Neonatal EncephalopathyV-DICASNCT03703622
Video-Debriefing for Improved Competence Among Skilled Birth Attendants in Lira District-Northern Uganda
A study testing Video-debriefing with standard HBB training compared with standard HBB training only in people with Neonatal Encephalopathy and Helping Babies Breathe (HBB) Training, run by Makerere University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Encephalopathy, Helping Babies Breathe (HBB) Training
- What is being tested?
- Video-debriefing with standard HBB training compared with standard HBB training only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUganda
- Study dates
- 4 Jun 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All health care workers attending to delivery and new-born care in both public and private facilities in Lira district.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Beatrice Odongkara, MBChB, MMed, Fellowship contact
Uganda1 site, 1 recruiting
- Recruiting
All public and Private delivery facilities (hospitals, health centers, maternity homes, and clinics) in Lira district
Lira, Northern Region, 256
Patricia Achola, +256777949408 ext. +256777949408, pachola343@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- Video-debriefing with standard HBB training compared with standard HBB training only
- Keywords
- HBB knowledge and skills attainment and retention, Video-debriefing, Skills, knowledge, Birth attendants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-debriefing with standard HBB training compared with standard HBB training onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-debriefing with standard HBB training | Experimental | 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. Receives: Behavioral: Video-debriefing with standard HBB training compared with standard HBB training only |
| Standard HBB training only | Active comparator | 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. Receives: Behavioral: Video-debriefing with standard HBB training compared with standard HBB training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health workers knowledge scores in percentage
The scores from HBB multiple choice questions (MCQs) will be used.
Measured: 6 months
Health workers skills scores in percentages
The scores from bag mask ventilation, OSCE A and B skills sessions will be used.
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start4 Jun 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703622
- Sponsor's protocol ID
- REC REF 2015-085
- Acronym
- V-DICAS
- Status last verified
- Oct 2018
- First submitted
- 28 Sep 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32524895
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03703622
- Acronym / sponsor ID
- V-DICAS / REC REF 2015-085
- Keywords
- HBB knowledge and skills attainment and retention, Video-debriefing, Skills, knowledge, Birth attendants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video-debriefing with standard HBB training | Experimental | Behavioral: Video-debriefing with standard HBB training compared with standard HBB training onlyHealth 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. |
| Standard HBB training only | Active comparator | Behavioral: Video-debriefing with standard HBB training compared with standard HBB training onlyHealth 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All health care workers attending to delivery and new-born care in both public and private facilities in Lira district.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-debriefing with standard HBB training compared with standard HBB training onlyWe 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. | Behavioural | Standard HBB training only, Video-debriefing with standard HBB training |
Primary outcome
Health workers knowledge scores in percentage
Time frame: 6 months
The scores from HBB multiple choice questions (MCQs) will be used.
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.
2 secondary outcomes
Knowledge and skills retention at 1, 3 and 6 months
Time frame: 6 months
Neonatal mortality at health facilities pre- and post training
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Derived from this study: PubMed 32524895Odongkara 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Odongkara, MBChB, MMed, Fellowship contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-debriefing with standard HBB training compared with standard HBB training only in people with Neonatal Encephalopathy and Helping Babies Breathe (HBB) Training, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatrice Odongkara, MBChB, MMed, Fellowship (+256772896397 ext. +256772896397, beachristo2003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health workers knowledge scores in percentage (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.