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Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction
JAMA ( IF 63.1 ) Pub Date : 2018-02-13 , DOI: 10.1001/jama.2017.21906 Mark D. Huffman 1 , Padinhare P. Mohanan 2 , Raji Devarajan 3, 4 , Abigail S. Baldridge 1 , Dimple Kondal 3, 4 , Lihui Zhao 3, 4 , Mumtaj Ali 3, 4 , Mangalath N. Krishnan 5 , Syam Natesan 6 , Rajesh Gopinath 7 , Sunitha Viswanathan 8 , Joseph Stigi 9 , Johny Joseph 10 , Somanathan Chozhakkat 11 , Donald M. Lloyd-Jones 1 , Dorairaj Prabhakaran 3, 4, 12 ,
JAMA ( IF 63.1 ) Pub Date : 2018-02-13 , DOI: 10.1001/jama.2017.21906 Mark D. Huffman 1 , Padinhare P. Mohanan 2 , Raji Devarajan 3, 4 , Abigail S. Baldridge 1 , Dimple Kondal 3, 4 , Lihui Zhao 3, 4 , Mumtaj Ali 3, 4 , Mangalath N. Krishnan 5 , Syam Natesan 6 , Rajesh Gopinath 7 , Sunitha Viswanathan 8 , Joseph Stigi 9 , Johny Joseph 10 , Somanathan Chozhakkat 11 , Donald M. Lloyd-Jones 1 , Dorairaj Prabhakaran 3, 4, 12 ,
Affiliation
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Importance Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India. Objective To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state. Design, Setting, and Participants Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016. During 5 predefined steps over the study period, hospitals were randomly selected to move in a 1-way crossover from the control group to the intervention group. Consecutively presenting patients with acute myocardial infarction were offered participation. Interventions Hospitals provided either usual care (control group; n = 10 066 participants [step 0: n = 2915; step 1: n = 2649; step 2: n = 2251; step 3: n = 1422; step 4; n = 829; step 5: n = 0]) or care using a quality improvement tool kit (intervention group; n = 11 308 participants [step 0: n = 0; step 1: n = 662; step 2: n = 1265; step 3: n = 2432; step 4: n = 3214; step 5: n = 3735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training. Main Outcomes and Measures The primary outcome was the composite of all-cause death, reinfarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome’s individual components, 30-day cardiovascular death, medication use, and tobacco cessation counseling. Mixed-effects logistic regression models were used to account for clustering and temporal trends. Results Among 21 374 eligible randomized participants (mean age, 60.6 [SD, 12.0] years; n = 16 183 men [76%] ; n = 13 689 [64%] with ST-segment elevation myocardial infarction), 21 079 (99%) completed the trial. The primary composite outcome was observed in 5.3% of the intervention participants and 6.4% of the control participants. The observed difference in 30-day major adverse cardiovascular event rates between the groups was not statistically