1. Obstetric Care for Women with Opioid Use Disorder: The AIM Bundle
Ronald E Iverson, Jr., MD, MPH
Vice-Chair, Obstetrics, Boston Medical Center
Director, Quality Improvement, OBGYN, Boston Medical Center
Assistant Professor, Boston University
September 7, 2018

2. Disclosure
I have no financial relationships with a commercial entity producing health care related products or services related to this presentation.

4. We created this epidemic

5. How we got here OPR: Opioid Pain Reliever
Rates of opioid pain reliever (OPR) overdose death, OPR treatment admissions, and kilograms of OPR sold --- United States, 1999—2010
Sales of opioid pain relievers quadrupled
2010 Rx = enough to medicate every American adult 5mg hydrocodone (Vicodin) every 4 hours for a month
Rx opioids account for more treatment admissions than heroin
OPR: Opioid Pain Reliever

6. Overdose deaths are rising

7. There are Many different substances

8. Substance use and pregnancy associated mortality
Percent of Pregnancy-Associated Deaths Related to Substance Use by Year
Preliminary Data from Massachusetts DPH

9. Substance use is involved in mortality more often than obstetric causes

10. Most substance-use associated pregnancy mortality is after delivery
Percent of Pregnancy-Associated Deaths Related to Substance Use by Time Period
Massachusetts DPH

13. The Opioid Epidemic is overtaking other public health crises

14. Some progress is being made

15. Texas is also decreasing opioid prescriptions

16. Addressing Opioid Use Across the Life Course
Family
Pregnancy
Newborn
Infant

17. AIM OUD BUNdle goals
Improve identification and care of women with OUD through screening and linkage to treatment
Optimize Medical Care of Pregnant Women with OUD
Increase access to MAT for pregnant and postpartum women with OUD
Prevent opioid use disorder by reducing the number of opioids prescribed for deliveries
Optimize the care of Opioid Exposed Newborns by improving maternal engagement in infant management

18. Recognition and Prevention Response Reporting/ Systems learning
Readiness
Recognition and Prevention
Response
Reporting/ Systems learning

19. Readiness: health system
Provide clinical and non-clinical staff education on SUDs
SUDs are chronic medical conditions.
Stigma, bias and discrimination negatively impact pregnant women with OUD.
Provide training regarding trauma-informed care.
Emphasize that SUDs are chronic medical conditions that can be treated.
Emphasize that stigma, bias and discrimination negatively impact pregnant women with OUD and their ability to receive high quality care.
Provide training regarding trauma-informed care.

20. Readiness: health system
Establish specific prenatal, intrapartum and postpartum clinical pathways.
Patient
Case mgmt
Mental Health team
Obstetric care team
Primary care
Peer support
OUD specialist
that incorporate care coordination among multiple providers

21. Trauma-Informed Care Understand the neurobiology of trauma
Recognize the signs and symptoms of trauma in patients and families
Screen for physical and sexual violence
Coordinate care with behavioral health/psychiatric care teams
Prevent re-traumatization

22. Readiness: Health System
Identify local SUD treatment facilities
Provide women-centered care.
Wrap-around services such as housing, child care, transportation and home visitation.
Drug and alcohol counseling.
Know
State reporting guidelines regarding the use of opioid pharmacotherapy and identification of illicit substance use during pregnancy.
Federal, state and county reporting guidelines for substance-exposed infants.
Understand “Plan of Safe Care” requirements.
Ensure that OUD treatment programs meet patient and family resource needs (i.e. wrap-around services such as housing, child care, transportation and home visitation).
Ensure that drug and alcohol counseling and/or behavioral health services are provided.
Develop pain control protocols
Account for increased pain sensitivity and avoidance of mixed agonist-antagonist opioid analgesics.
Order sets.
Remove agonist/antagonists from Pyxis.

23. Readiness: OUD patient/family
OUD education
Medication Assisted Therapy (MAT) and behavioral therapy is recommended.
Family and peer support is necessary.
Recovery is possible.
NAS education
Signs/symptoms of NAS.
Neonatal consult pre-delivery.
Plan for breastfeeding.
Plan for rooming in.
Eat Sleep Console
substance use disorders (SUDs) are chronic medical conditions
treatment is available
family and peer support is necessary
recovery is possible.
Medication Assisted Therapy (MAT) and behavioral therapy are effective treatments for OUD.

24. treatment decreases deaths
Opioid agonist treatments and heroin overdose deaths in Baltimore, Maryland,
Schwartz RP1, Gryczynski J, O'Grady KE et al, Am J Public Health. 2013 May;103(5):
doi: /AJPH Epub 2013 Mar 14.

25. MAT decreases maternal overdoses
MAT Received

26. Eat, Sleep, Console
Grossman MR, Berkwitt AK, Osborn RR,et al. An Initiative to Improve the Quality of Care
of Infants With Neonatal Abstinence Syndrome. Pediatrics. 2017;139(6):e

27. Readiness: OUD patient/family
Develop a “plan of safe care” for mom & baby
Child Abuse Prevention and Treatment Act (CAPTA)
Ensure the safety and well-being of infants affected by substance use following release from health care providers.
Engage appropriate partners to assist patients & families in development of a “plan of safe care” for mom & baby

28. Recognition and Prevention: clinical setting
Assess all pregnant women for SUDs
Drug and alcohol use.
Screening, Brief Intervention and Referral to Treatment (SBIRT)
Screen for polysubstance use among women with OUD.
Utilize validated screening tools to identify drug and alcohol use.
Incorporate a screening, brief intervention and referral to treatment (SBIRT) approach in the maternity care setting.
Ensure screening for polysubstance use among women with OUD.

29. Screening tools

30. The 5 Ps
PARENTS
PEERS
PARTNER
PAST
PRESENT

31. Sbirt Screening, Brief Intervention Refer to Treatment

32. Recognition and Prevention: clinical setting
Screen for commonly occurring co-morbidities for all patients with OUD
Infectious diseases
Psychiatric disorders
Physical and sexual violence
Smoking cessation
Ensure the ability to screen for infectious disease (e.g. HIV, Hepatitis and sexually transmitted infections (STIs)).
Ensure the ability to screen for psychiatric disorders, physical and sexual violence.
Provide resources and interventions for smoking cessation.

33. checklist

34. Recognition and Prevention: clinical setting
Match treatment response to each woman’s stage of recovery and/or readiness to change.

35. Response: Medication Assisted Treatment (MAT)
For pregnant women with an opioid use disorder, opioid agonist pharmacotherapy is the recommended therapy and is preferable to medically supervised withdrawal because withdrawal is associated with high relapse rates, which lead to worse outcomes. More research is needed to assess the safety (particularly regarding maternal relapse), efficacy, and long-term outcomes of medically supervised withdrawal.

36. Response: health system
All patients with OUD are enrolled in a woman-centered OUD treatment program
Establish clinic relationships.
Link to local resources that support recovery.
Incorporate key counseling, education and resources into care pathways
Establish communication with OUD treatment providers and obtain consents for sharing patient information.
Assist in linking to local resources (e.g. peer navigator programs, narcotics anonymous (NA), support groups) that support recovery.
Breastfeeding and lactation support.
Immediate postpartum contraceptive (LARC) options.
Pain management strategies
Infant care

37. Breastfeeding education

38. Response: health system
Coordinate among providers during pregnancy, postpartum and the inter-conception period
Referrals to providers for co-morbid conditions.
Lead provider responsible for care coordination.
Communication strategy.
Engage child welfare services
Provide referrals to providers (e.g. social workers, psychiatry, and infectious disease) for identified co-morbid conditions.
Identify a lead provider responsible for care coordination, specify the duration of coordination and assure a “warm handoff” with any change in the lead provider.
Develop a communication strategy to facilitate coordination among the obstetric provider, OUD treatment provider, health system clinical staff (i.e. inpatient maternity staff, social services) and child welfare services.
Develop safe care protocols tailored to the patient and family’s OUD treatment and resource needs.

