Chyi Et Al 2023 Independent Impact of Eat Sleep Console Assessment On Neonatal Opioid Withdrawal
Chyi Et Al 2023 Independent Impact of Eat Sleep Console Assessment On Neonatal Opioid Withdrawal
research-article2023
CPJXXX10.1177/00099228231204448Clinical PediatricsChyi et al
Article
Clinical Pediatrics
Abstract
Compared with the Finnegan Neonatal Abstinence Scoring System (FNASS), the Eat, Sleep, Console (ESC) approach
reduces pharmacotherapy and length of stay (LOS) for neonatal opioid withdrawal syndrome (NOWS) infants. The
independent outcome contribution of ESC is unknown as the approach combines ESC assessment with additional
management changes. Our objective was to evaluate ESC assessment’s independent impact on outcomes compared
with FNASS. We conducted a retrospective cohort study of in utero opioid-exposed infants ≥35 weeks gestation
managed with FNASS versus ESC. Outcomes included pharmacotherapy initiation, LOS, length of pharmacotherapy,
and emergency department visit/readmissions. Among 151 FNASS and 100 ESC managed infants, pharmacotherapy
initiation (P = .47), LOS for all infants (P = .49), and LOS for pharmacologically treated infants (P = .68) were
similar. Length of pharmacotherapy did not differ (P = .84). Emergency department evaluation/NOWS readmission
was equally rare (P = .65). Using equivalent models of care, comparison of ESC and FNASS assessment tools
showed no difference in NOWS outcomes.
Keywords
neonatal opioid withdrawal, Finnegan score, Finnegan neonatal abstinence, Eat, Sleep, Console
Figure 1. Regional neonatal opioid withdrawal syndrome management guideline for FNASS and ESC cohort.
implementation in pediatric and neonatal intensive care Except for the assessment tool, the NOWS manage-
units (NICU), including a recent cluster-randomized ment guideline across all 6 sites was unchanged over
controlled trial, showed significant decreases in pharma- the study period. This regional guideline included pre-
cotherapy initiation and LOS as well.11-19 natal consults, nonpharmacologic care optimization, a
In all prior publications, ESC assessment was standardized methadone initiation, escalation and
always one component of a larger NOWS model of weaning protocol,21 clonidine adjunctive therapy,
care change including increasing nonpharmacologic breakthrough morphine, and standardized discharge
care, converting to as-needed morphine, or changing criteria (Figure 1).
admission to inpatient pediatrics.9,11-20 It is unclear
whether the ESC approach was successful because of
Study Population
the ESC assessment tool itself, additional care compo-
nents, or a combination. From April 2018 to December 2019, infants at risk for
Our objective was to evaluate whether a change to NOWS from opioid exposure during the month preced-
the ESC assessment tool alone could safely reduce ini- ing delivery were evaluated by FNASS. To achieve
tiation of pharmacotherapy and decrease LOS compared score reliability, nurses completed the Finnegan
with FNASS. Interrater Reliability Program. Infants were admitted to
the mother baby unit where parents, family caregivers,
and nurses optimized nonpharmacologic care by room-
Methods ing-in, minimizing environmental stimuli, responding
early to infant hunger and irritability cues, and using
Study Design
comforting techniques. Mothers receiving opioids
We used a retrospective cohort design to compare out- through a treatment program were encouraged to breast-
comes of in utero opioid-exposed infants from the same feed. The FNASS assessment was done every 3 to 4
centers managed using ESC (February 2020 to August hours following feeding. Opioid replacement therapy
2021) versus FNASS assessment (April 2018 to criteria included 2 FNASS scores >10 or a single score
December 2019). >14 despite nonpharmacologic care optimization. In 5
study sites, infants needing pharmacotherapy transferred
to the NICU. In one site, infants needing pharmacother-
Study Setting apy transferred to a private pediatric unit room.
This study was conducted in the 2 level III NICUs and From February 2020 to August 2021, infants at risk
4 level II NICUs with the highest NOWS incidence for NOWS were evaluated by ESC assessment. Staff
within our regional health care system. All 6 NICUs at all centers completed the same ESC training mod-
have an open-bay design preventing rooming-in at the ule. Following birth, these infants roomed-in on the
bedside. mother baby unit with parents and nurses optimizing
Chyi et al 1099
nonpharmacologic care. The ESC assessment was identified from feeding documentation in the electronic
done every 3 to 4 hours following feeding. After ESC, medical record.26-28 We used the neighborhood depriva-
an FNASS assessment was also completed but not tion index (NDI) as a measure of socioeconomic status.
used to guide management. If an infant could not eat, The NDI measures aspects of poverty proven to be
sleep, or console on 2 occasions despite nonpharmaco- markers for health outcomes. Higher NDI indicates
logic care optimization, they transferred for metha- higher deprivation/lower neighborhood socioeconomic
done management to the same NICU/Pediatric unit as status.29 Additional factors that could affect LOS such as
in the FNASS period. delivery mode, gestational age (GA), small for gesta-
All infants born at ≥35 weeks gestation at the 6 study tional age (SGA<10%), sex, and facility were obtained
centers from April 2018 to August 2021 were screened from our regional health system databases.
for eligibility. We included infants at risk for NOWS
who had FNASS or ESC assessments for withdrawal.
