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

Primary Purpose

Postpartum Hemorrhage, Neonatal Asphyxia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Helping Mothers Survive - Bleeding After Birth training
Helping Babies Breathe
Mentor
Phone
oxytocin and misoprostol
Newborn bag and mask
Sponsored by
Jhpiego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postpartum Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

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

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

    Comparison - Train/oxy & miso/ B&M

    Arm Description

    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.

    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.

    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,.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    July 20, 2017
    Last Updated
    August 18, 2017
    Sponsor
    Jhpiego
    Collaborators
    United States Agency for International Development (USAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03254628
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 14, 2014 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jhpiego
    Collaborators
    United States Agency for International Development (USAID)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage, Neonatal Asphyxia

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3440 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Full - Train/oxy&miso/ B&M/Mentor/Phone
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Partial - Train/oxy & miso/ B&M/Mentor
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Comparison - Train/oxy & miso/ B&M
    Arm Type
    Active Comparator
    Arm Description
    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,.
    Intervention Type
    Other
    Intervention Name(s)
    Helping Mothers Survive - Bleeding After Birth training
    Other Intervention Name(s)
    HMS BAB
    Intervention Description
    One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.
    Intervention Type
    Other
    Intervention Name(s)
    Helping Babies Breathe
    Other Intervention Name(s)
    HBB
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mentor
    Other Intervention Name(s)
    CM
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Phone
    Intervention Description
    District trainers telephone clinical mentors and encourage them to lead practice sessions.
    Intervention Type
    Drug
    Intervention Name(s)
    oxytocin and misoprostol
    Other Intervention Name(s)
    oxy&miso
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Newborn bag and mask
    Other Intervention Name(s)
    B&M
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage
    Description
    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.
    Time Frame
    Baseline, Midline (6 months), Endline (12 months)
    Secondary Outcome Measure Information:
    Title
    Change in provider performance on simulator-based assessments
    Description
    The proportion of providers that obtain a passing score on the assessments, based on assessments done by clinical trainers.
    Time Frame
    Pre-test (before training)- post-test (immediately after training) - midline (6 months)
    Title
    Difference in differences: change in care of the mother composite score
    Description
    A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
    Time Frame
    Baseline (before training), Midline (6 months), Endline (12 months)
    Title
    Difference in differences: change care of the newborn composite score
    Description
    A composite variable of care provided to laboring mothers, based on direct clinical observation using a standardized checklist.
    Time Frame
    Baseline (before training), Midline (6 months), Endline (12 months)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cherrie Evans, DrPH
    Organizational Affiliation
    Jhpiego
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30925890
    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.
    Results Reference
    derived
    PubMed Identifier
    30557350
    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.
    Results Reference
    derived

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

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