PreTerm Birth Clinical Trial
Official title:
Strengthening Intrapartum and Immediate Newborn Care to Reduce Morbidity and Mortality of Preterm Infants in Health Facilities in Migori County, Kenya and Busoga Region, Uganda: an Implementation Science RCT
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.
The randomized, controlled cluster trial (RCCT) will test whether the study intervention
reduces the combined incidence of fresh stillbirth and neonatal mortality by 30% compared
with the control group incidence of FSB+NMR. Given a Type I error of 0.05, power=80%, a
one-tailed test, a balanced (1 control :1 intervention) sample, and a baseline PTB NMR of
10%, the RCCT requires 1,133 PTBs in each study group. The sample size has been increased by
35% to account for a 25% design effect and a 10% loss to follow-up/missing information,
requires 1,530 PTBs in each study group. Secondary outcomes will be assessed using this
sample. The study randomized facilities to either the control or intervention group, matched
on various characteristics to improve the similarity of the study groups and minimize design
effect. This a priori hypothesis is proposed prior to analyzing the intervention period study
primary outcome, using the baseline PTB incidence of FSB+NMR, and an effect size previously
observed with PRONTO.
This implementation science study includes a package of interventions. Control sites receive
only the limited package of data strengthening and implementation of the modified Safe
Childbirth Checklist. The randomly selected intervention facilities receive an enhanced
package which also includes provider training/mentoring using PRONTO simulation and teamwork
training, ongoing clinical mentoring, and support for Quality Improvement cycles (PDSA
cycles) using a Model for Improvement framework. More detail about the contents of the
intervention is included below.
Data Strengthening Strategies: initial training focused on routinely collected data plus
ongoing refreshers and mentorship throughout study duration
- Strengthen the MOH data collection system (birth registries, admission/discharge
registries), as well as introduction of expanded documentation to capture preterm birth
details
- Perform facility assessment to determine gaps in infrastructure, supplies as well as
skills and competencies of providers and data managers to accurately and consistently
report routine facility data
- Support facilities to use standardized definitions of indicators currently collected for
antenatal and postnatal care
- Support adherence to national guidelines on documentation in the registers and patient
charts through training, provision of registers/charts and motivation
- Introduce expanded routine documentation of preterm births including improving the
register to capture data on preterm and still births, and implementation of the modified
WHO Safe Childbirth Checklist (see below)
- Support periodic data quality assessment cycles
- Create a synchronized online data dashboard repository system representing key
indicators on an ongoing basis with selective access for health care providers and
national policy makers
WHO Safe Childbirth Checklist modified to address identification of preterm labor and newborn
care for preterm babies: initial training plus ongoing refreshers and mentorship throughout
study duration
- Introduce expanded routine documentation of preterm births including the piloting and
use of a modified WHO Safe Childbirth Checklist (mSCC)
- Introduce and train on use of the mSCC to detect, manage and treat high risk
labor/babies
- Collect routine facility data including register reviews (study staff will visit each
selected facility at least once per month)
- Conduct periodic audits of the mSCC to determine uptake and completeness, review for
phenotyping information, and/or review for additional service indicators on preterm
babies
Measures to strengthen, recommended intrapartum, postnatal and neonatal care in facilities
through PRONTO simulation-based provider training and mentorship: training of trainers and
initial trainings in Kenya and Uganda plus ongoing mentorship in Kenya and modular refreshers
in Uganda, throughout study duration
- Improve intrapartum, postnatal and neonatal management by using a customized PRONTO
curriculum that includes highly realistic simulation and focused team training to
address gaps in emergency obstetric and neonatal response. The training emphasizes
lifesaving response during labor, delivery, postnatal and neonatal periods with specific
emphasis on the care of preterm babies.
- Initial 2-days modular PRONTO training will be followed by periodic modular refreshers
and supplemental mentoring. In Kenya, this involves 6 one-week mentoring sessions led by
trained preterm champions over a 9-12 month period. In Uganda, a modular training model
with intermittent refresher trainings and two-day clinical mentoring sessions will be
offered over a 9-12 month period. Special emphasis will be put on evidence-based
practices and the views gathered from Kenya and Uganda stakeholders.
- Promote close follow-up of preterm babies up to 28-days
Measures to strengthen Quality Improvement (QI) cycles: initial training with ongoing
mentorship; QI team meetings each week with quarterly cross-facility collaboration workshops
throughout study duration
- Develop tools for, introduce and institutionalize QI cycles and regular project
monitoring and evaluation
- Reinforcement of accurate and timely documentation in charts and registers in the
facilities
- Reinforcement of use of the mSCC, including its use as a data source to track progress
of change efforts
- Link system gaps or latent errors uncovered during simulation training and suggested
solutions with QI efforts
- Develop and recommend some tools to improve data collection such as for triage,
discharge and referral
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