Evaluation of Maternal & Newborn Health Simulation Lab Centers of Excellence in Seven Referral Hospitals of Nepal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,464
- 试验地点
- 1
- 主要终点
- Proportion of women with primary postpartum hemorrhage after vaginal delivery
研究概览
简要总结
Postpartum hemorrhage and birth asphyxia are the leading causes of maternal and neonatal mortalities worldwide. Prevention and adequate treatment are, therefore crucial. While Nepal has made significant improvements in maternal and neonatal health, these efforts are insufficient to achieve the Sustainable Development Goal 3. Several studies have revealed critical gaps in the knowledge and clinical skills of maternal and neonatal health (MNH) providers in Nepal, likely due to limited clinical experience and practical exposure. Therefore, One Heart Worldwide is implementing the 'Maternal and Newborn Health Simulation Lab Centers of Excellence' project in 7 referral hospitals of Nepal wherein in simulation labs will be established and simulation-based training will be provided to hospital staff with a focus on essential care of labor and birth, bleeding after birth, and helping babies breathe modules. This implementation study will evaluate the project implementation and effectiveness using a REAIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. A mixed-methods approach will be used to evaluate each component of RE-AIM using a quasi-experimental pre-test and post-test design. The pre-test data collection will be of 6 months' duration. During this phase, we will collect daily data on maternal and neonatal health outcomes (Post-partum hemorrhage (PPH) incidence, proportion of newborns with APGAR score<7 at 5 minutes' assessment, and rate of maternal blood transfusion after PPH), and also assess the skills assessment scores of the MNH service providers. After the completion of pre-test data collection, training will be provided to MNH service providers of the hospital in the established simulation labs. The daily MNH routine data collection will continue during project implementation phase, and till six months after the training MNH service providers of the hospitals. In addition to the assessments done in the pre-test, we will also assess the reach, implementation status, challenges, utilization, and maintenance of established simulation labs. The post-test assessment of skills of MNH service providers will be conducted six months after the completion of the in-hospital trainings. Written informed consent will be obtained from the study participants. For the quantitative data, descriptive and inferential statistical methods will be used for data analysis. Qualitative data will be analyzed using thematic analysis supported by NVIVO 12 software.
详细描述
Post-partum hemorrhage (PPH) and birth asphyxia are significant contributor to maternal and neonatal mortalities globally. Postpartum hemorrhage leads to around 70,000 deaths, mostly in low and middle-income countries. Despite evidence indicating that active management of the third stage of labor (AMTSL) can mitigate PPH occurrence by 40-70%, adherence to this practice remains limited according to guidelines. Similarly, birth asphyxia accounts for an estimated 900,000 deaths each year and is one of the primary causes of early neonatal mortality. Addressing these critical issue requires multiple approach including the competency of health care providers. In order to optimally utilize the knowledge and skills learnt by the students and health care service providers, it is important to create opportunities for reorientation not only with regard to knowledge but also to reinforce skills. Creating simulation based skills lab for pre-service and in-service with linkages for post training mentorship is a step in this direction. Comprehensive simulation lab with skills stations are designed with the aim of acquisition and upgradation of skills of healthcare providers to enhance their capacity in providing quality maternal and neonatal health care. A simulation skills laboratory has the advantage that allows learners opportunities for repetition and feedback and permits individualized learning. Globally, simulation based intervention studies report evidence of impact of patient level outcomes including, reduction is maternal complication such as PPH and retained placenta; as well as neonatal outcomes such as birth asphyxia, stillbirth, and newborn deaths. Simulation lab provides a safe and controlled environment for healthcare providers to practice and refine their skills particularly in managing obstetric emergencies such as post-partum hemorrhage and birth asphyxia. Therefore, this study will help to bridge the gap in healthcare provider's skills and improve patient safety in maternal and neonatal healthcare by establishing high fidelity simulation labs in seven strategically located referral hospitals. The hospital staff will also benefit from training available within the simulation labs. The current study will assess the effect of establishing high-fidelity simulation labs on both implementation and patient outcomes in the hospitals. In this study the patient-level assessments include assessment of the proportion of PPH, rate of blood transfusions after PPH, and proportion of newborns with APGAR score less than 7 at 5 minutes' assessment. Our study will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for the evaluation as it focuses on the issues, dimensions, and steps in program design, dissemination, and implementation process, which has been translated and used in different contexts and settings.
Research Method:
Concurrent nested mixed- method study to evaluate each component of RE-AIM using a quasi-experimental pre and post-test design.
Study sites:
The study sites will be the seven referral hospitals from five different Provinces of Nepal- Paropakar Maternity and Women's Hospital (Bagmati Province), Provincial Hospital Janakpur (Madhesh Province), Koshi Hospital (Koshi Province), Narayani Hospital (Madhesh Province), Province Hospital Surkhet (Karnali Province), BPKIHS (Koshi Province), and Pokhara Academy of Health Sciences (Gandaki Province) with annual deliveries of 24344; 8058; 8065; 7118; 5239; 3620; and 8915 respectively. Overall, these sites have a total of 65,359 deliveries in a year (Source HMIS data (2078/79))
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women who have recently delivered in the study hospital via vaginal delivery
- •Newborn delivered at the same hospital with gestational age ≥ 37 weeks, birth weight ≥2500 gm, and a fetal heart sound present at the time of admission
- •Maternal and Newborn Health staff working in selected hospitals for at least 3 months
排除标准
- •Women with Postpartum Hemorrhage (PPH) referred from other hospital, babies born outside of study hospital, and newborns with congenital abnormalities will be excluded.
结局指标
主要结局
Proportion of women with primary postpartum hemorrhage after vaginal delivery
时间窗: 15 months
Daily data will be collected by reviewing the hospital records, patient charts and reports.
Proportion of newborns with APGAR score <7 at 5 minutes' assessment
时间窗: 15 months
Daily data will be collected by reviewing the hospital records, patient charts and reports.
Skills score of maternal and newborn health service providers on Essential Care for Labor and Birth (ECLB), Bleeding after Birth (BAB), and Helping Babies Breathe (HBB) module.
时间窗: 6 months
Skills will be measured by experts before and 6 months after the simulation based trainings. The higher the scores, better the outcomes. The maximum obtainable score will be 100% (scores will be converted into percentage).
次要结局
- Rate of maternal blood transfusion after primary postpartum hemorrhage(15 months)
