Protocols, Checklists and I HAVE NOTHING TO DISCLOSE - PowerPoint PPT Presentation

Protocols, Checklists and I HAVE NOTHING TO DISCLOSE Standardization Steven L. Clark, M.D. Texas Children’s Hospital/Baylor College of Medicine AUDIENCE RESPONSE QUESTION PROTOCOLS AND STANDARDIZATION � Rationale for standardization How do you feel about protocols and standardization in obstetric practice? � Examples of successful standardization in obstetrics A. This is simply “cookbook medicine” and is a step � How do I do it at my facility? backwards 72% � The future B. This is the future and I embrace it C. Undecided 19% 9% d e . . . d . . . i k e c o e o I d b d n k n U o a o e c r “ u y t l u p f m e i h s t s s i i s s h i h i T T

NO DECREASE IN DECADES IN RATES OF : � Cerebral palsy � Brachial plexus injury � Maternal mortality � Cesarean delivery rate � Preterm birth rate * � We rank 47 th in perinatal mortality rate NO DECREASE IN DECADES IN RATES OF : WHY TO WE DO SO POORLY? � Cerebral palsy � Large geographic area � Brachial plexus injury � Non- homogeneous population � Maternal mortality � Poverty � Cesarean delivery rate � The Democrats � Preterm birth rate * � The Republicans � Climate change � We rank 47 th in perinatal mortality rate and have � The dog ate my homework a maternal mortality rate approximating that in some low-resource countries � OUR HEALTH CARE EXPENDITURES ARE TWICE THAT OF ANY OTHER NATION

WHY TO WE DO SO POORLY? “EVERY SYSTEM IS � Large geographic area � Non-homogenous population PERFECTLY DESIGNED TO � Poverty � The Democrats ACHIEVE EXACTLY THE � The Republicans RESULTS IT IS ACHIEVING” � Climate change � The dog ate my homework Batalden/ Berwick � THE U.S. SYSTEM OF OBSTETRIC CARE IS BROKEN PROTOCOLS AND STANDARDIZATION “ We are confident that this higher level of care cannot be achieved by further stressing current systems of care. The current care system cannot do the job. Trying harder will not work. Changing systems of care will . The Institute of Medicine – Crossing the Quality Chasm

A BROKEN HEALTH CARE SYSTEM OBSTETRIC PRACTICE IN THE U.S. � HOW WE PAY FOR HEALTH CARE � HOW WE TRAIN – THE NATURE OF THE SPECIALTY � HOW WE ORGANIZE SERVICES � HOW WE DELIVER SERVICES Based upon 2 fundamental conceptual errors PROTOCOLS AND STANDARDIZATION � Physician autonomy is a positive good. STANDARDIZATION OF PRACTICE : ONE KEY TO PATIENT SAFETY � Litigation is best reduced by ambiguity in � Protocols guidelines, such that almost any action can be � Checklists defended. � Drills � Team Training � Forcing functions

PROTOCOLS AND STANDARDIZATION UNIFORM PROCESS = IMPROVED PRODUCT STANDARDIZATION OF PRACTICE : THE KEY TO � Commercial aviation LITIGATION REDUCTION � Nuclear power generation � Automobile manufacturing 1. REDUCES ADVERSE OUTCOMES � Professional baseball 2. CANONIZES ACCEPTABLE PRACTICE � Organic evolution Appears to apply to any human activity, particularly if technology or other humans are involved. PROTOCOLS AND STANDARDIZATION � PROCESS STANDARDIZATION WILL IMPROVE OUTCOMES EVEN WHEN MULTIPLE APPROACHES EXIST WHICH, BY THEMSELVES ARE EQUALLY EFFECTIVE. EXAMPLES OBSTETRICS

STANDARDIZATON AND PROTOCOLS STANDARDIZATON AND PROTOCOLS Recent examples Early examples � Oxytocin administration Clark et al AJOG 2015;212:494 � Early onset group B Streptococcus. � Steroids for lung maturity OXYTOCIN CHECKLIST OXYTOCIN CHECKLIST (q 30 minutes) (q 30 minutes) No more than 5 UCs/10 min for any 2 consecutive 1 acceleration (15 x 15) is present, 10 minute intervals � OR adequate variability for at least 10 of past 30 No 2 UCs lasting > 2 minutes minutes Uterus palpates soft in between contractions � No more than 1 late deceleration If IUPC in place, < 300 MVU, and baseline tone < 25 � No more than 2 variables exceeding 60 bpm mmHg depth from baseline for > 60 seconds

Oxytocin Protocol : Impact PROTOCOLS AND STANDARDIZATION STANDARDIZATON AND PROTOCOLS � PROCESS STANDARDIZATION WILL IMPROVE Recent examples OUTCOMES EVEN WHEN MULTIPLE APPROACHES � Oxytocin administration EXIST WHICH, BY THEMSELVES ARE EQUALLY � Post cesarean VTE prophylaxis EFFECTIVE. Clark et al AJOG 2014;211:32 � Need only to establish rough equivalence and N = 2.7 million standardize/ implement one good approach. Deaths from post cesarean pulmonary embolism decreased from 2/100,000 to 0.2/100,000, p = 0.038

STANDARDIZATON AND PROTOCOLS STANDARDIZATON AND PROTOCOLS Recent examples Recent examples � Oxytocin administration � Oxytocin administration � Post cesarean VTE prophylaxis � Post cesarean VTE prophylaxis � Elective delivery < 39 weeks � Elective delivery < 39 weeks Clark et al AJOG 2010;203:449 � Management of hypertensive crisis Clark et al AJOG 2014;211:32 N = 17,000 Early elective delivery declined from 9.6% to 4.3% N = 2.7 million (p=0.001) Mortality from hypertension reduced from 1/100,000 Accompanied by a 16% decrease in NICU to 1/300,000 (p=0.02) admissions (p=0.001) From #1 cause of death to #10 cause of death Hypertensive Crisis � 160/110 mmHg well established � What about 170/100? � What about 158/112? � Should you repeat the BP before treatment? � If so, how long should you wait to repeat the BP?

HYPERTENSIVE CRISIS STANDARDIZATON AND PROTOCOLS The following protocol should be initiated if the systolic blood pressure is ≥ 160 mmHg OR the diastolic blood pressure is Recent examples ≥ 110 mmHg. __ Notify physician � Oxytocin administration __ Administer hydralazine, 5 mg IV over � Post cesarean VTE prophylaxis 2 minutes __ Repeat blood pressure in 15 minutes � Elective delivery < 39 weeks __ If either blood pressure threshold is still exceeded, administer hydralazine 10 � Management of hypertensive crisis mg IV over 2 minutes. � Management of morbidly adherent placenta __ Repeat blood pressure in 15 minutes Shamshsiraz et al AJOG 2015;212:218 ___If either blood pressure threshold is still exceeded, administer labetalol, 20 mg IV over 2 minutes ___ Repeat blood pressure in 10 minutes ___If either blood pressure criteria is still exceeded, administer labetalol 40 mg IV over 2 minutes and obtain emergency maternal-fetal medicine, internal medicine or anesthesia consultation. STANDARDIZATON AND PROTOCOLS STANDARDIZATON AND PROTOCOLS Recent examples Recent examples � Oxytocin administration � Oxytocin administration � Post cesarean VTE prophylaxis � Post cesarean VTE prophylaxis � Elective delivery < 39 weeks � Elective delivery < 39 weeks � Management of hypertensive crisis � Management of hypertensive crisis � Management of morbidly adherent placenta � Management of morbidly adherent placenta � Massive transfusion protocols � Massive transfusion protocols Pacheco et al. AJOG 2015 Sept 15 (epub ahead of print) � Postpartum hemorrhage Shields et al AJOG 2015;212:272

STANDARDIZATON AND PROTOCOLS Frequency Trends - HCA Reported Claims per 10,000 Births 16 Recent examples 14 � Oxytocin administration 12 � Post cesarean VTE prophylaxis � Elective delivery < 39 weeks 10 � Management of hypertensive crisis 8 � Management of morbidly adherent placenta 6 � Massive transfusion protocols � Postpartum hemorrhage 4 � Management of category II FHRT 2 Clark et al 2013;209:89 Clark et al 2016 – SMFM 0 Significantly less metabolic acidosis with identical cesarean rate 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 PROTOCOLS AND STANDARDIZATION PROTOCOLS AND STANDARDIZATION � PROCESS STANDARDIZATION WILL IMPROVE STANDARDIZATION OF PRACTICE : ONE KEY TO OUTCOMES EVEN WHEN MULTIPLE APPROACHES PATIENT SAFETY EXIST WHICH, BY THEMSELVES ARE EQUALLY � Protocols EFFECTIVE. � Checklists � Drills � “ There is no literature to support the superiority of � Team Training that approach over mine ” is irrelevant if patient � Forcing functions safety is of principle concern. � Variation from protocol is always allowed, with a note explaining why, but is subject to peer review.

FORCING FUNCTIONS IN PATIENT SAFETY The next frontier � Forcing function : A process or procedure which “ Leaders must ensure that their organization has prevents patient harm even when an error is the ability to change. Yet many leaders now view made. their role as shielding and protecting the organization from environmental pressures that may require them to change.” � Examples: - MgSO4 only in 4 g bags Institute of Medicine – Crossing the Quality Chasm - EMR order stops for incorrect doses of hazardous meds - Integration of pattern recognition software with the oxytocin pump.