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Peer Learning and HBB in Managing Maternal Newborn and Child Health Emergencies in Rural Uganda (SimForLife)

Primary Purpose

Maternal, Newborn and Child Health Emergencies

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer learning
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Maternal, Newborn and Child Health Emergencies

Eligibility Criteria

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

Inclusion Criteria:

  • Health workers involved in performing deliveries of mothers at health center IVs and IIIs (i.e, county and subcounty level)

Exclusion Criteria:

  • Health facilities based in municipalities, urban dwellings

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Standard HBB and ECEB training with peer learning

    Standard HBB and ECEB training only

    Outcomes

    Primary Outcome Measures

    Skills on key maternal, newborn and child health emergency procedures
    Ability to perform key maternal, new born and child health emergency procedures measured using Multiple choice questions (MCQs). A composite score with a maximum of 100% will be computed from these MCQs

    Secondary Outcome Measures

    Clinical teamwork scores
    Ability to work as a team through communication, sharing roles and completing tasks together measured using the Clinical Teamwork scale (CTS). A composite score will be computed by adding up all the items on the CTS scale. CTS has 15 items, each item with a maximum score of 10

    Full Information

    First Posted
    August 9, 2017
    Last Updated
    August 14, 2017
    Sponsor
    Mbarara University of Science and Technology
    Collaborators
    University of Calgary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03252275
    Brief Title
    Peer Learning and HBB in Managing Maternal Newborn and Child Health Emergencies in Rural Uganda
    Acronym
    SimForLife
    Official Title
    Use of Simulation Based Education With Peer Learning to Enhance HBB Training for Managing Maternal Newborn and Child Health Emergencies in Rural Uganda: A Cluster-randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 30, 2017 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    June 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mbarara University of Science and Technology
    Collaborators
    University of Calgary

    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 aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda.
    Detailed Description
    The aim of this study is to test an intervention that has potential to improve acute care skills and confidence related to safe delivery and newborn care for mid-level health providers in Uganda by the development of a 'mobile' simulation package including scale-up materials based upon research evidence. In this randomized study investigators will compare the impact of a peer learning package on skills, knowledge and team work regarding newborn care among health workers in rural south western Uganda. The cluster randomized study will have two arms; intervention arm receives peer learning program. In this program, two health workers at the same health facility teach each other using case scenarios. The case scenarios will be based on common neonatal conditions such as neonatal sepsis, hypothermia and prematurity. The two study arms will both receive training on HBB and Essential care for every baby (ECEB)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maternal, Newborn and Child Health Emergencies

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    We will conduct a parallel comparison of intervention and control arms to measure study endpoints
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    77 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Standard HBB and ECEB training with peer learning
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Standard HBB and ECEB training only
    Intervention Type
    Other
    Intervention Name(s)
    Peer learning
    Intervention Description
    Peer learning plus HBB and ECEB
    Primary Outcome Measure Information:
    Title
    Skills on key maternal, newborn and child health emergency procedures
    Description
    Ability to perform key maternal, new born and child health emergency procedures measured using Multiple choice questions (MCQs). A composite score with a maximum of 100% will be computed from these MCQs
    Time Frame
    Change in skills scores at 6 and 12 months from Baseline
    Secondary Outcome Measure Information:
    Title
    Clinical teamwork scores
    Description
    Ability to work as a team through communication, sharing roles and completing tasks together measured using the Clinical Teamwork scale (CTS). A composite score will be computed by adding up all the items on the CTS scale. CTS has 15 items, each item with a maximum score of 10
    Time Frame
    Change in CTS scores at 6 and 12 months from Baseline

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Health workers involved in performing deliveries of mothers at health center IVs and IIIs (i.e, county and subcounty level) Exclusion Criteria: Health facilities based in municipalities, urban dwellings
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Santorini Data, MD
    Phone
    +256752214458
    Email
    sdata@must.ac.ug
    First Name & Middle Initial & Last Name or Official Title & Degree
    Francis Bajunirwe, PhD
    Phone
    +256772576396
    Email
    fbaj@must.ac.ug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Santorini Data, MD
    Organizational Affiliation
    Mbarara University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Authorization to share data will be sought
    Citations:
    PubMed Identifier
    35794462
    Citation
    Data S, Mirette D, Cherop M, Bajunirwe F, Kyakwera C, Robinson T, Josephine NN, Abesiga L, Namata T, Brenner JL, Singhal N, Twine M, Wishart I, McIntosh H, Cheng A. Peer Learning and Mentorship for Neonatal Management Skills: A Cluster-Randomized Trial. Pediatrics. 2022 Aug 1;150(2):e2021054471. doi: 10.1542/peds.2021-054471.
    Results Reference
    derived

    Learn more about this trial

    Peer Learning and HBB in Managing Maternal Newborn and Child Health Emergencies in Rural Uganda

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