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ParturitionHMS-ECL&BNCT03890276

Field Study of Health Worker Training on Helping Mothers Survive Module 'Essential Care for Labor & Birth' in Zanzibar

A study testing HMS EL&C training module and Videos used to supplement live trainer in people with Parturition, run by Jhpiego at 6 sites in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Parturition
What is being tested?
HMS EL&C training module and Videos used to supplement live trainer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
6 sitesTanzania
Study dates
1 May 2019to 15 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Tanzania6 sites
  • Makunduchi Hospital

    Makunduchi, Zanzibar

  • Chukwani PHCU+

    Mbweni, Zanzibar

  • Chakechake Hospital

    Pemba, Zanzibar

  • Wete Hospital

    Pemba, Zanzibar

  • Fuoni Primary Health Care Unit +

    Stone Town, Zanzibar

  • Mnazi Mmoja Hospital

    Stone Town, Zanzibar

Other trials in Tanzania

About this study

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

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?
Read the 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.

Conditions
Parturition
Being tested
HMS EL&C training module, Videos used to supplement live trainer
Keywords
labor, birth, routine care, midwifery, Zanzibar, Sub-Saharan Africa, training, skilled birth attendant, competency, simulation, video

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMS EL&C training moduleOther

    No additional information

  • Videos used to supplement live trainerOther

    [Cherrie to add]

Study groups in NCT03890276
Study groupRoleWhat they receive
HMS EL&C training without videoActive comparatorParticipant health care providers will receive a 1-2 day training in the new 'Helping Mothers Survive Essential Labor and Childbirth' (HMS EL\&C) training module. They will be able to: 1) distinguish normal and abnormal findings, 2) competently and confidently manage normal labor and birth to help prevent complications, 3) employ evidence-based practices, 4) rapidly identify and manage complications when they arise and 5) provide respectful care
Receives: Other: HMS EL&C training module
HMS training with video supplementationExperimentalParticipant health care providers will receive a 1-2 day training in the new 'Helping Mothers Survive Essential Labor and Childbirth' (HMS EL\&C) training module. They will ALSO receive the training with interspersed with short video clips that that aim to improve understanding and skills acquisition ('Videos used to supplement live trainer'). Video supplementation is meant to standardize the cascaded training in the future as the training is offered at a much larger scale in low and middle income countries.
Receives: Other: HMS EL&C training module; Other: Videos used to supplement live trainer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The health care provider's ' 'mean percent correct score' on the Objective Structured Clinical Exam (OSCE)

    The mean percent of items answered or performed correctly on OSCE, a simulation of offering care

    Measured: 1 day post-training

Secondary outcomes (1)
  1. Percentage of providers who score above the passing threshold of 80% correct on OSCE ('pass rate')

    Percentage of providers who score above the passing threshold of 80% correct on OSCE

    Measured: 1 day post-training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start1 May 2019
  3. Primary completion15 May 2019
  4. Study completion15 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890276
Sponsor's protocol ID
IRB9400
Acronym
HMS-ECL&B
Status last verified
Nov 2019
First submitted
20 Mar 2019
Last updated
6 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Any indirect identifiers and facility names will be stripped from the datasets. Data on learning on assessment tools may be made available to other researchers with a signed Data Use Agreement.

Publications

  • 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.

    PubMed 30557350
  • 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.

    PubMed 24834851

Questions about this trial

What is this clinical trial studying?

A study testing HMS EL&C training module and Videos used to supplement live trainer in people with Parturition, run by Jhpiego at 6 sites in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The health care provider's ' 'mean percent correct score' on the Objective Structured Clinical Exam (OSCE) (time frame: 1 day post-training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03890276, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.

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