Updates in the Clinical Pathways for Induction of … DHA...Updates in the Clinical Pathways for...

Pre-Decisional Deliberative Matter – For Official Use Only Within DoD

Updates in the Clinical Pathways for Induction of Labor, Venous Thromboembolism and Postpartum Hemorrhage Management

23 JAN 20201005 - 1105 ET

Women and Infant Clinical Community (WICC)

“Medically Ready Force…Ready Medical Force”


PresentersNavy Cmdr. Monica A. Lutgendorf, M.D.,

F.A.C.O.G.Chair, Defense Health Agency Women and Infants Clinical Community

Associate Residency Program Director, Obstetrics and Gynecology (OB/GYN)Associate Professor, Uniformed Services University of the Health SciencesDivision Head Maternal Fetal Medicine, Naval Medical Center San Diego

Air Force Lt. Col. Dalia J. Wenckus, M.D., F.A.C.O.G.

Physician, Department of OB/GYNMaternal Metal Medicine Division

Core Faculty, San Antonio Military Medical Center (SAMMC)Brooke Army Medical CenterJoint Base San Antonio (JBSA)

Army LTC Erin A. Keyser, M.D., F.A.C.O.G.

Army Representative, Defense Health Agency Women and Infants Clinical Community

Associate Residency Program Director, OB/GYNSan Antonio Military Medical Center (SAMMC)

Associate Professor, Uniformed Services University of the Health Sciences

Air Force Lt. Col. Larissa Weir, M.D., FACOG

Women and Infants Clinical CommunityResidency Program Director, OB/GYN

San Antonio Uniformed Services Health Education Consortium

San Antonio Military Medical Center (SAMMC)Assistant Professor, Uniformed Services University of the

Health Sciences

“Medically Ready Force…Ready Medical Force” 2


CDR Monica A. Lutgendorf, M.D., F.A.C.O.G.

CDR Monica Lutgendorf, MD grew up in Ridgecrest, California, and attended the University of Southern California on a Naval ROTC scholarship. She served as Battalion Commander, and earned her Bachelor of Science degree in Chemistry in 2000.

CDR Lutgendorf was selected to attend medical school upon commissioning, and earned her Medical Doctorate in 2004 from the Uniformed Services University of the Health Sciences in Bethesda, MD.

CDR Lutgendorf completed internship and residency in Obstetrics and Gynecology at Naval Medical Center Portsmouth, in 2008, serving as an OB/GYN staff physician at Naval Medical Center Portsmouth until 2011. CDR Lutgendorf completed her subspecialty fellowship in Maternal-Fetal Medicine at Madigan Army Medical Center in Tacoma, WA in 2014

In 2014 CDR Lutgendorf was stationed at Naval Medical Center San Diego, where she is the Division Director for Maternal-Fetal Medicine. She is currently the Associate Residency Program Director and is an Associate Professor at the Uniformed Services University of the Health Sciences. CDR Lutgendorf is the chair of the Defense Health Agency’s Women and Infant’s Clinical Community. She is committed to clinical standardization, provider support, medical simulation, and empowerment for women in healthcare.

Her research interests include neuroprotection in preterm infants, non-invasive prenatal screening, simulation, quality improvement and domestic violence and posttraumatic stress disorder in pregnancy and the military.

Her awards include: Meritorious Service Medal, Navy Commendation Medal, Army Commendation Medal with oak leaf, Navy Achievement Medal with gold star and Army Achievement Medal.



LTC Erin Keyser, M.D., F.A.C.O.G.

LTC Erin A. Keyser, MD is the Associate Residency Program Director for the Department of Obstetrics and Gynecology at the San Antonio Military Medical Center in San Antonio, Texas.

She received her undergraduate degree from the University of California, Davis and her medical degree from Albert Einstein College of Medicine in New York.

She accepted a military scholarship and completed her residency at San Antonio Uniformed Services Health Education Consortium in San Antonio, Texas. After completing her residency, she worked as an Obstetrician Gynecologist at William Beaumont Army Medical Center in El Paso, Texas and during that time she served in Afghanistan as a Battalion Surgeon for the 4th Infantry Division.

She returned to San Antonio in 2015 where she is an Associate Professor of OB/GYN at the Uniformed Services University of the Health Sciences and enjoys working with and teaching residents.

In February 2019, she was appointed the Army Representative to the Defense Health Agency Women and Infant Clinical Community.

Dr. Keyser has been actively involved with ACOG since 2009 when she became a junior fellow district officer. From 2016-2019, Dr. Keyser served as the ACOG National Young Physician-at-Large Officer, representing young physicians nationwide.

She also serves on the ABOG Qualifying Exam Committee and is a board examiner.



Lt. Col. Larissa F. Weir, M.D., F.A.C.O.G. Lt Col Larissa F. Weir, MD received her Doctorate of Medicine in 2005 from

the University of Iowa Carver College of Medicine where she attended on an Air Force Health Professions Scholarship. She came on active duty in 2005 and completed her internship and residency in Obstetrics and Gynecology at the San Antonio Uniformed Services Health Education Consortium.

Lt Col Weir is currently stationed at Brooke Army Medical Center where she is an Assistant Professor of Obstetrics and Gynecology at the Uniformed Services University of the Health Sciences and serves as the Residency Program Director for the Department of Obstetrics and Gynecology at the San Antonio Uniformed Services Health Education Consortium (since 2015).

She is board certified in obstetrics and gynecology and a fellow in the American College of Obstetricians and Gynecologists.

Dr. Weir provides the full scope of general obstetrics and gynecology care and has a special interest in contraception, family planning and health care for lesbian/bisexual/transgender patients. She serves as a surgical consultant for the Air Force Medical Multidisciplinary Team for Transgender Care and during her Air Force career has had the opportunity to lead two surgical humanitarian missions to Central America.

Lt Col Weir is an Air Force section officer for the American College of Obstetricians and Gynecologist and a board examiner for the American Board of Obstetrics and Gynecology.



