Development of a Mobile Application for HBB Prompt Study

Neonatal Death Clinical Trial

— HBB-Prompt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577054
• Other study ID #: MUST 16/09-17
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2018
• Source: Mbarara University of Science and Technology
• Contact: Francis Bajunirwe, PhD
• Phone: +256772576396
• Email: fbaj[@]must.ac.ug
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Neonatal Death
• Perinatal Death

Intervention

Behavioral:
• HBB Prompt
Mobile app developed through user-centred design in phase 1 of this study
• Low-Dose High Frequency training
Participants will be encouraged to practice their HBB skills daily

Locations

Country	Name	City	State
Uganda	Mbarara University of Science and Technology	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology	The Hospital for Sick Children

Country where clinical trial is conducted

Uganda, 

References & Publications (10)

Arabi AM, Ibrahim SA, Ahmed SE, MacGinnea F, Hawkes G, Dempsey E, Ryan CA. Skills retention in Sudanese village midwives 1 year following Helping Babies Breathe training. Arch Dis Child. 2016 May;101(5):439-42. doi: 10.1136/archdischild-2015-309190. Epub 2016 Jan 29. — View Citation

Bang A, Patel A, Bellad R, Gisore P, Goudar SS, Esamai F, Liechty EA, Meleth S, Goco N, Niermeyer S, Keenan W, Kamath-Rayne BD, Little GA, Clarke SB, Flanagan VA, Bucher S, Jain M, Mujawar N, Jain V, Rukunga J, Mahantshetti N, Dhaded S, Bhandankar M, McClure EM, Carlo WA, Wright LL, Hibberd PL. Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time? BMC Pregnancy Childbirth. 2016 Nov 22;16(1):364. — View Citation

FDIs, I. (2009). 9241-210 (2009). Ergonomics of human system interaction-Part 210: Human-centered design for interactive systems (formerly known as 13407). International Organization for Standardization (ISO). Switzerland.

Goudar SS, Somannavar MS, Clark R, Lockyer JM, Revankar AP, Fidler HM, Sloan NL, Niermeyer S, Keenan WJ, Singhal N. Stillbirth and newborn mortality in India after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e344-52. doi: 10.1542/peds.2012-2112. Epub 2013 Jan 21. — View Citation

Kc A, Wrammert J, Clark RB, Ewald U, Vitrakoti R, Chaudhary P, Pun A, Raaijmakers H, Målqvist M. Reducing Perinatal Mortality in Nepal Using Helping Babies Breathe. Pediatrics. 2016 Jun;137(6). pii: e20150117. doi: 10.1542/peds.2015-0117. — View Citation

Krueger RA, Casey MA. Focus Groups: A practical guide for applied research. 4th ed. California: Sage Publications Inc., 2008.

Mduma E, Ersdal H, Svensen E, Kidanto H, Auestad B, Perlman J. Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation. 2015 Aug;93:1-7. doi: 10.1016/j.resuscitation.2015.04.019. Epub 2015 May 6. — View Citation

Msemo G, Massawe A, Mmbando D, Rusibamayila N, Manji K, Kidanto HL, Mwizamuholya D, Ringia P, Ersdal HL, Perlman J. Newborn mortality and fresh stillbirth rates in Tanzania after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e353-60. doi: 10.1542/peds.2012-1795. Epub 2013 Jan 21. — View Citation

Reisman J, Arlington L, Jensen L, Louis H, Suarez-Rebling D, Nelson BD. Newborn Resuscitation Training in Resource-Limited Settings: A Systematic Literature Review. Pediatrics. 2016 Aug;138(2). pii: e20154490. doi: 10.1542/peds.2015-4490. Epub 2016 Jul 7. Review. — View Citation

Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delivery Volume	number of births will be recorded from the birth register of each site	during 12 month study period
Other	Infants requiring bagging	number of babies requiring bagging will be recorded from the birth register of each site	during 12 month study period
Other	Fresh stillbirths	number of fresh stillbirths will be recorded from the birth register of each site	during 12 month study period
Other	In hospital neonatal mortality	number of neonatal deaths prior to discharge will be recorded from the birth register of each site	during 12 month study period
Primary	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	OSCE B score	standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score	immediately before initial HBB training
Secondary	OSCE B score	standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score	immediately after initial HBB training
Secondary	OSCE B score	standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score	3 months from initial HBB training
Secondary	OSCE B score	standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score	6 months from initial HBB training
Secondary	HBB 2.0 Knowledge Check	18 questions pertaining to newborn resuscitation	at unannounced visits within 12 months of training
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)