Improving Perinatal Outcomes: Lessons from Premier s Perinatal Safety Initiative

Improving Perinatal Outcomes: Lessons from Premier s Perinatal Safety Initiative December 14, 2011 William Riley, Ph.D. Associate Dean, School of Public Health University of Minnesota School of Public Health Kathy Connolly, RN, MSEd, CPHRM KTConnolly & Associates, LLC Rebecca Price, CPHQ PIMS Claims and Quality Improvement Project Manager Premier healthcare alliance Copyright 2011 Premier, Inc. All rights reserved.

PPSI PHASE I Kick-off January 2008 Data collection through December 2010 16 hospitals in 12 states Introduced three clinical care bundles Education and transparent benchmarking High Reliability Perinatal Risk Assessment AHRQ Culture of Safety Surveys 2

Original participating hospitals Illinois -Methodist Medical Center of Illinois (Peoria, IL) Kentucky -Baptist Hospital East, Baptist Healthcare System (Louisville, KY) Massachusetts -Baystate Medical Center, Baystate Health (Springfield, MA) Minnesota -Fairview Ridges Hospital, Fairview Health System (Burnsville, MN) -Univ. of Minnesota Medical Center, Fairview, Fairview Health System (Minneapolis, MN) New Mexico -Presbyterian Hospital, Presbyterian Healthcare Services (Albuquerque, NM) Ohio - Bethesda North Hospital, TriHealth (Cincinnati, OH) -Good Samaritan Hospital, TriHealth (Cincinnati, OH) -Summa Health System, Akron City Hospital (Akron, OH) Tennessee -Indian Path Medical Center, Mountain States Health Alliance (Kingsport, TN) Texas -Texas Health Harris Methodist Fort Worth Hospital (Forth Worth, TX) -Texas Health Presbyterian Hospital of Dallas (Dallas, TX) Washington -St. Joseph Hospital, PeaceHealth (Bellingham, WA) Wisconsin -West Allis Memorial Hospital, Aurora Health Care (West Allis, WI) 3

Building blocks Goals Reduce Harm Increase Patient Centered Care Create High Reliability Perinatal Units Reduce Costs Best Practices Care Bundles (Induction, Augmentation, Devices) Shoulder Dystocia Risk Management (1 st 48 hours response) Foundational Concepts Quality Basics (Reliability Concepts, PDCA model) Team Building & Communication Reliable Metrics and Data Development Situational Awareness & Critical Events Training (Simulation & Debriefing) Cost Analysis (Supply Chain, LOS, Claim/Legal) EFM (Common Interpretation and Communication) 4

Building blocks Goals Reduce Harm Increase Patient Centered Care Reduce Costs CREATE HIGH RELIABILITY PERINATAL UNITS 5

High reliability characteristics Categories assessed and scored Team work and communication Reliability concepts Situational awareness Fetal monitoring Care bundles Critical event management Risk and liability exposure Scoring criteria all firmly based in HRO principles 6 Copyright 2011 Premier, Inc. All rights reserved.

Documents reviewed Policies & procedures Nursing orientation Medical staff credentialing Medical records Induction order sets Quality indicators & trending reports Equipment maintenance records Patient satisfaction history 7 Copyright 2011 Premier, Inc. All rights reserved.

Assessment participants Nursing staff Physicians OB/Gyn Anesthesia Pediatrics Neonatology Nurse midwives Quality improvement Risk management Executive sponsor 8

Assessment results Scores are used by hospitals to identify existing characteristics of high performing perinatal teams, and to identify other opportunities for improvement in: Clinical processes Team collaboration and communication Risk management Avoidable adverse outcomes Report includes recommendations for improvement in low-scoring areas 9

Building blocks RELIABLE METRICS AND DATA DEVELOPMENT Foundational Concepts Quality Basics (Reliability Concepts, PDCA model) Team Building & Communication Situational Awareness & Critical Events Training (Simulation & Debriefing) Cost Analysis (Supply Chain, LOS, Claim/Legal) EFM (Common Interpretation and Communication) 10

Process measures Monthly chart audits of: 20 randomly selected elective induction and 20 randomly selected augmentation medical records 20 randomly selected vacuum delivery charts, or all if less than 20 vacuum deliveries that month Review each record looking for compliance with all elements of the respective bundle No credit unless all elements of the bundle have been met 11