significant after adjustment (adjusted risk difference, −0.09% [95% CI, −1.32% to 1.14%]; adjusted odds ratio, 0.98 [95% CI, 0.80-1.21]). The intervention group had a higher rate of medication use including reperfusion but no effect on tobacco cessation counseling. There were no unexpected adverse events reported. Conclusions and Relevance Among patients with acute myocardial infarction in Kerala, India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. Further research is needed to understand the lack of efficacy. Trial Registration clinicaltrials.gov Identifier: NCT02256657
中文翻译：
质量改进干预对印度急性心肌梗死患者临床结果的影响
重要性 印度的急性心肌梗死治疗和结果存在广泛的异质性。目的 评估适用于当地的质量改进工具包对印度南部喀拉拉邦的临床结果和过程措施的影响。设计、设置和参与者 集群随机阶梯楔形临床试验于 2014 年 11 月 10 日至 2016 年 11 月 9 日在印度喀拉拉邦的 63 家医院进行，最后随访日期为 2016 年 12 月 31 日。在研究期间的 5 个预定义步骤中，随机选择医院以单向交叉从对照组移动到干预组。连续出现的急性心肌梗死患者被提供参与。干预 医院提供常规护理（对照组；n = 10 066 名参与者 [步骤 0：n = 2915；第 1 步：n = 2649；第 2 步：n = 2251；第 3 步：n = 1422；第四步; n = 829；步骤 5：n = 0]）或使用质量改进工具包进行护理（干预组；n = 11 308 名参与者 [步骤 0：n = 0；步骤 1：n = 662；步骤 2：n = 1265；步骤 3： n = 2432；第 4 步：n = 3214；第 5 步：n = 3735]），包括审核和反馈、检查表、患者教育材料以及与紧急心血管护理和质量改进培训的联系。主要结果和措施 主要结果是使用标准化定义的 30 天全因死亡、再梗死、中风或大出血的复合。次要结果包括主要结果的各个组成部分、30 天心血管死亡、药物使用和戒烟咨询。混合效应逻辑回归模型用于解释聚类和时间趋势。结果 在 21 374 名符合条件的随机参与者中（平均年龄，60.6 [SD，12.0] 岁；n = 16 183 名男性 [76%]；n = 13 689 [64%] 名 ST 段抬高型心肌梗死），21 079 (99 %) 完成了试验。在 5.3% 的干预参与者和 6.4% 的对照参与者中观察到主要复合结果。调整后观察到的组间 30 天主要不良心血管事件发生率的差异无统计学意义（调整后风险差异，-0.09% [95% CI，-1.32% 至 1.14%]；调整后比值比，0.98 [95% CI，0.80-1.21]）。干预组的药物使用率更高，包括再灌注，但对戒烟咨询没有影响。没有报告意外的不良事件。印度喀拉拉邦急性心肌梗死患者的结论和相关性，与常规护理相比，使用质量改进干预并没有减少 30 天主要不良心血管事件的复合。需要进一步的研究来了解缺乏疗效。试验注册clinicaltrials.gov 标识符：NCT02256657
更新日期：2018-02-13
中文翻译：
质量改进干预对印度急性心肌梗死患者临床结果的影响
重要性 印度的急性心肌梗死治疗和结果存在广泛的异质性。目的 评估适用于当地的质量改进工具包对印度南部喀拉拉邦的临床结果和过程措施的影响。设计、设置和参与者 集群随机阶梯楔形临床试验于 2014 年 11 月 10 日至 2016 年 11 月 9 日在印度喀拉拉邦的 63 家医院进行，最后随访日期为 2016 年 12 月 31 日。在研究期间的 5 个预定义步骤中，随机选择医院以单向交叉从对照组移动到干预组。连续出现的急性心肌梗死患者被提供参与。干预 医院提供常规护理（对照组；n = 10 066 名参与者 [步骤 0：n = 2915；第 1 步：n = 2649；第 2 步：n = 2251；第 3 步：n = 1422；第四步; n = 829；步骤 5：n = 0]）或使用质量改进工具包进行护理（干预组；n = 11 308 名参与者 [步骤 0：n = 0；步骤 1：n = 662；步骤 2：n = 1265；步骤 3： n = 2432；第 4 步：n = 3214；第 5 步：n = 3735]），包括审核和反馈、检查表、患者教育材料以及与紧急心血管护理和质量改进培训的联系。主要结果和措施 主要结果是使用标准化定义的 30 天全因死亡、再梗死、中风或大出血的复合。次要结果包括主要结果的各个组成部分、30 天心血管死亡、药物使用和戒烟咨询。混合效应逻辑回归模型用于解释聚类和时间趋势。结果 在 21 374 名符合条件的随机参与者中（平均年龄，60.6 [SD，12.0] 岁；n = 16 183 名男性 [76%]；n = 13 689 [64%] 名 ST 段抬高型心肌梗死），21 079 (99 %) 完成了试验。在 5.3% 的干预参与者和 6.4% 的对照参与者中观察到主要复合结果。调整后观察到的组间 30 天主要不良心血管事件发生率的差异无统计学意义（调整后风险差异，-0.09% [95% CI，-1.32% 至 1.14%]；调整后比值比，0.98 [95% CI，0.80-1.21]）。干预组的药物使用率更高，包括再灌注，但对戒烟咨询没有影响。没有报告意外的不良事件。印度喀拉拉邦急性心肌梗死患者的结论和相关性，与常规护理相比，使用质量改进干预并没有减少 30 天主要不良心血管事件的复合。需要进一步的研究来了解缺乏疗效。试验注册clinicaltrials.gov 标识符：NCT02256657
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