Clinical trial NCT03254628: Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
Official title: Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Neonatal Asphyxia
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2017-08-18
Enrollment: 3440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage
timeFrame: Baseline, Midline (6 months), Endline (12 months)
Secondary outcomes:
measure: Change in provider performance on simulator-based assessments
timeFrame: Pre-test (before training)- post-test (immediately after training) - midline (6 months)
measure: Difference in differences: change in care of the mother composite score
timeFrame: Baseline (before training), Midline (6 months), Endline (12 months)
measure: Difference in differences: change care of the newborn composite score
timeFrame: Baseline (before training), Midline (6 months), Endline (12 months)
Other outcomes:
Locations:
Study officials:
affiliation: Jhpiego
name: Cherrie Evans, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams E, Bazant ES, Holcombe S, Atukunda I, Namugerwa RI, Britt K, Evans C. "Practice so that the skill does not disappear": mixed methods evaluation of simulator-based learning for midwives in Uganda. Hum Resour Health. 2019 Mar 29;17(1):24. doi: 10.1186/s12960-019-0350-z.
citation: Evans CL, Bazant E, Atukunda I, Williams E, Niermeyer S, Hiner C, Zahn R, Namugerwa R, Mbonye A, Mohan D. Peer-assisted learning after onsite, low-dose, high-frequency training and practice on simulators to prevent and treat postpartum hemorrhage and neonatal asphyxia: A pragmatic trial in 12 districts in Uganda. PLoS One. 2018 Dec 17;13(12):e0207909. doi: 10.1371/journal.pone.0207909. eCollection 2018.