We defined “at risk for NOWS” as those infants with in
Study Outcomes
utero opioid exposure as verified by pharmacy records, The primary outcomes assessed were pharmacotherapy
urine drug screen (UDS) results, and/or chart review. initiation and LOS among in utero opioid-exposed
Our network pharmacies provide members with nearly infants. Initiation of pharmacotherapy included any
all their prescriptions.22 Maternal opioid prescriptions infant administered methadone for NOWS. The total
dispensed from pregnancy onset until infant delivery LOS of the birth hospitalization in all locations (mother
were extracted from pharmacy records. As many opioid baby unit, NICU, and Pediatrics) was determined. For
use disorder medication programs occur outside our mothers with nonprescribed opioid or polysubstance
health care system, methadone or buprenorphine treat- abuse, a full psychosocial evaluation is performed to
ment was confirmed by chart review. All maternal and establish if a Child Protective Services referral is
infant UDS results were obtained from our regional required. Child Protective Services determination of
health system databases. We perform universal UDS custody/disposition can prolong hospital stay beyond
during the first trimester with additional maternal UDS the medically necessary observation or treatment period.
performed if the initial screen is positive or if there is The LOS was calculated from when the infant was med-
suspected substance abuse. Our regional guidelines rec- ically ready for discharge as determined by chart review.
ommend infant testing if maternal testing is unavailable We included LOT as a secondary outcome. The LOT
or if the infant displays drug exposure or withdrawal was calculated as the total days that the infant received
symptoms. Infant testing reduced nonresponse bias methadone, adjunct clonidine, breakthrough morphine, or
resulting from mothers who refused UDS or had no pre- phenobarbital treatment. Due to concern that using a
natal care. We performed chart review for hospital function-based assessment could lead to premature dis-
administered opioids to avoid misclassification of posi- charge, we examined the balancing measure of emer-
tive maternal or infant UDS from opioids received dur- gency department (ED) visits/readmissions. We identified
ing labor. Ninety-two percent of women in our study had all ED visits/readmissions within 30 days of hospital dis-
at least one UDS. The FNASS or ESC evaluation was charge and performed chart review to determine whether
identified from inpatient nursing flowsheets. We NOWS was the encounter indication.
excluded infants <35 weeks gestation as they are all
admitted to the NICU after birth in our centers and with-
drawal presentation is more variable at younger gesta-
Data Analysis
tions. Infants transferred from/to a nonstudy site were Sample size was determined by including all infants
also excluded. meeting study eligibility during the study period.
We ascertained factors affecting NOWS incidence Baseline characteristics of infants managed using
and severity.23-25 From outpatient pharmacy records and/ ESC or FNASS assessment were compared using t tests
or maternal and infant UDS, we determined the type of for continuous variables and chi-square tests for cate-
maternal opioid and additional maternal exposures, gorical variables. We compared pharmacotherapy initia-
including alcohol, selective serotonin reuptake inhibi- tion by chi-square test. For skewed LOS and LOT data,
tors, benzodiazepines, marijuana, cocaine, and metham- we performed the Wilcoxon rank sum test. We evaluated
phetamines/amphetamines. We conducted chart review ED visits/readmissions by Fisher exact test.
to verify nicotine exposure and to confirm the additional Comparing ESC with FNASS assessment, we used
substance exposures above. As breastfeeding reduces logistic regression to estimate the adjusted odds ratio of
NOWS incidence and length of treatment (LOT), any pharmacotherapy initiation and ED visits/readmissions
breastfeeding during the birth hospitalization was and log-gamma regression for LOS and LOT.30 Given
1100 Clinical Pediatrics 63(8)
Ethical Considerations
Our regional institutional review board approved this
study. This study was performed in accordance with the
Declaration of Helsinki.
Results
From April 2018 to August 2021, 50 324 infants were
born at ≥35 weeks at the study hospitals (Figure 2).
We excluded one infant due to non-NOWS-related
medical acuity requiring a morphine infusion and
another infant due to mixed use of FNASS and ESC
assessments. Among those evaluated for withdrawal,
we identified in utero opioid exposure in 251 infants (5
per 1000); 151 were evaluated by FNASS and 100 by
ESC assessment.
The FNASS and ESC groups were similar in terms of
sex, GA, birthweight, infant race/ethnicity, and delivery
mode (Table 1). The FNASS infants were more likely to
be SGA (11.9% vs 4%, P = .03). The type of in utero
opioid exposure was comparable between groups apart
from higher fentanyl use during the ESC period (7% vs
0%, P = .001). Individual substance co-exposure to tet-
rahydrocannabinol, cocaine, methamphetamines, ben-
zodiazepines, alcohol, or nicotine was the same among
FNASS and ESC infants. Maternal selective serotonin Figure 2. Flowchart for FNASS and ESC cohort selection.
reuptake inhibitor use was more common in the ESC
group (28% vs 14.6%, P = .01). The overall substance
co-exposure rate was greater in the ESC period (75% vs buprenorphine-exposed subgroup, pharmacotherapy
62%, P = .03). The 2 groups had equally high breast- initiation was also the same (FNASS 17.6% vs ESC
feeding rates. They were also similar regarding socio- 22.5%, P = .5). For infants exposed to short-acting opi-
economic indicators such as insurance payor and NDI. oids, 10.7% of FNASS and 13% of ESC (P = .69)
Child Protective Services assigned custody to other fam- received pharmacotherapy. Median LOS for all in utero
ily members or foster care in 11.9% and 14% of FNASS opioid-exposed infants was 3.4 (interquartile range
and ESC infants, respectively (P = .63). [IQR] 3-5.3) and 3.7 (IQR 3-5.5) days (P = .49) for
There was no difference in pharmacotherapy initia- FNASS and ESC groups, respectively. Among infants
tion between the FNASS and ESC groups (14.6% vs receiving methadone treatment, median LOS was com-
18%, P = .47) (Table 2). For the methadone- or parable between FNASS 14.4 days (IQR 12-20.2) and
Chyi et al 1101
Abbreviations: ESC, Eat, Sleep, Console; FNASS, Finnegan Neonatal Abstinence Scoring System; IQR, interquartile range; SSRI, selective
serotonin reuptake inhibitor; THC, tetrahydrocannabinol; UDS, urine drug screen; CI, confidence interval.
a
Hydrocodone/acetaminophen, oxycodone/acetaminophen, acetaminophen/codeine, oxycodone, morphine sulfate extended release,
hydromorphone.
b
Standard urine drug screen does not detect methadone or buprenorphine.
c
Opioid plus THC, cocaine, methamphetamine/amphetamine, benzodiazepine, alcohol, nicotine, or SSRI exposure.
ESC 14.1 days (IQR 12.6-14.7) (P = .68). Median LOT Comparing infants managed with ESC versus FNASS
was similar between FNASS 9 days (IQR 8-15) and assessment, the unadjusted odds of receiving pharmaco-
ESC groups 9.5 days (IQR 9-10) (P = .84). The ED therapy were odds ratio (OR) = 1.29, 95% confidence
visits/hospital readmissions for NOWS indications interval (CI) = 0.65-2.55, P = .47 (Table 3). Following
demonstrated no significant difference: FNASS 1.3% adjustment, the odds of receiving pharmacotherapy
and ESC 2% (P = .65). were no different between groups (adjusted odds ratio
1102 Clinical Pediatrics 63(8)
Abbreviations: ESC, Eat, Sleep, Console; FNASS, Finnegan Neonatal Abstinence Scoring System; IQR, interquartile range; LOS, length of stay;
NOWS, neonatal opioid withdrawal syndrome.
NOWS outcome Unadjusted (95% CI) P value Adjusted (95% CI) P value
Initiation of pharmacotherapy OR 1.29 (0.65-2.55) .47 aORa 0.85 (0.34-2.1) .72
LOS all opioid-exposed infants ROM 1.00 (0.83-1.2) .97 aROMb 0.92 (0.78-1.08) .3
LOS opioid-treated infants ROM 0.86 (0.65-1.14) .28 aROMc 0.87 (0.74-1.01) .07
Length of treatment ROM 0.84 (0.6-1.18) .31 aROMb 0.91 (0.71-1.16) .42
Emergency department visit/Readmission for NOWS OR 0.96 (0.36-2.56) .93 aORd 0.9 (0.35-2.34) .83
Abbreviations: aOR, adjusted odds ratio; CI, confidence interval; ESC, eat, sleep, console; LOS, length of stay; NOWS, neonatal opioid
withdrawal syndrome; OR, odds ratio; ROM: ratio of means.
a
Adjusted odds ratio (logistic model). Adjusted for type of maternal opioid, gestational age, small for gestational age, maternal SSRI,
benzodiazepine, alcohol, nicotine, insurance, cesarean delivery, and facility.
b
Adjusted ratio of means (log-gamma model). Adjusted for type of maternal opioid, gestational age, small for gestational age, maternal SSRI,
benzodiazepine, alcohol, nicotine, insurance, cesarean delivery, and facility.
c
Adjusted ratio of means (log-gamma model). Adjusted for type of maternal opioid, gestational age, small for gestational age, maternal SSRI,
benzodiazepine, nicotine, insurance, cesarean delivery, and facility.
d
Adjusted odds ratio (logistic model). Adjusted for type of maternal opioid, gestational age, maternal SSRI, benzodiazepine, nicotine, insurance,
and cesarean delivery.
[aOR] = 0.85, 95% CI = 0.34-2.1, P = .72). Among all component of a new ESC approach resulted in
opioid-exposed infants, the mean LOS was the same for decreased pharmacotherapy initiation and LOS.9,11-19 A
FNASS and ESC groups by log-gamma regression potential reason for the differing results is that ESC
(ROM = 1.00, 95% CI = 0.83-1.20, P = .97). In multi- assessment in these studies was always accompanied
variable models, the mean LOS was also similar between by other substantial NOWS management changes.
groups (aROM = 0.92, 95% CI = 0.78-1.08, P = .3). Pharmacotherapy initiation may have been impacted
The unadjusted LOS (ROM = 0.86, 95% CI = 0.65- by nonpharmacologic care optimization9,11,14-17 or
1.14, P = .28) and adjusted LOS (aROM = 0.87, 95% admission to the pediatric ward instead of NICU.9,13 A
CI = 0.74-1.01, P = .07) with ESC trended toward decrease in time to medical readiness for discharge, as
shorter stays for infants receiving methadone. Both LOT seen in the recent randomized controlled trial, may
(ROM = 0.84, 95% CI = 0.60-1.18, P = .31) and have resulted from significant increases in nonpharma-
adjusted LOT (aROM = 0.91, 95% CI = 0.71-1.16, P = cologic interventions such as breastfeeding, potential
.42) were comparable among ESC and FNASS groups. location of care changes, or implementation of a strict
The probability of ED visit/readmission for NOWS ESC study protocol compared with usual care which
(aOR = 0.9, 95% CI = 0.35-2.34, P = .83) did not may have lacked NOWS management standardiza-
increase with ESC. tion.19 In addition, LOT in prior studies was likely
affected by switching from a prolonged opioid taper to
as-needed morphine9,12,14-17 or shifting from scheduled
Discussion morphine to methadone.11 This implementation of mul-
For infants at risk for NOWS, our study showed similar tiple practice changes makes it difficult to identify
initiation of pharmacotherapy, LOS, and LOT using whether previously reported improvements resulted
FNASS versus ESC assessment. These results contrast from ESC assessment itself or other care model
with prior publications where ESC assessment as one changes.
Chyi et al 1103
Baseline opioid treatment rates for NOWS in these versus 16 in the treated FNASS and ESC groups
publications ranged from 31% to 98%. Our baseline (P = .97). In addition, nursing completion of the
treatment rate was substantially lower at 14.6%. During Finnegan interobserver reliability program may have
our study period, the only new intervention was the reduced inconsistent high scores and contributed to our
change in withdrawal assessment tool. Adherence to the low baseline opioid treatment rate. The improvement in
same model of care with emphasis on nonpharmaco- pharmacotherapy initiation seen in the recent random-
logic interventions allowed us to evaluate the indepen- ized controlled trial may be partly attributable to a
dent impact of ESC assessment. The approximately change from usual care with unknown Finnegan score
15% requiring opioid treatment may represent infants reliability and higher baseline treatment rates (45%-
with severe NOWS that cannot be managed with non- 61%) to the ESC approach with required inter-rater reli-
pharmacologic measures alone, regardless of the assess- ability training.19
ment tool used. This theory is supported by all prior ESC The similar LOS among infants managed with
implementation studies where pharmacotherapy rates FNASS versus ESC assessment was likely multifacto-
following introduction of the ESC approach did not go rial. The main driver of LOS is pharmacotherapy initia-
below a level of 14%.9,11-19 Our data highlight that ESC tion. Since ESC did not decrease initiation of
assessment may not be as vital to the ESC approach as pharmacotherapy, we did not see a consequent decline in
standardized practice or nonpharmacologic care. In our LOS attributable to infants who avoided opioid treat-
population where both these elements were already ment. In addition, ESC implementation did not reduce
maximized, we reached a low baseline treatment rate LOT which would have resulted in a shorter LOS. Most
with FNASS and saw no additional improvement with pharmacologically treated infants received the mini-
ESC assessment. The heterogeneity of treatment effect mum 8-day methadone taper in both the FNASS and
reported in the recent New England Journal of Medicine ESC groups which left little opportunity for ESC to sig-
study,19 where some centers also saw no improvement in nificantly reduce LOT. Previous studies changed from a
outcomes, suggests factors other than ESC assessment standardized taper to as-needed morphine which may
itself play an important role in predicting success of the have shortened LOT and/or LOS in conjunction with
ESC approach. In centers with higher medication treat- ESC.9,12,14-17
ment rates, the ESC approach may reduce pharmaco- Prior ESC publications were before and after quality
therapy primarily from standardization of NOWS improvement evaluations which usually did not adjust
management protocols, including better nonpharmaco- for differences in maternal and infant characteristics
logic care adherence. between the 2 time periods. One strength of our study is
Our lower baseline pharmacotherapy rate may be that we adjusted for differences in case mix as well as
partially attributable to our patient population. While potential confounders in our analyses evaluating the
previous publications report 87% to 100% public insur- effect of ESC assessment on NOWS outcomes. Our
ance,9,12,15-17,20 our study population primarily had com- closed hospital and clinic system and integrated elec-
mercial insurance (51%). Most of our mothers had tronic medical records allowed for more complete ascer-
prenatal care and were in a treatment program or receiv- tainment of maternal pregnancy data, including
ing chronic pain medications. In addition, our Early prescription history, type of opioid exposure, and sub-
Start Program provides one-on-one substance use disor- stance co-exposures. Our integrated health care system
der support during pregnancy which destigmatizes opi- combined with higher patient commercial insurance
oid usage, engages maternal involvement early in coverage also allowed for better determination of ED
pregnancy, and sets delivery expectations.31 The seam- visits/readmissions.
less integration between early start, prenatal care, and Another study strength is that we examined NOWS
delivery helps us to maximize nonpharmacologic care. outcomes following a single change from FNASS to
Our FNASS protocol may have likewise impacted ESC assessment. In previous studies, ESC assessment
medication initiation. The conventional treatment was always bundled with other major NOWS manage-
threshold in many centers is 3 scores ≥8 or 2 scores ment changes making it difficult to discern which ele-
≥12 despite lack of research validating these treatment ment of the quality improvement bundle was driving
thresholds.32 Our treatment threshold of 2 scores >10 change.
may have led to less treatment than centers using a cut- Our study was limited in its ability to detect small
off of 8 but more than centers using a cutoff of 12. The differences in outcomes between FNASS and ESC
difference in treatment is likely small as the maximum groups. To see a significant difference in medication
FNASS score (median) was 7 and 6 in the untreated treatment, however, all of the next 133 ESC patients
FNASS and ESC groups, respectively (P = .46), and 15 would need to completely avoid pharmacotherapy.
1104 Clinical Pediatrics 63(8)
Another study limitation is that ESC implementation EMW and SL: designed the data collection instruments, col-
occurred during the COVID era which prohibited post- lected and analyzed the data, and critically reviewed and
maternal discharge boarding and restricted additional revised the manuscript.
family/friend visitation. This visitor restriction pre- All authors approved the final manuscript as submitted and
agree to be accountable for all aspects of the work.
vented caregiver ability to optimize nonpharmacologic
care which may have impacted NOWS outcomes. A
final limitation was that we could not measure the non- Declaration of Conflicting Interests
pharmacologic interventions to assure equivalence The author(s) declared no potential conflicts of interest with
between the 2 periods. respect to the research, authorship, and/or publication of this
article.
Conclusion Funding
Our results suggest the impact of ESC or FNASS on The author(s) disclosed receipt of the following financial sup-
NOWS outcomes lies in a standardized model of care port for the research, authorship, and/or publication of this
and not in the assessment tool itself. The ESC assess- article: This study was supported by The Permanente Medical
ment alone did not reduce pharmacotherapy or shorten Group Delivery Science Research Grant. The funder/sponsor
did not participate in the work.
LOS compared with FNASS. Eat, sleep, console also
did not lead to increased ED visits/readmissions in the
immediate newborn period. With ESC assessment, with- ORCID iD
drawal symptoms themselves are not an indication for Lisa J. Chyi https://orcid.org/0000-0001-8357-9115
pharmacologic treatment unless they interfere with a
baby’s function. It is unknown whether less aggressive References
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