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多方面干预措施改善急性冠状动脉综合征出院后患者的用药依从性和二级预防措施:一项随机临床试验。

Multifaceted intervention to improve medication adherence and secondary prevention measures after acute coronary syndrome hospital discharge: a randomized clinical trial.

机构信息

VA Eastern Colorado Health Care System, Denver2Department of Medicine, University of Colorado, Denver3Colorado Cardiovascular Outcomes Research Group, Denver.

VA Eastern Colorado Health Care System, Denver.

出版信息

JAMA Intern Med. 2014 Feb 1;174(2):186-93. doi: 10.1001/jamainternmed.2013.12944.

Abstract

IMPORTANCE

Adherence to cardioprotective medication regimens in the year after hospitalization for acute coronary syndrome (ACS) is poor.

OBJECTIVE

To test a multifaceted intervention to improve adherence to cardiac medications.

DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial, 253 patients from 4 Department of Veterans Affairs medical centers located in Denver (Colorado), Seattle (Washington); Durham (North Carolina), and Little Rock (Arkansas) admitted with ACS were randomized to the multifaceted intervention (INT) or usual care (UC) prior to discharge.

INTERVENTIONS

The INT lasted for 1 year following discharge and comprised (1) pharmacist-led medication reconciliation and tailoring; (2) patient education; (3) collaborative care between pharmacist and a patient's primary care clinician and/or cardiologist; and (4) 2 types of voice messaging (educational and medication refill reminder calls).

MAIN OUTCOMES AND MEASURES

The primary outcome of interest was proportion of patients adherent to medication regimens based on a mean proportion of days covered (PDC) greater than 0.80 in the year after hospital discharge using pharmacy refill data for 4 cardioprotective medications (clopidogrel, β-blockers, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [statins], and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers [ACEI/ARB]). Secondary outcomes included achievement of blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) level targets. RESULTS Of 253 patients, 241 (95.3%) completed the study (122 in INT and 119 in UC). In the INT group, 89.3% of patients were adherent compared with 73.9% in the UC group (P = .003). Mean PDC was higher in the INT group (0.94 vs 0.87; P< .001). A greater proportion of intervention patients were adherent to clopidogrel (86.8% vs 70.7%; P = .03), statins (93.2% vs 71.3%; P < .001), and ACEI/ARB (93.1% vs 81.7%; P = .03) but not β-blockers (88.1% vs 84.8%; P = .59). There were no statistically significant differences in the proportion of patients who achieved BP and LDL-C level goals.

CONCLUSIONS AND RELEVANCE

A multifaceted intervention comprising pharmacist-led medication reconciliation and tailoring, patient education, collaborative care between pharmacist and patients' primary care clinician and/or cardiologist, and voice messaging increased adherence to medication regimens in the year after ACS hospital discharge without improving BP and LDL-C levels. Understanding the impact of such improvement in adherence on clinical outcomes is needed prior to broader dissemination of the program.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00903032.

摘要

重要性

急性冠状动脉综合征(ACS)住院后一年内,患者对心脏保护药物的依从性很差。

目的

测试一种多方面的干预措施,以提高对心脏药物的依从性。

设计、地点和参与者:在这项随机临床试验中,来自丹佛(科罗拉多州)、西雅图(华盛顿州)、达勒姆(北卡罗来纳州)和小石城(阿肯色州)的 4 家退伍军人事务部医疗中心的 253 名 ACS 住院患者在出院前被随机分为多方面干预(INT)组或常规护理(UC)组。

干预措施

INT 持续 1 年,包括(1)药剂师主导的药物调整和调整;(2)患者教育;(3)药剂师与患者的初级保健临床医生和/或心脏病专家之间的协作护理;和(4)两种语音信息(教育和药物补充提醒电话)。

主要结果和测量

主要结果是根据出院后 1 年内 4 种心脏保护药物(氯吡格雷、β受体阻滞剂、3-羟基-3-甲基戊二酰辅酶 A 还原酶抑制剂[他汀类药物]和血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂[ACEI/ARB])的平均覆盖天数(PDC)大于 0.80 的比例,评估患者对药物治疗方案的依从性。次要结果包括血压(BP)和低密度脂蛋白胆固醇(LDL-C)水平目标的实现。结果:在 253 名患者中,241 名(95.3%)完成了研究(INT 组 122 名,UC 组 119 名)。在 INT 组中,89.3%的患者依从治疗,而 UC 组为 73.9%(P = 0.003)。INT 组的平均 PDC 更高(0.94 对 0.87;P < 0.001)。干预组中更多的患者对氯吡格雷(86.8%对 70.7%;P = 0.03)、他汀类药物(93.2%对 71.3%;P < 0.001)和 ACEI/ARB(93.1%对 81.7%;P = 0.03)更依从,但β受体阻滞剂(88.1%对 84.8%;P = 0.59)无统计学差异。两组患者血压和 LDL-C 水平目标的达标率无统计学差异。

结论和相关性

包括药剂师主导的药物调整和调整、患者教育、药剂师与患者的初级保健临床医生和/或心脏病专家之间的协作护理以及语音信息在内的多方面干预措施,提高了 ACS 出院后一年内的药物治疗依从性,而不改善血压和 LDL-C 水平。在更广泛地推广该方案之前,需要了解这种依从性提高对临床结果的影响。

试验注册

clinicaltrials.gov 标识符:NCT00903032。

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