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 University4 CHEOS, St. Paul’s Hospital

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

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

PROJECT AIM

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

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

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

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

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

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

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

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

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

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.

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 regression for each item

RESULTSLogistic Regression of Parental Self-Reported Preventive Safety Behaviors and Removal of Hazards: Safety Kit vs. Control: 12 Months *

Variable Control N

Control %

Kit N

Kit %

Odds Ratio (R)

95% Confidence Intervals

Lights 144 98.6 161 99.4 2.90 0.25 – 34.10

Clutter 135 93.8 152 93.8 0.91 0.34 – 2.42

Unattend. 69 46.6 89 55.3 1.23 0.74 – 2.06

Walker 117 79.1 140 86.4 1.90 1.00 – 3.62

Toy 126 87.5 139 89.1 1.36 0.61 – 3.00

Choke 134 91.2 136 83.4 0.55 0.27 – 1.14

Blinds 125 85.6 145 90.1 1.79 0.86 – 3.71

Hot 147 98.7 158 96.9 0.56 0.10 – 3.17

Extinguisher 98 66.2 94 58.0 0.86 0.48 – 1.57

Homehot 80 53.7 113 69.3 2.21 1.32 – 3.69

Meds 147 98.7 160 98.2 3.05 0.26 – 35.32

Plants 112 76.2 123 76.9 1.12 0.62 – 2.04

Tub 145 97.3 159 97.5 0.91 0.20 – 4.21

Pools 104 72.2 105 65.2 0.85 0.49 – 1.47

* Adjusted for income and baseline measure of dependent variable

RESULTS

Variable Control N

Control %

Kit + HV N

Kit + HV%

Odds Ratio (R)

95% ConfidenceIntervals

Lights 144 98.6 169 98.8 1.25 0.17 – 9.32

Clutter 135 93.8 160 94.7 1.44 0.51 – 4.09

Unattend. 69 46.6 84 49.4 1.15 0.69 – 1.92

Walker 117 79.1 147 85.0 1.53 0.83 – 2.82

Toy 126 87.5 158 93.5 2.31 0.97 – 5.49

Choke 134 91.2 150 86.7 0.68 0.32 – 1.42

Blinds 125 85.6 150 87.7 1.26 0.64 – 2.49

Hot 147 98.7 167 97.1 0.68 0.11 – 4.29

Extinguisher 98 66.2 110 64.0 1.22 0.67 – 2.21

Homehot 147 98.7 121 69.9 2.65 1.57 – 4.46

Meds 80 53.7 171 98.8 1.20 0.16 – 8.91

Plants 112 76.2 136 79.1 1.90 1.03 – 3.52

Tub 145 97.3 172 99.4 3.51 0.36 – 34.31

Pools 104 72.2 112 65.1 0.76 0.44 – 1.32

Logistic Regression of Parental Self-Reported Preventive Safety Behaviors and Removal of Hazards: Safety Kit plus Home Visit vs. Control: 12 Months *

* Adjusted for income and baseline measure of dependent variable

RESULTS Logistic Regression of Attitudes Towards Injury at 12 Months: Perceived Seriousness & Preventability *

Attitude at 12 months Control N (%)

Kit N (%)

OR

95% CI Kit + HVN (%)

OR 95% CI

Serious or Very Serious 122(83%)

130(80.7%)

0.84

(0.44 - 1.65) 141(83.4%)

0.84

(0.43 - 1.67)

Almost/Completely or Quite Preventable

119(81.5%)

132(82%)

1.24

(0.64 - 2.40) 139(82.2%)

1.12

(0.59 - 2.16)

* Adjusted for income and attitude at baseline

RESULTSLogistic Regression of Parent Reported Injuries at 12 Months

* Adjusted for income

Injuries Reported at 12 months

Control N (%)

Kit N (%)

OR

95% CI Kit + HVN (%)

OR 95% CI

 Yes, medically attended injury

15(10.3%)

16(10.0%)

1.03

(0.49 – 2.18) 16(9.3%)

1.05

(0.50 – 2.21)

RESULTS Logistic Regression of Safety Kit Item Use

* Adjusted for income

Safety Kit Items KitN (%)

Kit + HVN (%)

OR 95% CI

Smoke Alarm 101(61.6%)

111(64.2%)

0.87 0.55-1.39

Stair Gate Coupon 64(39%)

57(32.9)

1.26 0.79-2.01

Blind Cord Windups 82(50.0%)

95(54.9%)

0.84 0.53-1.31

Drawer Latches 106(64.6%)

123(71.1%)

0.76 0.47-1.22

Corner Cushions 69(42.1%)

75(43.4%)

1.09 0.69-1.72

Door Stops 86(52.4%)

97(56.1%)

0.86 0.55-1.34

Outlet Caps 140(85.4%)

157(90.8%)

0.66 0.33-1.35

Water Temperature Test Card 104(63.4%)

135(78%)

0.42 0.25-0.71

Poison Control Emerg. Number 98(59.8%)

120(69%)

0.64 0.40-1.03

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

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

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

STUDY LIMITATIONS

• Sample size• Longer follow-up period• Blinding of nurses

ACKNOWLEDGEMENTS

• Rick Hansen Neurotrauma Institute, BC• Chilliwack Health Unit, Fraser Health

Authority• Kiwanis Club of Chilliwack

THANK YOU!