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

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ClinicalTrials.gov Identifier: NCT03703622
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Makerere University

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.

Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Helping Babies Breathe (HBB) Training Behavioral: Video-debriefing with standard HBB training compared with standard HBB training only Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Health Services Research
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
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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.
Behavioral: Video-debriefing with standard HBB training compared with standard HBB training only

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.
Behavioral: Video-debriefing with standard HBB training compared with standard HBB training only

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 Measures :
  1. Health workers knowledge scores in percentage [ Time Frame: 6 months ]
    The scores from HBB multiple choice questions (MCQs) will be used.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03703622


Contacts
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Contact: Beatrice Odongkara, MBChB, MMed, Fellowship +256772896397 ext +256772896397 beachristo2003@gmail.com
Contact: Patricia Achola, BLIS +256777949408 pachola343@gmail.com

Locations
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Uganda
All public and Private delivery facilities (hospitals, health centers, maternity homes, and clinics) in Lira district Recruiting
Lira, Northern, Uganda, 256
Contact: Patricia Achola    +256777949408 ext +256777949408    pachola343@gmail.com   
Sponsors and Collaborators
Makerere University
University of Bergen

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03703622     History of Changes
Other Study ID Numbers: REC REF 2015-085
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 12 months
Access Criteria: Direct contact to the PI

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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 Makerere University:
HBB knowledge and skills attainment and retention
Video-debriefing
Skills, knowledge, Birth attendants

Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases