NCT03890276

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. 1.How acceptable and appropriate for adequate teaching and learning is the training module?
  2. 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

14 days

First QC Date

March 20, 2019

Last Update Submit

November 4, 2019

Conditions

Parturition

Keywords

laborbirthroutine caremidwiferyZanzibarSub-Saharan Africatrainingskilled birth attendantcompetencysimulationvideo

Outcome Measures

Primary Outcomes (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

    1 day post-training

Secondary Outcomes (1)

  • Percentage of providers who score above the passing threshold of 80% correct on OSCE ('pass rate')

    1 day post-training

Study Arms (2)

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

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.

Other: HMS EL&C training moduleOther: Videos used to supplement live trainer

Interventions

HMS EL&C training moduleOTHER

No additional information

HMS EL&C training without videoHMS training with video supplementation
Videos used to supplement live trainerOTHER

\[Cherrie to add\]

HMS training with video supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Makunduchi Hospital

Makunduchi, Zanzibar, Tanzania

Location

Chukwani PHCU+

Mbweni, Zanzibar, Tanzania

Location

Chakechake Hospital

Pemba, Zanzibar, Tanzania

Location

Wete Hospital

Pemba, Zanzibar, Tanzania

Location

Fuoni Primary Health Care Unit +

Stone Town, Zanzibar, Tanzania

Location

Mnazi Mmoja Hospital

Stone Town, Zanzibar, Tanzania

Location

Related Publications (2)

  • 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.

    PMID: 30557350BACKGROUND

  • 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.

    PMID: 24834851BACKGROUND

Related Links

Study Officials

  • Cherrie Evans, CNM, DrPH

    Jhpiego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Jhpiego data analysts will be blinded to which participants were in which arm.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 26, 2019

Study Start

May 1, 2019

Primary Completion

May 15, 2019

Study Completion

May 15, 2019

Last Updated

November 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF
Time Frame
Jan 10, 2020
Access Criteria
Undetermined

Locations

TA(6)