An Electronic Medical Record Best-Practice Alert of Progesterone to Prevent Preterm Birth: A Pragmatic, Pilot, Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention, assessed by proportions of successful implementation and recommendation by care providers
研究概览
简要总结
Progesterone can be given to women at risk for preterm birth, and is advocated by many guidelines as progesterone has been shown to markedly decrease preterm birth, death in newborns, and disability. However, not all eligible women are currently receiving this medication. Thus, there is an urgent need to improve prevention of preterm birth with progesterone. In response to the low number of women receiving this medication, the investigators have designed a potential method to increase progesterone use.
This method involves the use of an "alert" programmed into electronic medical records, to prompt doctors to prescribe progesterone to women at risk of preterm birth. This study is a randomized controlled trial that will assess the feasibility of using this "alert", by randomly assigning 8 clinics to either use this alert, or to provide their usual prenatal care. The investigators will then study whether the alert improved prescription of progesterone, and examine neonatal outcomes such as preterm birth and birth weight. Care providers will be asked for their feedback and thoughts about the alert, through questionnaires and structured interviews.
The investigators hypothesize that the electronic medical record alert will increase care provider recommendations and prescription of progesterone for women at risk of preterm birth. The investigators hope that this study will lay the groundwork for larger future studies aimed to strengthen health care quality and improve the health outcomes of women and their babies.
详细描述
Preterm birth affects a significant number of babies born every year, increasing risks of death and life-long disability. Progesterone has been found to halve the odds of preterm birth <34 weeks and neonatal death. Although progesterone is a proven standard medication for pregnant women at risk of preterm birth based on some guidelines (e.g. recommendations by the Current Society for Maternal-Fetal Health Medicine, and National Institute for Health and Care Excellence), few women are receiving this effective prevention. There is an urgent need to improve prevention of preterm birth with progesterone, which the investigators propose to do with an innovative and cutting-edge best-practice alert in electronic medical records (EMRs). Improving care may decrease the risks related to preterm birth, and improve patient experiences and outcomes for women and their babies.
This study will test the feasibility of an EMR alert for progesterone, which provides the opportunity for researchers and care providers to implement and advance the use of proven medical practices in preventing preterm birth and decreasing associated risks of death, life-long disability, family stress, health care use, and lost economic potential. The EMR alert would be transferable to other institutions or regions of the province, and is low-cost, sustainable, embeddable and scalable in the current system health system.
STUDY DESIGN:
The investigators propose a pilot cluster randomized control trial (RCT) with a 1:1 allocation of 8 clinics randomized to usage of an EMR alert (intervention) versus usual prenatal care without the usage of the EMR alert (control). Individual women will not be approached since this is a pilot cluster RCT. Rather, clinics (and care providers therein) have been approached and have agreed to participate in this study.
Investigators have followed the SPIRIT statement (Standard Protocol Items: Recommendations for Interventional Trials).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For clinics:
- •Usage of an EMR with the ability to have alerts inserted and that is searchable.
- •Location in Ontario (for proximity to the researchers),
- •Have a clinician willing to serve as the local site lead, and
- •Lack of an existing alert for progesterone.
- •For patients:
- •Women at risk of spontaneous preterm birth, based on >1 of the following criteria:
- •previous preterm birth <37 weeks,
- •a short cervix defined as <25 mm by transvaginal ultrasound during the current pregnancy.
- •One or two viable fetus(es) between 12 weeks + 0 days to 24 weeks + 6 days gestation.
排除标准
- •For patients:
- •Women with triplets or other higher order multiples,
- •Women with a miscarriage or termination of pregnancy, or
- •Women with a pregnancy with a known lethal fetal anomaly.
研究组 & 干预措施
Intervention
Clinics randomized to intervention will use the electronic medical record alert for progesterone, informed by guidelines and the foundational meta-analyses demonstrating its efficacy.
干预措施: Electronic medical record alert (Other)
Control
Clinics randomized to control will not use the electronic medical record alert for progesterone. The control group will receive the usual prenatal care.
结局指标
主要结局
Feasibility of the intervention, assessed by proportions of successful implementation and recommendation by care providers
时间窗: 10 months
Feasibility of the intervention will assessed by the proportion (%) of clinics which successfully implement the intervention (the electronic medical record alert), and the proportion (%) of care providers who would recommend the alert to colleagues. The intervention will be defined as feasible if \>80% of clinics successfully implement the alert, and if \>80% of care providers would recommend the alert to colleagues.
Feasibility of a cluster RCT, assessed by proportions of clinics agreeing to participation and completeness of outcome data
时间窗: 10 months
Feasibility of a cluster RCT will be assessed by the proportion (%) of approached clinics which agree to participate in the study, and by the proportion (%) of outcome data which is complete. The cluster RCT will be defined as feasible if \>80% of approached clinics agree to study participation, and if \>80% of outcome data is complete.
次要结局
- Process outcomes - rates of progesterone offer and usage(10 months)
- Facilitators to the intervention (qualitative measures), assessed by survey and interview(10 months)
- Perceptions of the effectiveness of the intervention (qualitative measures), assessed by survey and interview(10 months)
- Care provider ratings of acceptability, feasibility, and usefulness, assessed by survey(10 months)
- Barriers to the intervention (qualitative measures), assessed by survey and interview(10 months)