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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]

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

Condition category

Condition code

Public Health

Health promotion/education

Injuries and Accidents

Other injuries and accidents

Reproductive Health and Childbirth

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]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Interviewing 0-7 days after the six week baby check with safe sleep calculator assessment.

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cure Kids

Address [1]

Laundry Building,
Suite 4 Level 4,
58 Surrey Cres,
Grey Lynn 1021
New Zealand

Country [1]

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]

Individual

Name [1]

Christine McIntosh

Address [1]

University of Auckland
Private Bag 92019
Auckland 1142
New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Health and Disability Ethics Comittee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

14/03/2016

Approval date [1]

Ethics approval number [1]

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

Dr Christine McIntosh

Address

c/o Kidz First Admin. Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Auckland

Country

New Zealand

Phone

+64 21 915220

Fax

[email protected]

Contact person for public queries

Name

Christine McIntosh

Address

Kidz First Admin. Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Auckland

Country

New Zealand

Phone

+64 21 915220

Fax

[email protected]

Contact person for scientific queries

Name

Christine McIntosh

Address

Kidz First Admin. Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Auckland

Country

New Zealand

Phone

+64 21 915 220

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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