Tiantan Clinical Trial and Research Center for Stroke, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
JAMA. 2018 Jul 17;320(3):245-254. doi: 10.1001/jama.2018.8802.
In China and other parts of the world, hospital personnel adherence to evidence-based stroke care is limited.
To determine whether a multifaceted quality improvement intervention can improve hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke (AIS) in China.
DESIGN, SETTING, AND PARTICIPANTS: A multicenter, cluster-randomized clinical trial among 40 public hospitals in China that enrolled 4800 patients hospitalized with AIS from August 10, 2014, through June 20, 2015, with 12-month follow-up through July 30, 2016.
Twenty hospitals received a multifaceted quality improvement intervention (intervention group; 2400 patients), including a clinical pathway, care protocols, quality coordinator oversight, and performance measure monitoring and feedback. Twenty hospitals participated in the stroke registry with usual care (control group; 2400 patients).
The primary outcome was hospital personnel adherence to 9 AIS performance measures, with co-primary outcomes of a composite of percentage of performance measures adhered to, and as all-or-none. Secondary outcomes included in-hospital mortality and long-term outcomes (a new vascular event, disability [modified Rankin Scale score, 3-5], and all-cause mortality) at 3, 6, and 12 months.
Among 4800 patients with AIS enrolled from 40 hospitals and randomized (mean age, 65 years; women, 1757 [36.6%]), 3980 patients (82.9%) completed the 12-month follow-up of the trial. Patients in intervention group were more likely to receive performance measures than those in the control groups (composite measure, 88.2% vs 84.8%, respectively; absolute difference, 3.54% [95% CI, 0.68% to 6.40%], P = .02). The all-or-none measure did not significantly differ between the intervention and control groups (53.8% vs 47.8%, respectively; absolute difference, 6.69% [95% CI, -0.41% to 13.79%], P = .06). New clinical vascular events were significantly reduced in the intervention group compared with the control group at 3 months (3.9% vs 5.3%, respectively; difference, -2.03% [95% CI, -3.51% to -0.55%]; P = .007), 6 months (6.3% vs 7.8%, respectively; difference, -2.18% [95% CI, -4.0% to -0.35%]; P = .02) and 12 months (9.1% vs 11.8%, respectively; difference, -3.13% [95% CI, -5.28% to -0.97%]; P = .005).
Among 40 hospitals in China, a multifaceted quality improvement intervention compared with usual care resulted in a statistically significant but small improvement in hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke when assessed as a composite measure, but not as an all-or-none measure. Further research is needed to understand the generalizability of these findings.
ClinicalTrials.gov Identifier: NCT02212912.
在中国和世界其他地区,医院人员对基于证据的中风护理的坚持程度有限。
确定多方面的质量改进干预是否可以提高中国急性缺血性中风(AIS)患者的医院人员对基于证据的绩效指标的坚持程度。
设计、地点和参与者:这是一项在中国 40 家公立医院进行的多中心、集群随机临床试验,共纳入了 4800 名因 AIS 住院的患者,入组时间为 2014 年 8 月 10 日至 2015 年 6 月 20 日,12 个月的随访时间为 2016 年 7 月 30 日。
20 家医院接受了多方面的质量改进干预(干预组;2400 名患者),包括临床路径、护理方案、质量协调员监督以及绩效指标监测和反馈。20 家医院参与了有常规护理的中风登记处(对照组;2400 名患者)。
主要结果是医院人员对 9 项 AIS 绩效指标的坚持程度,主要复合指标为坚持的绩效指标的百分比,以及全或无。次要结局包括住院期间死亡率和长期结局(新发血管事件、残疾[改良 Rankin 量表评分 3-5]和全因死亡率),随访时间为 3、6 和 12 个月。
在 40 家医院共纳入了 4800 名 AIS 患者进行随机分组(平均年龄 65 岁;女性 1757 名[36.6%]),其中 3980 名(82.9%)完成了 12 个月的试验随访。干预组患者接受绩效指标的比例高于对照组(综合指标,分别为 88.2%和 84.8%;绝对差异,3.54%[95%CI,0.68%至 6.40%],P=0.02)。干预组和对照组之间的全或无指标没有显著差异(分别为 53.8%和 47.8%;绝对差异,6.69%[95%CI,-0.41%至 13.79%],P=0.06)。与对照组相比,干预组在 3 个月(3.9%对 5.3%;差异,-2.03%[95%CI,-3.51%至-0.55%];P=0.007)、6 个月(6.3%对 7.8%;差异,-2.18%[95%CI,-4.0%至-0.35%];P=0.02)和 12 个月(9.1%对 11.8%;差异,-3.13%[95%CI,-5.28%至-0.97%];P=0.005)时新发临床血管事件显著减少。
在中国的 40 家医院中,与常规护理相比,多方面的质量改进干预在评估为综合指标时,与急性缺血性中风患者的医院人员坚持基于证据的绩效指标相比,可显著改善,但幅度较小,但在评估为全或无时则无明显改善。需要进一步研究以了解这些发现的普遍性。
ClinicalTrials.gov 标识符:NCT02212912。