Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000201178
Ethics application status
Approved
Date submitted
2/02/2019
Date registered
12/02/2019
Date last updated
12/02/2019
Date data sharing statement initially provided
12/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthcare worker knowledge and skills following coaching in WHO Early Essential Newborn Care program in the Solomon Islands
Scientific title
Healthcare worker knowledge and skills following coaching in WHO Early Essential Newborn Care program in the Solomon Islands
Secondary ID [1] 297280 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
newborn care 311358 0
Condition category
Condition code
Reproductive Health and Childbirth 309994 309994 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Newborn mortality in Oceania countries declined slower than other regions in the past 25 years. The World Health Organization (WHO) introduced the Early Essential Newborn Care program (EENC) in 2015 in the Solomon Islands, a Small Island Developing State, to address high newborn mortality. We explored knowledge and skills retention among participating healthcare workers following EENC coaching.


Between March 2015 and December 2017, healthcare workers in five hospitals were assessed: pre- and post-clinical coaching and at a later evaluation. Standardised written and clinical skills assessments for breathing and non-breathing baby scenarios were used. Additionally, written surveys were completed during re-evaluation for feedback on the EENC experience

The EENC program was implemented as part of the standard neonatal training package for the Solomon Islands, by the ministry of health and medical services. The observational study was embedded into the implementation and included an additional evaluation, which was coupled with a planned refresher. The additional involvement for participants was in the evaluation component.
Intervention code [1] 313532 0
Not applicable
Comparator / control treatment
No comparitor or control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318906 0
Healthcare worker knowledge and skills is a composite outcome

The primary outcome measures were knowledge and simulated skill scores according to standardised simulated assessments contained in EENC, as have been used in the implementation of EENC throughout the Western-Pacific region. Knowledge and skills were assessed immediately before and following EENC coaching, and then immediately prior to refresher coaching. One participant in each coaching group was assessed pre-coaching in the two scenarios to form the baseline scores. Timing of the EENC coaching, evaluation and refresher was dependent on availability and accessibility to the hospitals.

Knowledge was assessed using a standardised written EENC multiple choice test, with 12 multiple choice questions.

Skills were assessed using the standardised EENC scenarios. Each participant attempted a "breathing" and "non-breathing" baby simulation using a MamaNatalie Birthing simulator. Skills demonstrated were assessed according to the EENC checklist for each scenario.
Timepoint [1] 318906 0
end of refresher training
Primary outcome [2] 318935 0
Health care knowledge and skills as assessed in standardised, simulated scenario involving a "breathing" and "non-breathing" baby. In small groups, participants first demonstrated their normal practice. The facilitator then explored why certain actions were taken, with discussion of the evidence base for correct practice, as well as the lack of evidence for unnecessary or potentially harmful practices (e.g. unnecessary routine suctioning). Participants were invited to share feedback in a supportive way pointing out correct actions or if improvement is required. Each participant then took part in repeated practice whilst the facilitator used the EENC skills checklist as a reference.

Timepoint [2] 318935 0
End of line assessment - up to 24 months following training, depending on access to outer provinces where the evaluation will be conducted
Secondary outcome [1] 366374 0
Satisfaction with EENC training was determined by asking participants about their experience and satisfaction of the content of EENC using a 5-point Likert scale. Opportunity was given to clarify questions using Solomon Islands Pigin during the written component and scenarios were carried out in Solomon Islands Pigin or English according to participant preferences.
Timepoint [1] 366374 0
Prior to refresher training
Secondary outcome [2] 366467 0
Health care workers were asked to describe and rate their experience of the EENC training program, using a questionnaire specifically designed for this study, with 5-point Likert scale responses.
Timepoint [2] 366467 0
End of line assessment up to 24 months following training depending on accessibility

Eligibility
Key inclusion criteria
Healthcare workers who attended EENC coaching and a later refresher coaching were included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-attendance at training

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
1/01/2019
Date of last data collection
Anticipated
Actual
1/01/2019
Sample size
Target
50
Accrual to date
Final
53
Recruitment outside Australia
Country [1] 21243 0
Solomon Islands
State/province [1] 21243 0

Funding & Sponsors
Funding source category [1] 301838 0
University
Name [1] 301838 0
University of Melbourne, Department of Paediatrics
Country [1] 301838 0
Australia
Primary sponsor type
University
Name
University of Melbourne, Dept Paediatrics
Address
50 Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 301620 0
None
Name [1] 301620 0
Address [1] 301620 0
Country [1] 301620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302539 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 302539 0
Ethics committee country [1] 302539 0
Australia
Date submitted for ethics approval [1] 302539 0
05/04/2016
Approval date [1] 302539 0
28/08/2016
Ethics approval number [1] 302539 0
1646267
Ethics committee name [2] 302540 0
Paediatrics Human Ethics Advisory Group
Ethics committee address [2] 302540 0
Ethics committee country [2] 302540 0
Australia
Date submitted for ethics approval [2] 302540 0
19/07/2016
Approval date [2] 302540 0
26/08/2016
Ethics approval number [2] 302540 0
1646267

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90574 0
Dr Shidan Tosif
Address 90574 0
Royal Children's Hospital
Dept Paediatrics
50 Flemington Rd
Parkville VIC 3052
Country 90574 0
Australia
Phone 90574 0
+61 3 9345 5522
Fax 90574 0
Email 90574 0
[email protected]
Contact person for public queries
Name 90575 0
Shidan Tosif
Address 90575 0
Royal Children's Hospital
Dept Paediatrics
50 Flemington Rd
Parkville VIC 3052
Country 90575 0
Australia
Phone 90575 0
+61 3 9345 5522
Fax 90575 0
Email 90575 0
[email protected]
Contact person for scientific queries
Name 90576 0
Shidan Tosif
Address 90576 0
Royal Children's Hospital
Dept Paediatrics
50 Flemington Rd
Parkville VIC 3052
Country 90576 0
Australia
Phone 90576 0
+61 3 9345 5522
Fax 90576 0
Email 90576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The participant information is protected by research ethics protocol requirements for confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.