Video-Debriefing for Improved Competence Among Skilled Birth Attendants in Lira District-Northern Uganda (V-DICAS)

October 9, 2018 updated by: Makerere University

The Effect of Standard Helping Babies Breathe Training With Video-debriefing on Health Workers Knowledge and Skills Attainment and Retention in Lira District Northern Uganda

Helping babies breathe (HBB) is a neonatal resuscitation training program for low-resource settings to health care workers to provide prompt respiratory support to save babies at birth. Despite massive roll-out, new-born mortality reduction has stagnated over the years. Innovative teaching methods with existing technology such as video-debriefing needs to be tested to promote competence (skills and knowledge) attainment and retention.

Study Overview

Detailed Description

In this study we will randomize both public and private delivery facilities in Lira district northern Uganda to receive either standard HBB with video-debriefing (intervention) or standard training alone (control). We hope video-debriefing will improve competence among the health workers and promote skills and knowledge retention over time, hence reduction in neonatal mortality.

The result of the study may also contribute to shaping refresher training program policy in low-resource settings.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Beatrice Odongkara, MBChB, MMed, Fellowship
  • Phone Number: +256772896397 +256772896397
  • Email: beachristo2003@gmail.com

Study Contact Backup

Study Locations

    • Northern
      • Lira, Northern, Uganda, 256
        • Recruiting
        • All public and Private delivery facilities (hospitals, health centers, maternity homes, and clinics) in Lira district
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All health care workers attending to delivery and new-born care in both public and private facilities in Lira district.

Exclusion Criteria:

  • Those who turn up for training just for daily allowances, having been sent by their facility in-charges to fill gaps such as community vaccinators, Village Health Teams (VHTs), security officers, cleaners, and laboratory technicians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Video-debriefing with standard HBB training
Health workers are given standard HBB training according to American Association of Pediatrics (AAP) plus video-debriefing. Filming of the simulated case scenarios will be done and after which the films will be used for debriefing or feedback. Participants will be encouraged to give feedback with the guidance of master trainer and the PI. Teams of three participants(birth attendant, mother and helper) will perform the HBB simulation or scenarios. After each scenario, debriefing is done until all participants have had the opportunity to participate in the simulation exercise. All the participants in this arm will undergo HBB practical sessions such as bag mask ventilation skills sessions, care of the health new-born and sick newborn baby who needs resuscitation care. Pre and post-tests will be done to assess performance of all participants.

We will use the AAP training curriculum for the HBB 2nd edition through out the training and course assessments pre-and post- training and during follow-up period.

Both intervention arms will a 2 days training consisting of: lectures, neonatal resuscitation demonstrations using NeoNatali mannequin, and practical skills s sessions. Pre- and post-tests knowledge (MCQs) and skills (bag mask ventilation, OSCE A, & OSCE B) will be given to all participants.

In the intervention arm, in addition to standard training, participants will work in teams of three (birth attendant, mother, and an assistant) to perform different HBB case scenarios. These will be filmed and used for subsequent debriefing after each case scenarios. After all participants in the intervention have had the opportunity to participate in the debriefing, then a post test is done to assess performance.

Analysis is done to compare the intervention and control arms performances.

ACTIVE_COMPARATOR: Standard HBB training only
Health workers are given standard HBB training according to AAP without video-debriefing. All the participants in this arm, like in intervention arm, will also undergo HBB practical sessions such as bag mask ventilation skills sessions, care of the health new-born and sick new-born baby who needs resuscitation care only. Pre-and post-tests will be done to assess performance of all participants.

We will use the AAP training curriculum for the HBB 2nd edition through out the training and course assessments pre-and post- training and during follow-up period.

Both intervention arms will a 2 days training consisting of: lectures, neonatal resuscitation demonstrations using NeoNatali mannequin, and practical skills s sessions. Pre- and post-tests knowledge (MCQs) and skills (bag mask ventilation, OSCE A, & OSCE B) will be given to all participants.

In the intervention arm, in addition to standard training, participants will work in teams of three (birth attendant, mother, and an assistant) to perform different HBB case scenarios. These will be filmed and used for subsequent debriefing after each case scenarios. After all participants in the intervention have had the opportunity to participate in the debriefing, then a post test is done to assess performance.

Analysis is done to compare the intervention and control arms performances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health workers knowledge scores in percentage
Time Frame: 6 months
The scores from HBB multiple choice questions (MCQs) will be used.
6 months
Health workers skills scores in percentages
Time Frame: 6 months
The scores from bag mask ventilation, OSCE A and B skills sessions will be used.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge and skills retention at 1, 3 and 6 months
Time Frame: 6 months
The knowledge and skills scores as described above will be used to assess retention at different time points
6 months
Neonatal mortality at health facilities pre- and post training
Time Frame: 6 months
We will determine the mortality at all the birth facilities from maternity registers to determine the effect of our training on birth outcomes
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 4, 2018

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (ACTUAL)

October 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After dissemination and Doctor of Philosophy (PhD) defence, I can avail the scores and demographics of the study participants after de-identification of the dataset.

IPD Sharing Time Frame

12 months

IPD Sharing Access Criteria

Direct contact to the PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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