- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03703622
Video-Debriefing for Improved Competence Among Skilled Birth Attendants in Lira District-Northern Uganda (V-DICAS)
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 Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beatrice Odongkara, MBChB, MMed, Fellowship
- Phone Number: +256772896397 +256772896397
- Email: beachristo2003@gmail.com
Study Contact Backup
- Name: Patricia Achola, BLIS
- Phone Number: +256777949408
- Email: pachola343@gmail.com
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:
- Patricia Achola
- Phone Number: +256777949408 +256777949408
- Email: pachola343@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC REF 2015-085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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