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

Overview

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.

Full Title of Study: “Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

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: 1. 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. 2. 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. 3. Estimate the appropriateness and effectiveness of referrals in intervention facilities compared to controls. 4. Calculate the incremental cost and cost-effectiveness of the EmONC skills and drills intervention

Interventions

  • Other: Skills training
    • Refresher training on Basic Emergency Obstetric and Newborn care
  • Other: Emergency obstetric drills
    • Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia
  • Other: Revised Case Sheets
    • Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns
  • Other: Supportive supervision
    • Quarterly supportive supervision visits each of the intervention first referral units.
  • Other: Referral strengthening
    • To support referral systems that ensure timely and appropriate treatment for obstetric emergencies

Arms, Groups and Cohorts

  • Other: 4 intervention first referral units
    • 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
  • No Intervention: Control Arm

Clinical Trial Outcome Measures

Primary Measures

  • Appropriate management of direct obstetric and perinatal complications
    • Time Frame: Month 18 of the project
    • Appropriate and timely management of postpartum hemorrhage (PPH), Preeclampsia, Obstructed or prolonged labor, Sepsis and birth asphyxia

Secondary Measures

  • Feasibility of the intervention
    • Time Frame: Month 18 of the project
    • We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.
  • Acceptability of the intervention
    • Time Frame: Month 18 of the project
    • 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
    • Time Frame: Month 18 of the project
    • 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
    • Time Frame: Month 18 of the project
  • Case-fatality rates
    • Time Frame: Month 18 of the project
    • Using data from obstetric and newborn case sheets we will assess case-fatality rates
  • Timeliness and appropriateness of referral
    • Time Frame: Month 18 of the project

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Harvard School of Public Health (HSPH)
  • Collaborator
    • St. John’s Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ana Langer, Director of the Women and Health Initiative – Harvard School of Public Health (HSPH)
  • Overall Official(s)
    • Beena Verghese, PhD, Principal Investigator, St. John’s Research Institute, Public Health Foundation of India
    • Prem Mony, MD, MSc, Principal Investigator, St. John’s Research Institute, Bangalore
    • Krishnamurthy Jeyanna, MD, Principal Investigator, Karnataka Health Promotion Trust
    • Ana Langer, MD, Principal Investigator, Harvard School of Public Health (HSPH)
    • Fernando Althabe, MD, Principal Investigator, Institute for Clinical Effectiveness and Health Policy

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