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Trial registered on ANZCTR


Registration number
ACTRN12614001032640
Ethics application status
Approved
Date submitted
17/09/2014
Date registered
25/09/2014
Date last updated
25/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a brief multi strategic child health nurse intervention to reduce infant secondhand smoke exposure
Scientific title
A cluster randomised controlled trial to determine the effectiveness of a brief multistrategic intervention delivered by child health nurses in reducing secondhand smoke exposure amongst infants <12 months of age.
Secondary ID [1] 285354 0
NIL
Universal Trial Number (UTN)
U1111-1161-8940
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infant secondhand smoke exposure 293085 0
Condition category
Condition code
Public Health 293360 293360 0 0
Health promotion/education
Public Health 293361 293361 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental conditions
This is a three armed trial. A brief multi-strategic intervention will be provided to parents during their clinic visit in each of two treatment conditions by existing clinic staff as part of routine care.

Treatment condition 1
Computer delivered care: prior to the clinic consultation parent/carers will complete a touch screen survey (approximately 20 minutes duration) in the clinic waiting room and will receive tailored on-screen and printed feedback regarding their infant’s risk of secondhand smoke(SHS) exposure, and tips on implementing household smoking bans. Parent/carers who are smokers will be provided advice to quit and contact details for the Quitline counselling service.

Child health nurse delivered care: during the consultation, nurses will provide a brief SHS intervention (approximately 15 minutes duration) modelled on the 5 A’s framework. Specifically nurses will Ask about parental smoking and infant SHS exposure, Advise on strategies to protect the infant from SHS exposure and the benefits of quitting smoking, Assess willingness to change and arrange Assistance to do so. Parent/carers interested in quitting smoking will be advised to use nicotine replacement therapy (NRT) and provided with the Quitline contact details.

Treatment Condition 2
Treatment condition 2 will include the same strategies as Treatment condition 1 plus two additional components. During the consultation a urine sample will be obtained from all infants by a cotton wool pad placed in the diaper of each infant. Results will be mailed to the parent/carer, the child health nurse and the parent/carer’s general practitioner.

Parents will also receive a booklet "Clearing the air for your baby". This guide provides information about preventing infant SHS exposure and strategies for quitting smoking .

Clinical practice change strategies
The following strategies will be implemented to support intervention delivery by nurses in treatment conditions 1 and 2 clinics.

Training: nurses will attend a training session that addresses the health risks associated with infant exposure to SHS and skills in supporting parent/carers to quit smoking and implement household smoking bans.

Prompts: the computer will generate a tailored checklist to support intervention delivery by the nurses. In addition medical record labels will be provided to facilitate recording of infant SHS exposure and parental smoking status and to prompt follow up care.

Resources: nurses will be provided with resource packs including SHS fact sheets, a 5 A’s flip chart, pamphlets and quit smoking fact sheets.

Cotinine feedback (Treatment condition 2): cotinine results of each infant, a results interpretation guide, and tips for discussion with parents will be provided to nurses.
Intervention code [1] 290273 0
Prevention
Intervention code [2] 290304 0
Behaviour
Comparator / control treatment
Control Group
Participants attending control group clinics will receive usual care consisting of brief advice regarding protecting infants from SHS and provision of a “Quit Kit” to parents/carers.
Control group
Active

Outcomes
Primary outcome [1] 293188 0
Parental self report of infant secondhand smoke exposure(anyone smoked in their infant’s presence in the home, car or at a friend or relative’s home (yes, no, don’t know) during that day or the previous 2 days. Validated by infant urinary cotinine levels.
Timepoint [1] 293188 0
Baseline and 12 months
Secondary outcome [1] 310553 0
Smoking status of parent/carers
Parent/carer self report (never smoker, ex-smoker, occasional smoker-‘smoke every now and then’, regular smoker-‘smoke at least one cigarette a day’, don’t know
Timepoint [1] 310553 0
Baseline and 12 months
Secondary outcome [2] 310554 0
Parent/carer self report of presence of household smoking bans: no smoking is allowed inside the home at all; smoking is limited to part of the house where the baby/children rarely go; smoking does not occur in the baby’s/children’s bedrooms but occurs elsewhere in the house; or smoking is allowed in any room
Timepoint [2] 310554 0
Baseline and 12 months

Eligibility
Key inclusion criteria
Infant lives in a home with one or more smokers .
Minimum age
No limit
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infant > 12 months of age
Parent/carer insufficient English to complete study procedures