Lt. Col. Dalia J. Wenckus, M.D., F.A.C.O.G.

Lt Col Dalia J. Wenckus, MD graduated from the United States Air Force Academy and received her Bachelor of Science in 2001. She attended Loyola Stritch School of Medicine as part of the Health Professions Scholarship Program and received her Doctorate of Medicine in 2005.

She came on active duty in 2005 and completed her internship and residency in Obstetrics and Gynecology at the San Antonio Uniformed Services Health Education Consortium.

In her first year after graduation, she deployed to Haiti after the earthquake as part of Operation Unified Response. When she returned, she began Maternal Fetal Medicine Fellowship training at University of Illinois at Chicago, and graduated Fellowship in 2013.

Her first station after fellowship training was Wright Patterson Air Force Base where she undertook the role of Perinatal Clinic and L&D Director while running a Maternal Fetal Medicine Ultrasound Clinic and Complicated Obstetrics Clinic at Wright Patterson Medical Center until 2018.

Lt Col Wenckus is currently stationed at Fort Sam Houston and is a Maternal Fetal Medicine Staff Physician at Brooke Army Medical Center as well as an Assistant Professor of Obstetrics and Gynecology at the Uniformed Services University of the Health Sciences. She became the Maternal Fetal Medicine Consultant to the Air Force Surgeon General in 2019. She is board certified in Maternal Fetal Medicine and Obstetrics and Gynecology and is a Fellow in the American College of Obstetricians and Gynecologists.



Disclosures∎ The presenters have no relevant financial or non-financial relationships to disclose relating to the

content of this activity.∎ The views expressed in this presentation are those of the authors and do not necessarily reflect the

official policy or position of the Department of Defense, nor the U.S. Government.∎ This continuing education activity is managed and accredited by the Defense Health Agency J-7

Continuing Education Program Office (DHA J-7 CEPO). DHA J-7 CEPO and all accrediting organizations do not support or endorse any product or service mentioned in this activity.

∎ DHA J-7 CEPO staff, as well as activity planners and reviewers have no relevant financial or non-financial interest to disclose.

∎ Commercial support was not received for this activity. ∎ Presenters will be discussing off-label use of misoprostol for cervical ripening.


Pre-Decisional Deliberative Matter – For Official Use Only Within DoDPre-Decisional Deliberative Matter – For Official Use Only Within DoD

Clinical Care Pathway for Induction of Labor


Learning ObjectivesAt the end of the presentation, participants will be able to:1. Recognize the importance of process standardization with decreased non-beneficial

clinical variation.2. List examples of improved obstetric outcomes with clinical process standardization.3. Implement evidence based best practices for safe induction of labor, including early

amniotomy, placement of an intrauterine pressure catheter, and titration of Pitocin to reach adequate contractions.



Clinical Communities ∎ Clinical Communities (CCs) are a component of the High Reliability Organization

(HRO) Operating Model (HROM)∎ Front-line caregivers optimize outcomes and reduce patient harm

Driving MHS-wide performance improvements in readiness and health Create, track and share the conditions for high reliability (processes, standards, metrics) at the point of care Identifying and resolving non-beneficial clinical variation Fostering a culture of safety and innovation

∎ Clinical Communities Drive Integration towards Tri-Service coordination Clinician engagement Clinical performance improvement Coordination with Clinical Support Services and sources of enabling expertise Patient-focused Care Pathways


*MHS – Military Health System


Standardization

∎Greater practice variation = poorer outcomes

∎Decrease healthcare disparities

∎Not always robust evidence

∎Arguments against standardization:Desire to be unique/individualsDesire to demonstrate unusual competence https://www.veltra.com/en/north_america/usa/las_vegas/a/137075


https://www.veltra.com/en/north_america/usa/las_vegas/a/137075


Real Life Examples

∎ Oxytocin administrationDecreases oxytocin infusion ratesDecreased cesarean delivery (CD) ratesImproved neonatal outcomes

∎ Hypertension managementReduced hypertension as cause of

maternal death (#1 to #11)Narrowly focused programs Specific clinical events



What is a Care Pathway?

∎Patient-centered approach for caring for specific high volume conditionsEvidence-basedSustained and reliable improved outcomesReduces non-beneficial variability Measurable & Data driven Outcomes Adherence

Supported by the Electronic Health Record (EHR)



Opportunities

∎Massive variation in clinical practices Continued reliance on the ‘craft of medicine’ Complexity (clinical uncertainty)

∎High rates of inappropriate care Inappropriate = risk of harm of treatment outweighs any potential benefitUnder treat as much as we over treatUnacceptable rates of preventable care-associated patient injury and death Inability to ‘do what works’

∎Reliability∎Huge amounts of waste Spiraling costs that limit access to care

∎As long as the process is “equivalent” - standardization improves outcomes



Procedure Alignment & Standardization

∎Recommended by BUMED Perinatal Inpatient Environment Standards Change plan (PIES-C)∎13 Care processes

Induction of Labor∎Variation60+ policies and procedures/Standard Operating Procedures

(SOPs)∎Healthcare disparities

* BUMED - Bureau of Medicine and Surgery



Standardized Induction of Labor (IOL)

∎Standardized management (> 36 weeks, cervix <2 cm, no prior cesareans)∎Protocol

Cervical ripening Amniotomy within 24 hours of starting IOL Intrauterine pressure catheter (IUPC) after membrane rupture Titration of oxytocin to achieve > 200 Montevideo units (MVUs) At least 12 hours oxytocin after membrane rupture before cesarean for failed IOL

∎After 12 hours No multips in latent labor 4% nullips in latent labor

∎Failed IOL eliminated as indication for cesarean in parous womenRouse DJ, Owen J, Hauth JC. Criteria for Failed Labor Induction: Prospective Evaluation of a Standardized Protocol. Obstet Gynecol 2000;96:671-7



