“Back to Sleep” Discharge Education Protocol for Preterm Infants:
An Evidence-Based Project
Abstract
Sudden Infant Death Syndrome (SIDS) and the “Back to Sleep” campaign have been the focus of a national health promotion effort for nearly twenty years in the United States. Despite the longevity of the campaign and widespread knowledge of its recommendations, non-compliance remains a consistent problem. The objective of this paper is to describe the development and proposed implementation of an evidence-based project in the Newborn/Infant Intensive Care Unit at the Children’s Hospital of Philadelphia. A multi-pronged discharge education protocol has been developed for the purpose of increasing long-term compliance with the “Back to Sleep” campaign and American Academy of Pediatrics (AAP) infant safe sleep guidelines among parents of preterm infants. The review of literature includes a critique of research on preterm infant sleep characteristics, followed by nursing practice, parent beliefs, and educational interventions. Background knowledge of the problem and theoretical framework of the evidence-based project are described in part one of this paper, followed by a thorough description of methodology, data analysis, and ethical implications.
Part I: Background
Problem Statement
Sudden Infant Death Syndrome (SIDS) has been the focus of national and worldwide attention since the initial recommendations were disseminated by the American Academy of Pediatrics (AAP) in 1992. The “Back to Sleep” campaign began two years later, successfully helping to reduce the rate of infant mortality in the United States. (American Academy of Pediatrics, 2005). The SIDS rate in 1992 was 1.2 deaths per 1,000 live births, and this rate trended down to 1.03 in 1994. (NICHD, 2010). Subsequent statements by the AAP in 2001 and 2005 have clarified best practice in the categories of safe sleep and infant sleep environment. Despite these widespread efforts, SIDS remains an important public health initiative, and the rate of SIDS-related deaths from 2000 to 2006 has hovered in the range of 0.53 to 0.62 per 1,000 live births. (AAP, 2005; NICHD, 2010).
Although SIDS can be defined in a variety of ways, the most comprehensive definition, as presented in the AAP 2005 statement, describes the sudden, unexplained death of an infant under the age of one year following a comprehensive investigation, autopsy, and patient history examination. Sudden Infant Death Syndrome (SIDS) can occur at any point during the infant’s first year of life, but the peak incidence is between two and three months. Through the study of this phenomenon, risk factors have been identified and publicized. Prone positioning of young infants is most commonly cited as a high SIDS risk, and side sleeping has also been designated as a dangerous position. The side position has been characterized as unstable, noting that the infant can easily roll into prone position. It is also important to note that when an infant is accustomed to sleeping on his or her back, suddenly changing to prone position puts the infant at a higher risk for SIDS. (AAP, 2005).
The main recommendations for SIDS prevention include placing the infant to sleep on his or her back at night and during daytime naps, using a fitted crib sheet and firm mattress, avoiding the use of pillows, blankets, toys, or bumpers in the sleep area itself, prohibiting smoking, and preventing overheating. Additionally, co-bedding is discouraged, along with the use of commercial SIDS prevention devices and home monitors. One of the newer interventions include offering a pacifier at nap and bedtime during the first year of life in order to potentially lower the arousal threshold. While prone positioning of young infants is discouraged during sleep, “tummy time” can help to prevent plagiocephaly, characterized by a flat or misshapen head resulting from infrequent position changes, but should only be done when the infant is awake and a caregiver can provide direct observation. (AAP, 2005).
Preterm and low birth weight infants are not exempt from the “Back to Sleep” campaign, as was the case initially. (Grazel et al., 2010). In fact, this is a vulnerable population that is at an increased risk for SIDS. (Raydo & Reu-Donlon, 2005). During the acute phase of treatment in the neonatal intensive care unit, these infants are often placed prone to provide developmentally appropriate care despite the known potential safety hazard of this practice. (Ariagno et al., 2003; Aris et al., 2006; Grazel et al.; Raydo & Reu-Donlon). The AAP SIDS task force specifically encourages healthcare professionals to educate and model correct behavior prior to discharge. This is especially important as parents have been shown to copy what they see being performed in the controlled hospital setting. In the AAP SIDS policy statement, it was specifically noted that the use of prone positioning tends to follow in a linear fashion, as preterm infants are often cared for in the prone position during the acute stage of illness, then infants and parents tend to get accustomed to using this position for sleep, and parents generally follow the advice of the hospital staff, especially in the event of a prolonged hospitalization. The goal is for healthcare professionals to adhere to hospital policy and AAP recommendations for the purpose of modeling best practice and sending a unified and accurate message of safe infant care. A vital component of the Task Force is the call for increased educational efforts, not only for parents, but also including caregivers, relatives, and babysitters, among others. It is important to note that a variety of people often care for these young infants after discharge from the hospital and restriction of the “Back to Sleep” message to one subset of the population will not completely ensure the infant’s safety. (AAP, 2005).
Purpose of the Evidence-Based Project
The purpose of this evidence-based project is to determine if a multi-pronged educational intervention will positively influence long-term compliance with supine sleep in the vulnerable preterm infant population following discharge from the neonatal intensive care unit. A primary goal of the study is to decrease the overall rate of SIDS due to non-supine sleep position. This project will highlight the importance of SIDS prevention and will raise awareness of the risk factors and prevention strategies. Additionally, the intent is to encourage healthcare professionals, specifically nurses involved in the discharge teaching process, to spend a significant amount of time educating parents and caregivers about the “Back to Sleep” message and modeling the safe infant positioning techniques for parents to replicate in the home setting. Healthcare professionals are vital to the success of this new protocol, and their constructive feedback can lead to a positive result, defined as a decline in SIDS rate and increase in supine infant sleep position. The desired immediate outcome is for all preterm infants discharged from the NICU to be placed in the supine position, with parents opting for “tummy time” only when the infant is awake, alert, and supervised. If the protocol demonstrates a consistent change in nurse and parent behavior to comply with the AAP guidelines, other neonatal intensive care units in the Delaware Valley and elsewhere in the country can implement similar discharge teaching and follow-up strategies.