39. Reporting & Systems Learning: health system
Develop mechanisms to collect data and monitor process and outcome metrics
Inpatient and outpatient
Data dashboard measures
Outcome
Process
Create multidisciplinary case review teams
Evaluate patient, provider and system-level issues.
Develop a data dashboard to monitor process and outcome measures (i.e. number of pregnant women in OUD treatment at specified intervals).
Develop learning opportunities for providers and staff
Use data and events to educate teams

40. Reporting/ Systems Learning
AIM Outcome measures
Reporting/ Systems Learning
Pregnancy Associated Opioid Deaths
Average length of stay for newborns with Neonatal Abstinence Syndrome (NAS)

41. Reporting/ Systems Learning
Aim process measures
Reporting/ Systems Learning
Percent of OEN receiving mother’s milk at newborn discharge
Percent of women with OUD during pregnancy who receive medication assisted treatment MAT or behavioral health treatment
Percent of OEN who go home to biological mother

42. AIM Structure measures
Reporting/ Systems Learning
Percent of Prenatal Care Sites which have implemented a universal screening protocol for OUD
Percent of delivery sites using post-delivery and discharge pain management prescribing practices for routine vaginal and cesarean births focused on limiting opioid prescription
Percent of delivery sites with OUD specific pain management and opioid prescribing guidelines

43. Aim state surveillance measures
Reporting/ Systems Learning
Percent of newborns diagnosed as affected by maternal use of opiates
Percent of newborns diagnosed with NAS

44. Aim glossary Newborn Neonatal Abstinence Syndrome (NAS)
Opioid Use Disorder (OUD)/Pregnant woman with OUD
Medication Assisted Treatment (MAT)
Opioid Exposed Newborn (OEN)
Mother’s milk at discharge
Screening
Testing
Ongoing OUD training

45. Reporting & Systems Learning: health system
Connect other stakeholders with clinical providers and health systems to share outcomes and identify ways to improve systems of care
Child welfare services
Public health agencies
Court systems
Law enforcement
Engage child welfare services, public health agencies, court systems and law enforcement to assist with data collection, identify existing problems and help drive initiatives.

46. Bundle Implementation
Multidisciplinary team
Agreement on Aims
PDSA testing of Bundle Components
Follow Process and Balancing Measures
Incorporate into the EMR
Education/Simulations
Incorporate into Policy

47. Tools and Resources: Slide Decks
Stigma
Screening
The Alliance for Innovation on Maternal Health, or AIM, is a multidisciplinary partnership whose goal is to eliminate preventable maternal mortality and severe morbidity in every US birth center by promoting safe maternal care for every US birth, engaging partners at the national, state, and local health levels, developing and implementing evidence based maternal safety bundles, utilizing data driven quality improvement strategies, aligning existing safety efforts, and developing/collecting resources. Rather than working in a silo, AIM facilitates collaboration between national organizations, states, and hospitals that are already doing work on maternal mortality. Our partner organizations include the American Academy of Family Physicians, The American College of Nurse Midwives, The Association of Maternal and Child Health Programs, National Healthy Start, The Association of State and Territorial Health Officers, the Association of Women’s Health Obstetric, and Neonatal Nurses, and more.
NAS

48. Tools and Resources: Clinical Pathways
The Alliance for Innovation on Maternal Health, or AIM, is a multidisciplinary partnership whose goal is to eliminate preventable maternal mortality and severe morbidity in every US birth center by promoting safe maternal care for every US birth, engaging partners at the national, state, and local health levels, developing and implementing evidence based maternal safety bundles, utilizing data driven quality improvement strategies, aligning existing safety efforts, and developing/collecting resources. Rather than working in a silo, AIM facilitates collaboration between national organizations, states, and hospitals that are already doing work on maternal mortality. Our partner organizations include the American Academy of Family Physicians, The American College of Nurse Midwives, The Association of Maternal and Child Health Programs, National Healthy Start, The Association of State and Territorial Health Officers, the Association of Women’s Health Obstetric, and Neonatal Nurses, and more.
Screening Tool Chart
Checklist