Standardized Protocol vs. Provider Preference∎Standardized management (included TOLAC)∎Protocol adherent group - Lower failed IOLNullips 3.8% (9.8% non-adherent), p = 0.043

3.5 hours shorter laborMultips 0% (6% non-adherent), p = 0.0004

1.5 hours shorter laborTOLAC 0% (22% non-adherent), p = 0.008

∎Lowest rates when ALL elements of the protocol followed∎Protocol adherent group – more frequent CD for category II FHR

tracing∎Protocol non-adherent group – more frequent CD for failed IOL

Rhinehart-Ventura J, Eppes C, Sangi-Haghpeykar H, Davidson C. Evaluation of outcomes after implementation of an induction-of-labor protocol

*TOLAC – Trial of Labor after a C-sectionFHR – Fetal Heart Rate



FHR/Oxytocin Recommendations

∎No clear definitions in prior studies∎Opportunity for evidence-based recommendations∎Oxytocin checklistsImproved neonatal outcomesReductions in cesarean delivery rates

Clark SL, et. al. Am J Obstet Gynecol 2007;197:480.e1-480.e5

Max dose lower in checklist-managed groupNo difference:

Length of any stage of laborTotal time of oxytocin administrationRates of operative vaginal deliveryAlign with IHI Recommendations

for Documentation of Oxytocin

*IHI – Institute for Healthcare Improvement



Problem Statement

∎Labor induction is commonly performed in the US∎2014 national data indicates that 23 percent of women

underwent labor induction∎Induction or augmentation of labor is indicated when there is

maternal or fetal benefit∎Literature shows a large degree of variation in labor induction

or augmentation practices∎Non-beneficial clinical variation may introduce unnecessary

maternal and/or fetal risk



Goals∎ Development of a standardized clinical pathway for obstetrics (OB) providers to use during

labor induction and/or augmentation ∎ GOAL - Improve maternal and neonatal outcomes by decreasing non-beneficial clinical

variation

∎ Outcome measures: Time from admission to delivery for inductions Infection rate associated with elective inductions Percentage of unplanned neonatal intensive care unit (NICU) admissions Number of failed inductions or inductions with complications

∎ Future considerations: Financial Impact: Monitor costs associated with project Patient Satisfaction: Improve labor and delivery (L&D) patient satisfaction scores



Outcome Measures

∎Time from admission to delivery∎Chorioamnionitis∎Endomyometritis∎Postpartum hemorrhage∎NICU admissions related to IOL∎Inductions resulting in cesarean section

∎Pathway adoption (compliance)* NICU – Neonatal Intensive Care Unit



Frequently Asked Questions∎ Cervical Ripening

Generally combination methods more effective∎ Amniotomy2

Nullips – shorter labor, less dystocia, lower CD rate, lower abruption rate No increases in complications

∎ IUPC1

More accurate assessment of contractions, improve ability to dose oxytocin Fewer operative vaginal deliveries and less fetal distress No increased risk of infection from IUPC2

Can I use an IUPC before active labor? YES Do I need to wait 6 hours to place an IUPC after artificial rupture of membrane (AROM)? NO

∎ Prior studies (Rhinehart-Ventura) using similar protocol with amniotomy and IUPC have not shown an increase in infections Protocol adherent

NS lower rates of postpartum hemorrhage (PPH), endomyometritis, chorioamnionitis, transfusions∎ IOL without medical indications at 39 weeks?

ARRIVE trial3 – randomized controlled trial (RCT) comparing IOL at 39 weeks to expectant management to 42+2 in low-risk nulliparous women CD rates 18.6% for immediate IOL vs. 22.2% for expectant management (No CD in latent phase prior to at least 15 hours ruptured with concurrent oxytocin)

No changes in American College of Obstetricians and Gynecologists (ACOG)/Society of Maternal-Fetal Medicine (SMFM) guidelines for IOL – IOL < 41+0 weeks with an unfavorable cervix should only be performed for medical indications

No longer a tracked pathway deviation1 Bakker JJ et.al. Internal versus external tocodynamometry during induced or augmented labour. Cochrane Database Syst Rev 2013;8:CD0069472 Macones G et. al. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol 2012;207:403.e1-5.3 Grobman WA et. al. A randomized trial of elective induction of labor at 39 weeks compared with expectant management of low-risk nulliparous women. Am J Obstet Gynecol 2018; 218:S601.

https://www.bhpalmbeach.com/recovery-stories/recovery-really-balancing-act/


https://www.bhpalmbeach.com/recovery-stories/recovery-really-balancing-act/


Frequently Asked Questions (Cont.)∎ Why do I need to follow the oxytocin portion of the protocol?

Oxytocin is a high-risk medication This is the documentation and administration recommended by the Institute for Healthcare Improvement (IHI) Prior studies using this protocol have demonstrated that this protocol

Decreases oxytocin infusion rates Decreases CD rates Improves neonatal outcomes

∎ Since there is no large RCT to prove the best method of labor induction, I should be able to do whatever I want. Not true! Though there are limitations in the currently published IOL literature, as long as a protocol is

equivalent in effectiveness, outcomes will improve if practice is standardized. The current IOL pathway is based on the best published evidence, and over time will continue to be modified

as new evidence emerges∎ Why do I need to follow a protocol? I am a physician [resident, staff, certified nurse midwife

(CNM), nurse] and I should be able to do what is necessary for my patient. Practicing in a standardized fashion improves patient outcomes by decreasing non-beneficial clinical variation

∎ What if I need to deviate from the protocol to care for my patient? You should do what is needed to take care of your patient and DOCUMENT WHY you did something different We know that this will occur approximately 10-15% of the time Documenting why it was necessary to deviate from the pathway will help us further improve the pathway

https://marinemillsfolkschool.org/event/stone-balancing-2/


https://marinemillsfolkschool.org/event/stone-balancing-2/


Frequently Asked Questions (Cont.)

