572077

research-article2015

CPJXXX10.1177/0009922815572077Clinical PediatricsAhlers-Schmidt et al

Brief Report

Does Providing Infant Caregivers With a Wearable Blanket Increase Safe Sleep Practices? A Randomized Controlled Trial

Clinical Pediatrics 1­–4 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0009922815572077 cpj.sagepub.com

Carolyn R. Ahlers-Schmidt, PhD1, Christy Schunn, LSCSW2, Michelle Nguyen, BS1, Joy Nimeskern-Miller, BS1, Rabea Ilahe, MBBS1, and Stephanie Kuhlmann, DO1 Introduction

Materials and Methods

In Sedgwick County, Kansas, the infant mortality rate has been consistently higher than that of Kansas or the United States as a whole.1,2 Nearly 20% of these deaths are attributed to sudden unexpected infant deaths (SUID). Sleep-related deaths, including sudden infant death syndrome, are part of this category. In 2011, the American Academy of Pediatrics (AAP) released revised recommendations to reduce the risk of sleeprelated deaths that focused on a safe sleep environment in addition to supine position.3 Several initiatives have been undertaken to improve safe sleep for infants in Sedgwick County. Community baby showers provide portable cribs and wearable blankets to equip high-risk caregivers with tools to promote safe sleep,4 resulting in high intentions to follow the AAP safe sleep guidelines. A hospital-based project improved safe sleep for newborns, but struggled to keep loose blankets out of the bassinet.5 In addition, pilot testing of the Medical Society of Sedgwick County Safe Sleep Toolkit in pediatric and obstetrical resident clinics found the majority of caregivers reported placing their infant supine to sleep in a safe location (crib, bassinet, or portable crib). However, more than 60% reported unsafe items in the crib, the most frequent of which were loose blankets.6 Physician promotion of safe sleep has been shown as one of the strongest indicators of whether a caregiver will use safe sleep strategies, such as supine position.7 In addition, social marketing strategies often incorporate functional promotional items to enhance behavioral change.8 Therefore, we hypothesized providing caregivers with a wearable blanket would increase safe sleep practices. The purpose of this study was to test the effectiveness of a wearable blanket versus a control item to increase safe sleep practices among parents or caregivers (henceforth “caregivers”) at a pediatric resident clinic.

Baseline This randomized control trial took place at a pediatric resident and faculty continuity clinic that serves mostly state-insured patients. Study personnel approached caregivers of patients in the University of Kansas Pediatric Clinic waiting room at the 1-month well-baby visit. Participants were English speaking and able to provide informed consent. Following consent, the Safe Sleep Checklist was collected. The Safe Sleep Checklist, which assessed caregiver-reported infant sleep location, position, and environment, was part of the standard of care at the clinic.6 Caregivers were then randomly selected to receive 1 of 2 incentives. Participants in the intervention group received a wearable blanket that contained a safe sleep message to use at home for their infant. Participants randomized to the control group received a reusable water bottle that did not contain a safe sleep message.

Follow-Up All caregivers were followed-up approximately 1 month later at the infant’s 2-month well-baby visit. Clinic staff members notified the study team of the 2-month wellbaby appointments. The Safe Sleep Checklist was readministered and participants were assessed on their continued practice of safe sleep in the home environment. A brief questionnaire was administered 1

University of Kansas School of Medicine–Wichita, Wichita, KS, USA Kansas Infant Death and SIDS (KIDS) Network, Inc, Wichita, KS, USA 2

Corresponding Author: Carolyn R. Ahlers-Schmidt, University of Kansas School of Medicine–Wichita, Office of Research, 1010 N. Kansas, Wichita, KS 67214, USA. Email: [email protected]

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regarding the use and helpfulness of the incentive. Caregivers who were unable to complete the follow-up questions at the 2-month visit or did not show up for their scheduled appointment were contacted by telephone or e-mail for the follow-up questions.

Data and Statistical Analysis Checklist and questionnaire responses were analyzed using frequencies and percentages for categorical data, while means with standard deviations were used for the continuous data (age). Within-group differences between pre- and postintervention assessment were compared using the related samples McNemar Change Test, while the between-group comparisons of control and intervention outcomes utilized χ2 testing. Open-ended comments were reviewed for themes.

