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Regionalization of Perinatal Care: US Experience


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International conference «Actual approaches to the extremely preterm babies: International experience and Ukrainian realities» (Kyiv, Ukraine, March 5-6, 2013)

International conference «Actual approaches to the extremely preterm babies: International experience and Ukrainian realities» (Kyiv, Ukraine, March 5-6, 2013)

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  • 1. Regionalization of Perinatal Care: US Experience The International Neonatology Conference March 5-6, 2013 Kiev, Ukraine Ann R Stark, MD Professor of Pediatrics Vanderbilt University Nashville, Tennessee, USA
  • 2. US Infant, Neonatal, Postneonatal Mortality Rates 1940-2006Neonatal mortality: deaths < 28 days decreased from28.8 to 4.5 per 1000 live births (85%); 4.04 in 2011 MMWR 2008; 57(14):377
  • 3. Causes of Infant Death in US 2011Causes (8 of top 10) %Congenital malformations, deformations, 20.8chromosomal abnormalitiesDisorders related to short gestation and low BW 17.2Newborn affected by pregnancy complications 6.6Newborn affected by complications of placenta, 4.1cord and membranesBacterial sepsis of newborn 2.2Respiratory distress of newborn 2.1Diseases of the circulatory system 2.1Neonatal hemorrhage 1.9Preliminary data Hamilton BE. Pediatrics 2013 ePub Feb 11
  • 4. History of Regionalization in the US• 1976 March of Dimes Committee on Perinatal Health wrote Toward Improving the Outcome of Pregnancy (TIOP I) - defined 3 levels of care in context of a regionalized system – Refer high-risk patients to centers with appropriate resources and personnel – Most Level III NICUs at academic centers• 1993 TIOP II: Designations changed to Basic, Specialty, Subspecialty with expanded criteria• 1997, 2002 Guidelines for Perinatal Care retained Basic, Specialty, and Subspecialty definitions
  • 5. Problems with Previous Definitions and Their Applications• Definitions were too broad to define services at an institution• Perinatal classification (birth hospitals) did not account for freestanding children’s hospitals• Many states do not have specific regulations defining levels of care; in those that do, many do not enforce them• Many institutions designate a level of care for themselves
  • 6. History - continued• 2004 American Academy of Pediatrics Committee on Fetus and Newborn developed a policy statement on Levels of Neonatal Care• General principles – Newborns have a gradation of risk based on gestational age and severity of illness – Definitions should be based on the capabilities of a neonatal unit to provide care appropriate for the level of risk
  • 7. Levels of Neonatal Care• General principles – continued – Each newborn should be delivered and cared for in a facility most appropriate for his or her needs – Further definitions of facility level should include requirements for equipment, personnel, ancillary services, training, and organization (including transport) AAP Committee on Fetus and Newborn. Levels of Neonatal Care 2004
  • 8. Deregionalization of Neonatal Intensive Care• 15 year retrospective study of data from US metropolitan areas 1980-1995 Increase (%) Births 18 Hospitals with NICU beds 99 Neonatologists 268 Occupancy rates of NICUs 3 Howell EM. Am J Public Health 2002; 92:119
  • 9. Neonatal Special Care Beds versus Births US 1987-2008 Special care beds 89.2% Births 14.6%Source: Goodman DC N Engl J Med 2002;346:1538; 2009 AHA Survey
  • 10. TIOP III: Regionalization Is Critical To Improved Perinatal Outcomes• Organizes a coordinated continuum of perinatal services within a geographic area• Increases survival of high risk newborns• Concentrates relatively rare cases at a few locations• Centralizes expensive technologies• Provides opportunities for clinical teams to develop expertise Toward Improving the Outcome of Pregnancy III, March of Dimes 2010