Previous studies have identified the decision-making processes of both healthcare professionals and parents or caregivers in terms of choice of infant sleep position. Their choice of position may depend upon presumed infant comfort measures, previous experience or knowledge, and/or recommendations from others. Healthy, full-term infants have been the most commonly used subjects for these studies. However, preterm infants have been identified in the literature as being increasingly at risk for SIDS-related death, and it appears as though an evidence-based project that focuses on this population is long overdue. In addition, previously developed educational interventions on the topic of infant safe sleep have not been shown to be universally efficient or enduring, thus supporting the need for new protocol development.
Critical Review & Analysis of Literature
Preterm Infant Sleep Characteristics
Contrary to popular belief, the commonly used prone sleep position for preterm infants is not considered a safe practice. In fact, non-supine position can put these infants at a 25% greater risk for SIDS after discharge from the NICU. (Aris et al., 2006). A review of “Back to Sleep” practices in 2005 noted that former premature infants discharged from the neonatal intensive care unit were twice as likely to succumb to SIDS in the first year of life. Factors contributing to this staggering statistic include a gestational age of less than 37 weeks, along with the widespread and prolonged practice of non-supine sleep position during the time period of highest risk for SIDS. (Raydo & Reu-Donlon, 2005). There have been a number of studies done to examine the physiology of preterm infant sleep, focusing on breathing patterns, overall sleep characteristics, and risk for adverse effects from common conditions, such as gastroesophageal reflux (GER). Research has supported the advantages of prone position in the acute phase of illness, but has not been shown to be advantageous in the recovery stage. (Aris et al.; Grazel et al., 2010) In terms of breathing, a study by Levy et al. (2006) indicated that there was no significant difference in lung compliance, tidal volume, and work of breathing in comparing prone and supine position. Also of note, the preterm infants in this study did not experience an increased number of apnea, bradycardia, and desaturation episodes in evaluating the safety of prone and supine position. Another study by Ariagno et al. (2003) found no significant difference among neonates in total sleep time between the supine and prone position at one month of age. Although the infant may experience more sleep transitions in the supine position, this trait, coupled with a decreased arousal threshold, can actually be a safety mechanism for the sleeping infant. (Ariagno et al.).
Parents, caregivers, and healthcare professionals often mention gastroesophageal reflux as a prohibiting factor in placing the infant supine to sleep. (Colson et al., 2001; Grazel et al., 2010; Mosley et al., 2007; Oden et al., 2010). However, various studies support the concept that the infant is in a substantially better position for protecting the airway when placed supine. From a physiological standpoint, when the infant refluxes, the fluid moves toward the path of least resistance. If the infant is supine, the trachea is positioned above the esophagus, thus making aspiration more unlikely than in the prone position, where the trachea is inferior. Basic anatomy supports placing an infant suffering from GER supine to sleep. (Aris et al., 2006; Grazel et al.). The findings of the study conducted by Ariagno et al. (2003) support the AAP SIDS Task Force statement, affirming that prone position for preterm infants is not a recommended therapeutic position for GER and actually increases the SIDS risk.
Nursing Practice
Nurses and healthcare have frequent contact with parents of preterm infants to educate them on the practice of safe sleep. Multiple studies have noted that parents are often influenced by and mimic at home what they see in the hospital setting. (Aris et al., 2006; Dattani et al., 2010; Grazel et al., 2010; Raydo & Reu-Donlon, 2005). Unfortunately, compliance regarding supine sleep position in the hospital is not universal. (Aris et al.; Grazel et al.; Shaefer et al., 2010). Therefore, parents may be copying the unsafe behaviors and practices of healthcare professionals and staff outside of a controlled environment upon discharge. Another issue that frequently surfaces is the lack of a consistent message given to the parents. (Aris et al.; Grazel et al.). Nurses often cite reflux and aspiration as rationale for placing the infant prone or, more commonly, in the side lying position. (Aris et al.; Grazel et al.; Raydo & Reu-Donlon). In a comprehensive review of a number of studies on this topic by Raydo and Reu-Donlon, a staggering 90% of nurses recommended the side position, even taking into account hospital policy, AAP guidelines, and the widespread findings that supine position does not increase the infant’s risk for emesis, reflux, respiratory difficulty, and sleep problems. (Raydo & Reu-Donlon). It is crucial that nurses, among other healthcare professionals, are consciously aware of the most current SIDS recommendations, as well as documented hospital policy. A written policy has been shown to increase the likelihood of proper sleep practice reinforcement and discharge teaching. (Aris et al.; Dattani et al.). While most healthcare professionals acknowledge the importance of supine position, the hazards of the unstable side position might be less obvious or potentially misunderstood, thus calling for a targeted educational intervention. Nurses and other staff members may have their own perceptions and opinions of “Back to Sleep,” but the culture of the hospital should revolve around safety and best practice outcomes. A consistent and accurate message will increase the likelihood of parent compliance after discharge (Dattani et al.; Shaefer et al.).
Neonatal intensive care nurses are in a unique position when it comes to caring for preterm infants. Developmentally appropriate and comfort care is a requirement, especially during the acute stage of illness. The transition of the infant to supine position should be done as soon as medically appropriate. (Aris et al., 2006; Grazel et al., 2010; Raydo & Reu-Donlon, 2005). The timing of the transition has potential to be an area of confusion, as there is no specific national guideline for exactly when this transition should be made. Adding to the confusion, different nurses often have different rationales for readiness to transition to the supine sleep position. Examples of rationales include a specific corrected gestational age, placement in an open crib, or a few days prior to the anticipated discharge date. (Aris et al.; Grazel et al.). Common factors in the delay of supine sleep position are knowledge deficit, fear, and staff opinion. Additionally, a study by Grazel et al. (2010) of AAP recommendations in the NICU revealed that one third of nurses surveyed had recently placed an infant prone because of nonmedical reasons, including fussiness and perceived discomfort. Although positioning aids and rolls are commonly utilized in the NICU, they actually contradict current AAP guidelines. Parents may also assume that since nurses are practicing in a particular manner, what they observe being done in the hospital can also be done at home. (Aris et al.; Grazel et al.; Raydo & Reu-Donlon) The use of soft bedding, containment, boundaries, and prone position are common in the NICU, but wrong messages may easily and inadvertently be passed along to the families that are present. (Grazel et al.). Education concerning safety measures should be ongoing throughout the course of hospitalization in order to clear up any misunderstandings or confusion regarding the topic of best practice.
The content of discharge teaching provided to parents of premature NICU infants is subject to variability among practitioners. Common nursing practice on the topic of safe sleep has not been shown to be predicted or influenced by nurses’ age, educational background, or years of experience, both in general nursing or neonatal intensive care. (Grazel et al., 2010). Interestingly, Grazel and colleagues noted that 85% of nurses could correctly identify current AAP strategies. In a study of NICU discharge teaching, just over half of the nurses recommended exclusively supine sleep position at home. (Aris et al., 2006). This finding, along with inconsistent parent education and role modeling, can easily lead to confusion among caregivers. It is crucial that nurses make the effort to comply with national and hospital guidelines and teach parents about the danger associated with prone and side sleeping position. Because of the fact that former NICU patients are at increased risk for SIDS, discharge teaching is paramount to the success of the “Back to Sleep” campaign. (Aris et al.). In order to increase compliance, using a variety of teaching methods can help to disseminate the safe sleep message more efficiently. This information can be presented in written form, or through the use of audiovisual materials and verbal instructions. Furthermore, reinforcement can be accomplished by the direct actions of nurses, doctors, and other healthcare providers, especially when witnessed by the family firsthand. (Grazel et al.).
Parent Beliefs and Practices
A number of studies have been performed to assess how parents commonly position their infants to sleep after discharge from the hospital. Moon and Omron (2002) have been involved in various studies of the African American population, through the use of both quantitative and qualitative methodology, to investigate what factors determine how and why parents position their infants in a particular fashion. In a study on factors influencing infant sleep position, choice of sleep position did not correlate with the infant’s age, parent’s age, educational background, prenatal visits, or type of insurance. (Moon & Omron). Written information was not found to be effective in positively influencing behavior of this specific population subset, and prone position was more commonly used when a grandparent was present in the home, as well as with the infant’s status of firstborn. (Moon & Omron). Oden et al. (2010) investigated specific factors that influence African American mothers from a variety of socioeconomic backgrounds. In the focus group survey, 57% of mothers had placed their infants in the prone position. The two common themes uncovered during the course of the study were infant comfort and safety. Healthcare provider recommendations influenced the parent’s choice of supine sleep as a SIDS prevention strategy, but side lying position was often chosen as a compromise to exclusive supine and prone position. Parents often chose prone position if the infant appeared to be visibly uncomfortable and/or was having trouble falling or staying asleep. Other influential factors included the parent’s need for improved quality and duration of sleep, as well as general skepticism about the validity of a connection between prone position and increased SIDS risk. This study underscored the importance of the source of information. Family members, friends, Internet websites, books, television, and healthcare provider advice were all mentioned as being an integral part of the decision making process. The researchers drew the conclusion that verbatim citation of medical studies was not an effective means of education in this population. Emphasizing reliable sources of information and tailoring this information to the patient and family circumstance has been shown to be an effective way to increase overall compliance. (Oden et al., 2010). In a qualitative study by Mosley et al. (2007), common themes affecting infant position were fear of choking and discomfort, misunderstood SIDS mechanism of action, and a mother’s inherent maternal instincts. This study noted that educational efforts need to specifically include a clear definition of SIDS, what is known to cause or increase the infant’s risk of SIDS-related death, as well as how and why specific recommendations are proven to be effective in prevention of this phenomenon. This information is vital to the parent’s understanding of how they can contribute to improving overall safety and decreasing or eliminating modifiable risk factors. Also, efforts should be made to educate the community as a whole, especially targeting grandparents since the perceptions of this generation can substantially differ from current recommendations. Mosley noted that tension can develop between African American elders and healthcare experts, thereby contributing to a wide range of potentially conflicting advice given to parents. (Mosley et al.).
Multiple studies emphasized the fact that when healthcare providers advise parents to place the infant in supine sleep position and the parents physically saw the infant placed in an exclusive supine position in the nursery, they were more likely to be compliant and place the infant supine to sleep when at home. (Aris et al., 2006; Colson et al., 2001; Grazel et al., 2010). Parent choice is also affected by their perception of the advice given by the healthcare provider. Goetter and Stepans (2005) mentioned that new mothers are heavily influenced by perceived newborn preference, along with maternal need for adequate sleep. In this population sample of new mothers, a one on one teaching intervention was shown to be effective, but could be increasingly effective if coupled with comprehensive nursing education and written materials to reinforce the message. (Goetter & Stepans).
Educational Interventions
Teaching parents about the importance of the “Back to Sleep” campaign is vital not only to the success of the message, but also in reducing the overall number of SIDS-related deaths during the first year of life. Nurses and other healthcare professionals do not need to wait until discharge to educate parents on the safe sleep topic. In a study by Lahr et al. (2005), education was initiated in the prenatal period and was shown to be successful, primarily in the setting of the state health department. The author hypothesized that greater compliance among those educated in this setting may be related to effective and culturally competent care. (Lahr et al.). In order to educate effectively, the frequency of education and quality of material must be taken into consideration. Interestingly, a study from the AAP looked into the photographic evidence of infant sleep environments found in a wide variety of magazines. The authors found that 64% of infants were depicted in the supine position, with advertisements consistently more compliant with AAP recommendations in their pictures. However, one third of pictures demonstrated an inappropriate environment, and advertisers often used infant comfort as a selling point for their product. (Joyner et al., 2009). Healthcare providers need to be aware of the type of information that is easily accessible to parents, since it can influence their choice of sleep position, regardless of medical advice.
A study by Moon (2004) evaluated the effect of an educational intervention used with African American mothers enrolled in the Women, Infants, and Children (WIC) federal assistance program. Behavior change is a slightly more challenging task in the African American population, and racial disparity can support this conclusion, as it relates to the higher national rates of sleep position noncompliance and SIDS-related deaths. Before the intervention, only 58% of families reported placing the infant supine to sleep. In comparison, 85% planned to use the supine position after receiving the targeted education. The group receiving this education was also more likely to be compliant in the long term. Moon suggests that by increasing knowledge, changing behavior, and empowering patients, parents may be more likely to refrain from the prone sleep position and opt for the widely recommended supine position. (Moon et al).
Literature Summarization
After reviewing the literature available on the topic of “Back to Sleep,” it has become evident that more information is needed in order to increase compliance among healthcare professionals, parents, and caregivers. Although a vast majority of the related studies are correlational or observational studies in methodology, they provide a great deal of insight into the areas that are in need of continued modification. Almost all of the studies agree on the fact that preterm infants and term infants can benefit from the AAP SIDS Task Force recommendations. Gastroesophageal reflux, risk of aspiration, infant comfort, and tradition frequently influence the choice of non-supine sleep position. Parents often receive advice from sources other than medical professionals, and this advice has the potential to directly conflict with current safety recommendations. Nurses, both in the well-baby nursery and neonatal intensive care unit, are in a prime position to intervene with the family prior to discharging an infant to the home environment. Education on the topic should be culturally sensitive, individualized, and relevant.
A significant amount of research has been done with the African American population, spanning across all socioeconomic statuses. While findings from these studies have the potential to be generalized to other population segments, further research is needed for confirmation. There does, however, appear to be enough information to support a practice change in the discharge teaching of parents of preterm infants cared for in the NICU setting, thus supporting the implementation of an evidence-based protocol. Studies explicitly indicate that preterm infants should be placed supine to sleep, but parent compliance after discharge from the NICU remains a constant concern. Specifically, it would be important to evaluate various educational interventions for effectiveness in increasing long term compliance with this particularly vulnerable population. As previously mentioned, former premature infants are at greater risk for SIDS than the typical healthy infant, and health promotion efforts would be beneficial in decreasing the incidence of SIDS-related deaths and increasing healthy outcomes.
Framework
The framework used for this evidence-based project was the Iowa Model of Evidence-Based Practice to Promote Quality Care. (Titler et al., 2001). The Iowa Model is closely aligned with the nursing profession’s goal of providing safe and effective care that is supported by sound research. Scientifically-driven nursing care is justifiable and beneficial to patients. The Iowa Model begins by highlighting a problem present in the healthcare organization that is based upon an inherent problem or lack of knowledge. Once the problem is identified as a priority, a research team can be formed. The first task is to identify the state of the science on that topic and apply knowledge to practice. As per the research findings, ample scientific evidence can justify a small-scale pilot study in which baseline data is collected, guidelines are designed and implemented, and the findings are assessed and modified. If the data is supportive of a practice change, this change can then be introduced. After extensive monitoring and evaluation, data can be circulated to other healthcare professionals. (Titler et al.). This synopsis of the Iowa Model demonstrates the process by which the preterm infant safe sleep discharge education protocol will be developed and implemented in the Newborn/Infant Intensive Care Unit at the Children’s Hospital of Philadelphia. If the protocol is shown to be effective in decreasing the rate of SIDS among preterm infants discharged from the NICU, a large-scale study can then be expanded to other neonatal intensive care units in the Delaware Valley region. (see Appendix A).
Project Objective
The objective of this evidence-based project is to successfully implement a multi-pronged educational intervention to improve discharge teaching on the topic of preterm infant safe sleep and SIDS prevention. The long-term goal is to decrease the rate of SIDS among infants discharged from the NICU at the Children’s Hospital of Philadelphia, as well as the Delaware Valley region. As for the protocol itself, the intention is to raise awareness among healthcare professionals and families about the importance of promoting a safe sleep environment and the potential consequences of disregarding the most current AAP guidelines. The protocol has also been developed so that parents and caregivers can easily model the safe behavior learned at the hospital in the home environment. Additionally, it is expected that nurses and other healthcare professionals will spend an increased amount of time educating families on this particular topic, thereby augmenting their own personal knowledge, as well as imparting a consistent and accurate message to others. For this evidence-based project to be successful in the future, all healthcare professionals are encouraged and expected to comply with the new protocol, while at the same time providing constructive feedback on the protocol’s inherent successes and failures.
Part II: Methods
As previously mentioned, the design used to construct this evidence-based project is the Iowa Model. This model allows for the discharge teaching protocol to be implemented in a linear and sequential manner. Additionally, avenues are available to modify the protocol components throughout this process without needing to discard the entire protocol and begin anew. This new protocol will be assessed in a longitudinal manner because the long-term effects of the discharge teaching are the main focus and inherent reason for implementing the protocol. The following description of the proposed evidence-based protocol will navigate through the Iowa Model concept map and will provide further explanation of its application.
Setting
This project will be conducted at the Children’s Hospital of Philadelphia, an accredited urban teaching hospital with over four hundred beds in the facility. The chosen setting is an appropriate location to implement this protocol because the CHOP Newborn/Infant Intensive Care Unit is expansive, boasting approximately seventy-five beds, and is the top ranked neonatology specialty in the country. CHOP clinical employees are frequently encouraged to utilize the most current research and/or develop new research studies where there is a lack of evidence. If the evidence-based project proves to be a success at CHOP, the protocol will be expanded to other neonatal intensive care units in the Delaware Valley region, which includes Southern New Jersey, Southeastern Pennsylvania, and Delaware.
Population and Sample
The focus of this protocol is on the parents or caregivers of preterm infants who are increasingly at risk for SIDS after being discharged from the NICU. A preterm infant is defined as an infant born at less than thirty-seven weeks gestational age. For this study, extremely low birth weight infants (ELBW) will be included, provided they do not meet the exclusion criteria. ELBW is defined as an infant born at less than 1500 grams. Because of compromised ability to protect the airway, infants with genetic anomalies will be excluded from this study. An example of a genetic anomaly that has an effect on respiratory function is Pierre Robin Syndrome, characterized by a small, recessed jaw. An infant with severe chronic lung disease (CLD) that requires the use of supplemental oxygen and apnea monitor at home must also be excluded from the sample. Severe pulmonary hypertension and bronchopulmonary dysplasia (BPD) spells, characterized by significant apnea, bradycardia, and desaturations, would fall under the CLD category. Congenital heart defects, such as tetralogy of fallot, must also be excluded from the study. Severe or uncontrolled gastroesophageal reflux (GERD) that requires surgical intervention or has resulted in hospital readmission will be excluded as well. In addition, infants with conditions for which supine position is contraindicated, such as a myelomeningocele or sacrococcygeal teratoma (SCT), will be excluded.
This evidence-based project will utilize a convenience sample from the CHOP NICU. The pilot study will be conducted on a small scale, taking advantage of only two of the eight total nursing teams and enrolling participants over two months. Preterm infants identified as being in the convalescent stage of treatment and working towards discharge will be included. After the discharge teaching protocol, these parents will be contacted for a phone survey at one and three months after discharge. Once the full study begins, all eight nursing teams will be involved, initial data collection will take place over four months, and follow-up at one, three, and six months after discharge. It is expected that enrollment, data collection, and follow-up will take one full calendar year to complete.
This project will be presented to the institutional review board at the Children’s Hospital of Philadelphia. The study will be initiated soon after receipt of this approval. In order to practice in an ethical manner, NICU staff and parents will be notified of the impending change in discharge protocol, reasoning behind the change, and significance of their participation, thereby requiring informed consent from the families.
Procedures
Staff Awareness
As previously mentioned, this evidence-based project will take place in the CHOP NICU. Following study approval, healthcare professionals of the NICU will be notified of the change in practice. In order to ensure complete awareness, posters on infant safe sleep, SIDS, and goals of parent education will be placed on the east and west side of the unit. Five to ten minute educational sessions, led by a member of the research committee, will occur in the break room once per shift over one week. Due to the abundance of computers located on the unit, screensavers are an easy way to remind staff about the new discharge teaching protocol.
Education Material & Protocol Development
An interdisciplinary staff will serve as the core committee of this study. To develop the most well-rounded and inclusive protocol, the committee will include one NICU attending doctor, one or two resident doctors, one Level III or IV registered nurse, three staff nurses, one respiratory therapist, one social worker or case manager, and one physical, speech, or occupational therapist. This group will define expectations of the study and create a protocol that satisfies the AAP SIDS Task Force guidelines. This committee will be a resource for questions and concerns about the protocol as it is being implemented. Following the pilot study, the committee will identify areas of concern and develop a more sound and applicable protocol.
One of the main tasks of this committee is to identify the appropriateness and quality of the education materials that are used. The Phase II Questionnaire on Infant Sleep Position developed by Aris et al. will serve as a pre and post-test to assess nurse knowledge and practice will be modified for the CHOP NICU population. A checklist will be used during the verbal discussion session between parents and nurses. The audiovisual component will include a video of five to seven minutes in length, followed by a physical demonstration of correct and incorrect infant positioning. The committee will assess the video in terms of message clarity and content. An observational checklist will be based upon AAP guidelines and CHOP practice standards. A follow-up parent phone survey will be tailored to the information delivered during each portion of the discharge teaching. In addition, members of this committee will contact CHOP Kids First primary care sites in order to educate staff on the commitment to provide a more well-rounded discharge teaching protocol to decrease SIDS and increase compliance. These sites will be involved in infant safe sleep follow-up and reinforcement during routine primary care visits in the first six months after NICU discharge.
Pilot Study
The pilot study will be used to assess the accuracy and effectiveness of the educational intervention in terms of delivery of intended infant safe sleep information and overall rate of compliance. For the purpose of the study, compliance will be defined as placing the infant in supine position for sleep and refraining from prone position unless the infant is awake and supervised. The education phase of the pilot study will take two months. Once the three-month follow-up is completed, data will be analyzed by the committee in order to evaluate the success of the study. Staff feedback will be crucial for long term success and staff support of the protocol.
Only two of the eight nursing teams will be utilized during the pilot study, but the pretest will be administered to all nurses in the NICU at this time. The involved teams will include Team 7, which is the “Neo-Core” premature infant specialty team, and one other medical-surgical team. Nurses will be notified of their involvement in the pilot and will receive detailed instructions from the committee. Following the completion of the pilot, the staff will be solicited for their opinions on the successes and failures of the study.
Evidence-Based Project Protocol Implementation
After the necessary revisions are made to the protocol, the full study will begin. All nursing teams on the unit will be involved and the education phase will last four months. Nurses will utilize the protocol for safe sleep discharge teaching, in combination with regular discharge education for general infant care. Nurses will begin by presenting the parents with written information about SIDS prevention and infant safe sleep from the American Academy of Pediatrics. After the parents have reviewed the written material, the video will be shown in its entirety. Following the video, the parents and nurses will engage in a discussion session. Nurses will be given a list of talking points to include during this session. The intent of oral discussion is to create an open forum where parents can ask questions related to SIDS and infant positioning as well as demonstrate their knowledge and understanding. The parents will be asked to physically demonstrate how to position their infant for sleep while under supervision of the nurse. It is the nurse’s responsibility to ensure that the parents have adequately absorbed the material that has been presented in each prong of the protocol. During the education phase, the nurses will be observed in order to evaluate how well they are following the new protocol. The observers will include one or two nurses per each NICU nursing team per shift. These nurses will have a checklist of staff behavior during this process. In addition, these nurses will serve as liaisons to the core committee and will be educated as advanced users of the protocol.
Following NICU discharge, the parents will receive a phone call to assess compliance at one, three, and six months. They will be questioned on how the infant has been recently positioned for sleep and rationale for this choice. If the parents are identified as being non-compliant with the “Back to Sleep” campaign, the nurse will take this opportunity to provide simple reinforcement. The staff at primary care sites will be encouraged to take the time to briefly provide “Back to Sleep” education at each visit. Kids First sites will present posters and pamphlets in the waiting rooms, thus providing further access to the information. The core committee will evaluate survey results as the information becomes available, with a final assessment and data analysis performed at the completion of the study.
If this protocol is shown to be an effective way of increasing infant supine sleep position, the protocol will be further expanded to include other neonatal intensive care units in the Delaware Valley region. Results of the study will be disseminated to these sites, and CHOP will serve as a resource for protocol implementation. Finalized results will be presented at various neonatal conferences, as well as DVANN chapter meetings. The Delaware Valley Association of Neonatal Nurses (DVANN) is a local chapter of the National Association of Neonatal Nurses (NANN).The involvement of DVANN will be invaluable to the success of protocol expansion.
Instruments
Pretest/Posttest & Observational Checklist
Aris et al. (2006) developed a questionnaire for a study designed to assess NICU nurses’ knowledge of correct infant sleep position. The questionnaire consists of questions focused on correct sleep position for both term and preterm infants and further probes for rationale for that selection. Practice habits of nurses and the presence of a hospital policy and written guidelines for infant safe sleep are also included. The end of the questionnaire presents a multiple choice question about relevant future education needs, such as positioning recommendations, SIDS statistics, and physiologic effects of positioning. Questions about co-bedding were removed from this questionnaire as they are not a variable of concern for this particular evidence-based project. Demographic data, consisting of nursing education and years of experience conclude this questionnaire. The questionnaire will be modified and applied to this project as the pretest-posttest nurse survey. (see Appendix B). The same questions, primarily multiple-choice, will be used for both pretest and posttest data collection times to examine the effectiveness of the teaching materials. A limitation of using the same survey for the pretest and posttest is reactivity, meaning the subjects alter their behavior because they are aware of being judged, but the benefits of using a reliable questionnaire outweigh the risk of developing an untested questionnaire. (Polit & Beck, 2007) Aris et al. (2006) revised their initial questionnaire, consisting of “Back to Sleep” guidelines and clinical experience information. The original survey was adjusted to incorporate more opportunities to examine rationale, as well as expand existing questions to become more clear, precise, and comprehensive. A panel of three neonatologists, three advance practice nurses, three NICU nurses, and a sociologist with a comprehensive understanding of SIDS evaluated the survey one question at a time as well as in its completed form. This tool was evaluated for its reliability, validity, comprehensiveness, and applicability properties. The thoroughness of this process explicitly indicates content and construct validity, in that each question was assessed by the expert panel in terms of relevance and applicability to SIDS-prevention and infant safe sleep. The questionnaire is measuring actual infant sleep practices and nursing behaviors in that context, thus allowing the researcher to determine the rate of compliance with the AAP and CHOP guidelines. (Aris et al.). Compliance is the concept of interest in this study. After seeking written approval from the author to use the questionnaire for this study, it will be distributed to all CHOP NICU nurses at the start of the pilot study and again at the completion of data collection. The AAP SIDS prevention guidelines and CHOP clinical practice guidelines were also used to formulate an observational checklist to observe nursing behaviors and practices. (see Appendix C). The use of a third party to observe discharge teaching will be used to measure nurses’ adherence to the protocol in the practice setting and can identify if the protocol is user-friendly, meaning easy to understand and apply to the discharge education process. Two nurses from each of the eight nursing teams per shift will be selected to become proficient in the evidence-based project objectives, thus being qualified to observe the practice of other nurses. Although it would be ideal to use a trained research assistant to observe nursing behavior, it is more feasible to privately select nurses from each nursing team. Volunteers will be asked to attend a short training seminar prior to the start of the pilot study in order to learn the intricacies of the project, “Back to Sleep” guidelines, and expectations for observation encounters. The limitation with observation is observer bias and reactivity, but relying on self-report may not give a good indication of what is actually happening in the clinical setting. Interrater reliability can be achieved by having two observers witness the nurse who is performing the discharge education with the family. It is a rare event to have two discharges at the same time on the same nursing team, therefore making it possible to have two observers available for the event. The two nurses can then compare checklist findings to confirm consensus on the observed behavior. The reliability and validity of this tool will be further tested during the pilot study and material adjusted appropriately. The tool does, however, include trustworthy and accurate information from the American Academy of Pediatrics (AAP) and CHOP standards of practice, thus demonstrating content validity. (Polit & Beck, 2007).
Verbal Discussion Tip Sheet
A verbal discussion checklist was developed exclusively for this evidence-based project, based upon the AAP SIDS Task Force guidelines and the CHOP infant sleep environment clinical guidelines. (see Appendix D). The intention of this checklist is to provide nurses with a list of important topics to talk about with parents or caregivers. The objective of the verbal discussion checklist is to standardize the information shared with all parents without being too restrictive. The goal is to facilitate nurses’ ability to conduct an infant safe sleep discussion in a manner that is tailored to the family’s specific needs. The information presented on the tip sheet is based upon reliable sources of infant safe sleep material, including the AAP guidelines, “Back to Sleep” campaign components, and CHOP practice guidelines. The tool has a high degree of content validity at baseline, and further reliability and validity testing will take place during the pilot study through the use of item analysis.
Follow-up Phone Call
A follow-up phone call will be conducted, with the content and structure of the information guided by the follow-up intervention phone calls by Moon et al. (2004). In Moon’s study, parents completed a written questionnaire based on intended behaviors for infant positioning, and a follow-up telephone survey was performed after the educational intervention. The study resembles the same basic principles used in the development of this evidence-based project. (Moon et al.) As with the pretest-posttest questionnaire, written permission will be obtained from Moon et al. in order to legally adapt the intervention to this project. Parents will be asked about recommended infant sleep position, as well as their personal behaviors and practices at home. It would be beneficial to ask the parent or caregiver’s opinion on the perceived impact and benefit of the education protocol used in the NICU. Likert Scale questions are included at the end of the survey to obtain self-report data on parent opinion of the education protocol, along with an open-ended question for clarification of that selection. Given this information, it can be better determined if the protocol achieved its intended purpose, which is promoting long-term compliance with the “Back to Sleep” campaign and a comprehensive understanding of the benefits of infant supine sleep. (see Appendix E).
Treatment of Data
Analysis will be performed by the core committee members, and data generated in this project will be analyzed primarily through the use of descriptive statistics. The level of measurement used for this project is nominal as it pertains to the description of the population and demographic data. This subset of demographic data will include the gender and age of the parents, gender and age of the infant, education level, and infant health status. Nurse education, background, and years of experience will also be collected in this study. The results of the pretest-posttest and follow-up parent phone survey can also be defined by a nominal level of measurement as it relates to their responses to the infant safe sleep survey questions. These questions are not designed to rank items along a spectrum, but rather to divide the participant’s behavior among predefined choice of infant sleep position. To further specify, nurses will be observed and evaluated using the criteria that they are either compliant or non-compliant with protocol implementation. A percentage frequency distribution will be used to analyze the demographic and survey data in order to gain a clearer understanding of what the data represents. Given the nature of this study, chi-square will be used for statistical analysis. Chi square is relevant to this study in that the goal is to discover the percentage of participants who fall into the two previously described compliance categories. A determination of compliance is applicable for both the nurses participating in the discharge education process as well as parents in their behavior following discharge. Observed versus expected frequency of behavior will be calculated to determine if the discharge education protocol is statistically significant among the two group. The accepted level of significance for this study is defined as a p value of less than 0.05. Data analysis will reveal if the protocol is effective among the population being studied and feasible to implement on a long-term basis. (Polit & Beck, 2007).
Ethical Implication & Protection of Human Subjects
Human subjects are clearly a vital component of this project. A thorough description of the protocol will be disseminated to staff prior to the initiation of the pilot study and staff pretest. No identifying data will be collected during the observation phase, only an indication of nursing team and time of day. Names will not be collected from healthcare professionals or families in order to protect all participants. Parents will be educated on the reasoning behind the change in protocol, along with how their participation and cooperation will be integral in successful data generation, analysis, and circulation. In addition, they will need to consent to the measures used to follow-up on compliance after discharge. The research team will possess vital information, in terms of phone numbers and addresses, and this information will be protected in accordance with HIPPA guidelines. All information will be password protected and strictly used by the members who are contacting families for the actual follow-up phone survey.
The final product of this evidence-based project will ideally be a more thorough and consistent message of infant safe sleep imparted to parents and caregivers prior to and following discharge from the NICU. A decrease in SIDS and increase in infant safe sleep compliance is the ultimate goal. Infant safety is the definitive motive behind the entire process of development, testing, and implementation of this education protocol. The success of the protocol can promote widespread safe practice behavior among the vulnerable preterm infant population as it extends beyond the walls of the Children’s Hospital of Philadelphia.
References
Ariagno, R. L., Mirmiran, M., Adams, M. M., Saporito, A. G., Dubin, A. M., & Baldwin, R. B. (2003). Effect of position on sleep, heart rate variability, and QT interval in preterm infants at 1 and 3 months’ corrected age. Pediatrics, 111(3), 622-625.
Aris, C., Stevens, T. P., LeMura, C., Lipke, B., McMullen, S., Côté-Arsenault, D., & Consenstein, L. (2006). NICU nurses’ knowledge and discharge teaching related to infant sleep position and risk of SIDS. Advances in Neonatal Care (Elsevier Science), 6(5), 281-294.
American Academy of Pediatrics (2005). The changing concept of sudden infant death syndrome: Diagnostic coding shifts, controversies regarding the sleeping environment, and new variables to consider in reducing risk. Pediatrics, 116(5), 1245-1255.
Colson, E. R., Bergman, D. M., Shapiro, E., & Leventhal, J. H. (2001). Position for newborn sleep: Associations with parents’ perceptions of their nursery experience. Birth: Issues in Perinatal Care, 28(4), 249-253.
Dattani, N., Bhat, R., Rafferty, G. F., Hannam, S., & Greenough, A. (2011). Survey of sleeping position recommendations for prematurely born infants. European Journal of Pediatrics, 170(2), 229-232.
Goetter, M. C., & Stepans, M. (2005). First-time mothers’ selection of infant supine sleep positioning. Journal of Perinatal Education, 14(4), 16-23.
Grazel, R., Phalen, A., & Polomano, R. (2010). Implementation of the American Academy of Pediatrics recommendations to reduce sudden infant death syndrome risk in neonatal intensive care units. Advances in Neonatal Care, 10(6), 332-342.
Joyner, B., Gill-Bailey, C., & Moon, R. Y. (2009). Infant sleep environments depicted in magazines targeted to women of childbearing age. Pediatrics, 124(3), 416-422.
Lahr, M. B., Rosenberg, K. D., & Lapidus, J. A. (2005). Health departments do it better: Prenatal care site and prone infant sleep position. Maternal & Child Health Journal, 9(2), 165-172.
Levy, J., Habib, R., Liptsen, E., Singh, R., Kahn, D., Steele, A., & Courtney, S. (2006). Prone versus supine positioning in the well preterm infant: Effects on work of breathing and breathing patterns. Pediatric Pulmonology, 41, 754-758.
Moon, R. Y., Oden, R. P., & Grady, K. C. (2004). Back to sleep: An educational intervention with women, infants, and children program clients. Pediatrics, 113(3), 542-547.
Moon, R. Y., & Omron, R. (2002). Determinants of infant sleep position in an urban population. Clinical Pediatrics, 41(8), 569-573.
Mosley, J., Stokes, S., & Ulmer, A. (2007). Infant sleep position: Discerning knowledge from practice. American Journal of Health Behavior, 31(6), 573-582.
National Institute of Child Health and Human Development (2010) Back to sleep public education campaign. Retrieved February 11, 2011, from http://www.nichd.nih.gov/sids/sids.cfm.
Oden, R. P., Joyner, B. L., Ajao, T. I., & Moon, R. Y. (2010). Factors influencing African American mothers’ decisions about sleep position: A qualitative study. Journal of the National Medical Association, 102(10), 870-2, 875-80.
Polit, D.F. & Beck, C.T. (2007). Nursing Research: Generating and Assessing Evidence for Nursing Practice. 8th edition. Philadelphia: Lippincott Williams & Wilkins.
Raydo, L., & Reu-Donlon, C. (2005). Putting babies “back to sleep”: Can we do better? Neonatal Network, 24(6), 9-16.
Shaefer, S. J., Herman, S. E., Frank, S. J., Adkins, M., & Terhaar, M. (2010). Translating infant safe sleep evidence into nursing practice. Journal of Obstetric, Gynecologic, and Neonatal Nursing : JOGNN / NAACOG, 39(6), 618-626.
Titler, M.G., Kleiber, C., Steelman, V., Rakel, B., Budreau, G., Everett, L.Q., Buckwalter, K.C., Tripp-Reimer, T., & Goode C. (2001).The Iowa Model of Evidence-Based Practice to Promote Quality Care. Critical Care Nursing Clinics of North America, 13(4), 497-509.
Appendix A
Iowa Model
Appendix B
Back To Sleep Education Protocol
Nursing Pretest/Posttest
Please select the best sleep position for premature infants:
Prone
Supine
Side or supine
Side
All positions
Prone or side
If you selected prone, please select any of the following reasons (may choose more than 1)
Improved oxygenation
Feeding intolerance
Comfort of breathing
Developmental (upper body tone, comfort, organization, sleep better)
Less apnea and bradycardia
Airway patency
Other
If you selected a position other than prone, please give rationale:
Typical sleep position(s) of premature infants in the NICU
Prone
Supine
Side
All positions
Supine or side
Prone until close to discharge
Prone or side
When should premature infants begin to sleep supine? (may choose more than one)
Anytime with proper positioning
Never
Between 34 to 36 weeks
After 37 weeks
When placed in open crib, maintaining temperature
When good head control is developed
When weight reaches 1800 grams
Other
Typical sleep position of term infants in NICU
Prone until stable
Supine or side
All positions
Side
Prone or side
Supine
Should term infants be placed prone for sleep in certain cases?
Yes
No
If answered yes to question 7, choose any of the following reasons:
Reflux
Upper airway anomalies that cause obstruction in prone position
Irritability/inconsolability
Neurologic impairment (e.g. hypotonia)
Respiratory distress
Spinal defects
While awake and observed for developmental purposes
Other
Which of the following most closely resemble the instructions that you give to parents about infant sleep position after discharge?
Always place infant to sleep on back
Back or side for sleep
Whatever position the infant is most comfortable sleeping is best
Side with positioning rolls
Please list any other instructions regarding infant positioning or sleep environment not listed above.
Does your unit have a policy on infant sleep positioning?
Yes
No
Don’t know
Do you use written discharge instructions that include instructions for infant sleep positioning on your unit?
Yes
No
If answered yes, do they include specific instructions for sleep positioning of premature infants?
Yes
No
Would you be interested in learning more about any of the topics mentioned in this survey?
Yes
No
Don’t know
If answered yes, please select from the following list of topics:
Indications for positioning term infants prone
Recommendations for elevating head of bed
Recommendations for positioning of premature infants
SIDS statistics since “Back to Sleep” campaign
Developmental effects of positioning
When to place premature infants supine for sleep
Physiologic effects of prone positioning in neonates
Premature versus term positioning
Current recommendations for sleep positioning of infants
Current findings supporting the current recommendations
All topics mentioned on questionnaire
Other
Nursing education/degree(s)
Associates
Bachelors
Doctorate
Diploma
Masters
Other
Years of nursing experience:
Years of NICU nursing experience:
(Aris et al., 2006)
Appendix C
Back To Sleep Education Protocol
Observational Checklist
Time: __________ AM/PM
Please select your location: NIC- A B C D F
Please place a checkmark for observed behaviors.
Video
RN introduced the video and explained its purpose.
RN provided a quiet, uninterrupted environment for the parents to watch the video.
RN answered any questions immediately following the video.
Written Information
RN distributed AAP safe sleep guidelines to the family.
“The Safe Sleep Top 10” (National Institute of Child Health and Human Development)
“A Parents’ Guide to Safe Sleep” (American Academy of Pediatrics)
CHOP Patient-Family Education sheet- Infant Sleep Environment
RN encouraged parents to read through all of the information.
RN asked if parents could comprehend information.
RN answered any questions after the parents reviewed the materials.
Verbal Discussion
RN encouraged parents to ask questions or verbalize concerns.
RN applied the “Verbal Discussion Tip Sheet” to the discussion.
RN elaborated on the “Verbal Discussion Tip Sheet” items.
RN asked parents to physically demonstrate correct infant sleep position.
RN provided constructive feedback and demonstrated correct position as necessary.
RN distributed contact information for further assistance following NICU discharge.
(AAP, 2005)
Appendix D
Back To Sleep Education Protocol
Verbal Discussion Tip Sheet
Please include the following AAP Guidelines in your discharge instructions.
Back to sleep during naps and nighttime sleep
Firm sleep surface
Single fitted sheet on crib
No toys or soft objects in crib- including blankets, pillows, soft bedding
“Tummy Time” while awake
Avoid smoking
Avoid letting baby get too hot- overheating
Keep baby’s sleep area separate
Offer pacifier before sleep
No commercial SIDS-prevention devices or positioning devices
Gradual removal of devices used during the baby’s NICU stay
Cannot send home devices used in the NICU- gel pillow, Snuggle-Up, Bendy-Bumper, Freddy-the-Frog, pillow rolls
Boppy pillow can only be used for breastfeeding or when baby is awake
(AAP, 2005)
Appendix E
Back To Sleep Education Protocol
Follow-up Phone Survey
Time: _______ AM/PM
Please ask the following questions over the phone:
Infant age and gender: ______
Parent/Caregiver age and gender: ______
Parent/Caregiver education level: _____________
Infant health status: (gestational age, health problems, reasons for prolonged hospitalization, etc.)
____________________________________________________________________________________________________________________________________________________________
Infant usual sleep position: Back Prone Back/Side Side
Previous night sleep position: Back Prone Back/Side Side
Previous nap sleep position: Back Prone Back/Side Side
Reason for sleep position: Family/Friend Suggestion Infant Comfort Previous Experience Vomiting/Choking SIDS Healthcare Professional Suggestion/Education Other
What is the AAP recommendation for infant sleep position?: Back Prone Back/Side Side Unknown
Does sleeping on the belly increase the risk of SIDS?: No Doubtful Unsure Possibly Definitely
Your first-choice sleep position: Back Prone Back/Side Side
Choice of sleep position affected by CHOP NICU safe sleep education?: Strongly Agree Agree Undecided Disagree Strongly Disagree
Why? __________________________________________________________________
(AAP, 2005; Moon et al., 2004)
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