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临床试验/NCT01459978
NCT01459978已完成不适用

Impact of Using Cumulative SUM (CUSUM) Control Chart in Maternity Department on Mother and Infant Health: a Cluster Randomized Trial

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60,000
试验地点
2
主要终点
Indicator of mother health

研究概览

简要总结

Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative Sum) will increase the awareness of health care staff in maternity and permit rapid detection of a small dip in performance in order to enable prompt investigations and corrective measures when necessary , which decrease maternal and neonatal mortality and morbidity.

Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity dashboard to decreases maternal and neonatal mortality and morbidity.

Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.

Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants could be collected over 2 year's period.

Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators previously selected by Delphi method.

Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality, adverse outcomes for women and newborn.

详细描述

  1. RATIONAL Quality improvement has become a central tenet of health care. In obstetrics and gynaecology departments, each admission may affect the health of not one, but two individuals, making high quality of care particularly important. In addition, most women admitted for obstetric reasons are healthy individuals in whom the goal is full preservation of health.

Measurement plays an important part in improving quality of care and promoting beneficial changes. Therefore, over the last decade much effort has gone into developing and using measures of quality.

The first step towards measuring quality of care in obstetrical departments is to select quality indicators. Conventional quality indicators are severe events such as maternal death and neonatal death. However, advances in obstetrical management have made such events extremely rare, and other quality indicators must now be sought.

Once quality indicators are identified, the best means of monitoring them must be determined. The use of statistical methods to monitor and control a process, known as Statistical Process Control (SPC), seems particularly promising for monitoring quality indicators. SPC uses rigorous time-series analysis methods, whose results are reported as a graph of changes in outcome rates over time. Moreover, SPC can help to determine whether these changes are real (i.e., related to a causative factor) or merely a manifestation of natural variability. Among SPC tools, CUmulative SUM (CUSUM) charts are widely used for industrial quality control and have been found effective for measuring and monitoring healthcare outcomes.

In obstetrics, Cumulative Sum (CUSUM) charts have been used to monitor Apgar scores or the performance of sonographers in assessing nuchal translucency in the first trimester of pregnancy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All deliveries during the study period:
  • Regardless of the mode of delivery: vaginal delivery, cesarean section, spontaneous or induced delivery
  • Regardless of the pregnancy term
  • Women followed or not from the first trimester of pregnancy in the concerned maternity
  • New born during the study period

排除标准

  • Pregnancies that ended with foetal death in UTERO or pregnancy termination for medical reasons

结局指标

主要结局

Indicator of mother health

时间窗: After 24 months

is a composite outcome taking into account : 1. - mortality, 2. - complications of pre-eclampsia * Hemolysis ,Elevated Liver enzymes, Low Platelet syndrome (HELLP): * Disseminated intravascular coagulation (DIC) * eclampsia * retro-placental hematoma, 3. - postpartum hemorrhage 4. - severe bleeding 5. - thromboembolism: * Phlebitis * Pulmonary embolism 6. - postpartum infections 7. - severe perineal injury 8. - need of intensive care transfer for women

Indicator of newborn health

时间窗: After 24 months

is a composite outcome of mortality and morbidity. Morbidities taken into account several clinical events: 1. - postnatal deaths (8days 1 month) 2. - prematurity: medical or spontaneous 3. - low birth weight (weight less than 2 kg at 37 weeks) 4. - maternal-fetal infection: occurring in the first hours of life (germs: B streptococcus, E. coli, streptococcus, non-B) 5. - transfer resuscitation term 6. - chromosomal abnormalities with absence of screening 7. - malformations without screening and diagnostic

次要结局

  • Women satisfaction(After 12 and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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