Harm measures Our teams reported coding data from billing to NPIC NPIC provides quarterly individual and aggregate reports for three metrics: AOI, WAOS, and SI Adverse Outcome Index (AOI) is ten adverse outcomes six maternal and four newborn Maternal death Birth trauma* Uterine rupture Admission to NICU Return to OR / L&D (>2500g & for >24hours) 3º or 4º perineal tear APGAR <7 at 5 minutes Maternal admission to ICU Intrapartum & neonatal death Blood transfusion (>2500g) *Defined differently than the AHRQ Birth Trauma Patient Safety Indicator 12

AHRQ patient safety and medical liability grant awarded in 2010 to: University of Minnesota School of Public Health Fairview Health System Premier healthcare alliance/pims 13

The Scope of Phase II work 2010-2013 14 of the original 16 PPSI hospitals will continue the work of improving patient safety and developing high reliability teams with these new project components 2011: Additional on-site training for high reliability team development Team STEPPS & In Situ Simulation 2012: Analysis of malpractice claims events and payouts for perinatal injury (2006-2013) 2012-13: High Reliability Perinatal Assessments to be repeated and compared to baseline scores 2013: AHRQ Culture of Safety to be repeated and compared to two previous scores 14

Summary of Phase I (2008-2010) William Riley, Ph.D., Associate Dean, School of Public Health Carmen Parrotta, MPH, Project Coordinator, School of Public health Kathy Connolly, RN, MSEd, CPHRM KTConnolly & Associates, LLC

Outline (1) Interventions: Bundle Compliance (2) Harm Measures: AOI, WAOS, SI, (3) Association between Interventions and Harm Measures 16

(1) Interventions: Bundle Compliance 17

Definition of bundles Elective induction Augmentation Vacuum Elective Induction Augmentation Vacuum Gestational age 39 weeks Normal Fetal status (per NICHD tiers) prior to onset of Oxytocin Pelvic exam prior to the onset of Oxytocin Recognition and management of tachysystole Documentation of estimated fetal weight Normal fetal status (per NICHD tiers) Pelvic exam prior to the onset of Oxytocin Recognition and management of tachysystole Alternative labor strategies considered Patient prepared High probability of success Maximum application time and # of pop-offs predetermined and documented Cesarean and resuscitation teams available at delivery Copyright 2011 Premier, Inc. All rights reserved.

Bundle compliance - Success! Significant increase in reliability of the collaborative s bundle compliance rates Increase in reliability is displayed by the process shift circled in each of the bundle graphs

Induction bundle compliance Conformity with the elective induction bundle increased from 40 percent to a peak of 91 percent in October of 2010. Phase I compliance increased 52 percent. 20

Augmentation bundle compliance Conformity began at approximately 24 percent and reached its highest level at 79 percent conformity in March of 2010. Phase I compliance increased 118 percent. 21

Vacuum bundle compliance Conformity began at approximately 9 percent and increased to 63 percent in April of 2010. Phase I compliance increased 467 percent. 22

Bundle compliance - Challenges There is substantial variation across the 16 hospitals in trends of bundle compliance performance. The aggregate intervention group has not achieved and sustained criterion compliance. (> or = 4 months of bundle achievement at or above 90 percent) Specific Bundle Components have impeded total compliance rates for each care bundle Estimated Fetal Weight, Gestational <39 weeks/medical Indication, Alternative Labor Strategies and Informed Consent Documented 23

Induction Bundle Individual hospitals (n=6) with criterion compliance 24

Low-compliance components of care bundles Augmentation Bundle Estimated Fetal Weight Normal Fetal Status Pelvic Exam Tachysystole Bundle Achievements Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent 10023 7385 73.7% 10023 9622 96.0% 10023 8848 88.3% 10023 9109 90.9% 10023 6017 60.0% Induction Bundle Gest. Age >=39 Weeks Medical Indication Doc. Normal Fetal Status Pelvic Exam Tachysystole Bundle Achievements Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent 10407 8587 82.5% 10407 1283 12.3% 10407 10097 97.0% 10407 9511 91.4% 10407 9539 91.7% 10407 8222 79.0% Vacuum Bundle Alternative Labor Strategy Informed Consent Doc. EFW, Fetal Pos. and Sta. App. Time & # Pop-Offs Cesarean and Res. Team Bundle Achievements Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent Count Sum Percent 2818 1729 61.4% 2818 1731 61.4% 2818 1964 69.7% 2818 2331 82.7% 2818 2378 84.4% 2818 1184 42.0% 25

What does this mean? While some individual hospitals achieved and maintained bundle compliance at or above 90 percent, the collaboration as a whole has not achieved or maintained the 90 percent compliance for any of the three bundles (the collaborative has not yet reached a level of high reliability ) Raises the question, is 90% compliance the right target? Issues of clinical efficacy and cost/benefit are important with respect to understanding how much standardization is required in order to achieve an improvement in perinatal patient safety. Deeper exploration of the organizational determinants of bundle compliance is needed 26

(2) Harm Measures: AOI, WAOS, SI, 27

Adverse outcome index: 10 Indicators of harm Complication Maternal death 750 Intrapartum neonatal death of a neonate > 2500 grams (excluding 400 cases with a congenital anomaly or fetal hydrops) Uterine rupture 100 Unexpected internal or external maternal transfer to an ICU for a 65 postpartum complication Birth trauma 60 Return to OR or labor and delivery 40 Admission of neonate > 2500 grams and > 37 weeks to NICU within 35 one day of birth for > 24 hours (excluding cases with a congenital anomaly or fetal hydrops) APGAR 5 < 7 (excluding cases with a congenital anomaly or fetal 25 hydrops) Maternal blood transfusion 20 3rd or 4th degree perineal laceration. 5 Weight 28

Calculating the AOI, WAOS, and SI Outcome Measure Formula Phase I Calculation Adverse Outcome Index (AOI) Deliveries with at least 1 AE = x100 Total Deliveries 13,695 100 x = 0.052 263,562 Weighted Adverse Outcome Score (WAOS) = Total Weighted Score Total Deliveries 310,5 263,562 = 1.18 Severity Index (SI) Total Weighted Score = Total Deliveries with Complications 310,575 13,695 = 22.68 29

Rates of change for harm measures : Baseline Quarterly Average for Time Period (2006-2008) Follow-Up Average for Time Period (Q3 2009-2010) Change Indices Adverse Outcome Index (AOI) per 1,000 deliveries Maternal AOI Measures Only Newborn AOI Measures (for Inborns Only) 53.6 50.5 (3.1)* 39. 7 37.8 (1.9) 16.7 15.7 (1.0) Weighted Adverse Outcome Score (WAOS) Weighted score per delivery Maternal WAOS Measures Only Newborn WAOS Measures (for Inborns Only) 1.18 1.18 0 0.58 0.61 0.03 0.61 0.56 (0.05) Severity Index (SI) Weighted score per A.E. 22.1 23.3 1.2* Maternal SI Measures Only 10.8 12.2 1.4** Newborn SI Measures (for Inborns Only) 11.3 11.1 (0.2) * is assigned for moderate change (p-value < 0.05) and ** is assigned for strong change (p-value < 0.01). Interim period not included in Follow-up data Baseline and Follow-up averages for AOI are calculated using quarterly adverse event counts, total deliveries and weighted adverse outcomes scores 30

Incremental change: Intervention vs. comparison Baseline Follow-up Incremental Change (Q1 2006 Q4 2007) (Q3 2008 Q2 2010) Collaborative Comparison Collaborative Comparison Collaborative Comparison AOI 53.6 55.0 50.5 55.0-3.1* 0 WAOS 1.18 1.30 1.18 1.39-0.0 +0.08 SI 22.10 22.95 23.27 24.19 +1.17* +1.24 *Significant change AOI is presented per 1,000 deliveries 1) 3.1 fewer adverse events for every 1,000 births 2) The Collaborative outperformed the Comparison on all three indices

Trending in obstetrical harm measures: Adverse Outcome Index Aggregate Trending of AOI through Phase I: Run Chart AOI Rate per 1,000 Deliveries 60.00 58.00 56.00 54.00 52.00 50.00 48.00 46.00 44.00 Q1 2006 Q2 2006 Q3 2006 Q4 2006 Baseline Q1 2007 Q2 2007 Aug/Ind bundles initiated Q3 2007 Q4 2007 Q1 2008 Q2 2008 Q3 2008 Q4 2008 Median = 51.7 Q1 2009 Q2 2009 Follow-up Vacuum bundle initiated Q3 2009 Q4 2009 Q1 2010 Q2 2010 Q3 2010 Q4 2010 32

Trending in obstetrical harm measures: Weighted Adverse Outcome Score Average WAOS per Delivery 1.35 1.30 1.25 1.20 1.15 1.10 1.05 1.00 0.95 Q1 2006 Q2 2006 Q3 2006 Aggregate Trending of WAOS through Phase I: Run Chart Q4 2006 Baseline Q1 2007 Q2 2007 Aug/Ind bundles initiated Q3 2007 Q4 2007 Q1 2008 Q2 2008 Q3 2008 Q4 2008 Q1 2009 Q2 2009 Follow-up Vacuum bundle initiated Q3 2009 Q4 2009 Q1 2010 Q2 2010 Median = 1.17 Q3 2010 Q4 2010 33

Trending in obstetrical harm measures: Severity Index Average SI per Adverse Event 27.00 25.00 23.00 21.00 19.00 17.00 15.00 Q1 2006 Q2 2006 Q3 2006 Q4 2006 Baseline Q1 2007 Aggregate Trending of SI through Phase I: Run Chart Q2 2007 Aug/Ind bundles initiated Q3 2007 Q4 2007 Q1 2008 Q2 2008 Q3 2008 Q4 2008 Q1 2009 Q2 2009 Follow-up Vacuum bundle initiated Q3 2009 Q4 2009 Q1 2010 Q2 2010 Median = 22.7 Q3 2010 Q4 2010 34

Item analysis of AOI scale: Collaborative baseline vs. follow-up Baseline (Q1 2006 Q4 2007) Follow-up (Q3 2008 Q2 2010) Maternal Incremental Change Lacerations 26.7 22.0 (4.7) Return to OR 1.50 1.39 (0.11) Mat_death 0.06 0.04 (0.02) Uterine rupt. 0.40 0.45 0.05 Mat_ICU 1.69 2.15 0.46 Blood_Trans 9.35 11.65 2.3 Neonatal NICU admit 10.25 8.86 (1.39) Birth Trauma 2.02 1.71 (0.31) Neo_death 0.04 0.05 0.01 Apgar 4.42 5.13 0.71 *Per 1,000 Deliveries

Item analysis of AOI scale: Collaborative baseline vs. follow-up 4.7 fewer lacerations for every 1,000 births 1.39 fewer NICU admissions for every 1,000 births 1 fewer birth trauma event for every 3,226 births 36

(3) Association between Interventions and Harm Measures 37

Augmentation and Induction Bundles: Multivariate regression analysis Increased Augmentation bundle compliance appears to be associated with: a decrease in AOI, WAOS, and SI scores a decrease in adverse events fewer complications of anesthesia, maternal hypertension, hypoxia and birth asphyxia. Increased Induction bundle compliance appears to be associated with fewer respiratory problems 38

Why do Augmentation and Induction Bundle compliance rates AND their relationships to outcomes differ? Induction Controlled environment Pre-determined expectations Planned based on convenience and workload Augmentation Dynamic Requires impromptu decision-making Uncertain outcomes produces heightened situational awareness and increased assessment cognition Increased team engagement 39

The High Reliability Perinatal Safety Assessment Higher scores on the High Reliability Perinatal Safety Assessment (HRPSA) tool are associated with a lower incidence of adverse events and improved AOI scores 40

High reliability assessment scorecard

0.08 Ability of HRPSA Tool (Total Score) to Predicting AOI Outcomes AOI (adverse events per Delivery 0.07 0.06 0.05 0.04 0.03 0.02 0.01 0 y = -0.0003x + 0.0659 0 10 20 30 40 50 60 70 80 90 HRPSA Total Score 42

Important to remember? AOI, WAOS and SI are hard to move Time lag -- requires longer time at sustained compliance Causal factors other than bundle compliance impact AOI and are picked up by HRPSA: TeamSTEPPS Use of clinical simulation Changes in the culture of safety

Notice of Rights to Data: THIS MATERIAL MAY NOT BE QUOTED IN THE PUBLIC REALM OR REPRINTED IN ANY FASHION WITHOUT THE PERMISSION OF THE PPSI PROJECT TEAM

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Contacts For the Perinatal Safety Initiative Rebecca Price, CPHQ, PIMS Claims and Quality Improvement Project Manager 858.509.6598 or rebecca_price@premierinc.com For perinatal assessments or services Margaret Douglass, MPH, RN, PIMS AVP Risk Management 704.733.5871 or margaret_douglass@premierinc.com For information regarding AEIX or PIMS Les Meredith, PIMS Senior Vice President 858.509.6529 or les_meredith@premierinc.com Kathy Connolly ktconnolly@bellsouth.net 704.542.9478. William Riley riley001@umn.edu 612.625.0615 Carmen Parrotta parro015@umn.edu 612.626.2738 46 46