2. AbstractThe MetroHealth System is a public health system committed to providing care to everyone

in Cuyahoga County, Ohio. It is organized and operated under Chapter 339 of the Ohio Revised Code. It consists of a 550-bed acute care hospital, the largest Emergency Department in the region, and 16 community health centers distributed throughout the County. The Magnet-credentialed MetroHealth Medical Center, the flagship of the system, provides care to nearly 30,000 inpatients, including 2,900 newborns annually, and boasts a superb high risk obstetrics service that has the only Maternal-Fetal medicine fellowship in the city and a level 3 NICU capable of caring for the smallest, sickest infants. MetroHealth Medical Center is recognized by the Ohio Department of Mental Health and Addiction Services as a provider for both mental healthcare and addiction treatment. MetroHealth has been an invaluable asset to the Cleveland area for 176 years.

The proposed pilot program will be coordinated from the main campus of MetroHealthMedical Center. The strength of this pilot is that it assembles resources that currently exist in the community and stitches them together into a “quilt” designed to wrap around opiate dependent pregnant women to facilitate the pregnant woman having the best possible outcome for herself and her baby. Each portion of the treatment plan has duplicate providers such that the grant is not dependent on any one agency for success.

The grant proposes to serve 50 patients per year for a total of 125 women over the course of the grant. This pilot will start opiate dependent pregnant women on Subutex rather than the current medication used in pregnancy, methadone. Subutex has been associated with less neonatal dependency and less time in the hospital for newborns exposed to it when compared with methadone (from 9.9 days in the hospital to 4.1 days). {Jones, NEJM, 2010} While the multidisciplinary opiate dependent mother’s clinic at MetroHealth is currently seeing close to100patients/year, it is anticipated that not all of these patients will present at <24 weeks or meet the pilot’s criteria for starting Subutex. Thus, we conservatively estimate enrolling 125 women over the 2.5 years of the grant.

There are several key components to the pilot: 1.) medical care (including prenatal, delivery, and postnatal care, nutrition, childbirth education, addiction psychiatry, neonatal care, general pediatric and behavioral pediatric care, hepatology and infectious disease care, and long term maternal primary care), 2.) MAT care (prescriptions for Subutex and monitoring with toxicology screens), 3.) drug treatment (intensive inpatient or outpatient care as appropriate, mutual aid groups), and 4.) ancillary services (GED, vocational, literacy, housing, and daycare).We will also collaborate with the Department for Child and Family Services (DCFS), the Cuyahoga County Common Pleas drug court, Medicaid Managed Care (MMC), and the local ADAMHS board. These components of care will be brought together by a care coordinator and social worker supported through the grant.

Each of our key components of care has duplication so that the grant is not dependent on any one community group. Our collaborator, University Hospitals, provides an alternative clinical site allowing for better geographic access for patients originating in the eastern portion of the county. Our MAT sites include Center for Community Action Against Addiction (CAAA),Rosary Hall, and Greg Boehm, MD. Drug treatment will be provided by Rosary Hall, Recovery Resources, Dr. Boehm, Matt Talbot House and Hitchcock Center for Women which also offers inpatient treatment and sober housing post treatment. For ancillary services including literacy, GED training and job readiness, our partners are Seeds of Literacy, the May Dugan House, and Merrick House which also provides day care services. Providence House, a residential facility

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for children when their mothers are in crisis or inpatient rehab, has agreed to work with us for 24/7 child care while mothers are in intensive drug treatment.

The grant requests $959,156 over 2.5 years to support: the care coordinator and social worker whose roles are pivotal to the program’s success; a data entry associate to meet the data collection/submission requirements; increased addiction psychiatry resources; a nurse practitioner to provide postpartum primary care; and co-located OB/GYN and addiction psychiatry resources at University Hospital. As the multi-disciplinary clinic at MetroHealth is already operational, we can start new patients on Subutex rather than methadone as soon as grant funding begins. The clinics at University Hospitals currently see opiate dependent mothers but do not have co-located services; we anticipate that the co-location will begin in March 2014.

We anticipate that this pilot program will show significant cost savings for the insurers as a result of reduced admissions to the neonatal intensive care unit (NICU) due to a decrease in frequency, intensity and duration of neonatal abstinence syndrome (NAS) in the babies born to pregnant mothers treated in our program with Subutex. At the conclusion of the grant period, we expect to be able to show insurers that reimbursement for care coordination services will result in better outcomes and lower costs of care leading to program self-sufficiency through clinical revenues.

