new york state opioid use disorder (oud) in pregnancy ... · (oud) in pregnancy and neonatal...

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New York State Opioid Use Disorder (OUD) in Pregnancy & Neonatal Abstinence Syndrome (NAS) Project

Recruitment Package

August 21, 2018

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TABLE OF CONTENTS This Recruitment Package provides details about the New York State (NYS) Opioid Use Disorder (OUD) in Pregnancy and Neonatal Abstinence Syndrome (NAS) Project. Once pilot sites have submitted their Participant Form (Attachment 1), the Pre-work Package and more information will be sent to help each team prepare for the project’s Informational Calls and first in-person Learning Session.

Introduction: Overview of the Learning Collaborative ................................................................................. 3

Purpose and Goals of the New York State (NYS) Opioid Use Disorder (OUD) in Pregnancy and Neonatal

Abstinence Syndrome (NAS) Project ......................................................................................................... 3

Collaborative Design ............................................................................................................................. 4

Collaborative Expectations ................................................................................................................... 6

Project Schedule ....................................................................................................................................... 8

Appendix A: Project and Team Expectations ................................................................................................ 9

Appendix B: Project Leadership and Faculty .............................................................................................. 11

Attachment 1: New York State (NYS) Opioid Use Disorder (OUD) in Pregnancy/Neonatal Abstinence

Syndrome (NAS) Project Participant Form .................................................................................................. 13

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Introduction: Overview of the Learning Collaborative

Purpose and Goals of the New York State (NYS) Opioid Use Disorder (OUD) in Pregnancy and

Neonatal Abstinence Syndrome (NAS) Project

This project is designed to enable hospital teams to improve care for both pregnant women with OUD and infants with NAS. It will require that teams engage with energy, skill and compassion. Together, we can identify and disseminate strategies that will serve as a model for improving practice and outcomes.

The project’s goal of improving the identification and treatment of pregnant women with OUD will be achieved by:

• Delivering provider and patient education;

• Implementing universal screening (verbal);

• Improving the management of patients during labor, delivery and immediately postpartum;

• Coordinating discharge care; and

• Collaborating across hospital teams to share and learn.

The project’s goal of improving the care of infants with NAS will be achieved by:

• Delivering provider and patient education;

• Improving early identification of infants at risk;

• Improving the management of patients using standardized NAS treatment protocols, including pharmacological and non-pharmacological management;

• Coordinating discharge care; and

• Collaborating across hospital teams to share and learn. This initiative will include 10 to 15 NYS birthing hospitals, selected as pilot sites based on the high rates of OUD and NAS in the populations they serve, and their interest in the project. Through this project, select pilot sites will work with the New York State Department of Health’s (NYSDOH) New York State Perinatal Quality Collaborative (NYSPQC), American College of Obstetricians and Gynecologists (ACOG) District II, Healthcare Association of New York State (HANYS), Greater New York Hospital Association (GNYHA) and National Institute for Children’s Health Quality (NICHQ) for 18-24 months to implement evidence-based interventions to improve maternal and infant outcomes. Participating birthing hospitals will learn and apply key principles to improve care and implement the core interventions, and associated measures, as the primary focus of their work. These core interventions are based on currently available scientific evidence. As part of the improvement process, teams will learn quality improvement strategies, and collect data that is sensitive to the changes they will be testing and implementing, to track performance and results.

New York is participating in the national Alliance for Innovation on Maternal Health (AIM) Program, led by national ACOG. The AIM project is focused on reducing severe maternal morbidity and mortality. The NYS OUD/NAS Project aligns with the AIM project focused on Maternal Opioid Use Disorder, and the evidence-based practices outlined in the Opioid Use Disorder in Pregnancy bundle1 and ACOG District

1 https://www.acog.org/-/media/Districts/District-II/Public/PDFs/ACOG_OpioidUse_Readiness_Recognition_Prevention_FINAL_Updated_July-2018.pdf?dmc=1&ts=20180813T1829452717

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II’s White Paper2. The Challenge: Opioid Use Disorder in Pregnancy

Opioid use disorder is “a pattern of opioid use characterized by tolerance, craving, inability to control use, and continued use despite adverse consequences.”3 It is a chronic disease that is treatable and can be managed by the use of medications, along with behavioral therapy and recovery support.1 The use of opioids during pregnancy is associated with adverse outcomes for both mothers and their infants, including low birth weight and respiratory complications, as well as, “increased risk of placental abruption, preterm labor, maternal obstetric complications, and fetal death.”4

The Challenge: Neonatal Abstinence Syndrome

Neonatal abstinence syndrome is a clinical diagnosis representing the pattern of effects that are associated with opioid withdrawal in newborns (please note: NAS can also be caused by exposure to other drugs such as barbiturates, benzodiazepines and selective serotonin re-uptake inhibitors), caused by the abrupt discontinuation of chronic fetal exposure to substances that were used by the mother during pregnancy. Symptoms are affected by a variety of factors, including the type of opioid to which the infant was exposed, the point in gestation when the mother used the opioid, genetic factors, and exposure to multiple substances. Neonatal abstinence syndrome is a generalized multisystem disorder, which predominantly involves the central and autonomic nervous systems, as well as the gastrointestinal tract. Neonatal withdrawal due to prolonged maternal opioid use may be severe and intense. Although NAS is rarely fatal, it can cause significant illness and often results in prolonged hospital stays.5

The Impact In recent years, New York, like the rest of the United States, has seen a dramatic increase in the incidence of OUD and NAS. In NYS, the rate of opioid overdose deaths for females of reproductive age, 18 to 44 years old, has doubled, from 4.2 per 100,000 in 2010, to 12.7 per 100,000 in 2016.6 Between 2010 and 2014, the incidence of NAS in NYS increased 79%, from a rate of 2.9 cases per 1,000 live births in 2010, to 5.2 cases per 1,000 live births in 2014.

Collaborative Design

The project will use the Institute for Healthcare Improvement’s Breakthrough Series (BTS)7 learning model modified to meet the requirements and unique needs of this topic and context, and a quality improvement change model, the Model for Improvement8, both of which have demonstrated effectiveness in previous NYS quality improvement projects. A BTS Collaborative is a vehicle for

2 https://www.acog.org/-/media/Districts/District-II/Public/PDFs/OpioidUseDisorderinPregnancyWhitePaper.pdf?dmc=1&ts=20180813T1830150999 3 https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Opioid-Use-and-Opioid-Use-Disorder-in-Pregnancy 4 https://www.samhsa.gov/data/sites/default/files/report_2724/ShortReport-2724.html 5 Kocherlakota, 2014, Neonatal Abstinence Syndrome, Pediatrics, Volume 134, Number 2, pp. 546-562. 6 Centers for Disease Control and Prevention, National Center for Health Statistics. Multiple Cause of Death 1999-2016 on CDC WONDER Online Database, released December, 2017. Accessed at http://wonder.cdc.gov/mcd-icd10.html 7 Institute for Healthcare Improvement (IHI), Boston MA 8 The Model for Improvement was developed by Associates in Process Improvement. www.apiweb.org/API_home_page.htm

http://wonder.cdc.gov/mcd-icd10.html

http://wonder.cdc.gov/mcd-icd10.html

http://www.apiweb.org/API_home_page.htm

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identifying, testing and spreading changes that are effective for improving care and outcomes for defined populations. Participating birthing hospitals will use rapid change Plan-Do-Study-Act (PDSA) cycles to implement evidence-based changes. The project will assist participating teams in embedding strategies to measure and address disparities in care and outcomes throughout the process. Project leadership and participating pilot site hospital teams will work together for approximately 18-24 months. Over the course of the Collaborative, representatives from these hospital teams will participate in two one-day in-person Learning Sessions. In addition, leadership staff will facilitate regular contact with participating teams through e-mail, conference calls and webinars. Participants will have access to a private project website, which includes journal articles, facility policies and protocols, patient and staff education materials, information on other state initiatives, practice guidelines and quality improvement tools. Participating hospital teams will be required to submit monthly data through the secure web-based NYSDOH Health Commerce System (HCS) to track progress in achieving the project goals. This data will include measures related to the change processes and outcomes identified. Monthly data submissions will be compiled by NYSDOH staff and analyzed for all participating hospitals. Further details regarding data collection will be forthcoming. This project will engage both obstetric and neonatal/pediatric staff who provide care for the mother/newborn dyad. We hope to increase multidisciplinary care coordination of discharge care, including creating a plan for how the home environment will support the mother/newborn dyad and incorporating a social work assessment to discuss community resources available. During this pilot project, we will work together to identify strategies that will serve as a model of how to improve practice and outcomes in NYS. Early universal screening of pregnant women for substance use is recommended to improve maternal and infant outcomes9. For this reason, we ask that hospitals work with at least one affiliated prenatal care clinic to increase the use of an evidence-based screening tool to increase screening for opioid use prior to delivery. Additional details on how to partner with these prenatal care clinics will be forthcoming.

Benefits to Participation

Facilities participating in the project will benefit from:

• The opportunity to work across disciplines and the perinatal continuum of care to improve systems and processes of care for mothers and their infants who are dependent on opioids;

• Support from national and regional faculty, including trained quality improvement, obstetric, and pediatric specialists who are subject matter experts on OUD and/or NAS;

• Coaching and technical assistance, including in-person Learning Sessions, regular Coaching Call webinars, support to implement and test improvements, and real-time feedback on data to make improvements;

• Access to the project website, a virtual learning community that will be used to share resources and engage participants in ongoing discussions;

9 https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Opioid-Use-and-Opioid-Use-Disorder-in-Pregnancy

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• Opportunities to connect with other participating hospital teams to share strategies, identify lessons learned, overcome barriers and expedite the implementation of project goals; and

• The opportunity to build quality improvement knowledge and capacity that can be applied

beyond the scope of this project.

Project Planning Group

The Collaborative Planning Group includes faculty and staff from the NYSDOH, NICHQ, ACOG District II, HANYS, GNYHA, and the OUD/NAS Clinical Advisory Workgroup. Additional NYS and national subject matter experts will be called upon as needed. This planning group will:

• Share evidence-based information and examples of best practices from across the country;

• Create and refine the change package of concepts and ideas for improvement; • Coach teams on improvement methodology; • Provide communication strategies to keep participants connected to faculty and their

colleagues during the Learning Collaborative; and

• Share resources to facilitate implementation and spread of effective changes. A listing of the full Project Planning Group can be found in Appendix B.

Collaborative Expectations

Informational Calls

Hospital teams are invited to participate in one of two Informational Calls to discuss the project and review its planned activities. There are two Informational Calls, scheduled for Thursday, August 23, from 10:00 to 11:00 AM, and Wednesday, August 29, from 10:00 to 11:00 AM. Please register for one of these calls, by e-mailing [email protected]. Following the Informational Calls, teams interested in joining the project will need to complete a Participant Form (Attachment 1).

Pre-work Activities for Hospital Teams

Prior to the first in-person Learning Session, teams will complete multiple activities to accelerate the start-up of their improvement efforts and equip them to gain the most from the in-person event. These Pre-Work activities include: convening their project team; holding an internal team meeting; collecting baseline data to assess current practices; submitting their facility’s current policies or procedures; and drafting a SMART (Specific, Measurable, Achievable, Realistic, Time bounded) AIM statement aligned with overall project goals and based on a review of baseline data. The Pre-work Package will be sent to hospital teams upon registering for the Informational Call.

Learning Sessions Learning Sessions are the major integrative events of the project where multidisciplinary teams from each participating hospital come together in-person for focused content and quality improvement learning. Through plenary sessions, small group discussions and team meetings, attendees have the opportunity to:

• Learn from faculty and colleagues;

• Receive individual coaching from faculty members; • Gather new knowledge on the subject matter and process improvement; • Share experiences and collaborate on improvement plans; and

mailto:[email protected]

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• Develop strategies to overcome improvement barriers. We encourage a minimum of two to four key members from each facility team to attend the Learning Sessions, including at least one physician champion from obstetrics and one from pediatrics, or their designees, and additional team members as appropriate. Please save the date for the first in-person Learning Session, scheduled for Thursday, September 20, in Albany, NY. More details and information regarding the Learning Session will be forthcoming.

Action Periods In between in-person Learning Sessions—times called Action Periods—hospital teams will be expected to test and implement changes within their organizations to accomplish the overall project goals. Using the Model for Improvement, teams will begin with small changes, and increase in scope and scale based on lessons learned through the process.

Coaching Call Webinars During Action Periods, monthly Coaching Call webinars are held to support teams in their onsite work to

implement and test improvements. During these webinars, data and progress to date are reviewed and

time is provided for teams to share experiences and lessons learned. These webinars will convene

following the Learning Session, and will run the duration of the Collaborative. Attendance is required.

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Project Schedule

Action Item Date and Time

☐ Recruitment Package sent to potential pilot site birthing hospitals

Week of August 20

☐ Hospitals register for one Informational Call and receive confirmation email with call information and Pre-work Package

Prior to Informational Call

☐ Attend one Informational Call

August 23, from 10:00 to 11:00 AM August 29, from 10:00 to 11:00 AM

☐ All participating hospitals will need to complete three steps following the Informational Call:

1. Review the project’s Recruitment and Pre-work Packages, including all

appendices;

2. Complete and submit the Participant Form (Attachment 1) electronically

to [email protected];

3. E-mail your hospital’s existing OUD in pregnancy and/or NAS policies and

procedures (if applicable) to [email protected].

By September 14

☐ Facilities may choose to submit an application to their IRB – please note that the NYSDOH has submitted an application to its IRB

As appropriate, if required

☐ Receive acknowledgement from NYSDOH of receipt of Participant Form

Ongoing

☐ Complete the Pre-work for Learning Session 1 (located in Pre-work Package) and submit to [email protected]

September 14

☐ Attend Learning Session 1 in Albany, NY at the Empire State Plaza Meeting Rooms 4 & 7

September 20, from 10:00 AM to 3 PM




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Appendix A: Project and Team Expectations

Form a Team and Review Team Expectations

An appropriate and effective team is a key component of successful improvement efforts. Team members should be selected based on their knowledge of hospital systems and care processes that will be impacted by improvement efforts, and their commitment to make the changes needed to achieve the project aim. More detail about the specific changes will be shared at the first Learning Session. Facilities should select a team of at least five people, including one Pediatric or Neonatal Physician Champion, one Obstetric Physician Champion and one Team Lead/Coordinator. These team members should include multidisciplinary staff in your labor and delivery units and mother-baby unit(s), and other appropriate departments who care for pregnant women and/or infants and who will work together to achieve the project goals and be impacted by improvement efforts (e.g. nurses, Nurse Practitioners (NPs), Certified Nurse Midwives (CNMs), obstetrician, neonatologist, pediatrician, anesthesiologist, social worker, discharge planner, dietitian, etc.). In addition to your hospital-based team please consider including a parent representative on your team.

Team Leadership

Team activities will be guided by the Physician Champions and a Team Lead/Coordinator. The individuals in these roles may be members of the “traveling” team who will represent the team at the Learning Sessions and share their learning with other team members. Ideally, team leaders should have the following attributes: Obstetric and Pediatric Physician Champions

• Is a practicing provider who is an opinion leader and is well respected by peers; • Has authority to allocate the time and resources needed to achieve the team’s improvement

efforts;

• Has authority over areas affected by the change;

• Will champion the spread of successful changes;

• Understands the processes of care in all units caring for pregnant women, their newborns and families;

• Has good working relationships with colleagues and the Team Lead/Coordinator; and

• Wants to drive improvements in the hospital system.

Team Lead/Coordinator

• Drives the project, ensuring that cycles of change are tested and implemented; • Coordinates communication between the team, and other Collaborative teams;

• Oversees data collection; and

• Works effectively with the Physician Champions.

Team members in leadership roles should understand how changes will affect hospital systems and plan to attend all Learning Sessions.

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Selecting Other Team Members

In addition to team leaders, the team should include members from areas potentially affected by system changes. These members might include individuals who represent multiple roles including managers, quality improvement and information technology staff, etc. For this initiative, all teams should designate a data coordinator for the project.

Data Coordinator

This individual will be the primary contact for data management and will be responsible for assuring the collection and reporting of all necessary data. The Data Coordinator will ensure that timely and complete data collection and submission to the NYSDOH Health Commerce System (HCS) occurs monthly. Engaging Patients and Parent Partners

Participating hospital teams are strongly encouraged to include one or more patient/parent partners on their QI team. As Celenza et al. stated in Family Involvement in Quality Improvement: From Bedside Advocate to System Advisor10, “families are more than stakeholders in quality improvement and can serve as active partners in system design and improvement.” This collaborative is an opportunity to enhance partnerships with families and this key relationship is imperative to nurture a culture that ensures the best possible outcomes for mothers and babies. Additional details on how to identify, recruit, and partner with these team members will be forthcoming.

Team Members who should attend the Learning Session

A minimum of two to four representatives from your hospital team are expected to attend all in-person Learning Sessions. We recommend that the Day-to-Day Leader and Physician Champions attend whenever possible. Additional team members may attend as appropriate, and we strongly encourage including your team’s patient/parent partners. Please select team members who can most effectively work together, learn the methodology, and plan for action when returning to the hospital.

Team Expectations

Hospital teams participating in the project are expected to:

• Communicate and collaborate in order to promote change and improve processes;

• Recruit a patient/parent partner to share unique life experience perspective;

• Complete Pre-Work activities to prepare for the first Learning Session;

• Use rapid change cycles Plan-Do-Study-Act (PDSA) tests to implement the changes;

• Participate in monthly Coaching Call webinars;

• Regularly communicate with faculty, leadership and other teams; and

• Report on the achievement of selected measures, including details of changes made and data to support these changes.

10 Celenza et. al. Family Involvement in Quality Improvement: From Bedside Advocate to System Advisor. Clin Perinatol 44 (2017) 553–566.

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Appendix B: Project Leadership and Faculty

NYSPQC Project Planning Team at the NYSDOH

Marilyn Kacica, MD, MPH, Executive Director Kristen Lawless, MS, Program Director Eileen Shields, Data Systems and Analysis Amanda Roy, MPH, Data Systems and Analysis Ritika Singh, MS, Data Systems and Analysis Lusine Ghazaryan, MD, DrPH, Project Advisor Christopher Kus, MD, MPH, Project Advisor Brandi Wells, MPH, Project Advisor

American College of Obstetrics and Gynecologists (ACOG) District II Christa Christakis, MPP, Executive Director Kelly Gilchrist, Manager, Executive Office/Medical Education

Healthcare Association of New York State (HANYS) Loretta Willis, RN, BS, CPHQ, CCM, Vice President, Quality Advocacy, Research and Innovation Kathleen Rauch, RN, MSHQS, BSN, CPHQ, Senior Director, Quality Advocacy, Research and Innovation

Greater New York Hospital Association (GNYHA) Lorraine Ryan, BSN, MPA, Esq., Senior Vice President, Legal, Regulatory and Professional Affairs Wing Lee, MBBS, MPH, Senior Project Manager

National Institute for Children’s Health Quality (NICHQ) Patricia Heinrich, RN, MSN, Quality Improvement Advisor Emma Smizik, MPH, Project Director Aviel Peaceman, MPH, Project Manager