Results Out of a total of 184 caregivers invited to participate in the study, 152 consented and completed baseline data (83%; Figure 1). Of these, 115 completed the 2-month follow-up survey (76%). The majority were white (75, 65%), female (106, 92%), with less than a 4-year degree (94, 82%), and 1 to 2 children (86, 75%). The average age was 26 years (SD = 6 years). Caregivers were randomized to receive a wearable blanket (57, 49.6%) or a water bottle (58, 50.4%). Demographics did not differ significantly by group (data not shown). Caregivers were more likely to report continued use of the wearable blanket than the water bottle, with only 12% (n = 7) reporting never using the wearable blanket compared with 34% (n = 20) for water bottles. In spite of reported use, only 35% (n = 20) of caregivers in the intervention group could accurately recall the safe sleep message embroidered on the wearable blanket. However, caregivers who received the wearable blanket were significantly more likely to report that the item was helpful in reminding them to use safe sleep practices (alone, back, crib) than those who received a water bottle, χ2(3) = 16.00, P = .001. In addition, caregivers reported the wearable blanket was significantly more likely to help them talk with others (family, friends, daycare providers, etc) about using safe sleep practices with their baby (36, 65%) than the water bottle (27, 47%), χ2(1) = 4.09, P = .04. However, no difference was observed in the percentage of caregivers who reported actually discussing safe sleep practices with others (Table 1). At baseline, the majority of caregivers in both groups reported placing their baby down to sleep on his/her back in a crib, bassinet, or portable crib. Fewer caregivers reported a safe environment. Safe environment was

defined as having a firm mattress and fitted sheet and NOT having the following: loose blankets, bumpers, pillows, stuffed toys, or other unsafe items. However, at follow-up no significant differences were found for within-group or between-group comparisons. Caregivers were asked whether their perception of the clinic’s concern for their child’s well-being, friendliness, professionalism, competence, or knowledge changed based on receiving the incentive. Higher percentages of caregivers who received wearable blankets reported an increase in each of the measures, although statistical significance was not obtained. Perceived competence showed the greatest difference between groups (51% vs 34%), χ2(1) = 3.18, P = .07.

Discussion Caregivers who received wearable blankets were more likely to report being reminded about safe sleep practices for their infants and were more likely to report the item helped them have discussions about safe sleep with other infant caregivers when compared with caregivers who received water bottles. However, these increases did not result in improved adherence to the safe sleep guidelines for position, location, or environment. In fact, some caregivers reported engaging in fewer safe sleep behaviors at follow-up than at baseline. A previous study suggested caregivers who received safe sleep education in the hospital5 had high intentions of following the AAP’s safe sleep recommendations. However, by the 2-month well-child appointment caregivers’ actual behavior was not as high as their intentions (unpublished data). Many factors may reduce the likelihood of caregivers following the AAP recommendations including receiving conflicting advice and fear of choking or discomfort.3 This is especially concerning as the greatest risk of death classified as sudden infant death syndrome is between 1 and 4 months of age.3 In addition, a recent study found infants 4 months or older were more likely than younger infants to die with an object (such as loose blanket) in the sleep environment.9 Strategies need to be developed to help educate caregivers on the safe sleep guidelines and facilitate continued use of safe sleep practices throughout the first year of life. While our study failed to find significant improvements in safe infant sleep after receiving a wearable blanket from a pediatric clinic, we feel further research is necessary before discounting the potential of wearable blankets for engaging caregivers in safe sleep discussions. To begin, the wearable blanket was presented by study personnel and not a health care professional. This may have reduced the perceived importance of the item and the safe sleep message. In addition, the dose of the

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Figure 1.  Flow chart of particpant recruitment and follow-up.

intervention may have been too small. When they received the incentive, caregivers were simply told the safest place for an infant to sleep was alone, on their back in a crib, bassinet, or portable crib with no loose bedding such as blankets, bumpers, pillows, or stuffed animals. Future studies should assess the effectiveness of wearable blankets given directly from the physician along with tailored counseling regarding caregivers’ report of infant sleep location, position, and environment. It should be noted that a small number of deaths have been

reported for infants in wearable blankets. However, in all cases additional risk factors were present.10 Finally, the self-report nature of our data is a limitation.

Conclusion Providing caregivers with wearable blankets did not significantly improve adherence to the AAP’s Safe Sleep guidelines when compared with caregivers in the control group. However, the wearable blankets were reported to

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Table 1.  Safe Sleep Checklist Responses. Intervention (N = 57)   Overall safe sleep Safe position (back) Safe location Safe environment   Firm mattress presenta   Fitted sheet present   No loose blankets   No bumper   No pillowa   No stuffed toysa   No other itemsa Discussed safe sleep with others

Pre

Post

20 (35%) 51 (89%) 47 (82%) 32 (56%) 52 (91%) 41 (72%) 34 (60%) 54 (95%) 55 (96%) 56 (98%) 55 (96%) 48 (84%)

19 (33%) 51 (89%) 44 (77%) 25 (44%) 49 (86%) 45 (79%) 33 (58%) 49 (86%) 50 (89%) 55 (96%) 49 (86%) 46 (81%)

