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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254628
• Other study ID #: AID-OAA-A-13-00012
• Status: Completed
• Phase: N/A
• First received: July 20, 2017
• Last updated: August 18, 2017
• Start date: November 14, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2017
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3440
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Hemorrhage
• Neonatal Asphyxia
• Postpartum Hemorrhage

Intervention

Other:
• Helping Mothers Survive - Bleeding After Birth training
One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.
• Helping Babies Breathe
One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag & mask device.

Behavioral:
• Mentor
A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.
• Phone
District trainers telephone clinical mentors and encourage them to lead practice sessions.

Drug:
• oxytocin and misoprostol
This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.

Device:
• Newborn bag and mask
All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jhpiego	United States Agency for International Development (USAID)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage	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.	Baseline, Midline (6 months), Endline (12 months)
Secondary	Change in provider performance on simulator-based assessments	The proportion of providers that obtain a passing score on the assessments, based on assessments done by clinical trainers.	Pre-test (before training)- post-test (immediately after training) - midline (6 months)
Secondary	Difference in differences: change in care of the mother composite score	A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.	Baseline (before training), Midline (6 months), Endline (12 months)
Secondary	Difference in differences: change care of the newborn composite score	A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.	Baseline (before training), Midline (6 months), Endline (12 months)