49. Tools and Resources: Collaborative chart
Opioid Collaborative Aim
(Bundle Component)
Key Drivers
Interventions
Resources
Metrics
Improve identification and care of women with OUD through screening and linkage to treatment
RECOGNITION
Universal Prenatal Screening
Brief Intervention
Referral to Treatment
Map local resources:
-Identify existing models
-Identify partners to receive referrals
-Establish protocols for referral
Select validated screening tool
Train staff to use screening tool
Assess screen positive women for OUD
Link women with OUD to OB and OUD treatment services
List of Validated Screening Tools
AIM Provider Education Slide Decks:
AIM Stigma Slides
AIM Screening Slides
ACOG Committee Opinions:
ACOG CO 711 “Opioid Use and Opioid Use Disorder During Pregnancy”
Screening resources:
-NNEPQIN local resource mapping template
-SAMHSA Guidance
-SnuggleME
-SBIRT Oregon
-WA State Screening Guidelines
-NNEPQIN Guidelines
-WHO Guidelines
Other Resources:
ACOG District II Slide Deck
1. (S1) Percent of Prenatal Care Sites which have implemented a universal screening protocol for OUD (Required AIM Structure Measure)
Denominator: Number of PNC sites associated with delivery sites Numerator: Among the denominator, those sites using universal screening for OUD with all pregnant patients
The Alliance for Innovation on Maternal Health, or AIM, is a multidisciplinary partnership whose goal is to eliminate preventable maternal mortality and severe morbidity in every US birth center by promoting safe maternal care for every US birth, engaging partners at the national, state, and local health levels, developing and implementing evidence based maternal safety bundles, utilizing data driven quality improvement strategies, aligning existing safety efforts, and developing/collecting resources. Rather than working in a silo, AIM facilitates collaboration between national organizations, states, and hospitals that are already doing work on maternal mortality. Our partner organizations include the American Academy of Family Physicians, The American College of Nurse Midwives, The Association of Maternal and Child Health Programs, National Healthy Start, The Association of State and Territorial Health Officers, the Association of Women’s Health Obstetric, and Neonatal Nurses, and more.

50. Bundles = complete care
Readiness
Recognition and Prevention
Response
Reporting/ Systems learning

51. Thank you

54. Readiness: Plan of Safe Care
Child Abuse Prevention and Treatment Act (CAPTA)
Ensure the safety and well-being of infants affected by substance use following release from health care providers
Address the health and substance use disorder treatment needs of the infant and family
Refer and deliver appropriate services to the infant and affected family or caregiver

55. Reporting/ Systems Learning
AIM Outcome measures
Reporting/ Systems Learning
Outcome Measures (O)
Description
Data Source
Frequency
Notes
O1: Pregnancy Associated Opioid Deaths
Denominator: Number of women delivering in that year Numerator: Among the denominator, those with opioid related death within 1 year of delivery
State Data
Annually
Maybe consistently delayed by 1-2 years based on state data availability
O2: Average length of stay for newborns1 with Neonatal Abstinence Syndrome (NAS)2
Denominator: Number of newborns ≥35 weeks gestation diagnosed with NAS Numerator: Among the denominator, total number of hospital days
Hospital Data Form/ State Data and ICD 10 code/ Linked LOS P96.1 Neonatal withdrawal symptoms from maternal use of drugs of addiction

