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.
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
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:
- How acceptable and appropriate for adequate teaching and learning is the training module?
- 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)
- 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:
- How acceptable and appropriate for adequate teaching and learning is the training module?
- 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)
- 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 group | Role | What they receive |
|---|---|---|
| HMS EL&C training without video | Active comparator | Participant 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 supplementation | Experimental | Participant 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.
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)
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.
- First posted26 Mar 2019
- Study start1 May 2019
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParturitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Foundation, Ministry of Health and Social Welfare, Zanzibar
- Responsible party
- Sponsor
- Investigators
- Cherrie Evans, CNM, DrPH, Principal investigator, Jhpiego
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 30557350Evans 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03890276
- Acronym / sponsor ID
- HMS-ECL&B / IRB9400
- Conditions
- Parturition
- Keywords
- labor, birth, routine care, midwifery, Zanzibar, Sub-Saharan Africa, training, skilled birth attendant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Laerdal Foundation, Ministry of Health and Social Welfare, Zanzibar
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How acceptable and appropriate for adequate teaching and learning is the training module?
- 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)
- 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:
- How acceptable and appropriate for adequate teaching and learning is the training module?
- 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)
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HMS EL&C training without video | Active comparator | Other: HMS EL&C training moduleParticipant 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 |
| HMS training with video supplementation | Experimental | Other: HMS EL&C training module, Other: Videos used to supplement live trainerParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Unable to attend the pre-training and post-training assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMS EL&C training moduleNo additional information | Other | HMS EL&C training without video, HMS training with video supplementation |
| Videos used to supplement live trainer[Cherrie to add] | Other | HMS training with video supplementation |
Primary outcome
The health care provider's ' 'mean percent correct score' on the Objective Structured Clinical Exam (OSCE)
Time frame: 1 day post-training
The mean percent of items answered or performed correctly on OSCE, a simulation of offering care
1 secondary outcome
Percentage of providers who score above the passing threshold of 80% correct on OSCE ('pass rate')
Time frame: 1 day post-training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Background: PubMed 30557350Evans 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.
- Background: PubMed 24834851Evans 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.
- Journal ArticleLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Parturition
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The Experience of Fathers and Mothers in Relation to the Presence of the Father at the Birth in the Case of a Planned Caesarean Section: a Qualitative Phenomenological Study
Cesarean Section, Parturition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherrie Evans, CNM, DrPH principal investigator
Jhpiego
6 sites in 1 country: see every site and its status.
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.