  • 11. Preterm Infant Mortality is Increased by Birth Outside of Level III Hospital• Review of 41 US and non-US studies from 1976 to 2010 – 104,944 very low birthweight infants• Risk of death is greater for infants born outside of level III hospitals – VLBW (< 1500 g) infants (37 studies)(38 vs 23%) • OR 1.62, 95% CI 1.44-1.83 – ELBW (< 1000 g) infants (4 studies) • OR 1.64 95% CI 1.14-2.36 – Very Preterm (≤32 weeks) infants (4 studies) • OR 1.55, 95% CI 1.21, 1.98• No changes over 30 year period Lasswell S. JAMA 2010; 304:992
  • 12. Extremely Low Birth Weight Mortality is Increased by Birth Outside Level III Hospital (59 vs 32%) Overall 1.80 Lasswell S. JAMA 2010;304:992
  • 13. Major Morbidity is Higher in Outborn Infants < 32 Weeks GestationOutcome Inborn (%) Outborn (%)Death 9 16*Severe (> grade 3) 7 17*intraventricular hemorrhageChronic lung disease 16 22*Patent ductus arteriosus 19 27*Respiratory distress syndrome 48 79*Late-onset infection 15 26*Data from Canadian Neonatal Network p<0.05 Chein L-Y Obstet Gynecol 2001; 98:247
  • 14. Other Factors May Affect Outcome• NICU volume - experience• Obstetric characteristics – antenatal steroids• Nursing staff• Race or health insurance status• Surveillance – how do we measure?• Approach to aggressive resuscitation• Congenital anomalies – typically not counted• Practice issues
  • 15. Risk of VLBW Mortality by NICU Level and Annual Volume NICU Level Volume Odds Ratio (95% CI) 1 <10 2.72 (2.37-3.13)* >10 2.39 (1.91-3.00)* 2 <10 2.53 (2.02-3.18)* 11-25 1.88 (1.56-2.26)* >25 1.22 (0.98-1.52) 3A <25 1.69 (1.28-2.24)* 26-50 1.78 (1.35-2.34)* >50 1.08 (0.96-1.21)* 3B,3C, 3D 51-100 1.19 (1.04-1.37)* >100 1.00 Reference48,237 infants 1991-2000, no anomalies Phibbs CS N Engl J Med 2007; 356:2165
  • 16. Very Low Birth Weight Delivery Volume StrongerInfluence on Mortality than Hospital Level of Care Adjusted Odds Ratio for VLBW Mortality Volume Level 500-1499 g, no anomalies California, 1997-2002 Chung JH. Med Care 2010; 48:635
  • 17. Patient Volume Only Partly Explains NICU QualityMean standardized mortality ratio(observed/expected deaths) 94,110 VLBW infants born in 332 Vermont-Oxford Network hospitals with NICUs, 1995-2000 Volume of admissions explained only 9% of variation in mortality rates, 7% other factors Rogowski J. JAMA. 2004;291(2):202-209. doi:10.1001/jama.291.2.202
  • 18. Vermont Oxford Network Outcomes 2009~58,000 Very Low Birth Weight infants in 812 NICUs NICU Percentiles 75 50 ● ●% 25 ● ● ● ● ● CLD=Chronic lung disease; NEC=Necrotizing enterocolitis; IVH= intraventricular hemorrhage; ROP= Retinopathy of prematurity
  • 19. Center Differences in Treatment with Salineand/or Vasopressor for Low Blood Pressure in Extremely Low Birth Weight Infants Lowest mean arterial pressure on 1st day (median)% mm Hg Center Laughon M, et al. ELGAN study. Pediatrics 2007; 119:273-280
  • 20. Updated Levels of Neonatal Care • Basis to compare health outcomes, resource use, and health care costs • Standardized nomenclature for public health • Uniform definitions for pediatricians and other health care professionals providing neonatal care (and parents!) • A foundation for consistent standards of service by institutions and other organizations focused on improvement of perinatal careAAP Committee on Fetus and Newborn 2012; Guidelines for Perinatal Care 7th edition, 2012
  • 21. Guidelines for Perinatal Care 7th Edition - 2012 Editors Laura Riley (ACOG) Ann Stark (AAP) Associate Editors Sarah Kirkpatrick (ACOG) LuAnn Papile (AAP)
  • 22. Level I Well Newborn Nursery• Provide neonatal resuscitation at every delivery• Evaluate and provide postnatal care to stable term newborn infants• Stabilize and provide care for infants 35 to 37 weeks gestation who are physiologically stable• Stabilize newborns who are ill or born before 35 weeks gestation until transfer to a higher level of care Guidelines for Perinatal Care, 7th edition, 2012
  • 23. Level II Special Care Nursery• Level I capabilities plus• Provide care for infants born at 32 weeks gestation or later and weigh 1500 g or more who have physiologic immaturity or are moderately ill with problems expected to resolve rapidly and are not anticipated to need subspecialty services on an urgent basis• Provide care for infants convalescing after intensive care• Provide mechanical ventilation for brief duration (less than 24 hours) or continuous positive airway pressure or both• Stabilize infants born before 32 weeks gestation and weigh less than 1500 g until transfer to a neonatal intensive care facility Guidelines for Perinatal Care, 7th edition, 2012
  • 24. Level III Neonatal Intensive Care Unit• Level II capabilities plus• Provide sustained life support• Provide comprehensive care for infants born before 32 weeks of gestation and weigh less than 1500 g and infants born at all gestational ages and birth weights with critical illness• Provide a full range of respiratory support that may include conventional ventilation and/or high frequency ventilation and inhaled nitric oxide Guidelines for Perinatal Care, 7th edition, 2012
  • 25. Level III NICU - continued• Provide prompt and readily available access to a full range of pediatric medical subspecialists, pediatric surgical specialists, pediatric anesthesiologists, and pediatric ophthalmologists• Perform advanced imaging, with interpretation on an urgent basis, including computed tomography, magnetic resonance imaging, and echocardiography Guidelines for Perinatal Care, 7th edition, 2012
  • 26. Level IV Regional NICU• Level III capabilities plus• Located within an institution with the capability to provide surgical repair of complex congenital or acquired conditions• Maintain a full range of pediatric medical subspecialists, pediatric surgical subspecialists, and pediatric anesthesiologists at the site• Facilitate transport and provide outreach education Guidelines for Perinatal Care, 7th edition, 2012
  • 27. Level Health Care Provider types I Pediatricians, family physicians, nurse practitioners, other advanced practice nurses II + Pediatric hospitalists, neonatologists, neonatal nurse practitioners III + Pediatric medical subspecialists*, pediatric anesthesiologists*, pediatric surgeons, and pediatric ophthalmologists* *at the site or at a closely related institution by prearranged consultative agreement IV + Pediatric surgical subspecialists Guidelines for Perinatal Care, 7th edition, 2012
  • 28. Percent of VLBW Infants Delivered at Hospital with Level III NICU Source: MCHB, Title V Information System, 2009
  • 29. Methods to Improve Provision of RiskAppropriate and Evidence-Based Care• Quality Improvement Methods – Multidisciplinary – Rapid cycle improvement• State Collaboratives – Reduce elective deliveries before 39 weeks• Collaborative Improvement and Innovation Network (COIIN)
  • 30. COIIN Priority Strategies• 13 states in southeastern US – Quality improvement methods• Infant mortality reduction strategies – Perinatal regionalization • 20% improvement from baseline in delivery of VLBW infants in risk-appropriate locations by December 2013 – Prevent elective deliveries less than 39 weeks – Prevention of Sudden Unexpected Infant Death – Smoking cessation in pregnancy – Interconception care
  • 31. COIIN Strategy – First Steps• Define hospital levels using new AAP criteria – Caring for infants less than 35 weeks gestation? – Providing > 24 hours of CPAP? – Providing advanced respiratory therapy? – Available pediatric subspecialists? – Surgical care of complex conditions? – Transport systems in place?• Data – Number of births and VLBW infants at each facility – Calculate neonatal mortality rate by facility
  • 32. Challenges• Transport – Geographical limitations (distance, weather) – Maternal transport – Back transport of convalescing baby• Policy – Limit number of NICUs in a region• Financial – NICU care is expensive
  • 33. Summary• Regionalization improves mortality because high- risk infants are cared for at facilities that can provide appropriate care• Provides opportunities for clinical teams to develop expertise – Concentrates rare cases at a few sites• Centralizes expensive technologies• However, we need to learn more – Optimal characteristics of a level III NICU such as staffing (physicians, nurses, others); equipment – Outcome measures other than mortality