Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda

Summary

The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.

Conditions

• Pregnancy Complications
• Preterm Labor
• PreTerm Birth
• Stillbirth
• Low Birth Weight

Interventions

BEHAVIORAL

data strengthening

Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments

BEHAVIORAL

modified Safe childbirth checklist - control

modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, limited feedback and mentoring on its use

BEHAVIORAL

modified Safe childbirth checklist - enhanced

modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, ongoing intensive feedback and mentoring on its use

BEHAVIORAL

PRONTO training

Health provider training (PRONTO): initial 2-days modular training followed by a 6-week mentoring sessions (Kenya) or periodic modular refreshers and supplemental mentoring (Uganda), each over a 9-12 month period

BEHAVIORAL

QI cycles

Quality Improvement Cycles (QI): facility teams performing PDSA cycles with mentoring support and twice annual Learning Collaborative sessions, plus opportunities to apply for small amounts of funds to support change efforts

Sponsors & Collaborators

• Makerere University

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Dilys Walker, MD · University of California, San Francisco

• Peter Waiswa, MD, MPH, PhD · Makerere University School of Public

• Phelgona Otieno, MBChB, MPH · Kenya Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-10-01

Primary Completion

2019-05-31

Completion

2019-05-31

Countries

• Kenya
• Uganda