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a cluster randomised controlled trial. Clinics are the unit of randomisation. All 39 child health clinics in the region stratified according to annual number of client appointments and then randomly allocated to experimental group ( Treatment 1, Treatment 2, Control) using SAS statistical software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on research suggesting that 40% of infants attending child health clinics live in households with smokers, and an assumed 25% loss to follow up at 12 months, it was determined that a final sample of 1200 infants (400 per group) would be attainable at 12 month follow up. Forty per cent of infants are estimated to be exposed to SHS in the past three days (n=160 per group) and 50% of parent/carers are estimated to be smokers at baseline (n=200 per group). Fifty per cent of homes are estimated to not have complete smoking bans (n=200 per group). Allowing for a 5% decrease in prevalence for each outcome measure in the control group, the samples are estimated to enable a difference of 9% between groups for infant SHS exposure, and 8% for parent/carers smoking, and existence of smoking bans (80% power; a =0.05).

The impact of the intervention on the primary and secondary outcomes will be examined using repeated measures logistic regression in a Generalised Estimating Equations (GEE) framework (three models). All models will include adjustment for clustering and covariates hypothesised to be related to the outcome measures (parent/carer smoking status, household smoking bans, parent/carer marital status, parent/carer educational attainment). The interaction of time and treatment group will be used to determine the significance of differences in outcomes over time between groups. All outcomes will be analysed on an intention to treat basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289973 0
Charities/Societies/Foundations
Name [1] 289973 0
The Financial Markets Foundation for Children
Address [1] 289973 0
GPO Box 3655
Sydney NSW 2000
Country [1] 289973 0
Australia
Funding source category [2] 289974 0
Charities/Societies/Foundations
Name [2] 289974 0
The Community Health and Anti Tuberculosis Association
Address [2] 289974 0
Suite 2/ 2 Norwich Rd, Rose Bay, NSW 2029
Country [2] 289974 0
Australia
Funding source category [3] 289975 0
University
Name [3] 289975 0
The Centre for Health Research & Psycho-oncology (CHeRP) - now University of Newcastle - Priority Research Centre for Health Behaviour (PRCHB)
Address [3] 289975 0
Room 4305, West Wing HMRI Building
John Hunter Hospital Campus
RANKIN PARK, NSW 2287
Country [3] 289975 0
Australia
Funding source category [4] 289976 0
Charities/Societies/Foundations
Name [4] 289976 0
Hunter Medical Research Institute.
Address [4] 289976 0
HMRI Building
1 Kookaburra Circuit
John Hunter Hospital Campus
RANKIN PARK, NSW 2287
Country [4] 289976 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Longworth Avenue Wallsend
NSW 2289
Country
Australia
Secondary sponsor category [1] 288661 0
University
Name [1] 288661 0
University of Newcastle
Address [1] 288661 0
School of Medicine & Public Health
University of Newcastle
University Drive
CALLAGHAN, NSW 2308
Country [1] 288661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291686 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 291686 0
Hunter New England Health
Lookout Road
New Lambton Heights NSW 2305
Ethics committee country [1] 291686 0
Australia
Date submitted for ethics approval [1] 291686 0
Approval date [1] 291686 0
13/10/1999
Ethics approval number [1] 291686 0
H7831099

Summary
Brief summary
Exposure to secondhand smoke (SHS) is a significant contributor to ill health among children. This study examines the effectiveness of a child health nurse intrvention delivered as part of routine care in reducing SHS exposure amongst infants, increaseing parental smoking cessation and implementation of household smoking bans.
Trial website
Trial related presentations / publications
Daly,J.,Wiggers,J., Burrows,S., Freund, M. Household smoking behaviours and exposure to environmental tobacco smoke among infants: are current strategies effectively protecting our young? Aust NZJ Public Health 2010:34(3): 269-273
Public notes

Contacts
Principal investigator
Name 51498 0
Ms Justine Daly
Address 51498 0
Hunter New England Population Health
Longworth Avenue
Wallsend NSW 2287
Country 51498 0
Australia
Phone 51498 0
61 2 49246390
Fax 51498 0
Email 51498 0
Justine.daly@hnehealth.nsw.gov.au
Contact person for public queries
Name 51499 0
Ms Justine Daly
Address 51499 0
Hunter New England Population Health
Longworth Avenue
Wallsend NSW 2287
Country 51499 0
Australia
Phone 51499 0
61 2 49246390
Fax 51499 0
Email 51499 0
Justine.daly@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 51500 0
Ms Justine Daly
Address 51500 0
Hunter New England Population Health
Longworth Avenue
Wallsend NSW 2287
Country 51500 0
Australia
Phone 51500 0
61 2 49246390
Fax 51500 0
Email 51500 0
Justine.daly@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary