Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000355471p
Ethics application status
Submitted, not yet approved
Date submitted
2/03/2016
Date registered
18/03/2016
Date last updated
18/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the acceptability of the delivery of the safe sleep calculator in primary care.
Scientific title
Determining the acceptability of the Safe Sleep Calculator for caregivers and for primary health care workers when it is used at the six week baby check, .
Secondary ID [1] 288679 0
nil
Universal Trial Number (UTN)
U1111-1180-3055
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden Unexpected Death in infancy 297890 0
Condition category
Condition code
Public Health 298055 298055 0 0
Health promotion/education
Injuries and Accidents 298141 298141 0 0
Other injuries and accidents
Reproductive Health and Childbirth 298142 298142 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Safe Sleep Calculator (SSC) is a new “advanced form” that functions as part of the practice management system in general practice. The algorithm behind the SSC is derived from five international case control studies on SUDI.
The SSC requires the GP doctor or nurse to ask a series of 11 questions about the baby and the family’s baby care practices, inputting the answers onto the electronic SSC form. The SSC then calculates individual baby's risk of Sudden Unexpected Death in Infancy (SUDI) utilising both non-modifiable risk factors (e.g. young maternal age, Maori and Pacific ethnicity) and modifiable risk factors (e.g. sleep position, bed sharing, smoking, and infant feeding). The GP doctor or nurse and then discuss the result with families and will be able to see what effect changing baby care behaviours has on the risk score, for example if they did not place baby to sleep on the front.
The specific objectives of this project are; to pilot the SSC as part of the six week check of babies, into volunteering general practices over 4 months. We aim to evaluate the acceptability of the SSC for up to 30 of these parents/caregivers (recruitment of participants spread over participating practices, consecutive qualifying parents/caregivers) by a single qualitative interview, either face to face or by telephone, 0-7 days from their SSC assessment in general practice.
Focus group discussions with GP doctors and nurses will be undertaken, after practices have used the SSC for 4 months, to capture their experiences of the SSC, acceptability and feasibility of the SSC used in the six week baby check.
Intervention code [1] 294180 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297579 0
Determine if the assessment of SUDI risk with the safe sleep calculator, used at the six week baby check, is acceptable to the baby's parent/s or caregivers. This will be assessed by qualitative interviewing of the parents/caregivers by face to face or phone interview.
Timepoint [1] 297579 0
Interviewing 0-7 days after the six week baby check with safe sleep calculator assessment.
Secondary outcome [1] 321427 0
Assessing acceptability and experience of the using the safe sleep calculator tool in primary care by general practice doctors and nurses. Assessed by focus group discussion with the GP doctors and nurses after triallinig the SSC for 4 months.
Timepoint [1] 321427 0
Assessment after a trial of the safe sleep calculator for 4 months.

Eligibility
Key inclusion criteria
Inclusion criteria for parent/caregiver interviews;
Infant seen at the practice for six week check
Safe sleep calculation assessment completed at the six week check
Parent/Caregiver consents to being contacted for the research.
Inclusion criteria for primary care staff;
Working at a primary care general practice where the safe sleep calculator is being trialled.
Attendance at the introductory session for the Safe Sleep Calculator
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for parents/caregivers; :
Consent to contact not obtained
Unsafe environment for follow up contact.
Unable to find interpretor if non english speaking.
Exclusion criteria for primary care staff;
nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential qualifying parents/caregivers seen at each general practice, within a time period determined by the flow of qualifying participants.

All qualifying GP doctors and nurses will be interviewed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Measure of acceptability of the safe sleep calculator by qualitative interviews of 15-30 consecutive qualifying caregivers sufficient to reach saturation of themes, and of at least 30 general practice doctors and nurses again to reach saturation of themes. The sample size can be increased if saturation is not reached. (The sample size is dependent upon the question being asked, however a review of 560 qualitative studies found that the mean number was 31 for in depth analysis.)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2016
Actual
Date of last participant enrolment
Anticipated
30/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 7638 0
New Zealand
State/province [1] 7638 0
Auckland

Funding & Sponsors
Funding source category [1] 293039 0
Charities/Societies/Foundations
Name [1] 293039 0
Cure Kids
Country [1] 293039 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Paediatrics
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291885 0
Individual
Name [1] 291885 0
Christine McIntosh
Address [1] 291885 0
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 291885 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294550 0
Health and Disability Ethics Comittee
Ethics committee address [1] 294550 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 294550 0
New Zealand
Date submitted for ethics approval [1] 294550 0
14/03/2016
Approval date [1] 294550 0
Ethics approval number [1] 294550 0

Summary
Brief summary
Unfortunately in New Zealand around 50 families each year experience the tragedy of their baby dying of Sudden Unexpected Death in Infancy (SUDI) (previously known as Sudden Infant Death Syndrome SIDS). There is an astonishing disparity with the majority of SUDI deaths occurring in Maori and Pacific families and disproportionately for babies living in deprivation. The goal of this research is to reduce SUDI deaths. Encouragingly there is compelling evidence that the majority of SUDI deaths are preventable by addressing the risk factors that contribute to a baby’s vulnerability and by providing a safe sleep environment every time a baby sleeps.

Primary health care providers are in a key position to identify SUDI risk and provide SUDI risk reduction education and support. However, the level of SUDI knowledge, and level of SUDI risk intervention amongst primary health care providers is not well known.

A Safe Sleep Calculator (SSC) has been developed to assess SUDI risk based on an algorithm constructed from the data of five international SUDI case control studies. The SSC has been adapted to integrate into the software used by primary healthcare providers. It creates the opportunity for the SSC to be a powerful instrument to increase SUDI awareness in primary care and provide an individualised SUDI risk assessment for each baby. The focus of the SSC is in identifying modifiable risk factors that the primary care team can then support the family to address.

Primary Healthcare Organisations will approach their General Practice groups to participate in trialling the SSC in their routine 6 week baby checks. A SUDI education session and introduction to the SSC will be followed by access to the SSC over a minimum period of 4 months trial.

This study will examine the acceptability of the integration of the SSC into routine six week baby checks in primary care for parents/caregivers of baby's and for the primary care staff delivering the SSC assessment. Acceptability will be assessed by qualitative interviewing of parents or caregivers of baby's where the SSC has been used during their baby's six week check. The experience of using the SSC tool and it acceptability with primary care staff will assessed through focus group discussion. Transcripts of the qualitative interviews and focus group discussions will be analysed. Themes will be identified, grouped and discussed and then used to guide improvements of the SSC and its implementation process in primary care general practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64098 0
Dr Christine McIntosh
Address 64098 0
c/o Kidz First Admin. Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Auckland
Country 64098 0
New Zealand
Phone 64098 0
+64 21 915220
Fax 64098 0
Email 64098 0
[email protected]
Contact person for public queries
Name 64099 0
Dr Christine McIntosh
Address 64099 0
Kidz First Admin. Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Auckland
Country 64099 0
New Zealand
Phone 64099 0
+64 21 915220
Fax 64099 0
Email 64099 0
[email protected]
Contact person for scientific queries
Name 64100 0
Dr Christine McIntosh
Address 64100 0
Kidz First Admin. Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Auckland
Country 64100 0
New Zealand
Phone 64100 0
+64 21 915 220
Fax 64100 0
Email 64100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23414Study protocol    370260-(Uploaded-04-03-2021-08-05-44)-Study-related document.docx
23415Informed consent form    370260-(Uploaded-04-03-2021-08-07-42)-Study-related document.doc
23416Ethical approval    370260-(Uploaded-04-03-2021-08-07-16)-Study-related document.pdf

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.