56. Reporting/ Systems Learning
AIM PROCESS MEASURES
Reporting/ Systems Learning
Process Measures (P)
Description
Data Source
Frequency
Notes
P1: Percent of women with OUD3 during pregnancy who receive medication assisted treatment MAT4 or behavioral health treatment
Denominator: Women with OUD Numerator: Among the denominator, those who received MAT or behavioral treatment during pregnancy
Hospital data form
Quarterly
ACOG currently recommends MAT for Opioid using pregnant women and does not recommend detox. Discussion about alternative treatment courses and women who may use MAT at some point in pregnancy, but not at delivery create differences in approach to this measure Optional- may specify prescribed and non-prescribed opioid type AIM Bundle: Response
P2: Percent of OEN5 receiving mother’s milk at newborn discharge
Denominator: Number of OEN ≥35 weeks gestation Numerator: Among the denominator, those receiving some mother’s milk at the time of discharge
Hospital data form log is preferred method of collection For ICD-10 code method of collection use:
100% is not the goal; there are circumstances in which mother’s milk is contraindicated AIM Bundle: Response
P3: Percent of OEN5 who go home to biological mother
Denominator: Number of OEN ≥35 weeks gestation Numerator: Among the denominator, those who are discharged to biological mother
Consulting safe plans of care and other child welfare policies. Highlight success of plan with mothers who engage in treatment. Sites may collect other discharge dispositions to define this measure 100% is not the goal; there are circumstances in which discharge to biological mother is contraindicated AIM Bundle: Response

57. AIM Structure measures
Reporting/ Systems Learning
Structure Measures (S)
Description
Data Source
Frequency
Notes
S1: Percent of Prenatal Care Sites which have implemented a universal screening7 protocol for OUD
Denominator: Number of PNC sites associated with delivery sites Numerator: Among the denominator, those sites using universal screening for OUD with all pregnant patients
Hospital/PNC Site Survey
annually
This will include SBIRT, linkage to care, brief intervention, and referral PNC sites includes provider groups, delivery sites AIM Bundle: Recognition & Prevention
S2: Percent of delivery sites using post-delivery and discharge pain management prescribing practices for routine vaginal and cesarean births focused on limiting opioid prescription
Denominator: Total delivery sites Numerator: Among the denominator, those sites with guidelines for pain management prescriptions in line with safe prescribing practices
State or hospital survey entered into AIM data portal
annually (one time for site)
Focus on reduction in unnecessary opioid prescriptions after delivery and on primary prevention of OUD Guidelines may include: ●Policy statements on the importance of decreasing opioid prescription ●Template or order set with limited use of opioids AIM Bundle: Readiness
S3: Percent of delivery sites with OUD specific pain management and opioid prescribing guidelines
Denominator: Total delivery sites Numerator: Among the denominator, those sites with OUD specific pain management including opioid prescribing guidelines
Hospital survey
Guidelines should include: ●Respect for a mother’s request to not have pain medication ●Access to sufficient medication to manage pain in relation to preexisting pain management plan of care Protocol/policy/guidelines/order sets all pertaining to patients with OUD are considered relevant for this measure AIM Bundle: Readiness

58. Aim STATE surveillance measures
Reporting/ Systems Learning
State Surveillance (SS) Measures
SS1: Percent of newborns diagnosed as affected by maternal use of opiates
Denominator: Number of newborns Numerator: Among the denominator, those diagnosed as affected by maternal use of opiates
Clinical Criteria from Hospital Data/ State Data and ICD 10 code P96.1 Neonatal withdrawal symptoms from maternal use of drugs of addiction P04.49 Newborn affected by maternal use of other drugs of addiction P04.14 Newborn affected by maternal use of opiates (new in October 2018)
Annually
short term goal is not to decrease these; improved screening will likely result in increase
SS2: Percent of newborns diagnosed with NAS
Denominator: Number of newborns Numerator: Among the denominator, those diagnosed with NAS
Hospital Data Form/ State Data and ICD 10 code P96.1 Neonatal Withdrawal Symptoms from Maternal Use of Opioids
short term goal is not to decrease these; improved screening will likely result in increase SS2 is a subset of SS1