We anticipate 3.75 million in revenue from Medicaid billing for the 125 women and their babies served. We have additional support through a grant from the March of Dimes that will continue through February of 2014. We have applied for a March of Dimes renewal. Thus, we anticipate that the State support in grant form would only be needed for the 2.5 years of the grant period. Clinical billing and philanthropy should cover services beyond that time.

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3. Project plan

3.1. Applicant

MetroHealth Medical Center is a safety net hospital located in the City of Cleveland. The

mission of MetroHealth is, “Leading the way to a healthier you and a healthier community

through service teaching, discovery and teamwork.” As opiate dependent pregnant women are a

particularly vulnerable group, they are very much part of the mission of MetroHealth.

MetroHealth has been treating opiate addicted mothers for much of its 176 year history of

providing care to the underserved. The number of opiate abusing pregnant mothers seeking

obstetric care at MetroHealth increased in the recent past from 7 in 2001 to 50 in 2010 and 89

year to date in 2013. In an effort to provide excellent services for this vulnerable population, we

established a multidisciplinary clinic that includes high risk obstetrics, addiction psychiatry, liver

and infectious disease specialists focused on Hepatitis C, neonatology, behavioral pediatrics as

well as a part time care coordinator and assistance from hospital social work. High risk

obstetrics, addiction psychiatry and neonatology are physically co-located on the day when most

of the opiate dependent pregnant women attend clinic. While MetroHealth is a certified mental

health and addiction treatment organization, MetroHealth does not currently offer outpatient

methadone or Subutex treatment. While a Subutex program is planned, we are, and have been

for many years, in a close working relationship with several community organizations that

provide methadone treatment and drug treatment. Currently all pregnant opiate dependent

patients are medically managed by the MetroHealth multidisciplinary clinic and referred to one

of several community organizations for MAT. The organizations to which we refer depends on

the proximity to the patients’ living situation.

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The high risk obstetrics service (Maternal-Fetal medicine) and the Neonatology service at

MetroHealth are particularly strong. There is 24/7 in hospital coverage by an attending

OB/GYN physician and Maternal-Fetal Medicine back up available at all times within 30

minutes. The large 50 bed Neonatal Intensive care unit (NICU) is staffed with physicians 24/7

and has the capability of taking care of even the smallest and sickest infants. Both services

accept transports from other institutions for sick patients. Both labor and delivery and the NICU

have extensive experience in taking care of patients in acute withdrawal (both mothers and

babies). We anticipate taking are of 100 mother baby couplets affected by opiate dependency in

2013.

3.2. Geographic location and accessibility

Of the 89 patients enrolled in the MetroHealth program this year, 89% are from

Cuyahoga County. Additionally, we have a smattering of patients from other surrounding

counties, Lorain – 6, Lake – 2, Geauga – 1, Summit – 1, Ashtabula – 1, Medina – 1.

MetroHealth is located on the near west side of Cleveland and primarily serves the western

suburbs. In order to expand and to better serve the east side of Cleveland, for this pilot, we have

partnered with University Hospitals. Rainbow Babies and Children’s as well as the maternity

hospital MacDonald House are part of the University Hospital system. University Hospital’s

major referral network is located on the east side Cleveland, where some of the highest rates of

deaths from opiates are found. We anticipate referrals from Lake County (Lake East and Lake

West hospitals) as well as Geauga County (Geauga Hospital) where rates of opiate use are high.

This referral system is well established for maternal-fetal medicine maternal transports and also

for NICU. (State data on overdose deaths showing high use in the eastern suburbs is found at:

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http://www.healthy.ohio.gov/~/media/HealthyOhio/ASSETS/Files/injury%20prevention/Updates

ODCountyDrugData%202011.ashx .) As most of the pregnant opiate addicts seen in these two

centers are suburban, adding University Hospitals to the MetroHealth team greatly improves our

ability to serve all of Northeast Ohio. While University Hospitals has all the same clinical care

elements that the MetroHealth team has, they currently do not have co-located services. They

will be co-locating services for this grant in the same manner as MetroHealth as noted above.

The vast majority of mothers at both sites have Medicaid, managed through the largest MMC in

Ohio, CareSource.

3.3. Collaboration

While all of the services required by the grant are available in the Cleveland area,

currently there is no coordination between these service resources resulting in delivery of

suboptimal and fragmented care to these complex opiate dependent pregnant women and their

babies. The grant from the Ohio Department of Mental Health and Addiction services will allow

us to create a comprehensive care system to wrap around the opiate dependent pregnant woman

throughout pregnancy and beyond. Below please find a description of all the different

institutions and agencies that have agreed to participate in this grant. Memoranda of

Understanding letters are found in attachment 4. All of these agencies are self-sufficient on

clinical billing and/or philanthropy. The grant funding will permit coordination and allow

patients to be followed for services through the first year of an infant’s life.

Many of the medical services that our opiate addicted mothers require are located

within the MetroHealth and University Hospitals Systems: obstetrical care and delivery,

addiction psychiatry, Hepatitis C treatment, neonatology, pediatrics and general primary care

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follow up. Both MetroHealth and University Hospitals have electronic medical records that

permit medical notes to be seen by any provider in the healthcare system allowing for the

seamless care of patients across specialties within the health care system. In the instances when

patients seek services at other institutions, MetroHealth has the ability, with written patient

permission, to download the medical records of most hospitals in the Cleveland area

electronically and instantly. This allows us to minimize duplication of services such as

ultrasounds and prenatal labs. In the event that the patient goes to a hospital that does not

support electronic data sharing, faxing of medical records occurs. Electronic medical records also

allow for efficient collection of patient level data for submission to the grantor as required by the

grant.

While MetroHealth and University Hospitals will provide obstetrical and medical care,

one of the key aspects of the pilot is the use of Subutex rather than methadone. Subutex

maintenance will not be done by the hospitals but by community agencies that will do not only

the Subutex prescriptions but the toxicology screening and other oversight of the MAT. Our

MAT sites include Center for Community Action Against Addiction (CAAA) located near

downtown Cleveland, Rosary Hall in central Cleveland, and Greg Boehm, MD who has clinics

on the east and west sides of town. CAAA has been in operation since 1971. The staff consists

of physicians, licensed (independent) social workers, certified chemical dependency counselors,

psychologists, registered nurses, HIV counselors and prevention specialists. They offer both

Subutex and methadone. Rosary Hall is affiliated with St. Vincent Charity Medical Center.

Rosary Hall was founded in 1952. There are two physicians, Ted Parrans, MD and Chris

Adelman, MD leading the Rosary Hall program. They offer Subutex and methadone as well as

intensive and non-intensive outpatient treatment. Their care model is based on a twelve step

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plan. Dr. Boehm has clinics in Shaker Heights (east side suburb) and North Olmsted (west side

suburb). He is certified in adult and adolescent psychiatry as well as addiction medicine. He

will offer Subutex treatment and monitoring as well as an ODADAS certified Intensive

Outpatient program. Referrals will be made to the Subutex programs based on proximity to the

patients’ housing to help minimize the burden of transportation for the patient.

Both inpatient and outpatient drug treatment programs will be available depending on

the assessment of the patient’s needs. Outpatient drug treatment will be offered by Rosary Hall

and Dr. Boehm as noted above. Drug treatment will also be offered through Recovery Resources.

Recovery Resources offers clinical assessment services, intensive outpatient, outpatient and after

care services, individual and group counseling and case management services, psychiatry and

nursing, partial hospitalization, housing, vocational training and job placement services. Of

particular note is a specialized intensive outpatient program for women who are pregnant,

immediately post-natal, and/or raising young children. Recovery Resources has multiple offices

throughout the region. Additionally, Hitchcock Center House and Matt Talbot House will offer

inpatient rehab treatment. Hitchcock Center has been in Cleveland for over thirty years. It is a

women’s only facility and allows women to bring children (up to age 12) with them. In the

inpatient program, women are required to have 30 hours of drug treatment services. Hitchcock

Center also offers outpatient treatment (intensive and non-intensive) as well as sober housing to

help support women after treatment. The grant will provide funds for sober housing for women

in need who are enrolled in this program. The Matt Talbot House is a residential treatment place

for women that is affiliated with Catholic Charities. They are located on the west side of

Cleveland. Their treatment program is for adult women, lasts 8-10week and requires 30 hours of

treatment/week.

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In addition to Subutex treatment and inpatient and outpatient drug treatment, the pilot

program will work with a variety of other community and government groups. DCFS and the

Cuyahoga County Common Pleas drug court have agreed to work with the grant by providing

data (DCFS) and referrals (drug courts) whenever legally appropriate. Medical providers and

social workers involved in the pilot will continue to make referrals to DCFS as needed and as

required by law. Mothers who have used illegal opiate drugs during pregnancy are automatically

referred to DCFS for evaluation. Because of the volumes of patients seen at MetroHealth, we

have developed a close working relationship with DCFS and have contact with them on a daily

basis. MetroHealth is also the primary medical provider for all Cuyahoga County foster care

placements and thus children entering foster care are likely to continue care through

MetroHealth. The local ADAMHS board has agreed to work with us to provide technical

assistance and support. The Medical Director of the University Hospitals site has previously been

involved with the ADAMHS board as the Chief Clinical Officer.

Both MetroHealth and University Hospitals have Alcoholics Anonymous (AA) and

Narcotics Anonymous (NA) groups that operate on the properties to which patients can be

referred. If patients are interested, we will provide space for groups that allow parents to bring

young children to the meetings making it easier for young mothers to attend. The Legal Aid

Society of Cleveland works with MetroHealth and is available at no cost for all patients who

need legal advice and help.

For ancillary services supporting literacy, GED training and job readiness we will be

working with Seeds of literacy, the May Dugan House, and Merrick House. Seeds of Literacy

provides one-on-one tutoring for literacy and GED preparation free of charge. They are located

near MetroHealth on the west side of Cleveland. Among the many services that the May Dugan

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Center performs is GED preparation. Located on the west side of Cleveland since 1969, the May

Duggan Center provides other adult educational services as well as GED preparation. Merrick

House is located in the Tremont neighborhood of Cleveland (west/central). They provide GED

preparation classes.

Merrick House also provides day care services. The grant will provide for up to 10 children

to have daycare for a year while their mothers attend outpatient drug treatment. For mothers

who are going through inpatient drug treatment and/or are not in a place where they can currently

participate in intensive outpatient treatment and take care of their children, the children can stay

at Providence House. Located in the Ohio City neighborhood, Providence House provides 24/7

child care for children newborn to age 10. Children can stay 60-90 days, depending on the

circumstances. Providence House is free of charge and is supported entirely by philanthropy.

As noted previously, Recovery Resources also provides vocational training and job

placement services. Referrals to other agencies that provide this type of help will be made on a

case by case basis as needed by the individual patient.

CareSource is a Medicaid managed care insurer and covers most of the opiate dependent

pregnant women cared for in the MetroHealth clinics. We have received a letter of support from

CareSource and they are eager to partner with us to find ways to improve outcomes and reduce

cost of care in this high risk population.

3.4. Staffing description

Because MetroHealth and University Hospitals have functioning clinics that currently

take care of opiate dependent pregnant women, in combination with the proposed collaborations,

very little additional staff is needed for the grant. The staff hired will be focused on coordinating

9

existing resources, data entry for the grant, and a small amount of clinical staff needed to

supplement current resources.

We anticipate hiring an additional full time care coordinator (an existing 0.5 Care

coordinator is already provided by a March of Dimes grant), one full time social worker,

increasing the time that addiction psychiatry will work with pregnant opiate dependent patients

(an additional 0.1 FTE at MetroHealth (0.1 is already provided by Dr. Turkson) and a .2 FTE at

University Hospitals (addiction psychiatry is currently not co-located with other clinical services

at University Hospitals and this grant will allow co-location of services). We will hire a 0.5 FTE

data entry person to be sure that all data collected is properly submitted. The care coordinator

and social worker will be MetroHealth employees but they will go to both MetroHealth and

University Hospitals. The data entry person will collect data for both organizations.

Additionally, we will add a 0.5 FTE nurse practitioner to the MetroHealth team to give primary

care follow up to women after delivery.

Currently the racial mix of patients in the MetroHealth clinic is: 91% Caucasian, 6%

black and 3% Hispanic or other. All patients speak English as a first language. At University

Hospital the pregnant opiate patients are 81% Caucasian and 19% black. Our medical teams

represent many different races including, Caucasian, Black, and Hispanic. The majority of the

provider teams are Caucasian and this matches the racial mix of the patients. The clinical staff-

to-patient ratios are not typically measured in a medical physician practice and these numbers are

not available. However, to give more information, there are at least 4 high risk obstetricians in

the MetroHealth program for 89 patients. However, these physicians see more than just opiate

addicted pregnant women and not all of the patients are pregnant at the same time so ratios

cannot be calculated. Both MetroHealth and University Hospitals have large physician numbers

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in high risk obstetrics, neonatology, pediatrics, hepatology and addiction psychiatry. These

services are robust and even if one or two physicians left, it would not change the ability for this

grant to see patients. We have multiple community partners for each of our other requirements

(MAT, inpatient and outpatient drug treatment, GED and vocational support, etc.) so that the loss

of any one agency would not derail our pilot.

