The Chilliwack Safe Baby Study: A Randomized Controlled Trial

1. The Chilliwack Safe Baby Study: A Randomized Controlled Trial Babul S1, Olsen, L1, McIntee, P2, Janssen, P4, Scanlan, A1, Brussoni, M1, Raina, P3 1 BC Injury Research & Prevention Unit, BC Children’s Hospital, Department of Pediatrics, University of British Columbia2 Chilliwack Health Unit, Chilliwack, British Columbia 3 McMaster University 4 CHEOS, St. Paul’s Hospital

2. INTRODUCTION • Unintentional injuries 4th leading cause of death for infants under one year of age • Falls leading cause of injury in this age group • increased mobility & exploration • dependent on adult supervision • Majority of unintentional injuries occur in the home

3. INTRODUCTION cont’d • Little evidence that providing safety devices translates into reduction of injuries • Studies examining safety behaviors to enhance infant safety have been defined and measured with considerable heterogeneity

4. PROJECT AIM • We tested a developmentally targeted intervention aimed at addressing safety behaviors of parents and injuries to infants aged 2-12 months.

5. METHODS • Design: • Three-arm non-blinded trial in which parental safety behaviors (use of safety devices and removal of hazards) were examined among parents randomly assigned to 1 of 3 groups • Home visit plus safety kit • Safety kit • Control Group

6. METHODS cont’d • Setting: • Subjects recruited from single public health unit in Chilliwack area • Health unit serves as population of approx. 70,000 • 82% living in urban communities or suburban neighbourhoods, balance in rural hillsides and farming areas

7. METHODS cont’d • Subjects: • ALL parents of newborns and residing in district of Chilliwack • Exclusion criteria: • Non-english speaking • Lived on First Nations reserve • Infants transferred to a tertiary pediatric facility

8. METHODS cont’d • Recruitment: • Mothers of newborns contacted by community health nurse (CHN) in hospital or by telephone shortly after discharge • Given information letter describing study • Written consent obtained • Non-participants completed a form documenting demographics and reasons for refusal

9. METHODS cont’d • Randomization: • Participants randomized to 1 of 3 groups • Allocation accomplished by means of random numbers table • Group allocation documented and concealed in sequentially numbered opaque envelopes • Opened when infant brought to health unit for first immunization (2 months) • Safety kits distributed to parents in intervention groups at 2 months

10. METHODS cont’d • Home Visitation: • Subjects randomized to receive home visit contacted by CHN to arrange convenient time for visit • Standardized protocol • Introduction • Outline of visit • Walk through each room (41 item checklist) • Parents taught how to remove/modify hazards to mitigate potential risks

11. METHODS cont’d • Safety Kit: • Selected from review of literature & CHIRPP • Nine items included: • Smoke alarm • 50% Coupon stair gate • Corner cushions • Cabinet locks • Blind cord windups • Water temp. card • Dorr stoppers • Electrical outlet covers • Poison control sticker • Additionally, a brochure and 2-page risk assessment checklist also included

12. METHODS cont’d • Outcomes: • Primary – parent reported use of preventive safety measures and removal of potential hazards in home • Secondary – attitudes toward safety, use of 9 safety kit items and rates of parent-reported medically attended injuries • Measured using a parent completed questionnaire at 2, 6, 12 months

13. METHODS cont’d • Sample Size Determination: • 200 per group with 80% power and type 1 error of p=0.05 allowed for detection of an absolute increase of 15% from a baseline of 30%, in the proportion of parents reporting use of at least 2 of 9 kit items.

14. STATISTICAL ANALYSIS • Multivariate analysis using logistic regression to estimate uptake of behavioral outcomes, improvement of dichotomized attitudinal measures & improvement of injury outcomes • Use of Nine Safety kit items: • Differences b/w two intervention groups • Logistic regressionfor each item

15. Logistic Regression of Parental Self-Reported Preventive Safety Behaviors and Removal of Hazards: Safety Kit vs. Control: 12 Months * RESULTS * Adjusted for income and baseline measure of dependent variable

16. Logistic Regression of Parental Self-Reported Preventive Safety Behaviors and Removal of Hazards: Safety Kit plus Home Visit vs. Control: 12 Months * RESULTS * Adjusted for income and baseline measure of dependent variable

17. RESULTS Logistic Regression of Attitudes Towards Injury at 12 Months: Perceived Seriousness & Preventability * * Adjusted for income and attitude at baseline

18. RESULTS Logistic Regression of Parent Reported Injuries at 12 Months * Adjusted for income

19. RESULTS Logistic Regression of Safety Kit Item Use * Adjusted for income

20. CONCLUSIONS • Parents in the intervention groups (i.e. safety kit and safety kit plus home visit) were more likely than those in the control group to report having their home hot water temperature adjusted to a safe level • Among nine safety kit items, parents receiving a home visit in addition to the safety kit were more likely to report having used the hot water temperature card than those receiving the safety kit alone

21. CONCLUSIONS • Parents receiving safety kit plus home visit were more likely than those in control group to report having plants placed out of reach from infants • No differences were found between intervention groups for attitudinal measures or injury outcomes

22. IMPLICATIONS • Design of interventions should take into account the level of use (i.e. safety kit items) • Home visits by a community health nurse may provide an added benefit in altering some safety behaviors

23. STUDY LIMITATIONS • Sample size • Longer follow-up period • Blinding of nurses

24. ACKNOWLEDGEMENTS • Rick Hansen Neurotrauma Institute, BC • Chilliwack Health Unit, Fraser Health Authority • Kiwanis Club of Chilliwack

25. THANK YOU!