∎ Why can’t I fill a 30 mL Foley balloon with 60 mL of fluid? Because the manufacturer recommends inflating to 30 mL, over-inflation risks balloon rupture

and patient harm Additionally the diameter of a 30 mL balloon is 3.86 cm, and the diameter if the 60 mL balloon is

4.85 cm (though the volume doubles, the diameter does not double), that is why there really isn’t much difference between the 2 volumes in the literature

The only 60 mL Foley balloons we could find were latex containing, putting 60 mL in the Cook balloon is a waste of money https://www.amazon.com/Close-Up-stones-Perfect-

balance/dp/B00CJBLIRM

∎ Why not allow a Cook double balloon catheter for cervical ripening? There is no improvement in outcomes with the Cook balloon – time to delivery is shorter for the Foley catheter The Cook catheter costs $60 compared to $3.00 for a regular Foley catheter The cost to use the Cook catheter for all IOL for one month (300 deliveries, 20% IOL rate = $3,600 compared to $180)

Annually $43,200 vs. $2,160

∎ Why not allow Cervidil for cervical ripening? Because it is not more effective (may be less effective), and it costs $218 compared to < $1.00


https://www.amazon.com/Close-Up-stones-Perfect-balance/dp/B00CJBLIRM


Documentation is important

Monitor Compliance

Find out why people deviate

from the protocol

Changes to Clinical Care

Pathway

Validate the Changes

Overrides – 15%

Demand clinicians varybased on patient need

Ask what providers would changeRapidly move to a better protocolDon’t rely on memoryDon’t destroy clinical productivity**Make it faster & easier**

If you deviate from the protocol, document why!



The PATHWAY



Outcome Metrics

Since adoption of the pathway, we noted a 2 hour decrease in time from admission to delivery Pathway compliant 3.8 hour decrease in time from admission to delivery Pathway deviations 1.6 hour increase in time from admission to delivery

Pathway adoption Lower average time from admission to delivery Lower chorioamnionitis rates Decreased NICU Admissions and Unanticipated Outcomes Decreased Cesarean delivery rates

In contrast, pathway deviations had worse outcomes compared to baseline Increased chorioamnionitis and endomyometritis Increased postpartum hemorrhage Increased NICU Admissions and Unanticipated Outcomes Increased Cesarean delivery rates

27


IOL Monthly Diversion Rate

* Re-education effort: In July of 2019 the following interventions were implemented in an effort to increase pathway adoption: Daily support of IOL discussion during nursing handoff, communication with residents on adoption tracking, data displayed in clinicians break room.

Re-

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Vers

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Vers

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Diversion rate for October: Focus on the divergent cases going forward, specifically those who deviate due to IUPC placement > 6hrs after AROM will assist with divergent rates reaching goal.



Implementation Challenges

∎Change management (Kotter’s 8 steps):Create urgencyForm an interdisciplinary teamCreate a vision for the changeCommunicate the visionRemove obstacles Get feedback, encourage participation, make it easier

Create short-term winsBuild on the changeAnchor the change


Keep a positive attitude & maintain enthusiasm!


The Development TEAM

∎ CDR Monica Lutgendorf∎ CDR Zachary Alexander∎ CAPT Christopher Cornelissen∎ CAPT Kristina Morocco∎ CAPT Amanda Simsiman∎ CDR Sara Gonzalez∎ LCDR Patricia Butler∎ LCDR Virginia Sullivan∎ LT Megan Northup∎ LT Whitney Brock∎ LT Melissa Schmidt∎ Irene Grepo, RN∎ Anne Taylor, RN∎ Jeff Budge, RN

∎ Dr. John Davidson∎ Theresa Hart∎ Dori Rogut∎ MAJ Diane Caranta, USAF∎ COL Lisa Foglia, USA∎ Dr. Eileen Hemman, MAMC

Booz Allen Hamilton∎ Pamela Carvalho∎ Meaghan Meeker

∎NMCSD / NMW ∎MHS

*NMCSD – Naval medical Center San DiegoNMW – Navy Medicine WestMHS – Military Health Services



Key Takeaways∎ Process standardization improves clinical outcomes

∎ Care pathways can be used to decrease non-beneficial clinical variation and improve outcomes

∎Quality improvement efforts require ongoing data analysis and review



ReferencesBakker, J.J., Janssen, P.F., van Halem, K., van der Goes, B.Y., Papatsonis, D.N., van der Post, J.A., & Mol, B.W. (2012). Internal versus external tocodynamometry during induced or augmented labour. Cochrane

Database System Review., 12: CD006947. https://doi.org/10.1002/14651858.CD006947

Clark, S., Belfort, M., Saade, G., Hankins, G. Miller, D., Frye, D., & Meyers, J. (2007). Implementation of a conservative checklist-based protocol for oxytocin administration: Maternal and newborn outcomes.

American Journal of Obstetrics and Gynecology, 197(5): 480.e1-480.e5. https://doi.org/10.1016/j.ajog.2007.08.026

Clark, S.L., Christmas, J.T., Frye, D.R., Meyers, J.A., & Perlin, J.B. (2014). Maternal mortality in the United States: predictability and the impact of protocols on fatal postcesarean pulmonary embolism and

hypertension-related intracranial hemorrhage. American Journal of Obstetrics and Gynecology, 211(1):32.e1-9. https://doi.org/10.1016/j.ajog.2014.03.031

Grobman, W.A., Rice, M.M., Reddy, U.M., Tita, A.T.N., Silver, R.M., Mallett, G., Hill, K., Thom, E.A., El-Sayed, Y.Y., Perez-Delboy, A., Rouse, D.J., Saade, G.R., Boggess, K.A., Chauhan, S.P., Iams, J.D., Chien, E.K.,

Casey, B.M., Gibbs, R.S., Srinivas, S.K., Swamy, G.K., . . . M.S.C.E. for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network.