McNemar Test Statistic χ2(1) = 0.00, P = 1.00 χ2(1) = 0.00, P = 1.00 χ2(1) = 0.44, P = .51 χ2(1) = 1.90, P = .17 χ2(1) = 0.44, P = .51 χ2(1) = 0.75, P = .39 χ2(1) = 0.00, P = 1.00 χ2(1) = 0.44, P = .51 χ2(1) = 0.80, P = .38 χ2(1) = 0.00, P = 1.00 χ2(1) = 1.50, P = .22 χ2(1) = 0.06, P = .80

Control (N = 58)

Postintervention Comparison

Pre

Post

McNemar Test Statistic

χ2 Test Statistic

10 (17%) 48 (83%) 47 (81%) 25 (43%) 52 (90%) 42 (72%) 30 (52%) 49 (84%) 56 (97%) 56 (97%) 55 (95%) 47 (81%)

16 (28%) 51 (88%) 50 (86%) 27 (47%) 54 (93%) 39 (67%) 32 (55%) 52 (90%) 54 (93%) 55 (95%) 57 (98%) 47 (81%)

χ2 (1) = 1.56, P = .21 χ2(1) = 0.44, P = .51 χ2(1) = 0.57, P = .45 χ2(1) = 0.45, P = .50 χ2(1) = 0.13, P = .73 χ2(1) = 0.36, P = .55 χ2(1) = 0.05, P = .82 χ2(1) = 0.36, P = .55 χ2(1) = 0.17, P = .69 χ2(1) = 0.00, P = 1.00 χ2(1) = 0.25, P = .63 χ2(1) = 0.00, P = 1.00

χ2(1) = 0.45, P = .50 χ2(1) = 0.07, P = .79 χ2(1) = 1.57, P = .21 χ2(1) = 0.08, P = .77 χ2(1) = 0.56, P = .52 χ2(1) = 3.14, P = .08 χ2(1) = 0.27, P = .60 χ2(1) = 0.01, P = .92 χ2(1) = 0.19, P = .74 χ2(1) = 2.92, P = .24 χ2(1) = 4.10, P = .56 χ2(1) = 0.50, P = .48

a

Fisher’s exact test.

act as reminders for safe sleep and to stimulate conversations regarding safe sleep. A stronger dose of safe sleep education, in addition to having a physician or nurse provide the wearable blanket, should be evaluated. Acknowledgments We would like to acknowledge the Administration and Staff at the University of Kansas Pediatric Clinic for their assistance and support on this study.

Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The incentives were purchased with funding from the AMERIGROUP Charitable Foundation, Kansas Gas Service, a Division of ONEOK, Inc, and March of Dimes Greater Kansas Chapter.

References 1. MacDorman MR, Hoyert DL, Matthews TJ. NCHS Data Brief: Recent Declines in Infant Mortality in the United States, 2005-2011. http://www.cdc.gov/nchs/data/databriefs/db120.htm. Accessed August 21, 2014.

2. Sedgwick County Health Department. Infant mortality health issue brief. http://www.kansashealthmatters. org/javascript/htmleditor/uploads/IMhb_Web___Final_ Copy.pdf. Accessed August 21, 2014. 3. Task Force on Sudden Infant Death Syndrome. SIDS and Other Sleep-Related Infant Deaths: Expansion of Recommendations for a Safe Infant Sleeping Environment. Pediatrics. 2011; 128:e1341. 4. Ahlers-Schmidt CR, Schunn C, Dempsy M, Blackmon S. Evaluation of community baby showers to promote safe sleep. Kansas J Med. 2014;7:1-5. 5. Mason B, Ahlers-Schmidt CR, Schunn C. Improving safe sleep environments for well newborns in the hospital setting. Clin Pediatr (Phila). 2013;52:9699-9675. 6. Ahlers-Schmidt CR, Kuhlmann S, Kuhlmann Z, Schunn C, Rosell J. To increase safe sleep practices more emphasize items in crib. Clin Pediatr. 2014;53: 1285-1287. 7. Colson ER, Rybin D, Smith LA, Colton T, Lister G, Corwin MJ. Trends and factors associated with infant sleeping position: the national infant sleep position study 1993-2007. Arch Pediatr Adolesc Med. 2009;163: 1122-1128. 8. Kotler P, Lee N. Social Marketing. Thousand Oaks, CA: Sage; 2008. 9. Colvin JD, Collie-Akers V, Schunn C, Moon RY. Sleep environment risks for younger and older infants. Pediatrics. 2014;134:e406-e412. 10. McDonnell E, Moon RY. Infant deaths and injuries associated with wearable blankets, swaddle wraps, and swaddling. J Pediatr. 2014;164:1152-1156.

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Does Providing Infant Caregivers With a Wearable Blanket Increase Safe Sleep Practices? A Randomized Controlled Trial.

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