Outpatient Therapy for Neonatal Abstinence Syndrome and Healthcare Utilization AcademyHealth ARM Pediatric Health Services Research Interest Group June 24, 2017 Stephen W. Patrick, MD, MPH, MS @stephenwpatrick @stephenwpatrick
Stephen Patrick has no conflicts of interest to disclose. All medications to treat neonatal abstinence syndrome are off label. @stephenwpatrick
Opioids • Prescriptions grew 4-fold over last decade • In 2012, enough OPR were prescribed to give every adult in the US one prescription • Rising deaths from heroin and synthetic opioids • More deaths than car accidents Source: Centers for Disease Control and Prevention @stephenwpatrick
Neonatal Abstinence Syndrome • A withdrawal syndrome experienced by drug exposed newborns after birth • Generally follows opioid exposure, though other drugs have been implicated • Signs include irritability, increased tone, tremors, poor feeding, seizures • Length of stay for NAS requiring pharmacotherapy – national mean 23 days @stephenwpatrick
Incidence of NAS in the US, 2000-2012 7.0 NAS per 1000 Hospital 6.0 5.0 Births 4.0 3.0 2.0 1.0 0.0 2000 2003 2006 2009 2010 2011 2012 Patrick SW, et. al. Neonatal Abstinence Syndrome and Associated Healthcare Expenditures – United States, 2000-2009. JAMA . 2012 May 9;307(18):1934-40. Patrick SW, Davis MM, Lehman CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol . 2015 Aug;35(8):650-5 @stephenwpatrick
Treatment • Setting/environment (mom/baby together, breastfeeding) • Severe NAS requires treatment with an opioid (e.g., morphine or methadone) • Recent focus on reducing length of stay – Discharge home on medication weans, common in some settings (40% in a recent study) • Limited data on post-discharge outcomes Patrick SW, Schumacher RE, Horbar JD, Buss-Frank ME, Morrow KA, Ferrelli KR, Picarillo AP, Gupta M, Soll RF. Improving Care for Infants with Neonatal @stephenwpatrick Abstinence Syndrome. Pediatrics. 2016 May;137(5).
Objectives • Compare length of therapy between patients treated as inpatient alone and patients treated as a combination of inpatient and outpatient therapy • Compare healthcare utilization patterns between both groups @stephenwpatrick
Methods • Tennessee Medicaid administrative data, vital records data, prescription data (2009-2011) • Study population: NAS treated with medication – Chart review for all NAS patients • Outcomes: – Length of therapy (LOT) – Length of stay (LOS) – 6-month ED visits and hospital readmissions @stephenwpatrick
Methods • Inclusion criteria – Patients with NAS treated with medication – >35 weeks GA • Exclusion criteria – Diagnosis of seizure at any time – Iatrogenic NAS • Ordinal logistic regression model used for ED and hospitalization counts @stephenwpatrick
Patients meeting inclusion criteria n = 736 NAS not requiring NAS treated with medication treatment n = 532 n = 204 Inpatient treatment Inpatient and only Outpatient treatment n = 290 n = 242 @stephenwpatrick
Inpatient treatment only Inpatient and outpatient treatment p-value n = 290 n = 242 Maternal Characteristics Maternal age (years) 26 26 0.41 Maternal race, n (%) 0.72 White 283 (98) 234 (97) Maternal education, n (%) 0.44 Less than High School 90 (31) 67 (28) High School 117 (41) 111 (46) More than High School 80 (28) 61 (26) Infant Characteristics Gestational age (week) 39 39 0.22 Birth weight (gram) 2902 3002 0.04 Sex, n (%) 0.70 Female 133 (46) 107 (44)
Results Inpatient and outpatient Inpatient treatment only treatment p-value Infant Characteristics n = 290 n = 242 Region of Tennessee <0.001 n (%) n (%) East 196 (68) 217 (90) Middle 69 (24) 16 (7) West 24 (8) 9 (4) • Medication used outpatient: – Phenobarbital 82%, Methadone 9%, Both 7% @stephenwpatrick
Differences in LOS and LOT @stephenwpatrick
Post-Discharge Utilization Patterns 25% 1 2 3 4 20% 15% 10% 5% 0% Inpatient only Inpatient + Outpatient Inpatient only Inpatient + Outpatient ED Visits (6 Months) Readmissions (6 Months) @stephenwpatrick
Utilization Patterns: Inpatient Treatment versus Outpatient Weans ED� count� � 30� days� ED� count� 6� months� Hospitaliza ons� 30� days� Hospitaliza ons� 6� months� 0� 0.5� 1� 1.5� 2� 2.5� 3� 3.5� 4� 4.5� 5� 5.5� 6� Adjusted� Odds� Ra o� *� *Adjusted for birth weight and region @stephenwpatrick
Discussion • Outpatient weans associated with – Longer lengths of treatment – Higher number of emergency department visits • Patient characteristics similar between groups, vast geographic differences – Suggest hospital/regional level reasoning for outpatient weans as opposed to patient characteristics • Phenobarbital – Widespread apoptotic neurodegeneration in rat brains – Lower passive avoidance performance suggesting impaired learning and/or recall – RCT, phenobarbital vs placebo for febrile seizures, IQ 8.4 lower in phenobarbital group at 2 years Bittigau et al. PNAS . 2002 Gutherz et al. Epilepsy & Behavior . 2014 Farwell et al. NEJM. 1990 @stephenwpatrick
Limitations • Potential for misclassification bias using administrative data – Mitigated by chart review • Generalizability beyond Tennessee • Not direct observation of medication administration @stephenwpatrick
Implications • Policies and innovations to reduce NAS length of stay, should be mindful of potential post-discharge implications • Focus on inpatient inefficiencies • Post-discharge support • Metrics that are not solely hospital/provider centric • Additional study needed – Innovations in inpatient care – Long-term outcomes @stephenwpatrick
Acknowledgements • Co-authors: – Faouzi I. Maalouf, MD – William O. Cooper, MD, MPH – J. Chris Slaughter, DrPH – Judith Dudley, BS • NIDA K23DA038720 @stephenwpatrick
LOS and LOT Calculation Inpatient treatment only LOS Observation Observation Inpatient pharmacotherapy (2 days) (2 days) LOT Inpatient and outpatient treatment LOS Observation Outpatient pharmacotherapy Inpatient pharmacotherapy (3 days) (length of prescription) LOT @stephenwpatrick
Infant Characteristics Inpatient treatment only Inpatient and outpatient p-value n = 290 treatment n = 242 Region of Tennessee, n (%) <0.001 East 196 (68) 217 (90) Middle 69 (24) 16 (7) West 24 (8) 9 (4) West Tennessee Middle Tennessee East Tennessee p-value Discharged home on 9 (27) 16 (19) 217 (53) <0.001 medications, n (%) @stephenwpatrick
Results • Patients receiving outpatient therapy were more likely to have a greater number of ED visits within 6 months of discharge (aOR 1.52, 95% CI 1.06-2.17) • No significant increase in hospital admissions within 6 months of discharge (aOR 2.00, 95% CI 0.78-2.85) *Adjusted for birth weight and region @stephenwpatrick
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