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

Skills and Drills Intervention for Improving Emergency Obstetric and Neonatal Care in Select First Referral Units in Northern Karnataka

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Postpartum Hemorrhage; Birth Asphyxia; Preeclampsia/Eclampsia; Obstetric and Perinatal Complications; Obstructed/Prolonged Labor
• Intervention / Treatment: Other: Skills training; Other: Emergency obstetric drills; Other: Revised Case Sheets; Other: Supportive supervision; Other: Referral strengthening

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

• Study Type: Interventional
• Enrollment (Actual): 15018
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 18 of the project

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention	We will evaluate barriers and facilitators of implementing these intervention packages, as well as costing them.	Month 18 of the project
Acceptability of the intervention	Using in-depth interviews with providers, we will assess the acceptability of the interventions.	Month 18 of the project
Self-efficacy of health care personnel to manage direct obstetric and neonatal complications	Providers will be assessed on self-efficacy pre and post intervention	Month 18 of the project
Knowledge and skills competency of health care personnel on the management of obstetric and neonatal complications		Month 18 of the project
Case-fatality rates	Using data from obstetric and newborn case sheets we will assess case-fatality rates	Month 18 of the project
Timeliness and appropriateness of referral		Month 18 of the project

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Bill and Melinda Gates Foundation; St. John's Research Institute; Karnataka Health Promotion Trust; Maternal Health Task Force
• Investigators: Principal Investigator: Fernando Althabe, MD, Institute for Clinical Effectiveness and Health Policy; Principal Investigator: Beena Verghese, PhD, St. John's Research Institute, Public Health Foundation of India; Principal Investigator: Prem Mony, MD, MSc, St. John's Research Institute, Bangalore; Principal Investigator: Krishnamurthy Jeyanna, MD, Karnataka Health Promotion Trust

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: provider skill and self-efficacy; Appropriate and timely referral for obstetric emergencies; Intervention feasibility and acceptability
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Death; Hypertension, Pregnancy-Induced; Uterine Hemorrhage; Emergencies; Hemorrhage; Eclampsia; Pre-Eclampsia; Postpartum Hemorrhage; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: MHTF IR India; REF/2013/05/005058 (Registry Identifier: Clinical Trials Registry- India)