(2018). Labor induction versus expectant management in low-risk nulliparous women. New England Journal of Medecine, 379: 513-523. https://doi.org/10.1056/NEJMoa1800566

Macones, G.A., Cahill, A., Stamilio, D.M., & Odibo, A.O. (2012). American Journal of Obstetrics and Gynecology, 207(5): 403.e1-403.e5. https://doi.org/10.1016/j.ajog.2012.08.032

Rhinehart-Ventura, J., Eppes, C., Sangi-Haghpeykar, H., & Davidson, C. (2014). Evaluation of outcomes after implementation of an induction-of-labor protocol. American Journal of Obstetrics and Gynecology,

211(3):301.e1-7. https://doi.org/10.1016/j.ajog.2014.05.007

Rouse, D.J. Owen, J., & Hauth, J.C. (2000). Criteria for failed labor induction: Prospective evaluation of a standardized protocol. Obstetrics & Gynecology, 96(5): 671–677. Obstetrics & Gynecology:

https://journals.lww.com/greenjournal/pages/articleviewer.aspx?year=2000&issue=11000&article=00006&type=Fulltext


https://doi.org/10.1002/14651858.CD006947

https://doi.org/10.1016/j.ajog.2007.08.026



https://journals.lww.com/greenjournal/pages/articleviewer.aspx?year=2000&issue=11000&article=00006&type=Fulltext


Decreasing Pregnancy-Related Venous Thromboembolic Events (VTE) with Adoption of a

Standardized Pregnancy VTE Bundle

Women and Infant Clinical CommunityLT Kevin Jiles, MC USN, Capt Jameaka Hamilton, MC USAF, LTC Erin Keyser, MC USA,

COL David Hsieh, MC USAF, CDR Lucas Muller, MC USN, Theresa Hart, RN, NCC-E, MS, Victoria M. Fratto, MD, CDR Monica Lutgendorf, MC USN


Learning Objectives

At the end of the presentation, the participants will be able to: 1. Discuss VTE in pregnancy & maternal morbidity/mortality.2. Summarize current recommendations for VTE prophylaxis.3. Recognize the importance of VTE screening and pharmacoprophylaxis after cesarean delivery.

https://www.europeanpharmaceuticalreview.com/news/42756/vte-therapeutics-market-3-billion-2025/


https://www.europeanpharmaceuticalreview.com/news/42756/vte-therapeutics-market-3-billion-2025/


Background

VTE in Pregnancy

∎ 0.2 to 2/1,000 pregnancies∎ 50% postpartum∎ 9% of maternal deaths in U.S.

97% of are preventable

Risk Factors

∎ Obesity∎ Cesarean Delivery

Quadruple risk compared to spontaneous vaginal delivery (SVD) 3/1,000 deliveries

http://www.youandbloodclots.com/en-vte/home


http://www.youandbloodclots.com/en-vte/home


California Pregnancy-Associated Mortality Review (CA-PAMR)

Main EK, McCain CL, Morton CH, Holtby S, Lawton ES. Pregnancy-Related Mortality in California Causes, Characteristics and Improvement Opportunities. Obstet Gynecol 2015;125:938-947



Virchow’s Triad

Pregnancy exacerbates all three factors!


https://www.researchgate.net/figure/rchows-triad-of-the-three-broad-categories-of-factors-that-are-thought-to-contribute-to_fig1_317266064


VTE Prevention

∎Mechanical Pneumatic compression devicesRecommend before cesarean

∎ ChemoprophylaxisLow molecular weight heparinCesarean delivery + risk factors


https://www.hopkinsmedicine.org/armstrong_institute/improvement_projects/infections_complications/VTE/patients.html

https://www.hopkinsmedicine.org/armstrong_institute/improvement_projects/infections_complications/VTE/patients.html


VTE Risk Categories

Prenatal, Antenatal Admission, Birth Admission, Postpartum, Dischargecmqcc.org



MAJOR VTE RISK FACTORS MINOR VTE RISK FACTORS BMI > 35 kg/m2 @ delivery Low risk thrombophilia Postpartum hemorrhage requiring:

Transfusion or further operation, (e.g. hysterectomy, D&C) or Interventional Radiology procedure

Infection requiring antibiotics Antepartum hospitalization ≥ 72 hours, current

or within the last month Chronic medical conditions: Sickle Cell disease,

Systemic Lupus Erythematosus, Significant Cardiac disease, active Inflammatory Bowel Disease, active cancer, Nephrotic syndrome

Multiple gestation Age > 40 Postpartum hemorrhage ≥1000 ml but not

requiring:Transfusion or further operation, (e.g. hysterectomy, D&C) or Interventional Radiology procedure

Family history of VTE (VTE occurring in a first-degree relative prior to age 50)

Smoker Preeclampsia

Women with one major or two minor risk factors should receive in-hospital post cesarean pharmacologic prophylaxis

*D&C – dilatation and curettagecmqcc.org

Risk factors



Clinical History Risk Level Prophylaxis Regimen

Encourage ambulation and avoid dehydration at all risk levels.All women having cesarean birth receive mechanical prophylaxis.

Not meeting medium or high risk criteria LOW

Mechanical prophylaxis placed prior to cesarean and continued until fully ambulatory

Cesarean Delivery with 1Major or > 2 Minor Risk Factors

MEDIUM

Mechanical prophylaxis placed prior to cesarean and continued until fully ambulatory PLUS

Prophylactic dose LMWH / UFH postpartum, continue until discharge

Prior VTEHigh risk thrombophilia Already on anticoagulant

HIGHMechanical prophylaxis placed prior to

cesarean and continued until fully ambulatory PLUS

Patient specific anticoagulation plan *LMWH – low molecular weight heparinUFH – unfractioned heparin

cmqcc.org

Risk factors



PROPHYLACTIC HEPARINLMWH (Enoxaparin fixed dose 40 mg once a day) orUFH dosing trimester dependent (ACOG 2013)Low Dose UFH 5,000 U SQ BID

