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

PreTerm Birth Clinical Trial

— PTBi-KE-UG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112018
• Other study ID #: A123218-K/U
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102988
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Individuals: Investigators will include in the analysis the birth outcomes of all women accessing delivery care services at selected hospitals with gestational age of > 24 weeks who are either admitted for labor or for hospitalization for another antenatal complication (preeclampsia, chorioamnionitis) or referred to a tertiary hospital. Women will be presenting at either control or intervention sites and their delivery information will be reviewed. For follow-up, the investigators will select women with infants born at greater than 1000 grams and less than 2500 grams, or between 2501 and 2999 grams with documented gestational age less than 37 weeks.

Related Conditions & MeSH terms

• Birth Weight
• Low Birth Weight
• Obstetric Labor, Premature
• Pregnancy Complications
• Premature Birth
• PreTerm Birth
• Preterm Labor
• Stillbirth

Intervention

Behavioral:
• data strengthening
Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments
• modified Safe childbirth checklist - control
modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, limited feedback and mentoring on its use
• 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
• 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
• 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

Locations

Country	Name	City	State
Kenya	Health facilities in Migori County: Rongo, Kehancha, Uriri, Kegonga, Karungu, Tisinye, Isibania, Macalder, Awendo, Ntimaru, Muhuru, Bugumbe, Nyamaraga, Othoro, St. Joseph, St. Camillus, Migori County Referral Hospital	Migori County
Uganda	Health facilities in Busoga Region: Bugiri, Buluba, Iganga, Kamuli Government, Kamuli Mission, Jinja Regional Referral Hospital	Busoga Region

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute, Makerere University

Countries where clinical trial is conducted

Kenya,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause neonatal mortality among preterms/low birth weight newborns	To determine the effect of the full package (data strengthening, mSCC, provider training and mentoring using the PRONTO method, QI cycles) on 28-day all-cause mortality rate among low birth weight neonates greater than 1000 grams and less than 2500 grams, and neonates between 2500 and 2999 grams with documented gestational age less than 37 weeks	28-days after facility-based delivery
Secondary	Data quality of key indicators in facility-based registers	Key indicators include gestational age, facility discharge status, preterm birth incidence	through study completion, an average of 18 months
Secondary	Pre-hospital discharge mortality among preterm infants and babies born alive between 500 and 999 grams at birth		at hospital discharge, an average of 1-7 days
Secondary	28-day mortality among babies born alive between 500 and 999 grams at birth		28-days after facility-based delivery
Secondary	Average number of evidence-based practices demonstrated in simulated case videos and live birth observations	Uptake and appropriate utilization of evidence-based interventions/ Ministry of Health management guidelines measured in PRONTO simulation videos, observed live births and/or mSCC	Baseline and through study completion, an average of 18 months
Secondary	Prevalence of preterm birth phenotypes in the study sites as measured by chart review and the mSCC		Every year over four years
Secondary	Facility readiness to handle delivery and newborn complications as measured by a facility assessment tool		Every six months over two years

External Links

•   PRONTO website
•   UCSF PTBi wesbite