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临床试验/NCT03254628
NCT03254628已完成不适用

Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation

Jhpiego0 个研究点目标入组 3,440 人开始时间: 2014年11月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Jhpiego
入组人数
3,440
主要终点
Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage

研究概览

简要总结

The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and district level health facilities in Uganda. The program is designed to improve provider competencies, provider performance and health outcomes among women giving birth and newborns.

详细描述

This study will take place in Uganda at Health Centers (level II, III and IV) and District Hospitals, to reach 'frontline' health providers who attend births. This study will take place in districts meeting study criteria in two regions to demonstrate ability to implement in different geographic settings and potential for scale up. It is a quasi-experimental design with three study arms/groups that receive different levels or intensities and modalities of the program intervention.

Briefly, the same simulator-based training will be provided in all three study arms. After the training, a simulator will be left in the health facility, and providers will be encouraged to practice with it regularly. In two of the study arms, specific health workers will be recruited to support the intervention by encouraging their colleagues to practice with the simulator. In one study arm, the practice will be further reinforced through mobile phone-based support. Following is a more detailed description of each of the three components.

Component 1 (Training): Training is composed of two separate training interventions. First, in each study facility, Ugandan master trainers (district trainers) will conduct a single day, simulator-driven training on PPH prevention and treatment; all providers who attend births will be invited to participate. Eight weeks later, in each facility, the same trainers will conduct a one-day, simulator-driven training for prevention and management of asphyxia in the newborn. After each one-day training, simulators will be left at the facility for practice with a corresponding practice schedule.

Component 2 (Peer-led Practice Sessions): On the day the first training (for PPH), 2 birth attendants at the facility will be selected to serve as clinical mentors (CM). The CMs will be trained to encourage their coworkers to participate in 15-minute practice sessions each week for 8 weeks, in which they will use the simulators to practice the skills learned in the one-day training. After the newborn asphyxia training occurs, these same CMs will be trained to support a similar practice schedule for the following 12 weeks - 8 weeks for newborn asphyxia practice and 4 weeks for combined PPH and asphyxia skills practice.

Component 3 (Mobile phone-based support): CMs will be connected to the district trainer via mobile phone for weekly phone calls during the practice periods to provide reminders and support for practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • For Providers: Health providers who attend births in participating health facility and consent to be assessed at the time of enrollment and at several points in time over two years.
  • For Clinical mentors: being an experienced skilled birth attendant and likely to remain at the facility during the study period
  • For Women in Labor and Delivery and Newborns: Women in any stage of labor in participating facility who consent to observation of their delivery and care of their newborn (or consent from the next of kin if the woman is incapacitated and not able to provide consent)
  • Facility In-charges and Stakeholders: Facility in-charges at sampled health facilities; stakeholders identified by Jhpiego senior managers as being influential in maternal and newborn health policy decisions in Uganda.

排除标准

  • Providers: has <1 year of experience, and has plans to be transferred to another facility or leave the facility soon
  • Other types of participants: none

研究组 & 干预措施

Full - Train/oxy&miso/ B&M/Mentor/Phone

Experimental

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

干预措施: Helping Mothers Survive - Bleeding After Birth training (Other)

Full - Train/oxy&miso/ B&M/Mentor/Phone

Experimental

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

干预措施: Helping Babies Breathe (Other)

Full - Train/oxy&miso/ B&M/Mentor/Phone

Experimental

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

干预措施: Mentor (Behavioral)

Full - Train/oxy&miso/ B&M/Mentor/Phone

Experimental

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

干预措施: Phone (Behavioral)

Full - Train/oxy&miso/ B&M/Mentor/Phone

Experimental

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

干预措施: oxytocin and misoprostol (Drug)

Full - Train/oxy&miso/ B&M/Mentor/Phone

Experimental

Helping Mothers Survive- Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of Clinical Mentor in each facility to support deliberate practice, phone-based support from district trainer for Clinical Mentor.

干预措施: Newborn bag and mask (Device)

Partial - Train/oxy & miso/ B&M/Mentor

Experimental

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.

干预措施: Helping Mothers Survive - Bleeding After Birth training (Other)

Partial - Train/oxy & miso/ B&M/Mentor

Experimental

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.

干预措施: Helping Babies Breathe (Other)

Partial - Train/oxy & miso/ B&M/Mentor

Experimental

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.

干预措施: Mentor (Behavioral)

Partial - Train/oxy & miso/ B&M/Mentor

Experimental

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.

干预措施: oxytocin and misoprostol (Drug)

Partial - Train/oxy & miso/ B&M/Mentor

Experimental

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask, designation of clinical mentor in each facility to support deliberate practice.

干预措施: Newborn bag and mask (Device)

Comparison - Train/oxy & miso/ B&M

Active Comparator

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.

干预措施: Helping Mothers Survive - Bleeding After Birth training (Other)

Comparison - Train/oxy & miso/ B&M

Active Comparator

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.

干预措施: Helping Babies Breathe (Other)

Comparison - Train/oxy & miso/ B&M

Active Comparator

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.

干预措施: oxytocin and misoprostol (Drug)

Comparison - Train/oxy & miso/ B&M

Active Comparator

Helping Mothers Survive - Bleeding After Birth training and Helping Babies Breathe training done at the facility, simulator present in each facility, oxytocin and misoprostol backfill, newborn bag and mask,.

干预措施: Newborn bag and mask (Device)

结局指标

主要结局

Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage

时间窗: Baseline, Midline (6 months), Endline (12 months)

The change in the percentage of women who received oxytocin in correct dose immediately after vaginal birth in three study arms, as assessed by direct clinical observation, using a standardized checklist.

次要结局

  • Change in provider performance on simulator-based assessments(Pre-test (before training)- post-test (immediately after training) - midline (6 months))
  • Difference in differences: change in care of the mother composite score(Baseline (before training), Midline (6 months), Endline (12 months))
  • Difference in differences: change care of the newborn composite score(Baseline (before training), Midline (6 months), Endline (12 months))

研究者

发起方
Jhpiego
申办方类型
Other
责任方
Sponsor

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