Clinical trial NCT03890276: Field Study of Health Worker Training on Helping Mothers Survive Module 'Essential Care for Labor & Birth' in Zanzibar
Official title: Field Validation of Training Materials and Methods to Build Capacity of Skilled Birth Attendants at Labor and Birth in the Helping Mothers Survive Module 'Essential Care for Labor & Birth' to Improve Quality of Care in Zanzibar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parturition
Keywords: labor
birth
routine care
midwifery
Zanzibar
Sub-Saharan Africa
training
skilled birth attendant
competency
simulation
video
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Asmund S. Laerdal Foundation for Acute Medicine
name: Ministry of Health and Social Welfare, Zanzibar
First posted: 2019-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a quasi-experimental two-arm study that is a formative, pre- and post-training assessment of healthcare providers who receive the training intervention. In the experimental arm, participants (health care providers) will receive training supplemented with videos. In the comparison arm, participants (heath care providers) will receive training with no video. Participants come from 36 health facilities. There are 18 health facilities sending participants, per study arm.
Primary purpose: OTHER

Brief summary: The goal of this study is to ensure that the training materials and methods for the training module Helping Mothers Survive Essential Care for Labor \& Birth (ECL\&B) are usable and acceptable by trainers and healthcare providers in Zanzibar. Findings from this study will be used to improve the modules and validate the trainee assessments. This study also compares provider learning outcomes in the training module delivered with and without video demonstration.

Focusing on the first two phases of the Kirkpatrick model, the field validation will answer the following research questions:

1. How acceptable and appropriate for adequate teaching and learning is the training module?
2. What is the gain in knowledge, clinical decision-making, communication, and psychomotor skills of the trainees from pre to post-training assessment? (immediate learner outcomes)
3. Is there a difference in immediate learner outcomes in training where video clips are used during training to supplement live trainer demonstration compared to training where video is not used as a supplement?

Detailed description: The goal of this study is to ensure that the training materials and methods for the training module Helping Mothers Survive Essential Care for Labor \& Birth (ECL\&B) are usable and acceptable by trainers and healthcare providers in Zanzibar prior to implementing the training. Findings from this study will be used to improve the modules and validate the trainee assessments. This study also compares provider learning outcomes in the training module delivered with and without video demonstration.

Focusing on the first two phases of the Kirkpatrick model, the field validation is designed to answer the following research questions:

1. How acceptable and appropriate for adequate teaching and learning is the training module?
2. What is the gain in knowledge, clinical decision-making, communication, and psychomotor skills of the trainees from pre to post-training assessment? (immediate learner outcomes)
3. Is there a difference in immediate learner outcomes in training where video clips are used during training to supplement live trainer demonstration compared to training where video is not used as a supplement?

Background: To improve the quality of antenatal, intrapartum, and postpartum care, and thus reduce maternal and newborn morbidity and mortality, Jhpiego, in conjunction with global partners, has developed Helping Mothers Survive (HMS), a suite of training modules for frontline providers to use in low- and middle-income countries. HMS is a series of one or two-day, hands-on training modules followed by low-dose, high-frequency (LDHF) practice and other quality improvement activities. These modules are delivered at the worksite to provide ongoing support for clinical performance after training.

The importance of high-quality care during routine labor and birth to ensure the survival of women and their newborns cannot be overstated. The third module in the HMS series addresses the training needs for care during normal labor and birth (ECL\&B). The ECL\&B module is based on latest WHO guidance.

HMS training modules are developed to specifically address this gap with a plan for "low dose, high frequency" training to offer "boosters" to ensure competency in individual clinical areas and to consolidate skills through practice after training. Local health facility-based providers are responsible for leading short, frequent refresher practice sessions with their peers. Trained providers also conduct quality improvement activities and offer initial simulation-based training for new employees. This emphasis on local capacity building within health facilities makes validation of this training method and accompanying materials important. In addition, because this training will ultimately be disseminated at a larger scale, it is vital that the materials and methods be tested in resource-limited settings at this early stage.

As training in the Helping Mothers Survive modules becomes more widely available through a variety of partner organizations, a concern is that local trainers' skills demonstrations will have high variability in terms of the quality of the training demonstrations resulting in variation in acquisition of learner competencies. This study will investigate whether HMS ECL\&B training using in-person trainer supplemented with video demonstrations for several key skills results in better learner competencies immediately post-training compared to the same training with live trainers only.

This mixed-methods, quasi-experimental two-arm study is formative and a pre- and post-training assessment of the training intervention. In the experimental arm, participants (clinicians also called skilled birth attendants) will receive training supplemented with video. In the comparison arm, participants will receive training with no video. This study is similar to the field validation studies for the Bleeding After Birth (BAB) module (Johns Hopkins Bloomberg School of Public Health IRB #0004062) and the BAB+ and Pre-eclampsia/Eclampsia (PE\&E) modules (IRB #0007038), completed in 2012 and 2016, respectively, with the addition of an evaluation of video use as a supplement to a live trainer using the HMS training materials.

To assess acceptability of the intervention, focus groups with trainers and providers will be conducted. To assess clinicians' learning in the HMS modules and skill acquisition, there will be knowledge tests, a confidence assessment and three objective structured clinical examination scenarios. Participants' characteristics and past clinical experience will be measured through the self-administered survey.

Eligibility criteria: Inclusion Criteria:

* Healthcare providers
* Clinically active birth attendants (defined as having attended or assisted with at least 1 birth in the last month or 3 births in the last 3 months)
* Aged 18 years or older
* Working in government health facilities in Zanzibar

Exclusion Criteria:

-Unable to attend the pre-training and post-training assessment

Primary outcomes:
measure: The health care provider's ' 'mean percent correct score' on the Objective Structured Clinical Exam (OSCE)
timeFrame: 1 day post-training
Secondary outcomes:
measure: Percentage of providers who score above the passing threshold of 80% correct on OSCE ('pass rate')
timeFrame: 1 day post-training
Other outcomes:
Locations:
city: Makunduchi
country: Tanzania
facility: Makunduchi Hospital
state: Zanzibar
city: Mbweni
country: Tanzania
facility: Chukwani PHCU+
state: Zanzibar
city: Pemba
country: Tanzania
facility: Chakechake Hospital
state: Zanzibar
city: Pemba
country: Tanzania
facility: Wete Hospital
state: Zanzibar
city: Stone Town
country: Tanzania
facility: Fuoni Primary Health Care Unit +
state: Zanzibar
city: Stone Town
country: Tanzania
facility: Mnazi Mmoja Hospital
state: Zanzibar
Study officials:
affiliation: Jhpiego
name: Cherrie Evans, CNM, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans CL, Bazant E, Atukunda I, Williams E, Niermeyer S, Hiner C, Zahn R, Namugerwa R, Mbonye A, Mohan D. Peer-assisted learning after onsite, low-dose, high-frequency training and practice on simulators to prevent and treat postpartum hemorrhage and neonatal asphyxia: A pragmatic trial in 12 districts in Uganda. PLoS One. 2018 Dec 17;13(12):e0207909. doi: 10.1371/journal.pone.0207909. eCollection 2018.
citation: Evans CL, Johnson P, Bazant E, Bhatnagar N, Zgambo J, Khamis AR. Competency-based training "Helping Mothers Survive: Bleeding after Birth" for providers from central and remote facilities in three countries. Int J Gynaecol Obstet. 2014 Sep;126(3):286-90. doi: 10.1016/j.ijgo.2014.02.021. Epub 2014 Apr 24.