THERAPEUTIC HEPARINLMWH (Enoxaparin 1 mg/kg twice a day) orUFH 10,000 international units or more subcutaneously every 12 hours adjusted to target aPTT (1.5-2.5) 6 hours after injection

https://en.wikipedia.org/wiki/Thrombosis_prevention

Risk factors


https://en.wikipedia.org/wiki/Thrombosis_prevention


Objective

Improve VTE screening and thromboprophylaxis in women undergoing cesarean delivery



Methods

∎Approved Quality Improvement ProjectNaval Medical Center San DiegoBrooke Army Medical CenterFt. Belvoir Community Hospital

∎ Baseline VTE Rates∎ Reviewed current VTE risk assessment and prophylaxis following cesarean∎ Interdisciplinary Education on risk assessment and post-cesarean prophylaxis ∎ Post-delivery VTE Risk Assessment in Essentris∎ Post-delivery VTE Order Set



Results

∎ Cesarean Sections from APR to JUN 2019 collected (n = 196)∎ Current Risk Factor Assessment Complete: 91% (n=178)Early Ambulation: 41% (n = 72)Sequential Compression Devices (SCD) only: 56% (n = 100)SCD + Chemoprophylaxis: 2.2% (n = 4)

∎New Guidelines – VTE Risk Re-assessment Low: 61% (n = 120), SCDs only recommendedMedium: 38% (n = 75), SCDs + chemoprophylaxis recommended

∎Most common risk factor contributing to medium risk in cesarean deliveries: body mass index (BMI) > 35 kg/m2



Conclusions

∎ Significant discrepancy between VTE prophylaxis practices and new recommendations from CMQCC Toolkit

∎ 36% increase in SCD + pharmacoprophylaxis after cesarean delivery

∎ Primarily due to BMI > 35 kg/m2



Future Aims

∎ Expand this project across the MHS/DHA

∎ Expand to prenatal visit assessment, antenatal admission assessment, inclusion of postpartum vaginal deliveries

∎ Compare VTE incidence before and after implementation of toolkit



Team MembersNaval Medical Center San Diego Brooke Army Medical Center

CDR Monica Lutgendorf, WICC ChairDr. Victoria Fratto, MD, MFMLT Kevin Jiles, Obstetrics & Gynecology ResidentJeffrey Budge, RN, Clinical Quality NMCSDLT Kristin Hildebrandt, L&D NurseLT Melissa Schmidt, RN, L&D Nurse OICRN Anne Taylor, Antepartum NursingDr. Michael Bogue, MD, OB AnesthesiaDr. Wenonah Usher, MD, OB AnesthesiaCDR Tiffany Uranga, CRNA

Col David Hsieh, WICC Air Force RepresentativeLTC Erin Keyser, WICC Army RepresentativeLt Col Dalia Wenckus, MD MFMCapt Jameaka Hamilton, OBGYN ResidentCPT Mario Macias, Staff OBGYNMAJ Jordan Yokley, OB AnesthesiaCapt Courtney Hood, Anesthesia ResidentLt Col Amber Barker, CNSLawanda Clark, L&D OICDanielle Merritt, RN Postpartum

Fort Belvoir Community Hospital Defense Health Agency

CDR Lucas Mueller, WICC TiMO RepresentativeLtCol Jenni Pickinpaughinocenio, OB/GYNMAJ Lauren Potts, AnesthesiaLCDR Merium Mays, L&D Nurse OICLT Allison Eubanks, Obstetrics & Gynecology Resident

Theresa Hart, RN NCC-E MSDr. Katharine NeufeldDr. Kelly BickelCOL Cynthia SanchezMeaghan Meeker, BAH ContractorDenise Hargrove, BAH Contractor



Key Takeaways

∎ Significant discrepancy between VTE prophylaxis practices and new recommendations from CMQCC Toolkit

∎ In our patient population, we noted a 36% increase in SCD + pharmacoprophylaxis after cesarean delivery, primarily due to BMI > 35 kg/m2

∎Opportunities exist to increase VTE screening in pregnancy



ReferencesAmerican College of Obstetricians and Gynecologists (ACOG). (2018). ACOG Practice Bulletin No. 196: Thromboembolism in pregnancy. Obstetrics & Gynecology, 132(1): e1-e17.

https://doi.org/0.1097/AOG.0000000000002706

California Maternal Quality Care Collaborative (CMQCC). (2018). Improving Health Care Response to Maternal Venous Thromboembolism. CMQCC: https://www.cmqcc.org/resources-

toolkits/toolkits/improving-health-care-response-maternal-venous-thromboembolism

Creanga, A.A., et al. Pregnancy-Related mortality in the United States, 2006-2010. Obstetrics & Gynecology, 2015. 125(1): p. 5-12.

Friedman, A.M., Ananth, C.V., Pendergrast, E., Chauhan, S.P., D’Alton, M.E., & Wright, J.D. (2015). Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations.

American Journal of Obstetrics and Gynecology, 212(2): 221.e1-221.e12. https://doi.org/10.1016/j.ajog.2014.09.017


https://doi.org/0.1097/AOG.0000000000002706



THANK YOUUS Army Analysis and Evaluation Division,

Directorate of Program Analysis & EvaluationRN Dawn M. Garcia, MHA, FACHE

Risk factors

51


Postpartum Hemorrhage BundleDEFENSE HEALTH AGENCYHIGH RELIABILITY ORGANIZATIONProgram Integration Office

January 2020


Learning Objectives

At the end of the presentation, the participants will be able to: 1. Discuss the standard definition of postpartum hemorrhage.2. Explain definitions of severe maternal morbidity (SMM).3. Recognize the importance of a standardized systems response to obstetric

hemorrhage.



Background – Clarifying the Problem

∎ BLUF: The MHS has no standardized mechanism for comprehensive risk assessment or prompt treatment of postpartum hemorrhage (PPH) to prevent maternal complications. PPH is not necessarily preventable. Risk assessment

and early treatment of PPH has been demonstrated to decrease the severity of bleeding and adverse outcomes for the mother.

