Development of a Mobile Application for HBB Prompt Study

Study Overview
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Brief Summary
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This study applies an iterative user-centred design approach involving frontline birth attendants to create a mobile application (HBB Prompt) to improve skills retention after initial newborn stabilization training through the Helping Babies Breathe (HBB) program. HBB Prompt will then be piloted at one site after HBB training and skills retention will be compared with a control site without HBB Prompt after HBB training.

Detailed Description
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Helping Babies Breathe (HBB) is a newborn stabilization course that has been shown to reduce neonatal mortality by up to 47%. Such mortality impact is however not sustained due to rapid skills deterioration. The investigators propose to improve sustainability of HBB's impact by increasing skills retention with an innovative mobile application called HBB Prompt. HBB Prompt will be an interactive tool that guides frontline providers through the steps needed to save newborn babies at birth. HBB Prompt will facilitate individual and group training in health facilities using the Low Dose High Frequency model (LDHF) for resuscitation skills retention. The investigators will robustly develop HBB Prompt by integrating human factors and user-centered design approaches. The investigators will engage end-users and HBB Master Trainers to iteratively collect feedback to develop HBB Prompt for both individual and small group resuscitation practice. The iterative approach will mitigate the common scenario of mobile health (mHealth) solutions unable to achieve sustained success at scale due to lack of comprehensive input from frontline users. The investigators will pilot the app at a single centre and compare it to a control site for HBB skills retention at different time points after initial HBB training.

Official Title
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Development of a Mobile Application Through User Centered Design to Improve Helping Babies Breath Skills Retention

Conditions
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Birth Asphyxia, Neonatal Death

Intervention / Treatment
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* Behavioral: HBB Prompt
* Behavioral: Low-Dose High Frequency training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Frontline birth attendants involved in the delivery or care of babies in the maternity ward, theater or pediatric wards with a possibility of involvement in newborn resuscitation. Exclusion Criteria: Health workers providing care in other wards other than maternity and pediatrics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBB Prompt<br>The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. Providers at this hospital will have access to the most updated version of HBB Prompt (beta) after HBB training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). The recommended frequency to use the app will be once per shift. | Behavioral: HBB Prompt<br>* Mobile app developed through user-centred design in phase 1 of this study<br>* Other names: mobile app;Behavioral: Low-Dose High Frequency training<br>* Participants will be encouraged to practice their HBB skills daily<br>* Other names: LDHF;|
| Placebo Comparator: Control<br>The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. The control group will not have exposure to the HBB Prompt app post training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). | Behavioral: Low-Dose High Frequency training<br>* Participants will be encouraged to practice their HBB skills daily<br>* Other names: LDHF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score | standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score with 23 being the highest score. The OSCE B is a standard Helping Babies Breathe assessment tool that comprises the steps required in successfully assisting a neonate in its transition after birth | 12 months from initial HBB training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSCE B score | standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score | immediately before initial HBB training | 
| OSCE B score | standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score | immediately after initial HBB training | 
| OSCE B score | standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score | 3 months from initial HBB training | 
| OSCE B score | standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score | 6 months from initial HBB training | 
| HBB 2.0 Knowledge Check | 18 questions pertaining to newborn resuscitation | at unannounced visits within 12 months of training | 
| Bag and mask ventilation skills check | evaluation of bagging skills to assist breathing - score out of 14 | at unannounced visits within 12 months of training | 
| Bag and mask ventilation quality measures with AIR Device | Augmented Infant Resuscitator (AIR) to objectively measure quality of newborn resuscitation during every ventilation epoch. AIR records time stamped data on ventilation quality, such as presence of air leak or obstruction and ventilation rate (www.air-device.com) | at unannounced visits within 12 months of training | 
| OSCE A | standardized evaluation of resuscitation skills (slightly different scenario than for OSCE B), 9 out of 12 constitutes a pass score | at unannounced visits within 12 months of training | 
| App analytics - pattern of usage | automated reports from the app regarding usage of different components of the app | during 12 months after initial training in intervention arm only | 
| App analytics - frequency of usage | frequency of access to different parts of the app, duration of app usage | during 12 months after initial training in intervention arm only | 
| App analytics - trends of performance | time trends of knowledge checks and simulation evaluations as noted in the app | during 12 months after initial training in intervention arm only | 
| Frequency of practice | for both intervention and control arms, log-books will be reviewed for frequency of practice and in the intervention arm, this will be compared to what is reported through the app | during 12 months after initial training | 
| Exit focus group feedback on barriers and facilitators to HBB training and skills maintenance | both intervention and control group participants will be interviewed to provide feedback on facilitators and barriers to HBB skills maintenance, and in the intervention arm, whether HBB Prompt helped or hindered their skills maintenance | at end of study (12 months from the start) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helping Babies Breathe, newborn resuscitation, skills retention, mobile health, user-centred design