10/24/2016 HOW DO WE SAFELY IMPROVE CARE IN THE NICU? Conflicts/FDA. What is the current environment?

Transcription

1 HOW DO WE SAFELY IMPROVE CARE IN THE NICU? Reese H. Clark, MD VP and Co-director of the CREQ Conflicts/FDA I have no conflicts of interested related to the talk. I am not discussing use of any drugs so no FDA disclosure. What is the current environment? 1

2 The Peterson-Kaiser Health System Tracker IMPACT Infections, surgical mistakes, and other medical harm contribute to the deaths of 180,000 hospital patients a year, according to projections based on a 2010 report from the Department of Health and Human Services. Another 1.4 million are seriously hurt by their hospital care. Medscape: What are your goals for healthcare in the United States? Interview with Dr. Berwick Create a healthcare system that is just, safe, infinitely humane, and that takes only its fair share of our wealth that engages only in work that actually improves the lives of patients, families, and communities. The healthcare system we have simply cannot be sustained. What we spend on healthcare takes away precious resources for other parts of the economy and the national infrastructure. October 15,

3 Medscape: What are your goals for healthcare in the United States? Interview with Dr. Berwick Healthcare is a human right. Focuses on patient-centered care. Patients need to be able to experience transparency, individualization, recognition, respect, dignity, and choice in all matters. Benefits of data. All philosophies of improvement depend on having information. Without transparency of data, improvement is really stymied. Improvement requires this transparency turning the lights on to support learning and to usher in productive changes. October 15, 2015 Do you know how they rank hospital? What are the measures? What should be the measures Does it matter? 3

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5 Tell me where all of these hospitals are failing? The answer is on the slide. italsafetyratings.pdf National Efforts Background on the National Quality Strategy Established by the Affordable Care Act to improve the delivery of health care services, patient health outcomes, and population health First published in 2011 and serves as a nationwide effort to improve health and health care across America Iteratively designed by public and private stakeholders and provides an opportunity to align quality measures and quality improvement activities 5

6 The Triple Aim, a concept developed by the IHI in 2007, aims to improve the experience of care and the health of populations while reducing the per capita cost of healthcare through improvement National Quality Strategy Focuses On Six Priorities 1. Making care safer by reducing harm caused in the delivery of care. 2. Ensuring that each person and family is engaged as partners in their care. 3. Promoting effective communication and coordination of care. 4. Promoting the most effective prevention and treatment practices for the leading causes of mortality, starting with cardiovascular disease. 5. Working with communities to promote wide use of best practices to enable healthy living. 6. Making quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models. Domains Delivered to defined patient/s, by a defined provider/s and must relate to one domain. Process-a health care service provided to or on behalf of a patient. Outcome -a patient's health state resulting from health care. Access -the patient's attainment of timely and appropriate health care. Patient experience -a patient report about observations of and participation in health care. 6

7 Neonatal Example of Harm Vitamin E Has anyone ever heard of E-ferol? Do You Remember E-Ferol? The Penalty for Selling Untested Drugs in Neonatology O'Neal/Jones & Feldman Pharmaceuticals began marketing E-Ferol in the fall of 1983 as a vitamin supplement. The product was never submitted for FDA approval. Physicians incorrectly assumed E-Ferol had been tested and approved for use by the FDA In 1984, E-Ferol killed at least 38 newborns Iatrogenic disasters are often caused primarily by well-intentioned physicians using logical therapies which turned out to have unexpected, lethal side effects On January 19, 1989, three defendants pleaded guilty and were sentenced to fines of $130,000 each and 6-month jail sentences. Legal settlements in 100,000,000 range. Jerold F. Lucey Pediatrics 1992;89;

8 Let's Stop the Bleeding: Preventing Errors with Heparin Therapy. PA PSRS Patient Saf Advis 2006 Dec;3(4):31. Medication error that occurred in an Indiana hospital received nationwide publicity when three premature infants died as a result. The infants mistakenly received overdoses of heparin because the wrong strength was used to prepare flush solutions for umbilical lines. The error occurred when heparin 10,000 units/ml, 1 ml vials inadvertently were placed into a unit-based automated dispensing cabinet (ADC) pocket where heparin 10 units/ml, 1 ml vials were normally kept. While nothing can erase the grief experienced by the families and hospital workers in the wake of this tragic incident, it does serve as a reminder of the need to take a closer look at heparin utilization in our facilities. Is there a modern day e-ferol? 24 8

