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A Note to the Speaker DELETE THIS SLIDE BEFORE PRESENTATION

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1 A Note to the Speaker DELETE THIS SLIDE BEFORE PRESENTATION
The following slides have been developed to support presentations on the elimination of non-medically indicated deliveries <39 weeks gestational age and should be tailored to meet the needs of the audience. When adapting the slide deck, the following guidelines must be considered: The slide deck is copyrighted by the State of California. Slides contained in this deck should not be changed or amended. Additional slides can be added, but new slides must not contain the CMQCC logo, March of Dimes logo or the State of California copyright.

2 Eliminating Non-medically Indicated (Elective) Delivery Before 39 Weeks in Our Hospital:
Difficult Q&A The following slides can be used to support a difficult Q&A discussion, to generate dialogue or to strategize how best to overcome barriers. It should be tailored to meet the needs of the audience and the hospital.

3 Difficult Q&A Physician autonomy Medical leadership Consensus
Absolute refusers Data collection Stillbirths

4 Physician Autonomy Outdated thinking
Reflective of underlying anxiety about loss of control and autonomy Lack of understanding that standardization of care improves patient outcomes Common quotes from the physicians who want to retain their autonomy when practicing medicine. “I am a Board Certified OB/GYN, I can do what I want.” “No one should ever look over my shoulder.” Resistance to “Cookbook” medicine

5 Medical Leadership Most “Hard Stop” reports in the literature have involved a hospital-based physician who can “take the heat” Many other specialties have standardized protocols Protocol examples include: Door-to-cardiac catheterization time Stroke ICU - for prevention of ventilator associated pneumonia and central line infections Quotes from physicians who are uncomfortable with their role as the hard stop for deliveries that don’t meet the scheduling criteria. “As Chair or Medical Director, I am uncomfortable with telling another physician what they can or cannot do with their patient.” “Am I responsible if something bad happens to the patient if she is not delivered according to their private doctor’s desires?” “What will my malpractice carrier say?”

6 Consensus Use logic and literature to build a consensus among hospital providers An outlier may conform to guidelines if data demonstrating their practice patterns vs. their colleagues is presented, instead of forcing a doctor to follow new rules Lack of consensus among all physicians. Question for the Audience: What should happen if a doctor absolutely refuses to follow the guidelines?

7 Absolute Refusers (1) Important to not allow a few physicians to affect the majority Physician level data can be very persuasive Accurate data are critical - if data are wrong everyone loses credibility A few months of using “Scouts’ Honor” (“Soft Stop”) can show the entire department how a few refusers can spoil the outcomes Assuming that your physicians are not working within an employment model (Kaiser-type system), there are several options: Important to not allow the few physicians to affect the majority. Physician-level data can be very persuasive (but more work) - it can show how much of an outlier one or two doctors are. Accurate data is critical - if the data are wrong everyone loses credibility. A few months of using “Scouts’ Honor” (“soft stop”) can show the entire department how a few physicians can spoil the outcomes and stats for all (unless they really are good Scouts!!) At that point, a hard stop is usually an easier sell.

8 Absolute Refusers (2) Require every physician upon admission to write a full note in the chart describing why they plan to perform a non-medically indicated cesarean or induction before 39 weeks Require that all patients sign a full consent that describes the neonatal risks before undergoing induction/cesarean before 39 weeks without medical indication Require all cases be reviewed in Perinatal Committee and require that formal letters be returned and placed in their Medical Staff file The department Chair can use physician-level data on this measure for Ongoing Professional Practice Evaluation (JC requirement) Even if the department Chair or leaders do not feel that they can strongly enforce a clinical standard/hard stop, they can increase the “hassle factor”: Require every physician to write a full note in the chart describing why they took this action Require that all patients sign a full consent that describes the neonatal risks before undergoing induction/c-section before 39 weeks without medical indication Require that all cases be reviewed in Perinatal Committee and require formal letters be returned and placed into their Medical Staff file The department Chair can use physician-level data on this measure for Ongoing Professional Practice Evaluation (OPPE) (JC requirement)

9 Absolute Refusers (3) A key influence in many hospitals has been the Director of the Nurseries and/or Director of the NICU (Neonatologist or Pediatrician) They are part of the team of champions for babies They can illustrate examples of poor outcomes and hopefully some statistics It is much harder to challenge the “baby’s doctor’s” reasons for eliminating non-medically indicated deliveries than those of another obstetrician The Director of the NICU can be a key influence in changing OB practice. The early engagement of the hospital NICU or Nursery Director should be an early step and can be a key factor in many hospitals because they can highlight the impact of non-medically indicated deliveries on <39 week deliveries.