59. Reporting/ Systems Learning
AIM glossary
Reporting/ Systems Learning
GLOSSARY
TERM
DEFINITION
1. Newborn
Infant admitted at 0 days old, transfer admission up to 1 week old, or readmission from home/ER/clinic up to 1 week old *Admitted at less than 7 days old
2. Neonatal Abstinence Syndrome (NAS)
Refer to ICD 10 Code P96.1 Neonatal Withdrawal Symptoms from Maternal Use of Drugs of Addiction
3. Opioid Use Disorder (OUD)/ Pregnant Woman with Opioid Use Disorder
Clinical Criteria: All women delivering at your hospital with: • positive self-report screen or positive opioid toxicology screen during pregnancy and assessed to have OUD, or • Patient endorses or reports misuse of opioids / opioid use disorder, or • using non-prescribed opioids during pregnancy, or • using prescribed opioids chronically for longer than a month in the third trimester
4. Medication Assisted Treatment (MAT)
Medication Assisted Treatment (MAT): the use of FDA- approved medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders (SAMHSA, 2018)
5. Opioid Exposed Newborn ≥ 35 weeks (OEN)
Clinical Criteria: All infants of mothers with opioid use disorder if mother has: • positive self-report screen or positive opioid toxicology screen during pregnancy and assessed to have OUD, or • Patient endorses or reports misuse of opioids / opioid use disorder, or • using non-prescribed opioids during pregnancy, or • using prescribed opioids chronically for longer than a month in the third trimester, or • if newborn has an unanticipated positive neonatal cord, urine, or meconium screen for opioids. ● if newborn affected by maternal use of opioids including NAS Using ICD-10 data will not be as accurate as clinical criteria above and will require a linkage of mother and baby discharge codes for best estimate and so is not recommended for routine use. Log created from hospital data form is preferred method of data collection. If using ICD-10 data, check both infant and maternal diagnoses: Newborn affected by maternal use of opiates P96.1 Neonatal withdrawal symptoms from maternal use of drugs of addiction P04.49 Newborn affected by maternal use of other drugs of addiction P04.14 Newborn affected by maternal use of opiates (new in October 2018) And Maternal codes for Opioid abuse, dependency, or use: F11.xx *Note: For process measures that use OEN ≥ 35 weeks as the denominator, this is limited to those OEN ≥ 35 who were discharged home (i.e. exlclude those who were discharged to another NICU/ death, etc)*
6. Mother's milk at discharge
Mother's Milk at Discharge: Any ongoing plan for use of some mother's milk after discharge
7. Screening
Screening: Verbal and written questions regarding opiate use. Screening tests include NIDA, 4Ps, 5Ps and others; refer to AIM screening tool guide
8. Testing
A biologic test of serum, urine, hair for presence of opioids
9. Ongoing Opioid Use Disorder (OUD) Training
Structured education completed every 2 years

60. 2018 Improvement Initiative Goals: MASSACHUSETTS-- pnqin
Measure
Improve the care of women with perinatal opioid use
Increase the percent of mothers of infants at risk for NAS who are on MAT at time of delivery
Increase family engagement in care of infant at risk for NAS
Increase the percent of infants at risk for NAS who are receiving mother’s milk at time of hospital discharge
Improve follow-up of newborns and families impacted by perinatal opioid use
Increase the percent of infants with NAS enrolled in EI at 1 year of age

61. Perinatal Opioid Use: Goals and Measures in MASSACHUSETTS
Family
Pregnancy
Newborn
Infant
Improve care of women with opioid use disorder (OUD)
Percent of mothers with OUD in medication assisted treatment (MAT)*
Percent of mothers screened for OUD in pregnancy
Improve care of opioid-exposed newborns (OEN) by increasing family engagement
Percent of OENs receiving mother’s milk at discharge*
Percent of OENs rooming in during hospitalization
Percent of OENs requiring pharmacologic therapy for NAS
Improve follow-up and support of families impacted by perinatal opioid use
Percent of infants with NAS enrolled in EI at 1 year of age*
Readmission rate for infants with NAS
Percent of mothers with OUD receiving MAT 1 year after delivery
* Primary outcome measures