OUD/NAS Clinical Advisory Workgroup

Deborah Campbell, MD, FAAP, Children's Hospital at Montefiore Adriann Combs, DNP, NNP-BC, Northwell Health Kathleen Dermady, LM, DNP, CNM, MSN, NP, SUNY Upstate University Hospital Michelle Eastman, MS, NNP-BC, Glens Falls Hospital and Albany Medical Center David Garry, DO, Stony Brook University Hospital Michael Horgan, MD, Albany Medical Center Leah Kaufman, MD, SUNY Upstate University Hospital Edmund LaGamma, MD, Westchester Medical Center Anne Marie Reynolds, MD, MPH, John R. Oishei Children’s Hospital Neil Seligman, MD, MS, University of Rochester Medical Center Timothy Stevens, MD, Strong Memorial Hospital / University of Rochester Medical Center Paul Updike, MD, Sisters of Charity Hospital

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For more information, write to: New York State Perinatal Quality Collaborative Division of Family Health New York State Department of Health Empire State Plaza, Corning Tower, Room 984 Albany, NY 12237 [email protected]

All rights reserved. Individuals and organizations participating in this Learning Collaborative may reproduce any of these materials solely for the purpose of training within their organizations. Any such reproduction should include an acknowledgement as follows:

Reproduced, with permission, from the Recruitment and Pre-work Package for the “New York State Opioid Use Disorder in Pregnancy/Neonatal Abstinence Syndrome Project”, copyright New York State Department of Health and National Institute for Children’s Health Quality. No other reproduction is authorized without the written permission of the copyright holder.


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Attachment 1: New York State (NYS) Opioid Use Disorder (OUD) in Pregnancy/Neonatal

Abstinence Syndrome (NAS) Project Participant Form

Please complete one Participant Form per hospital and return it electronically to [email protected], by September 14, 2018. If you have questions about the project or this form, please contact the NYSPQC Project Team at the e-mail address above, or by calling (518) 473-9883. Hospital Information

Hospital Address Street City Zip

Regional Perinatal Center affiliation: ________________________________________________________ Team Information (Individuals may be assigned to more than one role.) Senior Leadership

Chief of Pediatrics or Neonatology

Name Credentials Email Phone

Chief of Obstetrics


Nurse Leadership for MCH


Improvement Team (Each improvement team should consist of at least two members.)

Physician Champion from Obstetrics


Nurse Representative for Obstetrics


Physician Champion from Pediatrics or Neonatology (Please circle one.)



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Nurse Representative from Pediatrics or Neonatology (Please circle one.)


Quality Improvement Lead/Designee


Social Worker


Discharge Planner


Additional Staff


Patient/Parent Advisor(s) (consider a prior patient, who previously had an infant treated for NAS)


Who will be responsible for each of the following? Team Lead/Coordinator and primary contact

Name Email Phone

Data Coordinator - Primary contact for data management

Name Email Phone

Please list prenatal care site(s) operated by your hospital who will be participating in the Collaborative. Name of Site ____________________________________________________________________________

Team Lead

Email Phone

Name of Site ____________________________________________________________________________

Team Lead

Email Phone

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Please identify at least two team members who will attend Learning Session(s) and all (or most) of the monthly conference calls. We encourage a minimum of two to four key members from each facility team to attend the Learning Sessions, including at least one physician champion from obstetrics and one from pediatrics, or their designees, and additional team members as appropriate.

Learning Session Location Duration Date LS 1 Albany, NY Full Day September 20, 2018

Learning Session 1 Name Name Name

Name

Senior Administrator Endorsement We wish to participate in the NYS OUD/NAS Project. As a Senior Administrator, I fully understand the project’s objectives and expectations. Furthermore, I agree to support the team and will work with them to remove any barriers and/or provide the resources necessary for them to achieve their improvement goals.

Senior Administrator Signature Date

Senior Administrator Name (Printed)

Application Completed By Date

The role of the Senior Administrator is as a sponsor and decision-maker. This individual has the authority to make formal decisions, policy changes, system changes and necessary resource allocation. A Senior Administrator from each organization where changes will be made during the Learning Collaborative should sign this form. This will likely pertain to all organizations involved/ represented on the Collaborative team. The Senior Administrator is not required to be a team member or travel to Learning Sessions.

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