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Field Study of Health Worker Training on Helping Mothers Survive Module 'Essential Care for Labor & Birth' in Zanzibar (HMS-ECL&B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890276
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
Asmund S. Laerdal Foundation for Acute Medicine
Ministry of Health and Social Welfare, Zanzibar
Information provided by (Responsible Party):
Jhpiego

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?

Condition or disease Intervention/treatment Phase
Parturition Other: HMS EL&C training module Other: Videos used to supplement live trainer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Jhpiego data analysts will be blinded to which participants were in which arm.
Primary Purpose: Other
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
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Medrysone

Arm Intervention/treatment
Active Comparator: HMS EL&C training without video
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
No additional information

Experimental: HMS training with video supplementation
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 module
No additional information

Other: Videos used to supplement live trainer
[Cherrie to add]




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of providers who score above the passing threshold of 80% correct on OSCE ('pass rate') [ Time Frame: 1 day post-training ]
    Percentage of providers who score above the passing threshold of 80% correct on OSCE



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890276


Locations
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Tanzania
Makunduchi Hospital
Makunduchi, Zanzibar, Tanzania
Chukwani PHCU+
Mbweni, Zanzibar, Tanzania
Chakechake Hospital
Pemba, Zanzibar, Tanzania
Wete Hospital
Pemba, Zanzibar, Tanzania
Fuoni Primary Health Care Unit +
Stone Town, Zanzibar, Tanzania
Mnazi Mmoja Hospital
Stone Town, Zanzibar, Tanzania
Sponsors and Collaborators
Jhpiego
Asmund S. Laerdal Foundation for Acute Medicine
Ministry of Health and Social Welfare, Zanzibar
Investigators
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Principal Investigator: Cherrie Evans, CNM, DrPH Jhpiego
Additional Information:
Publications:
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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03890276    
Other Study ID Numbers: IRB9400
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Jan 10, 2020
Access Criteria: Undetermined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jhpiego:
labor
birth
routine care
midwifery
Zanzibar
Sub-Saharan Africa
training
skilled birth attendant
competency
simulation
video