China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.
Vascular Neurology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
JAMA Netw Open. 2023 Jun 1;6(6):e2316465. doi: 10.1001/jamanetworkopen.2023.16465.
Reperfusion therapy is the most effective treatment for acute ischemic stroke but remains underused in China.
To evaluate the effect of a problem-oriented, culturally adapted, targeted quality improvement intervention on reperfusion therapy for patients with acute ischemic stroke in China.
DESIGN, SETTING, AND PARTICIPANTS: In this stepped-wedge cluster randomized clinical trial, patients from 16 secondary and 33 tertiary hospitals in China with acute ischemic stroke within 6 hours of symptom onset were consecutively recruited between July 1, 2018, and June 30, 2020.
Hospitals were randomly assigned to 1 of 3 sequences to receive the targeted quality improvement intervention (n = 5689), in which workflow reconstruction was promoted to reduce in-hospital reperfusion treatment delays, or usual care (n = 6443), in which conventional stroke care was left to the discretion of the stroke team.
The primary outcome was the reperfusion therapy rate, a composite outcome of intravenous recombinant tissue plasminogen activator (IV rtPA) or endovascular thrombectomy (EVT) for eligible patients who arrived within 3.5 or 4.5 hours of symptom onset. Secondary outcomes were the IV rtPA administration rate among eligible patients who arrived within 3.5 hours of symptom onset, the EVT rate among eligible participants who arrived within 4.5 hours of symptom onset, the proportion of patients with door-to-needle time within 60 minutes, the proportion of patients with door-to-puncture time within 90 minutes, in-hospital mortality, and 3-month disability as measured by a modified Rankin Scale score greater than 2.
All 12 132 eligible patients (mean [SD] age, 66 [12.1] years; 7759 male [64.0%]) completed the trial. The reperfusion rate was 53.5% (3046 of 5689) for the eligible patients in the intervention period and 43.9% (2830 of 6443) in the control period. No significant improvement in primary outcomes was found for the intervention after adjusting for cluster, period, and imbalanced baseline covariates (adjusted risk difference [ARD], 5.5%; 95% CI, -8.0% to 19.0%; adjusted odds ratio [AOR], 1.26; 95% CI, 0.72-2.21) or for the secondary outcomes. However, significant improvements were found in secondary hospitals for reperfusion therapy (1081 of 1870 patients [57.8%] vs 945 of 2022 patients [42.9%]; ARD, 19.0%; 95% CI, 6.4%-31.6%; AOR, 2.24; 95% CI, 1.29-3.88), IV rtPA administration (1062 of 1826 patients [58.2%] vs 916 of 2170 patients [42.2%]; ARD, 20.3%; 95% CI, 7.4%-33.1%; AOR, 2.37; 95% CI, 1.34-4.19), and EVT (51 of 231 patients [22.1%] vs 37 of 259 patients [14.3%]; ARD, 13.6%; 95% CI, 1.0%-26.3%; AOR, 3.03; 95% CI, 1.11-8.25) in subgroup analyses.
In this stepped-wedge cluster randomized clinical trial of patients with acute ischemic stroke in China, the use of a targeted quality improvement intervention compared with usual care did not improve the reperfusion therapy rate. However, the intervention may be effective in secondary hospitals.
ClinicalTrials.gov Identifier: NCT03578107.
重要性：再灌注治疗是急性缺血性脑卒中最有效的治疗方法，但在中国仍未得到充分应用。
目的：评估以问题为导向、文化适应性、靶向的质量改进干预对中国急性缺血性脑卒中患者再灌注治疗的效果。
设计、地点和参与者：在这项阶梯式楔形集群随机临床试验中，2018 年 7 月 1 日至 2020 年 6 月 30 日期间，连续招募了来自中国 16 家二级和 33 家三级医院的发病 6 小时内的急性缺血性脑卒中患者。
干预措施：医院被随机分配到 3 个序列中的 1 个，以接受靶向质量改进干预（n=5689），其中促进工作流程重构以减少院内再灌注治疗延迟，或接受常规护理（n=6443），其中中风团队自行决定常规中风护理。
主要结果和措施：主要结局是再灌注治疗率，这是一个综合结局，包括有资格在症状出现后 3.5 或 4.5 小时内到达的患者接受静脉重组组织纤溶酶原激活剂（IV rtPA）或血管内血栓切除术（EVT）的情况。次要结局包括有资格在症状出现后 3.5 小时内到达的患者接受 IV rtPA 治疗的比例，有资格在症状出现后 4.5 小时内到达的患者接受 EVT 的比例，门到针时间在 60 分钟内的患者比例，门到穿刺时间在 90 分钟内的患者比例，院内死亡率，以及 3 个月时改良 Rankin 量表评分大于 2 的残疾率。
结果：所有 12132 名合格患者（平均[SD]年龄 66[12.1]岁；7759 名男性[64.0%]）完成了试验。干预期内符合条件的患者再灌注率为 53.5%（3046 例），对照组为 43.9%（2830 例）。在调整了聚类、周期和不平衡基线协变量后，干预组对主要结局没有显著改善（调整风险差异[ARD]，5.5%；95%CI，-8.0%至 19.0%；调整后的优势比[AOR]，1.26；95%CI，0.72-2.21）或次要结局。然而，在二级医院发现了一些次要结果的显著改善，包括再灌注治疗（1870 名患者中的 1081 名[57.8%]与 2022 名患者中的 945 名[42.9%]；ARD，19.0%；95%CI，6.4%-31.6%；AOR，2.24；95%CI，1.29-3.88）、IV rtPA 治疗（1826 名患者中的 1062 名[58.2%]与 2170 名患者中的 916 名[42.2%]；ARD，20.3%；95%CI，7.4%-33.1%；AOR，2.37；95%CI，1.34-4.19）和 EVT（231 名患者中的 51 名[22.1%]与 259 名患者中的 37 名[14.3%]；ARD，13.6%；95%CI，1.0%-26.3%；AOR，3.03；95%CI，1.11-8.25）。
结论：在这项针对中国急性缺血性脑卒中患者的以问题为导向、文化适应性、靶向的质量改进干预的阶梯式楔形集群随机临床试验中，与常规护理相比，使用靶向质量改进干预并未提高再灌注治疗率。然而，该干预措施在二级医院可能是有效的。
试验注册：ClinicalTrials.gov 标识符：NCT03578107。
