HBB-Prompt: Development of a Mobile Application for HBB Prompt Study

Sponsor

Mbarara University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT03577054

Collaborator

The Hospital for Sick Children (Other)

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Birth Asphyxia Neonatal Death	Behavioral: HBB Prompt Behavioral: Low-Dose High Frequency training	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessor at analysis stage will be masked to allocation of participants

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 14, 2018

Anticipated Primary Completion Date :

Apr 30, 2019

Anticipated Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HBB Prompt 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 Mobile app developed through user-centred design in phase 1 of this study Other Names: mobile app Behavioral: Low-Dose High Frequency training Participants will be encouraged to practice their HBB skills daily Other Names: LDHF
Placebo Comparator: Control 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 Participants will be encouraged to practice their HBB skills daily Other Names: LDHF

Arm

Intervention/Treatment

Experimental: HBB Prompt

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

Mobile app developed through user-centred design in phase 1 of this study

Other Names:

mobile app

Behavioral: Low-Dose High Frequency training

Participants will be encouraged to practice their HBB skills daily

Other Names:

LDHF

Placebo Comparator: Control

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

Participants will be encouraged to practice their HBB skills daily

Other Names:

LDHF

Outcome Measures

Primary Outcome Measures

Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score [12 months from initial HBB training]
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

Secondary Outcome Measures

OSCE B score [immediately before initial HBB training]
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
OSCE B score [immediately after initial HBB training]
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
OSCE B score [3 months from initial HBB training]
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
OSCE B score [6 months from initial HBB training]
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
HBB 2.0 Knowledge Check [at unannounced visits within 12 months of training]
18 questions pertaining to newborn resuscitation
Bag and mask ventilation skills check [at unannounced visits within 12 months of training]
evaluation of bagging skills to assist breathing - score out of 14
Bag and mask ventilation quality measures with AIR Device [at unannounced visits within 12 months of training]
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)
OSCE A [at unannounced visits within 12 months of training]
standardized evaluation of resuscitation skills (slightly different scenario than for OSCE B), 9 out of 12 constitutes a pass score
App analytics - pattern of usage [during 12 months after initial training in intervention arm only]
automated reports from the app regarding usage of different components of the app
App analytics - frequency of usage [during 12 months after initial training in intervention arm only]
frequency of access to different parts of the app, duration of app usage
App analytics - trends of performance [during 12 months after initial training in intervention arm only]
time trends of knowledge checks and simulation evaluations as noted in the app
Frequency of practice [during 12 months after initial training]
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
Exit focus group feedback on barriers and facilitators to HBB training and skills maintenance [at end of study (12 months from the start)]
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

Other Outcome Measures

Delivery Volume [during 12 month study period]
number of births will be recorded from the birth register of each site
Infants requiring bagging [during 12 month study period]
number of babies requiring bagging will be recorded from the birth register of each site
Fresh stillbirths [during 12 month study period]
number of fresh stillbirths will be recorded from the birth register of each site
In hospital neonatal mortality [during 12 month study period]
number of neonatal deaths prior to discharge will be recorded from the birth register of each site

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.