Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial
Lu Ke, Jiajia Lin, Gordon S. Doig, Arthur R. H. van Zanten, Yang Wang, Juan Xing, Zhongheng Zhang, Tao Chen, Lixin Zhou, Dongpo Jiang, Qindong Shi, Jiandong Lin, Jun Liu, Aibin Cheng, Yafeng Liang, Peiyang Gao, Junli Sun, Wenming Liu, Zhenyu Yang, Rumin Zhang, Xing Wei, An Zhang, Zhigang Zhou, Tingfa Zhou, Yang Liu, Fei Tong, Qiuhui Wang, Aijun Pan, Xiaobo Huang, Chuming Fan, Weihua Lü, Dongwu Shi, Lei Wang, Wei Li, Liming Gu, Liming Gu, Rongqing Sun, Rongqing Sun, Lin Han, Lihua Zhou, Xiangde Zheng, Feng Shan, Jianbo Liu, Jianbo Liu, Yuhang Ai, Liandi Li, Liandi Li, Zhiguo Pan, Donglin Xu, Zhiqiang Zou, Yan Gao, Yan Gao, Chunli Yang, Xijing Zhang, Jinglan Wu, Chuanyun Qian, Weixing Zhang, Minjie Zhang, Yuan Zong, Bingyu Qin, Fusen Zhang, Fusen Zhang, Zhe Zhai, Ping Chang, Bo Yu, Bo Yu, Shiying Yuan, Yijun Deng, Liyun Zhao, Bin Zang, Yuanfei Li, Fachun Zhou, Xiaomei Chen, Min Shao, Ming Wu, Weidong Wu, Zhaohui Zhang, Zhaohui Zhang, Qiang Guo, Zhiyong Wang, Yuanqi Gong, Yunlin Song, Kejian Qian, Yongjian Feng, Baocai Fu, Xueyan Liu, Zhiping Li, Chuanyong Gong, Cheng Sun, Jian Yu, Zhongzhi Tang, Linxi Huang, Linxi Huang, Zhijie He, Qingshan Zhou, Qingshan Zhou, Rongguo Yu, Weiqin Li, Weiqin Li, Lu Ke
Abstract
BACKGROUND: Previous cluster-randomized controlled trials evaluating the impact of implementing evidence-based guidelines for nutrition therapy in critical illness do not consistently demonstrate patient benefits. A large-scale, sufficiently powered study is therefore warranted to ascertain the effects of guideline implementation on patient-centered outcomes. METHODS: We conducted a multicenter, cluster-randomized, parallel-controlled trial in intensive care units (ICUs) across China. We developed an evidence-based feeding guideline. ICUs randomly allocated to the guideline group formed a local "intervention team", which actively implemented the guideline using standardized educational materials, a graphical feeding protocol, and live online education outreach meetings conducted by members of the study management committee. ICUs assigned to the control group remained unaware of the guideline content. All ICUs enrolled patients who were expected to stay in the ICU longer than seven days. The primary outcome was all-cause mortality within 28 days of enrollment. RESULTS: Forty-eight ICUs were randomized to the guideline group and 49 to the control group. From March 2018 to July 2019, the guideline ICUs enrolled 1399 patients, and the control ICUs enrolled 1373 patients. Implementation of the guideline resulted in significantly earlier EN initiation (1.20 vs. 1.55 mean days to initiation of EN; difference - 0.40 [95% CI - 0.71 to - 0.09]; P = 0.01) and delayed PN initiation (1.29 vs. 0.80 mean days to start of PN; difference 1.06 [95% CI 0.44 to 1.67]; P = 0.001). There was no significant difference in 28-day mortality (14.2% vs. 15.2%; difference - 1.6% [95% CI - 4.3% to 1.2%]; P = 0.42) between groups. CONCLUSIONS: In this large-scale, multicenter trial, active implementation of an evidence-based feeding guideline reduced the time to commencement of EN and overall PN use but did not translate to a reduction in mortality from critical illness. TRIAL REGISTRATION: ISRCTN, ISRCTN12233792 . Registered November 20th, 2017.