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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Obstetric and Perinatal Complications, Postpartum Hemorrhage, Preeclampsia/Eclampsia, Obstructed/Prolonged Labor, Sepsis, Birth Asphyxia

Intervention / Treatment
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* Other: Skills training
* Other: Emergency obstetric drills
* Other: Revised Case Sheets
* Other: Supportive supervision
* Other: Referral strengthening


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4 intervention first referral units<br>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<br>* Refresher training on Basic Emergency Obstetric and Newborn care<br>Other: Emergency obstetric drills<br>* Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia<br>Other: Revised Case Sheets<br>* Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns<br>Other: Supportive supervision<br>* Quarterly supportive supervision visits each of the intervention first referral units.<br>Other: Referral strengthening<br>* To support referral systems that ensure timely and appropriate treatment for obstetric emergencies<br>|
| No Intervention: Control Arm<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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provider skill and self-efficacy, Appropriate and timely referral for obstetric emergencies, Intervention feasibility and acceptability