During implementation of the Navy PPH bundle, the Navy was able to reduce maternal sentinel events (SE) to zero

Maternal SE include unintended death, permanent harm, or temporary harm (defined as four or more unit blood product transfusion and/or ICU admission) per The Joint Commission

∎ In-Scope

Five tIMO sites: Naval Hospital Jacksonville, Fort Belvoir Community Hospital, Walter Reed National Military Medical Center, Keesler Air Force Base, Army Medical Center Womack

∎ Out-of-Scope All care outside of obstetric care at five tIMO

sites∎ Time Line

March 2018-December 2019

Navy’s Implementation of Postpartum Hemorrhage Bundle in 2016*tIMO – Transitory Intermediate Management Office



Historic Data from the Navy

∎ DHA adopted the Navy Obstetrical Hemorrhage Bundle, based on decreased maternal morbidity events across the Navy Decreased Hysterectomies (73%) Decreased Blood Transfusions (5%) Decreased ICU Admissions (8%)



Standard Definition for Postpartum Hemorrhage

Adopted by MHS in January of 2015COUNCIL ON PATIENT SAFETY IN WOMEN’S HEALTH CARE developed the reVITALize Obstetric Data Definitions which are formally endorsed by the following organizations:

American Academy of Family Physicians American College of Nurse-Midwives The American College of Obstetricians and Gynecologists/The American Congress of Obstetricians and Gynecologists Association of Women's Health, Obstetric and Neonatal Nurses Society for Maternal-Fetal Medicine

∎ Cumulative blood loss of GREATER THAN or equal to (>=)1000ml or blood loss accompanied by sign/symptoms of hypovolemia within 24 hours following the birth process (includes intrapartum loss). Cumulative blood loss of 500-999ml alone should trigger increased supervision and potential interventions as

clinically indicated



Severe Maternal Morbidity & Sentinel Events

Severe Maternal Morbidity (Centers for Disease Control & Prevention): Severe maternal morbidity (SMM) includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman’s health

Severe Maternal Morbidity Sentinel Event (The Joint Commission): A patient safety event that occurs intrapartum through the immediate postpartum period (24 hours) that requires: The transfusion of 4 or more units of RBCs (previously defined as blood products, such as fresh frozen

plasma, packed red blood cells, whole blood, platelets) And/or admission to the ICU



Break Down the Problem/ Identify Performance Gaps

∎ Lack of standardized process for comprehensive risk assessment and readiness for equipment and resources can: Lead to increased incidence and severity of PPHDecrease response and recognition of PPH

∎ At baseline, MHS-wide rate of PPH is 5.9%, which is higher than National Perinatal Information Center (NPIC) benchmark of 5.8% (Average of Calendar Year (CY)2018 Q1 and Q2)

∎ At baseline, MHS-wide rate of PPHs receiving blood transfusion is 24.4% which is below the NPIC benchmark of 24.8% (Average of CY2018 Q1 and Q2)



Alliance for Innovation in Maternal Care

∎ The Alliance for Innovation on Maternal Health (AIM) is a national data-driven maternal safety and quality improvement initiative based on proven implementation approaches to improving maternal safety and outcomes in the U.S.

∎ Creation of multiple evidence-based, collaborative Maternal Safety BundlesMaternal Mental Health: Depression and AnxietyMaternal Venous ThromboembolismObstetric Hemorrhage Postpartum Care Basics for Maternal Safety Prevention of Retained Vaginal Sponges after Birth Reduction of Peripartum Racial/Ethnic Disparities Safe Reduction of Primary Cesarean Birth Severe Hypertension in Pregnancy



Alliance for Innovation in Maternal Care



Quantitative Blood Loss (QBL)

∎ Quantification of Blood Loss (QBL) QBL is an objective method used to evaluate excessive bleeding.Weigh all blood-soaked materials and clots to determine cumulative volume. 1 gram weight = 1 milliliter blood loss volume

∎ Methods to quantify blood loss, such as weighing, are significantly more accurate than Estimates of Blood Loss (EBL)

∎ QBL reduces the likelihood that clinicians will underestimate the volume of blood lost and delay early recognition and treatment.



Identifying Solutions

Gap(s)Addressed

Solution (If We Implement…) Expected Outcome (Then We Expect…)

Readiness • Standardized resources (medication and supplies) for early response to OB emergencies and initiation of Massive Transfusion Protocol

• Frequent interdisciplinary in-situ drills and standardized education for providers

• Immediate access to resources including blood products to treat PPH

• Improved interdisciplinary team coordination during PPH event

Recognition • Standardized use of Quantitative Blood Loss (QBL) and active management of third stage of labor

• Standardized PPH risk assessment and documentation in electronic medical record (EMR)

• 20-30% reduction in total blood transfusion due to more accurate quantification of blood loss and assessment of PPH risk status

Response • Standardized response to PPH with stage-based checklist • 20-30% reduction in massive transfusion due to early intervention per checklist

Reporting • Standardized outcome measures • Increased awareness and earlier diagnosis of PPH due to preoccupation with failure driving continued process improvement

• 100% bundle implementation



Postpartum Hemorrhage Bundle

• DHA WICC developed a DHA PI for PPH standardized practice and outcome metrics using both national (Alliance for Innovation in Maternal Care PPH bundle) and Service (Navy Obstetric Hemorrhage Bundle version 2.0) resources

Navy data reflected a reduction in maternal sentinel events (SE)* after implementing their PPH bundle

• PPH bundle is a priority in Quadruple Aim Performance Plan (QPP) supplemental for Fiscal Year (FY) 2021.