10 Data Collection Data collection on non-medically indicated deliveries <39 weeks can be onerous Variety of methods used to calculated rates of elective deliveries <39 weeks A number of organizations have made collecting data and calculating the rates of elective deliveries <39 weeks easier: The Joint Commission California Maternal Quality Care Collaborative (CMQCC) March of Dimes The Joint Commission has defined a methodology for calculating the rate of non-medically indicated deliveries March of Dimes has established a data portal for selected hospitals CMQCC has a data collection and reporting initiative for this measure available since May 2012: Uses linked administrative data sets (93%) Minimizes the chart review needs – only 7% chart reviews Will also provide sub-measures to help guide QI e.g. “I have a high rate, what do I do next?” Is it because if I have a high: % medical complications; % moms under 39wks % inductions <39wks (of uncomplicated moms) % CS <39wks (of uncomplicated moms) Can also provide a list of patients to examine further

11 What About the Risk of Stillbirths?
Even one day longer “in-utero” does increase the risk for stillbirth, but it is extremely low. What is the reported risk of stillbirth during the 38th week? U.S. data (NCHS)1 = 0.36/1,000 births Population rate - includes all risk categories Anyone who remains pregnant is at risk for having a stillbirth. But that risk is extremely low. U.S. natality data indicates that the stillbirth risk is 3.6 per 10,000 births, or one stillbirth will occur for every 3,000 deliveries at 38 weeks. And this rate includes patients with high-risk conditions such as hypertension, diabetes, and other medical conditions and babies with birth defects. This rate should be lower if only restricted to low- risk patients. 1MacDorman MF, Kirmeyer SE, Wilson EC. Fetal and perinatal mortality, United States, National vital statistics reports; vol 60 no 8. Hyattsville, MD: National Center for Health Statistics

12 What Have Intervention Studies Observed for the Risk of Stillbirth?
New Intervention Study Total Population Studied Stillbirth Rate Findings Oshiro (2009)1 (large health system) 160,394 Decline during intervention period Clark (2010)2 (large health system) 433,551 No change during the intervention period Ehrenthal (2011)3 (single hospital) 24,028 (>37 wk only) Increase noted at 37 and 38 wks Benedetti (2012)4 (state of Washington) 505,445 (>37wk only) Another source of data are observational studies looking at term stillbirth rates before and after implementation of programs to reduce elective delivery before 39 weeks. Three studies totaling nearly 1.2 million mothers saw no difference in stillbirths after reducing the rates of elective deliveries under 39 weeks. One single hospital study with 24,000 mothers did show an increase in stillbirths. However, unlike the other studies, the study population was smaller, the follow-up time was shorter, and there were significant changes in the population demographics. Many of the stillbirths occurred in a high-risk population and occurred during the 37th week. 1Obstet Gynecol 2009;113:804–11 2Am J ObstetGynecol 2010;203:449.e1-6 3Obstet Gynecol 2011;118:1047–55 4Obstet Gynecol 2012;119:656-7

13 Increased Infant Mortality (birth to 1 year) for Babies Born at 37/38wks Gestation Compared to 39wks or Greater New Study Relative Risk compared to 39 wks Absolute Increase per 1,000 births Zhang (2009)1 (US cohort, ) 37wk: wk: 1.25 37wk: wk: 0.3 Donovan (2010)2 (Ohio ) 37wk: wk: 1.4 37wk: wk: 0.8 Reddy (NICHD)(2011)3 (NCHS US ) 37wk: wk: 0.5 Altman (2012)4 (Sweden ) 37wk: wk: 1.4 37wk: wk: 0.5 It is important to balance the possible small risk of a potential stillbirth, with the risk of infant mortality, which is also low, but higher than that of a stillbirth at 37 and 38 weeks. In a normal, healthy pregnancy, the statistics favor continuing the pregnancy until at least 39 weeks. Four large population-based studies have consistently shown that the risk of infant mortality is 90% higher at 37 weeks, and 40% higher at 38 weeks. The absolute increased neonatal deaths average 1.6 per thousand at 37 weeks and 0.5 per thousand at 38 weeks. Both numbers are higher than the stillbirth risk at the same gestational ages seen in the Ehrenthal study. In determining the optimal timing of delivery, it is important to balance both the risk of fetal mortality and the risk of infant mortality. Results are quite consistent and show higher rates of observed infant mortality at 37/38 weeks than predicted for fetal mortality. 1J Pediatric 2009;154:358-62 2Am J ObstetGynecol 2010;203:58 3Obstet Gynecol 2011;117: 4BMJ Open 2012;2:e001152

14 Barbara Murphy Leslie Kowalewski For More Information, Contact:
Leslie Kowalewski The March of Dimes and California Maternal Quality Care Collaborative Toolkit is a great place to start for further information.


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