9 Ranitidine is associated with infections, necrotizing enterocolitis, and fatal outcome in newborns. 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Exposed to Ranitidine Not exposed 34/91 (37%) vs 18/183 (10%) OR=5.5 [2.9, 10.4] 9.8 vs 1.6% OR=6.6 [ ] 9.9 vs 1.6% OR=6.6 [ ] Infection NEC Mortality Terrin G, et al. Pediatrics 2012;129(1):e40-e45 Ranitidine Use in MEDNAX NICUs Percent of NICU Patients 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% FDA DRUG SAFETY COMMUNICATION: FDA RECOMMENDS AGAINST USE OF REVATIO (SILDENAFIL) IN CHILDREN WITH PULMONARY HYPERTENSION 08/30/ Barst RJ, et al. Circulation 2012;125:

10 Unexplained Variation Center variation in outcomes for 25 to 27 week infants (median, range). Brian Smith et al. Pediatrics 2012;129;e1508 Hospital Rates of Risk-Adjusted Outcomes and Active Treatment by Gestational Age at Birth. Rysavy MA et al. N EnglJ Med 2015;372:

11 MANAGING SITE VARIABILITY Any Report of Use of H2 blockers By Site 30% 25% Outliers Baseline 09to10 11to12 20% 15% 10% 5% Overall 0% Site Random Code More than 0 Extra Cases Less than 0 fewer Cases 5 year period, Inborn, VLBW Potential Extra Cases 0 Case Avoided

12 Can We Do Better? Absolutely Make sure antenatal steroids are given Antimicrobial Exposure and NEC Yale cohort replicates association reported by Cotten Alexander. J Pediatr. 2011;159(3):

13 Early (0 1 or 2) Ampicillin Duration 4 to 7 8 to 10 GT 10 40% 35% 30% 25% 20% 15% 10% 5% 0% WHAT IS THE MOST IMPORTANT CARE WE PROVIDE IN THE NICU? 13

14 Monitor growth David Casarett, M.D. The Science of Choosing Wisely Overcoming the Therapeutic Illusion NEJM 374: Success is limited by the tendency of human beings to overestimate the effects of their actions; the illusion of control. In medicine, it is the therapeutic illusion. When physicians believe that their actions or tools are more effective than they actually are, the results can be unnecessary, dangerous and costly care. 14

15 100,000 Babies Campaign Redesigning the Delivery of Neonatal Intensive Care A national quality improvement program designed to improve the outcomes of all critically ill newborns Ellsbury DL, et al. A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix Babies Campaign. Pediatrics 2016;137(4). Despite advances in neonatal medicine, infants requiring neonatal intensive care continue to experience substantial morbidity and mortality. The purpose of this initiative was to generate large-scale simultaneous improvements in multiple domains of care in a large neonatal network through a program called the "100,000 Babies Campaign." METHODS: Key drivers of neonatal morbidity and mortality were identified. A system for retrospective morbidity and mortality review was used to identify problem areas for project prioritization. NICU system analysis and staff surveys were used to facilitate reengineering of NICU systems in 5 key driver areas. Electronic health record-based automated data collection and reporting were used. A quality improvement infrastructure using the Kotter organizational change model was developed to support the program. Ellsbury DL, et al. A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix Babies Campaign. Pediatrics 2016;137(4). From 2007 to 2013, data on infants, including a subset with birth weight of 501 to 1500 g (n = 58,555) were analyzed. Key driver processes (human milk feeding, medication use, ventilator days, admission temperature) all improved (P <.0001). Mortality, necrotizing enterocolitis, retinopathy of prematurity, bacteremia after 3 days of life, and catheter-associated infection decreased. Survival without significant morbidity (necrotizing enterocolitis, severe intraventricular hemorrhage, severe retinopathy of prematurity, oxygen use at 36 weeks' gestation) improved. Implementation of a multifaceted quality improvement program that incorporated organizational change theory and automated electronic health record-based data collection and reporting program resulted in major simultaneous improvements in key neonatal processes and outcomes 15

16 Ellsbury DL, et al. A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix Babies Campaign. Pediatrics 2016;137(4). Ellsbury DL, et al. A Multifaceted Approach to Improving Outcomes in the NICU: The Pediatrix Babies Campaign. Pediatrics 2016;137(4). Quality Summit Attendance & CDW Utilization by Clinicians Activity Quality Summit Attendance CDW Unique Visitors CDW Visits 1,626 2,568 3,274 4,190 4,094 4,049 4,579 CDW Reports Viewed 6,511 10,132 12,859 15,326 15,443 16,148 17,522 Increased # of clinicians attending Quality Summits # of clinicians utilizing the CDW # of CDW visits # of CDW reports generated 16

17 Results: Process Measures( gm) Processes P Value Any human milk, n (%) 6217 (77.3) 6648 (78.5) 6910 (82.3) 7184 (85.2) 7239 (85.9) 7326 (86.9) 7351 (87.9) <.0001 Any human milk at 3057 (42.5) 3199 (42) 3477 (45.4) 3712 (48.4) 3779 (49) 3889 (50.3) 4043 (52.7) <.0001 discharge in survivors, n (%) Dexamethasone, n (%) 645 (8) 644 (7.6) 612 (7.3) 571 (6.8) 576 (6.8) 568 (6.7) 562 (6.7) H2 blockers, n (%) 1386 (17.2) 1286 (15.2) 1199 (14.3) 932 (11.1) 885 (10.5) 694 (8.2) 589 (7) <.0001 Metoclopramide, n (%) 1660 (20.6) 1415 (16.7) 1097 (13.1) 411 (4.9) 181 (2.1) 142 (1.7) 90 (1.1) <.0001 Cefotaxime, n (%) 1152 (14.3) 940 (11.1) 769 (9.2) 692 (8.2) 679 (8.1) 677 (8) 599 (7.2) <.0001 Patients receiving early (on 6432 (80) 6745 (79.7) 6603 (78.7) 6702 (79.5) 6404 (76) 6361 (75.4) 6197 (74.1) <.0001 day 0, 1, 2) ampicillin, n (%) Early ampicillin duration of >3 days with negative cultures, n (%) Patients ventilated in first 3 days after birth, n (%) Ventilator days in ventilated patients, median (10-90 th ) Hypothermia (admit temperature <36 C), n (%) 2138/ / / / / / /5893 <.0001 (35.2) (34.8) (33.6) (32.8) (32.2) (30.2) (28.4) 4831 (60.1) 4875 (57.6) 4677 (55.7) 4625 (54.9) 4400 (52.2) 4280 (50.7) 3899 (46.6) < (1-46) 6 (1-45) 6 (1-43) 5 (1-42) 5 (1-41) 5 (1-40) 5 (1-42) < (23.2) 1762 (20.8) 1619 (19.3) 1446 (17.2) 1180 (14) 1070 (12.7) 968 (11.6) <.0001 Results: Outcome Measures( gm) Outcomes P Value 836 (10.4) 838 (9.9) 728 (8.7) 750 (8.9) 714 (8.5) 702 (8.3) 681 (8.1) <.0001 Died IVH grade 3 or (7.2) 466 (6.5) 493 (6.9) 474 (6.6) 471 (6.6) 452 (6.3) 422 (5.8) 0.1 NEC medical or surgical 529 (6.6) 542 (6.4) 454 (5.4) 463 (5.5) 410 (4.9) 338 (4) 323 (3.9) <.0001 Medical NEC 351 (4.4) 363 (4.3) 301 (3.6) 329 (3.9) 296 (3.5) 236 (2.8) 220 (2.6) <.0001 Surgical NEC 178 (2.2) 179 (2.1) 153 (1.8) 134 (1.6) 114 (1.4) 102 (1.2) 103 (1.2) <.0001 ROP 3,4 or 5 in patients with an eye exam reported ROP treated (Laser or Avastin)/All 346 (5.9) 373 (5.8) 373 (5.7) 353 (5.3) 304 (4.6) 295 (4.4) 272 (4.1) < (2.9) 237 (2.8) 224 (2.7) 193 (2.3) 162 (1.9) 175 (2.1) 153 (1.8) <.0001 CLD (alive on > room air at 1816 (22.6) 1803 (21.3) 1756 (20.9) 1742 (20.7) 1744 (20.7) 1760 (20.9) 1680 (20.1) weeks PMA) Late onset sepsis (positive 1579 (19.6) 1499 (17.7) 1360 (16.2) 1150 (13.6) 983 (11.7) 888 (10.5) 754 (9) <.0001 blood culture obtained > 3 days after birth) Survived with no morbidity 5092 (63.3) 5491 (64.9) 5545 (66.1) 5563 (66) 5651 (67.1) 5674 (67.3) 5733 (68.5) <.0001 Age at discharge in 52 (26-98) 52 (26-100) 54 (27-102) 55 (27-103) 55 (28-103) 56 (28-105) 55 (28-104) <.0001 survivors, median (10-90th) Discharge weight (kg) <.0001 ( ) ( ) ( ) ( ) ( ) ( ) ( ) Weight gain (grams/day), 21 (16-27) 22 (16-27) 22 (16-28) 22 (17-28) 23 (17-28) 23 (17-28) 23 (18-28) <.0001 median (10-90th) Cumulative Reduction in Morbidity and Cost Observed vs Expected Morbidity ( , compared to 2007 baseline) Cumulative Cost Savings* ( , compared to 2007 baseline) 324 fewer babies with severe IVH $3,904, fewer babies with NEC $12,352, fewer babies with BPD $23,516,000 3,272 fewer babies with late sepsis $32,900,000 (total: $72,672,000) *Cost of morbidities in very low birth weight infants. Johnson TJ et al J Pediatr. 2013;162(2):243 17

18 Cumulative Reductions in Mortality, Medications Observed vs Expected Morbidity ( , compared to 2007 baseline) Cumulative Cost Savings* ( , compared to 2007 baseline) 65,118 fewer days of H-2 blockers??? 1,885 fewer deaths (all BW)??? 842 fewer deaths ( g)??? 1,815 MORE babies g who??? survived without morbidity Total $$:??????????? *Cost of morbidities in very low birth weight infants. Johnson TJ et al J Pediatr. 2013;162(2):243 Take Home Continue to learn Constantly work on good communication Share concerns Pay attention Participate Be willing to change Safety 18

19 Are We Safe? Are the fragile patients we care for safe? Would you want a loved one to be a patient at your hospital? Your unit? Would you want to be a patient in the unit where you work? Can you say with 100 percent certainty that you believe that your hospital does everything it can to protect its patients? What are the important measures? Communication 500 hospitals earned our lowest score for communication about new medications and discharge plans, and none earned our top score. Drug errors in hospitals are common and sometimes serious, and poor discharge planning can lead to readmissions. Scores are based on questions answered by millions of discharged patients in a federally mandated survey. A Comprehensive Patient Safety Program Can Significantly Reduce Preventable Harm, Associated Costs, and Hospital Mortality Richard J. Brilli, MD, FAAP, FCCM, Richard E. McClead, MD, Wallace V. Crandall, MD, Linda Stoverock, RN, MSN, NEA-BC, Janet C. Berry, RN, MBA, T. Arthur Wheeler, MS, MSES, MBA, J. Terrance Davis, MD The Journal of Pediatrics Volume 163, Issue 6, Pages (December 2013) DOI: /j.jpeds

20 A Comprehensive Patient Safety Program Can Significantly Reduce Preventable Harm, Associated Costs, and Hospital Mortality. The Journal of Pediatrics , DOI: ( /j.jpeds ) CUSP Supports TeamSTEPPS. Six Sigma. Institute for Healthcare Improvement Model for Improvement. Plan-Do-Study-Act. Root Cause Analysis. Failure Mode Effect Analysis 20

21 CUSP Principles: Science of Safety CUSP works because it recognizes the central importance of culture in sustainable patient safety improvements. A unit s safety culture can reliably predict a wide range of complications and infections, as well as such operational outcomes as nurse turnover. Because culture is local, it must be targeted at the unit level, with support at the organizational level CUSP Framework Engage staff to identify defects How is the next patient going to be harmed on this unit? How can we prevent this harm from occurring? This survey embodies the core CUSP principle of respecting the wisdom and observations of frontline staff, who have both the expertise and the knowledge needed to improve safety. Also find potential areas of improvement based on review of incident reports, claims, and sentinel events. CUSP Framework Continue to learn from defects Use the Learning from Defects tool to address the top risks identified by the team. What happened? Why did it happen? What did you do to reduce risk? How do you know that risks were reduced? 21

22 CUSP Framework Implement tools for improvement The safety team members highlight several priority areas needing improvement and use the many tools in the public domain to address them. Morning briefing (for communication and rounding efficiency), Huddle Shadowing other providers (for collaboration, teamwork and communication) Daily goals (for communication and care plan). Ongoing CUSP Framework Establish real-timedata feedback to keep staff aware of changes Keep front-line staff engaged in reporting defects and encourage ongoing participation system fixes and innovative problem solving Safety teams must continue to meet frequently (suggest WEEKLY) and rapidly address new problems Barriers Inconsistency in team membership. Lack of time. Lack of information sharing. Hierarchy. Varying communication styles. Presence of conflict. Lack of coordination and follow-up. Misinterpretation of cues. Lack of role clarity. 22