*Maternal SE include unintended death, permanent harm, or temporary harm (defined as four or more unit blood product transfusion and/or ICU admission) per The Joint Commission


*DHA - Defense Health AgencyPI - Procedural Instruction


Policy Update

• DHA-Procedural Instruction (PI) is in formal coordination

• Standardization of equipment, process, policies and responses are the key to success of this initiative. Essentris documentation feature changes & updates – i.e. quantifiable blood loss (QBL) Expansion into Genesis is part of the WICC implementation plan

• Guidance for implementation is available through the High Reliability Network (HRN) WICC website



PPH Bundle Components –Implementation Checklist

Full Implementation of OB Emergency Cart?Carts are stocked and available in each Operating Room, in Labor & Delivery area, postpartum area. Number is unique to each MTF based on volume and acuity

Full Implementation of PPH Risk Assessment?EMR (Essentris) H&P, Clinical Notes have the agreed upon Risk assessment for low, moderate and high.

Full Implementation of QBL?Policy within MTF to measure blood loss during delivery and postpartum for quantitative measurement of blood loss.

Full Implementation of Stage-Based Checklist?Physical check list on the Code Purple cart that lists the actions in Stages 1-3 of postpartum hemorrhage.

Full Implementation of MTP?All personnel aware of how to activate MTP; blood bank in agreement with protocol; MTP part of unit drills; MTF able to meet par levels for blood products, MTP includes emergency release

Full Implementation of Education & Training?PPH education included in orientation and every 2 years; drills scheduled every 2 years; patient education about PPH provided during admission

Full Implementation of Oxytocin Protocol?Oxytocin Standard Operation Procedure developed for MTF, programmable IV pumps available, education done about protocol



Measures of Success

Consistent with the QPP Supplemental FY 2021, CMT will collect and report the following measures for each Military Medical Treatment Facility (MTF) with inpatient obstetric services:

More guidance forthcoming about collection of metric data

* Metrics will be facility specific time series measures, not intended for inter-hospital comparisons.



Severe Maternal Morbidity (SMM)

• Currently, NPIC data/quarterly reports – w/ SMM metrics review• Heat Maps and specific numerator cases sent to Services

• SMM Workgroup (WICC) – standardized process for morbidity & mortality review committees across MHS

• SMM reviews to be conducted to identify systems and processes that can be improved

• SMM metrics, such as ICU admissions within facilities, could also be monitored

*NPIC – national Perinatal Information Center



Key Takeaways∎ Postpartum Hemorrhage is defined as cumulative blood loss of GREATER THAN or EQUAL TO

1,000 mL OR blood loss accompanied by signs or symptoms of hypovolemia within 24 hours following the birth process (includes intrapartum blood loss. Cumulative blood loss of 500-999ml alone should trigger increased supervision and potential interventions as clinically indicated

∎ Severe Maternal Morbidity (Centers for Disease Control & Prevention): Severe maternal morbidity (SMM) includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman’s health

∎ Severe Maternal Morbidity (Joint Commission): A patient safety event that occurs intrapartum through the immediate postpartum period (24 hours) that requires:Transfusion of 4 or more units of RBCsAnd/or admission to the ICU

∎ A standardized systems response to PPH results in improved patient outcomes



Resources

∎ High Reliability Network (HRN) Website:∎ Postpartum Hemorrhage Bundle ∎ https://info.health.mil/sites/hro/WICC/PPH/Forms/AllItems.aspx

∎ Induction of Labor Care Pathway∎ https://info.health.mil/sites/hro/WICC/IOL/Forms/AllItems.aspx

WICC Mailbox: [email protected]


https://info.health.mil/sites/hro/WICC/PPH/Forms/AllItems.aspx

https://info.health.mil/sites/hro/WICC/IOL/Forms/AllItems.aspx

mailto:[email protected]


ReferencesAmerican College of Obstetricians and Gynecologists (ACOG). (2014). Obstetric Data Definitions. https://www.acog.org/-/media/Departments/Patient-Safety-and-Quality-

Improvement/2014reVITALizeObstetricDataDefinitionsV10.pdf?dmc=1&ts=20200107T1650061822

American College of Obstetricians and Gynecologists (ACOG). Severe maternal morbidity: screening and review. Obstetrics & Gynecology. 128(3):670-671. Obstetric Care Consensus No. 5.

The Centers for Disease Control and Prevention (CDC). (2017). Severe Maternal Morbidity in the United States.

https://www.cdc.gov/reproductivehealth/maternalinfanthealth/severematernalmorbidity.html


https://www.acog.org/-/media/Departments/Patient-Safety-and-Quality-Improvement/2014reVITALizeObstetricDataDefinitionsV10.pdf?dmc=1&ts=20200107T1650061822

http://www.acog.org/Resources-And-Publications/Obstetric-Care-Consensus-Series/Severe-Maternal-Morbidity-Screening-and-Review

https://www.cdc.gov/reproductivehealth/maternalinfanthealth/severematernalmorbidity.html


Questions

Questions?


How to Obtain Continuing Education Credits

To receive CE/CME credit, you must register by 0745 ET on 24 January 2020 to qualify for the receipt of CE/CME credit or certificate of attendance. You must complete the program posttest and evaluation before collecting your certificate. The posttest and evaluation will be available through 6 February 2020 at 2359 ET. Please complete the following steps to obtain CE/CME credit:

1. Go to URL https://www.dhaj7-cepo.com/content/clinical-communities-speaker-series-23-jan-20202. Click on the REGISTER/TAKE COURSE tab

a. If you have previously used the CEPO CMS, click login.b. If you have not previously used the CEPO CMS, click register to create a new account.

3. Click “ENROLL.”4. Follow the onscreen prompts to complete the following for each session you wish to claim CE/CME Credit:

a. Read the Accreditation Statementb. Select the CE/CME credit type(s) you are seekingc. Complete the Evaluationd. Take the Postteste. Download your Certificate(s)f. Complete the Commitment to Change survey (optional)

5. After completing the posttest at 80% or above, your certificate will be available for print or download.6. You can return to the site at any time in the future to print your certificate and transcripts at https://www.dhaj7-cepo.com/7. If you require further support, please contact us at [email protected]


https://www.dhaj7-cepo.com/content/clinical-communities-speaker-series-23-jan-2020

https://www.dhaj7-cepo.com/

mailto:[email protected]

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