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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03254628
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Jhpiego

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE August 18, 2017
Last Update Posted Date August 22, 2017
Actual Study Start Date  ICMJE November 14, 2014
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
  • Change in provider performance on simulator-based assessments [ Time Frame: Pre-test (before training)- post-test (immediately after training) - midline (6 months) ]
    The proportion of providers that obtain a passing score on the assessments, based on assessments done by clinical trainers.
  • Difference in differences: change in care of the mother composite score [ Time Frame: Baseline (before training), Midline (6 months), Endline (12 months) ]
    A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
  • Difference in differences: change care of the newborn composite score [ Time Frame: Baseline (before training), Midline (6 months), Endline (12 months) ]
    A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
Official Title  ICMJE Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Postpartum Hemorrhage
  • Neonatal Asphyxia
Intervention  ICMJE
  • 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.
    Other Name: HMS BAB
  • Other: 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.
    Other Name: HBB
  • 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.
    Other Name: CM
  • Behavioral: 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.
    Other Name: oxy&miso
  • 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
    Other Name: B&M
Study Arms  ICMJE
  • Experimental: Full - Train/oxy&miso/ B&M/Mentor/Phone
    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.
    Interventions:
    • Other: Helping Mothers Survive - Bleeding After Birth training
    • Other: Helping Babies Breathe
    • Behavioral: Mentor
    • Behavioral: Phone
    • Drug: oxytocin and misoprostol
    • Device: Newborn bag and mask
  • Experimental: Partial - Train/oxy & miso/ B&M/Mentor
    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.
    Interventions:
    • Other: Helping Mothers Survive - Bleeding After Birth training
    • Other: Helping Babies Breathe
    • Behavioral: Mentor
    • Drug: oxytocin and misoprostol
    • Device: Newborn bag and mask
  • Active Comparator: Comparison - Train/oxy & miso/ B&M
    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,.
    Interventions:
    • Other: Helping Mothers Survive - Bleeding After Birth training
    • Other: Helping Babies Breathe
    • Drug: oxytocin and misoprostol
    • Device: Newborn bag and mask
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2017)
3440
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03254628
Other Study ID Numbers  ICMJE AID-OAA-A-13-00012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jhpiego
Study Sponsor  ICMJE Jhpiego
Collaborators  ICMJE United States Agency for International Development (USAID)
Investigators  ICMJE
Principal Investigator: Cherrie Evans, DrPH Jhpiego
PRS Account Jhpiego
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP