Opioid abuse has been an increasing issue in the United States since the late 1990s. In 2015, the US Drug Enforcement Administration released a statement classifying the level of opioid abuse as an epidemic and a direct threat to public health. As opioid use has continued to spike, the number of neonates exposed in utero has increased following the same trend. Newborns who experience an immediate discontinuation of opioids that were received in utero are at risk for developing neonatal abstinence syndrome (NAS).1–3 Neonatal abstinence syndrome consists of a spectrum of signs and withdrawal symptoms, which include neurological (eg, tremors, high-pitched, excessive crying, and seizures), gastrointestinal (eg, diarrhea, vomiting, and excessive sucking), and autonomic manifestations (eg, fever, sweating, and tachypnea). Some degree of these clinically recognizable signs is present in 60% to 80% of opioid-exposed newborns.1,2,4 The severity of the withdrawal can depend on the amount and purity of the drug used, the length of use by the mother, and the drug metabolism of both the mother and the newborn.2 The incidence of NAS has increased significantly from 2002 to 2012, with the number of newborns being diagnosed with NAS rising from 1.2 per 1000 live births to 5.6 per 1000 live births.5–7 The growing rates have resulted in more newborns being treated pharmacologically, increased mortality rates, increased number of days spent in the hospital, and higher hospital expenses.5,8 Increased rates of NAS have been reported among all ethnicities and communities.1
The most common tool used to assess NAS in the United States is the Finnegan Neonatal Abstinence Scale (FNASS), which was developed in 1975.5,9 The FNASS assigns points to the 21 most common neonatal opioid withdrawal symptoms based on perceived severity. Newborns who show a score of 7 or less on the scale are not treated with medication, while newborns with a score of 8 or higher are treated pharmacologically.6,8 The FNASS is used by 95% of institutions to determine whether a newborn should receive pharmacological treatment.6 Although the scale is widely used and accepted, its validity and reliability are not well established.10 In addition, the FNASS requires initial and repetitive trainings to obtain reliability among healthcare staff leading some institutions to modify the tool to improve accuracy and ease of use.11 Several studies indicate that this approach has led to unnecessary opioid treatment among NAS newborns, causing a longer hospitalization.6,12 Long length of stay (LOS) paired with a nonwelcoming environment (minimal space at the infant's bedside and staff's judgmental attitude) makes it easier for the family not to come, visit, and participate in the care of their infant.13 The Eat, Sleep, Console model gives the family both place and purpose within the neonatal intensive care unit (NICU) environment and creates a working relationship with staff. By using strategies to maximize nonpharmacologic interventions and involving family more, the need for postnatal opioid treatment and LOS can be significantly reduced.6,12
EAT, SLEEP, CONSOLE
In 2017, Grossman and colleagues6 developed a new program to manage NAS based upon the newborn's ability to function. This program is known as the Eat, Sleep, Console (ESC) approach. Eat, Sleep, Console assesses critical functions of a newborn such as eating and sleeping. Interruption in these functions indicates that the infant is unable to perform activities of daily living and is having withdrawal symptoms that require pharmacological intervention. If these functions are not interrupted by NAS symptoms, the newborn does not receive pharmacologic interventions even when FNASS scores are elevated to 8 or more. To quantify ESC, the following guidelines were used as evaluative criteria:
- Eat—The newborn should eat an appropriate amount based on days of age. For the 1- to 2-day-old, this may be less than an ounce per feeding. For 3 days old or greater, this should be 1 or more ounce(s) per feed. Breastfeeding quality should be “good” as defined by the mother and nursing staff assessment.
- Sleep—The newborn should be able to sleep undisturbed for a minimum of 1 hour. Holding the newborn to support an undisturbed sleep period is often necessary.
- Console—Determine whether the newborn can be consoled within 10 minutes. If not, nonpharmacologic interventions should be increased including a second caregiver making attempts to console the newborn. If the newborn remains inconsolable, this would be an indication that the newborn may need pharmacologic treatment and the medical team should be notified.
Although the FNASS is used by a vast majority of institutions in the United States and provides a detailed list of symptoms associated with NAS, it can be complex and does not assess how the symptoms affect the newborn's functionality.6,10 The ESC's focus on the newborn's functionality greatly simplifies the assessment of NAS symptoms. The ESC has been shown to decrease the use of postnatal opioids in the treatment of NAS.6,10 The purpose of this evidenced-based practice brief was to summarize and critically review emerging research on the ESC method of managing NAS and develop a recommendation for implementing an ESC model.
CLINICAL QUESTION AND SEARCH STRATEGY
A literature review was done to answer the following clinical question, “Does management of neonates with NAS using ESC decrease hospital LOS and decrease the need for pharmacologic treatment?” PubMed and Cochrane library databases were searched as well as Google Scholar for original research articles, randomized controlled trials, descriptive studies, and retrospective chart reviews with the following search terms: neonates and NAS, neonatal abstinence syndrome; Eat, Sleep, Console; and nonpharmacologic management of NAS. In addition, the American Academy of Pediatrics (AAP) Web site was searched for their most recent position statement to look for the current standard of practice guidelines. The original search produced more than 20 articles, but only 3 met inclusion criteria providing specific details on ESC.
EBP BRIEF FINDINGS
Because of the increased incidence of opioid-exposed infants in the last 10 years, the AAP has developed a statement for recognition and treatment. The AAPs' current position statement recognizes that the pathophysiology of NAS is not well understood. The AAP reports that clinical presentation of NAS varies widely and that commonly used NAS scoring systems are subject to significant interobserver variability. The AAP's recommendation for the treatment of NAS states that nonpharmacologic management should be the first line of treatment for all newborns with NAS.1Table 1 summarizes the findings and implications of the 3 studies included in this EBP review.
TABLE 1. -
Research on Eat
, and Console
|Grossman et al 20187
||Implementation of several PDSA cycles from 2010 to 2015 that focused on standardizing nonpharmacologic treatment coupled with (1) involving parents in treating their infant, (2) infants were cared for on a pediatric unit, (3) development of a novel approach to assessing NAS, and (4) using morphine on an as-needed basis.
N = 287
|Average length of stay decreased from 22.4 to 5.9 d.
Pharmacologic treatment with morphine decreased from 98% to 14%.
Costs decreased from $44,824 to $10,289 per patient.
|Provides evidence that length of stay and costs are significantly reduced by (1) sending an empowering message to the parents, (2) training staff that nonpharmacologic interventions are equivalent to pharmacologic treatment, and (3) developing a novel tool that simplifies NAS assessment and management.
The long-term impact on these infants and our healthcare system is yet to be studied.
|Wachman et al 20185
||Utilized stakeholder interviews and PDSA cycles. Compared pre- and postintervention on NAS outcomes after a Q1 initiative that included: A nonpharmacologic care bundle, function-based assessments consisting of symptom prioritization, use of early version of ESC, or a switch to methadone for pharmacologic treatment.
||Opioid-exposed infants ≥36 wk
N = 240
|Decreases were found in:
• Pharmacological treatment from 87.1% to 40.6%
• Adjunctive agent use from 33.6% to 2.4%
• Hospitalization rates down from 17.4 to 11.3 d
• Opioid treatment days from 16.2 to 12.7 d
|Provides evidence that models of care that promote parental engagement and other nonpharmacological care measures should be implemented in hospitals to improve NAS outcomes. Also implicates a need for the current NAS assessment tool to be reevaluated and that function-based approaches should be considered.
|Grossman et al 201814
||All subjects were managed using the ESC method. FNASS scores were simultaneously collected every 4-6 h. Treatments using the ESC approach were compared with what treatment decisions would have been selected on the basis of the FNASS scores.
||Opioid-exposed infants at the Yale New Haven Children's Hospital
N = 50
|Six infants (12%) were treated with morphine using the ESC approach compared with 31 infants (62%) who would have been treated with morphine using the FNASS approach.
There were no readmissions or adverse effects reported.
|Provides evidence that the ESC method shows decrease in opioid-exposed infants being treated with morphine. Reevaluating the FNASS system should be considered in the management of NAS.
Abbreviations: ESC, Eat, Sleep, Console; FNASS, Finnegan Neonatal Abstinence Scale; NAS, neonatal abstinence syndrome; PDSA, Plan-Do-Study-Act.
Grossman et al6 were the first to publish the concept of ESC. A quality improvement team looked at several interventions in a Plan-Do-Study-Act cycle over a 6-year period at Yale New Haven Children's Hospital. The preintervention group consisted of newborns treated with scheduled morphine every 3 hours on the basis of elevated FNASS scores (ie, 3 scores ≥8 or 2 scores ≥12 to initiate treatment) cared for in the NICU or on a pediatric unit. There were 4 areas of intervention consisting of (1) nonpharmacologic interventions, (2) simplified assessment of newborns, (3) decreased use of morphine, and (4) communication between units. Nonpharmacologic interventions included several components. Prenatal counseling was completed with parents as well as sending an empowering message to parents that “we want you to be involved in your child's treatment.” Newborns were placed in a low stimulation environment and staff completed training in techniques shown to be effective nonpharmacologic interventions in the management of infants with NAS. The simplified assessment consisted of changing management on the basis of the newborn's ability to eat, sleep, and be consoled. Decreased use of morphine was defined as weaning by 10% up to 3 times a day and dosing given only as needed once scheduled dosing was discontinued. Communication between the units involved a pediatric unit, the well-baby nursery, and the NICU working together to identify newborns with NAS quickly and begin parental involvement using ESC when newborns showed symptoms of NAS. A total number of 50 infants were included in this retrospective study. By implementing the 4 intervention groups in Plan-Do-Study-Act cycles, average LOS was reduced from 22.4 to 5.9 days and the number of newborns treated with morphine decreased from 98% to 14% (P < .001). An additional finding was that cost of hospitalization decreased by $34,535 per patient. There were no reported readmissions within 30 days related to NAS. This study shows significant decreases in LOS and cost without any noted adverse short-term outcomes. However, there are no data on long-term neurodevelopmental outcomes or growth and development of newborns affected by NAS, which is a significant limitation.
Wachman et al5 conducted a similar Plan-Do-Study-Act quality improvement project at Boston Medical Center with 240 opioid-exposed newborns. The preintervention group consisted of newborns with NAS assessed using the FNASS between April 2015 and April 2016. These newborns were started on pharmacologic treatment when scores were 8 or more twice or 12 or more once. Implementation phases occurred between May and December of 2016. Cycle 1 consisted of implementing a nonpharmacologic care bundle, initiating prenatal/parental messaging to review expectations, and prioritization of Finnegan symptoms. This prioritization was defined as conducting a team huddle when a newborn's FNASS scores were 8 or more twice or 12 or more once. The huddle consisted of the resident physician/attending or NP, the nurse, and the parent when available. Symptoms would be assessed, and the team would intervene only if there was 1 or more of the following: poor feeding, excessive vomiting/diarrhea, poor sleep, and/or poor consolability. The initial intervention was to increase nonpharmacologic measures, followed by pharmacologic treatment if needed. Cycle 2 involved staff education on programs implementing similar NAS interventions (specifically ESC), and changing the first line of pharmacologic treatment from morphine to methadone. Cycle 3 incorporated using function-based ESC assessments and launching a comprehensive cuddler volunteer program. The results included a decrease in LOS from 17.4 to 11.6 days and a decrease in pharmacologic treatment from 87.1% to 40%. There were also statistically significant findings in caregiver presence (55.6% pre- vs 79.9% postintervention) and decreased adjunctive medication use in the treatment of NAS (33.6% pre- vs 2.4% postintervention). This retrospective review also did not report any findings on long-term behavioral or neurodevelopmental outcomes, which is a limitation.
More recently, Grossman et al14 retrospectively reviewed charts on 50 newborns managed with an early version of ESC between March 2014 and August 2015. These newborns were cared for in the well newborn nursery and on the general inpatient pediatric unit. Early nonpharmacologic interventions were optimized including parent involvement and rooming-in. If a newborn did not eat well (≥1 oz per feed or breastfeed well), sleep 1 hour or more undisturbed, or could not be consoled within 10 minutes, nonpharmacologic interventions were escalated. If the newborn was still having difficulty, morphine at 0.05 mg/kg was started every 3 hours. Weaning occurred by 0.04 mg/kg for newborns considered well managed by ESC assessment. Simultaneous FNASS scores were obtained but did not affect the decision to administer morphine. The results revealed that only 12% of newborns received morphine using the ESC assessment tool compared with 62% who would have received it if managed using FNASS scores. Length of stay would have been 10 days longer for 25 newborns if traditional pharmacologic treatment was implemented where a newborn's morphine is weaned 10% each day. This study did not report any long-term neurodevelopmental outcomes.
These 3 retrospective studies/quality improvement projects show consistently significant decreases in LOS and subsequent cost of hospitalization for an infant experiencing NAS. With decreased LOS, infants are transitioning to home environments sooner and thus able to work on normal infant developmental tasks such as sleep-wake patterns, tummy time, and quiet-alert interactions with caregivers. There was also decreased use of postnatal pharmacologic treatment in the management of NAS across all 3 articles. The lack of long-term behavioral and neurodevelopmental outcomes is a major limitation in all 3 articles. However, this is not an unexpected finding as there currently are little to no data on long-term outcomes in substance-exposed newborns experiencing NAS. Confounding factors such as environment, postnatal opioid administration, and socioeconomic circumstances often limit our ability to distinguish which components contribute directly to long-term neurodevelopmental outcomes in this population. The authors of this EBP brief recognize that developmental outcomes in infants should be the priority in measuring success in any management approach to NAS. However, given the generalized lack of research regarding long-term neurodevelopmental outcomes, secondary measures including LOS and postnatal pharmacologic treatment persist as primary measures to guide the recommendations for practice.
RECOMMENDATIONS FOR PRACTICE
As the opioid epidemic has continuously increased since 2009 and was identified as a national issue by the president of the United States in March of 2018, research and treatment of NAS have received more attention. Of that emerging research, ESC is 1 modality that has shown to significantly reduce postnatal opioid use for the management of NAS and decrease LOS by as much as 73%. The financial savings to the healthcare industry could be substantial as a majority of newborns with NAS are insured by Medicaid.7
Successful implementation of ESC into hospital units takes time and education, as it is a radical change for many healthcare providers familiar with the age-old approach of giving newborns medication to manage their “suffering” from withdrawal. Units considering a change to ESC can start by identifying where these families and newborns will be cared for. Will it be the mother–baby unit, the NICU, the pediatric unit, or a combination of these? The location is crucial with a private room preferable where families can be comfortable for a number of days, have a private bathroom, and possibly a television for relaxation during downtime. The goal is to make families want to be present with their infant as opposed to anywhere else. Once the units are identified, a 3-step implementation process occurs simultaneously: identification of a point of contact, development of a core NAS work group, and community outreach. Figure 1 outlines the process for implementing ESC.
Identification of a Point of Contact
Identifying a point of contact or a process for meeting expectant mothers simplifies the process of navigating the healthcare system. It also gives expectant mothers the opportunity to understand how their newborn may be impacted by NAS, how NAS is managed, and how they themselves can be part of the treatment. One point of contact is preferred as the women develop an ongoing relationship with this person and may be more likely to continue prenatal care. The point of contact can be someone with specialized training in NAS and ESC. It is preferable to have a background in social work as many women with substance use disorder have concurrent social issues that a social worker is best equipped to handle. If your institution elects to utilize a process rather than an individual, the expectant mothers are scheduled for a consultation with the physician group that will be managing the newborn. For example, a consultation with neonatology can be done by a neonatologist or a neonatal nurse practitioner. During the consultation, the discussion will include information about signs and symptoms of NAS, expected incidence and timing of withdrawal, management of NAS including ESC, and the expectations that the mother/family be present around the clock. The hospital team will partner with the mother and her family to care for her newborn.
Development of a Core NAS Work Group
Development of a multidisciplinary core NAS group, led by several champions, should be used to lead the transformation to ESC. This core group should consist of representatives from all disciplines and will be responsible for researching and developing guidelines to support and guide staff in the management of these newborns. The ESC guidelines are outlined in the research, but there are often physical differences in locations and/or staffing that may require slight modifications to the general principle of ESC. Sending several core members to learn from an institution that has successfully implemented ESC is one recommended strategy. This allows experiential learning for the learners to foster the transition to ESC. In addition, each one of these families comes with a different background and will have unique needs. Modifying the environment and care provided to meet individual health equity needs will increase success for these families.
After a core team is identified, the next step is gathering input from hospital staff on beliefs related to care of NAS newborns and families. This can be done in the form of an anonymous questionnaire as it allows staff to give honest opinions and feedback without being judged. It is crucial to understand potential barriers prior to implementation, and a questionnaire is one way to identify these barriers. Once results from the questionnaire are received, an educational plan should be developed and implemented by the core team for all staff caring for newborns using ESC. The educational plan should include the following: (1) previous management of NAS, (2) rationale for change to ESC, (3) program details of ESC, (4) education on addiction, (5) education on partnering with families in a nonjudgmental manner, (6) nonpharmacologic interventions to utilize in calming the newborn (eg, The 5 S's of Soothing baby by Harvey Karp15), (7) criteria for discharge, and (8) how to handle difficult situations (eg, when a family continues illicit use). Education will take the majority of the time needed to prepare your hospital for the transition to ESC.
Meeting and speaking with local medication-assisted treatment facilities create relationships that allow for improved communication and continuity of care. One example is when a mother is several days postdelivery, her methadone dose may be too high due to her newly decreased circulating blood volume. This can manifest as a mother that is lethargic and unable to care for her newborn. Having the ability and contact person to speak with at the medication-assisted treatment center and ask him or her to assess the appropriateness of the mother's dose can change the course of events for this family. By having the mother's medication dose adjusted, she may be more able to care for her newborn. Communication with the department of child safety or the department of child family services is another key player in the safety of the newborn and the success of these families. Given that LOS is significantly decreased, facilitation of much-needed family resources and/or nurse visits should be scheduled prior to discharge. The department of child safety can often assist with this and need to know that the newborns are going home much earlier than previous newborns managed for NAS.
When the aforementioned steps have been completed, the team will be ready to care for newborns using ESC. With the first several patients and families, it is advisable that your NAS champions and core team assume the majority of the medical, nursing, and communication tasks enabling early identification of any processes that require further refining. In addition, it is ideal to have multiple assessments on how the newborn is eating, sleeping, and consoling when first transitioning to ESC. Once care is delivered successfully to several patients, all staff should participate in care of these newborns and families with core NAS staff providing support. Ongoing education, evaluation, and quality improvement should be continued as with any new healthcare intervention. Celebrations of these families should be held just as any NICU graduate party celebration is held, as these families should be recognized for the challenges they have overcome.
Implications for Research
Although ESC is a relatively new modality for managing NAS, significant decreases in LOS and pharmacologic treatment indicate that ESC is superior for assessing and managing NAS as compared with FNASS and regularly scheduled opioid dosing. Because of the degree of repetitive training needed for FNASS interrater reliability, flawed or subjective assessment by the scorer can result in medical management decisions based on potentially inaccurate scores. The ESC simplifies assessment and looks at newborn functions as the primary measure, which minimizes the subjective component. The ESC also uses as-needed opioid dosing when newborns exceed parameters but does not commit them to an extended course of treatment based on one rough period. Additional research on ESC will continue to prove beneficial due to the relatively new implementation and quantity of current original research articles. Research on neurodevelopmental and behavioral long-term outcomes is lacking on all newborns with NAS, despite methods of assessment and treatment. This may be due to stigma, as mothers believe that their children are normal and avoid developmental follow-up appointments because of fear of discovering problems. It could also be due to several factors including judgment by staff at follow-up clinics, transportation issues, social barriers, communication, or loss of follow-up due to placement with department of child safety. Whatever the reason, this area of research requires reviewing the different methods of assessing and managing NAS. In addition, research on adverse outcomes (hospital readmissions, abuse, neglect, etc) is limited and should be studied to ensure that implementation of ESC is equivalent, if not better, to outcomes from infants with NAS who are treated with a primarily pharmacological approach.
The authors of this article thank the families that entrusted and partnered with them in providing care for their infants. The authors also thank the Family Centered NAS Core team at Banner UMC Tucson, Joy Subrin, LMSW; Alan Bedrick, MD; Susan Hadley, MD; Lisa Stephens; and the team of NICU nurses, mother–baby nurses, neonatal nurse practitioners, social workers, occupational therapists, physical therapists, dieticians, pharmacists, chaplains, and neonatologists who provide top-quality care in a nonjudgmental manner to all of our NICU families.
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