower in the intervention vs control groups (mean [SD], 89 [31.8] vs 91 [32.1] mg/dL; adjusted difference in percentage points, -1.8; 95% CI, -2.9 to -0.6; P = .002), as was systolic blood pressure (mean [SD], 133 [15.7] vs 135 [16.4] mm Hg; adjusted difference in percentage points, -1.7; 95% CI, -2.8 to -0.6; P = .003).

CONCLUSIONS AND RELEVANCE

In this study, a pay-for-performance model led to modest increases in the use of CVD medications in a range of organizations, despite high medication use at baseline.

摘要

重要性:百万心脏心血管疾病(CVD)风险降低模型为测量和降低医疗保险患者的心血管风险向服务提供者组织付费。

目的:评估该模型是否会增加血压或低密度脂蛋白胆固醇(LDL-C)水平高于治疗强化指南阈值的患者开始使用或强化降压药物或他汀类药物的情况。

设计、地点和参与者:这是一项对美国的初级保健和心脏病学实践、医疗保健中心和医院门诊部门进行的集群随机、实用试验的预设二次分析。参与者包括在 2017 年通过参与组织加入该模型的医疗保险患者,这些患者在未来 10 年内患有心肌梗死或中风的高危和中危患者。使用意向治疗设计分析了患者在入组后 1 年(截至 2018 年 12 月)的结果。分析于 2019 年 11 月开始。

干预措施:美国医疗保险和医疗补助服务中心向组织支付费用,通过讨论风险评分、制定个体化风险降低计划以及每年两次与患者进行随访,对医疗保险患者进行风险分层并降低 CVD 风险。

主要结果和措施:在入组后 1 年内开始或强化他汀类药物或降压药物治疗,在医疗保险 Part D 索赔中测量,在入组后约 1 年时测量 LDL 胆固醇和收缩压水平,在常规护理中报告并通过数据登记处向医疗保险和医疗补助服务中心报告(高危入组者的数据完整率为 51%)。该试验正在进行中,因此未报告研究的主要结果(首次心肌梗死和中风的发生率)。

结果:共有 330 个初级保健和心脏病学实践、医疗保健中心和医院门诊部门以及 125436 名医疗保险患者纳入本分析。干预组的高危患者平均(SD)年龄为 74(4.1)岁,15213(63%)为男性,21657(90%)在基线时接受降压药物治疗,16558(69%)接受他汀类药物治疗。几乎所有(21791 [91%])高危干预组患者的收缩压水平(>130 mm Hg)、LDL-C 水平(>70 mg/dL)或两者均高于阈值。与对照组患者相比,具有这些危险因素的干预组患者更有可能开始或强化他汀类药物或降压药物治疗(8127 [37.3%] vs 4753 [32.4%];调整后的百分比差异,4.8;95%CI,2.9-6.7;P<.001)。医疗保险和医疗补助服务中心不为中危患者支付 CVD 风险降低的费用,但这些患者的起始或强化率在干预组也高于对照组(12668 [27.9%] vs 7544 [24.8%];调整后的百分比差异,3.1;95%CI,1.9-4.3;P<.001)。在入组后大约 1 年有临床数据的高危患者中,干预组的 LDL-C 水平略低于对照组(平均[SD],89[31.8] vs 91[32.1]mg/dL;调整后的百分比差异,-1.8;95%CI,-2.9 至-0.6;P=.002),收缩压也更低(平均[SD],133[15.7] vs 135[16.4]mmHg;调整后的百分比差异,-1.7;95%CI,-2.8 至-0.6;P=.003)。

结论和相关性:在这项研究中,尽管基线时药物使用率较高,但在一系列组织中,基于支付绩效的模型导致 CVD 药物的使用略有增加。

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