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A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka

Primary Purpose

Obstetric and Perinatal Complications, Postpartum Hemorrhage, Preeclampsia/Eclampsia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Skills training
Emergency obstetric drills
Revised Case Sheets
Supportive supervision
Referral strengthening
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstetric and Perinatal Complications focused on measuring provider skill and self-efficacy, Appropriate and timely referral for obstetric emergencies, Intervention feasibility and acceptability

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All women age who are referred or admitted directly to the first referral unit for a delivery or with a complication Staff working in the First Referral Units

Exclusion Criteria:

no specific exclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    4 intervention first referral units

    Control Arm

    Arm Description

    A Quasi-experimental intervention/control trial will be implemented to assess the impact of the following interventions on the outcome measures in a cluster of 4 intervention sites relative to a matched cluster of 4 control sites: Refresher/simulation training to improve provider skills/knowledge Implementation of Emergency Obstetric Drills Revised Case sheets(for data collection and therefore part of both control and intervention sites), Mentoring and Supportive supervision, and Referral Strengthening

    Outcomes

    Primary Outcome Measures

    Appropriate management of direct obstetric and perinatal complications
    Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia

    Secondary Outcome Measures

    Feasibility of the intervention
    We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.
    Acceptability of the intervention
    Using in-depth interviews with providers, we will assess the acceptability of the interventions.
    Self-efficacy of health care personnel to manage direct obstetric and neonatal complications
    Providers will be assessed on self-efficacy pre and post intervention
    Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications
    Case-fatality rates
    Using data from obstetric and newborn case sheets we will assess case-fatality rates
    Timeliness and appropriateness of referral

    Full Information

    First Posted
    May 28, 2013
    Last Updated
    January 26, 2015
    Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    St. John's Research Institute, Maternal Health Task Force, Bill and Melinda Gates Foundation, Karnataka Health Promotion Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01865656
    Brief Title
    A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka
    Official Title
    Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    St. John's Research Institute, Maternal Health Task Force, Bill and Melinda Gates Foundation, Karnataka Health Promotion Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn Care (EmONC) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared to control arm and to calculate the incremental cost and cost effectiveness of EmONC skills and drills intervention.
    Detailed Description
    The aim of this intervention is to improve the quality of care for institutional births with a special focus on improving the quality of Emergency Obstetric and Newborn Care (EmONC). This intervention will focus on improving the skills and practices of providers and through the improvement of referral networks, ensure timely and appropriate management of complications. The specific objectives include: Evaluate the effectiveness of an FRU-level Basic and EmONC Skills and Drills intervention combined with the existing primary health centre (PHC) based nurse mentoring intervention in improving appropriate diagnosis and management of obstetric and perinatal complications. Assess the additional benefit of the EmONC Skills and drills intervention at FRUs in terms of improvement of obstetric and perinatal outcomes compared to the PHC-level intervention alone. Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls. Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstetric and Perinatal Complications, Postpartum Hemorrhage, Preeclampsia/Eclampsia, Obstructed/Prolonged Labor, Sepsis, Birth Asphyxia
    Keywords
    provider skill and self-efficacy, Appropriate and timely referral for obstetric emergencies, Intervention feasibility and acceptability

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15018 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    4 intervention first referral units
    Arm Type
    Other
    Arm Description
    A Quasi-experimental intervention/control trial will be implemented to assess the impact of the following interventions on the outcome measures in a cluster of 4 intervention sites relative to a matched cluster of 4 control sites: Refresher/simulation training to improve provider skills/knowledge Implementation of Emergency Obstetric Drills Revised Case sheets(for data collection and therefore part of both control and intervention sites), Mentoring and Supportive supervision, and Referral Strengthening
    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Skills training
    Intervention Description
    Refresher training on Basic Emergency Obstetric and Newborn care
    Intervention Type
    Other
    Intervention Name(s)
    Emergency obstetric drills
    Intervention Description
    Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia
    Intervention Type
    Other
    Intervention Name(s)
    Revised Case Sheets
    Intervention Description
    Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns
    Intervention Type
    Other
    Intervention Name(s)
    Supportive supervision
    Intervention Description
    Quarterly supportive supervision visits each of the intervention first referral units.
    Intervention Type
    Other
    Intervention Name(s)
    Referral strengthening
    Intervention Description
    To support referral systems that ensure timely and appropriate treatment for obstetric emergencies
    Primary Outcome Measure Information:
    Title
    Appropriate management of direct obstetric and perinatal complications
    Description
    Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia
    Time Frame
    Month 18 of the project
    Secondary Outcome Measure Information:
    Title
    Feasibility of the intervention
    Description
    We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.
    Time Frame
    Month 18 of the project
    Title
    Acceptability of the intervention
    Description
    Using in-depth interviews with providers, we will assess the acceptability of the interventions.
    Time Frame
    Month 18 of the project
    Title
    Self-efficacy of health care personnel to manage direct obstetric and neonatal complications
    Description
    Providers will be assessed on self-efficacy pre and post intervention
    Time Frame
    Month 18 of the project
    Title
    Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications
    Time Frame
    Month 18 of the project
    Title
    Case-fatality rates
    Description
    Using data from obstetric and newborn case sheets we will assess case-fatality rates
    Time Frame
    Month 18 of the project
    Title
    Timeliness and appropriateness of referral
    Time Frame
    Month 18 of the project

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All women age who are referred or admitted directly to the first referral unit for a delivery or with a complication Staff working in the First Referral Units Exclusion Criteria: no specific exclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beena Verghese, PhD
    Organizational Affiliation
    St. John's Research Institute, Public Health Foundation of India
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Prem Mony, MD, MSc
    Organizational Affiliation
    St. John's Research Institute, Bangalore
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Krishnamurthy Jeyanna, MD
    Organizational Affiliation
    Karnataka Health Promotion Trust
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ana Langer, MD
    Organizational Affiliation
    Harvard School of Public Health (HSPH)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fernando Althabe, MD
    Organizational Affiliation
    Institute for Clinical Effectiveness and Health Policy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka

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