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

Primary Purpose

Neonatal Encephalopathy, Helping Babies Breathe (HBB) Training

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Video-debriefing with standard HBB training compared with standard HBB training only
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neonatal Encephalopathy focused on measuring HBB knowledge and skills attainment and retention, Video-debriefing, Skills, knowledge, Birth attendants

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • All public and Private delivery facilities (hospitals, health centers, maternity homes, and clinics) in Lira districtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video-debriefing with standard HBB training

Standard HBB training only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Health workers knowledge scores in percentage
The scores from HBB multiple choice questions (MCQs) will be used.
Health workers skills scores in percentages
The scores from bag mask ventilation, OSCE A and B skills sessions will be used.

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2018
Last Updated
October 9, 2018
Sponsor
Makerere University
Collaborators
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT03703622
Brief Title
Video-Debriefing for Improved Competence Among Skilled Birth Attendants in Lira District-Northern Uganda
Acronym
V-DICAS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
Collaborators
University of Bergen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Encephalopathy, Helping Babies Breathe (HBB) Training
Keywords
HBB knowledge and skills attainment and retention, Video-debriefing, Skills, knowledge, Birth attendants

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The AAP HBB curriculum will be used to train participants. Lectures will be delivered by the PI (Master Trainers), followed by demonstration of HBB skills using NeoNatali Mannequin. The participants will then be divided into two groups. One group for practical sessions with master trainers and the other group video-debriefing. The video-debriefing group will have their practical sessions filmed and then the film used for debriefing feedback. First the experiences of the team performing resuscitation will be obtained then positive feedback and learning points from other learners will be given in a respectful safe environment. All participants will be encouraged to contribute in the discussion. Pre- and Post-Test knowledge and skills will be assessed will be done using MCQs, and bag mask ventilation, OSCE A and B checklists from 2nd edition AAP HBB training manual.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Cluster randomization was done by an independent statistician from the University of Bergen who is not part of the study. The health workers from randomised facilities were randomly assigned to two groups of 24 participants, each to be trained for two days. The participants and the assessors did not know the intervention groups which they belonged to until the day of training. During follow-up the assessors and the PI will not know which intervention arms the participants are in.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video-debriefing with standard HBB training
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard HBB training only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video-debriefing with standard HBB training compared with standard HBB training only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health workers knowledge scores in percentage
Description
The scores from HBB multiple choice questions (MCQs) will be used.
Time Frame
6 months
Title
Health workers skills scores in percentages
Description
The scores from bag mask ventilation, OSCE A and B skills sessions will be used.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knowledge and skills retention at 1, 3 and 6 months
Description
The knowledge and skills scores as described above will be used to assess retention at different time points
Time Frame
6 months
Title
Neonatal mortality at health facilities pre- and post training
Description
We will determine the mortality at all the birth facilities from maternity registers to determine the effect of our training on birth outcomes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice Odongkara, MBChB, MMed, Fellowship
Phone
+256772896397
Ext
+256772896397
Email
beachristo2003@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Achola, BLIS
Phone
+256777949408
Email
pachola343@gmail.com
Facility Information:
Facility Name
All public and Private delivery facilities (hospitals, health centers, maternity homes, and clinics) in Lira district
City
Lira
State/Province
Northern
ZIP/Postal Code
256
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Achola
Phone
+256777949408
Ext
+256777949408
Email
pachola343@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32524895
Citation
Odongkara B, Tylleskar T, Pejovic N, Achora V, Mukunya D, Ndeezi G, Tumwine JK, Nankabirwa V. Adding video-debriefing to Helping-Babies-Breathe training enhanced retention of neonatal resuscitation knowledge and skills among health workers in Uganda: a cluster randomized trial. Glob Health Action. 2020 Dec 31;13(1):1743496. doi: 10.1080/16549716.2020.1743496.
Results Reference
derived

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Video-Debriefing for Improved Competence Among Skilled Birth Attendants in Lira District-Northern Uganda

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