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Organization of staffing Attachment 1a, b and c combined

Staff title Person in the position

Qualifications Direct supervisor

Job Description Location Metro University

Grant Director (Project Manager)

Jennifer Bailit

MD, MPH Maternal-Fetal Medicine physician and Director of Women and Children Patient Care Unit at Metrohealth

NA Oversees operations, budgets, and non physician grant personnel. Responsible for managing overall relationships with outside collaborators. She also functions as the medical director for the Metrohealth site. 0.2 FTE in kind

X

Medical Director

Jennifer Bailit

MD, MPH Maternal-Fetal Medicine physician and Director of Women and Children Patient Care Unit at Metrohealth

NA Insures good quality care for women at the Metrohealth site. Insures good communication with other physicians on the project. Runs every other week multidisciplinary conference to discuss patients. Trouble shoots any patient care problems at Metrohealth. 0.2 FTE in kind

x

Medical Director

Christina Delos Reyes

MD Addiction psychiatry provider

Jennifer Bailit for the grant reporting and

Insures good quality care for women at the University site. Insures good

X

coordination with outside collaborators

communication with other physicians on the project. Runs every other week multidisciplinary conference to discuss patients. Trouble shoots any patient care problems at University Hospitals. Subcontract between Metrohealth and University hospitals for 0.2 FTE for a total of $102,225 over the entire course of the grant. University Hospitals will invoice the grant at Metrohealth for the cost of the provider.

Care coordinator

TBA LISW Jennifer Bailit

Keeps track of patient medical appointments and referrals. Sends out reminders and helps patient make sure that they have transportation to appointments. Collects questionnaire data and outcomes data for data entry. Cross covers for social worker when he/she is out. 1 FTE for a total of $ 220,781.00 over the entire course of the grant

x x

Social Worker

TBA LISW Jennifer Bailit

Coordinates referrals to outside collaborators and is the day to day contact for outside collaborators. Works with hospital social work to insure appropriate DCFS referrals. Works with health care providers to communicate with outside collaborating agencies. Cross covers for care coordinator when he/she is out. 1 FTE for a total of $ 220,781.00 over the entire course of the grant

x x

Data entry TBA Organizes collected data to include form preparation, coding, and entering of data into the system. Structures and verifies data in appropriate computer files. Analyzes collected data by various means which may include: a. The use of purchased/programmed statistical packages. b. Preparation of tables, charts, and graphs suitable for presentation. Assists in the preparation

Care coordinator

Enters data for grant. Makes sure that grant data base of patients and outcomes is up to date. 0.5 FTE for a total of $ 56,401 over the entire course of the grant

X X

of reports through proofreading and reference organization. Performs other functionally related duties as assigned. High School graduate or GED equivalent One year of work experience in a health care environment or college coursework in a related field of study Previous experience working with a Personal Computer and various software packages Preferred: Completion of college level coursework Working knowledge of statistics and statistical analysis Working knowledge of Medical Terminology

Nurse Practitioner

TBA CNP Sandy Espar, Director of nurse practitioners at Metro

Does follow up primary care for women after delivery. Participates in multidisciplinary conference. .5 FTE for a total of $169,111 over the entire course of the grant

x

Key Medical Staff not paid for by grant but who serve patients enrolled in

See table below. This is not an inclusive list of providers in the

MD or DO with board certification or eligibility in their specialty

Chair of the department of the respective institution

the project specialty seeing patients but represents key personnel not listed above.

Personnel in Kind

Specialty Location Metro University

Peter Turkson Addiction Psychiatry

x

Deepak Kumar Neonatology x Robert Needleman

Behavioral Pediatrics

x

Philip Fragassi General pediatrics

x

Lydia Furhman General Pediatrics

x

Lydia Furhman Behavioral Pediatrics

x

UH Nurse practitioner TBA

Certified Nurse Practitioner

x

Robert J. Ronis, MD, MPH University Hospitals

Robert J. Ronis, MD, MPH Robert J Ronis, MD, MPHDouglas Danford Bond Professor Psychiatrist in Chief and Chairman University Hospitals Health SystemDepartment of Psychiatry 10524 Euclid Avenue, Suite 13129 Phone: 216.844.3883 Fax: 216.844.3851 Cleveland, Ohio 44106Email: rjr4@cwru.edu Robert.Ronis@uhhospitals.org

December 5, 2013

To Whom It May Concern:

I am pleased to commit to participation of our fulltime faculty member, Christina Delos Reyes MD, to serve as “Medical Director” for the proposed Ohio Department of Mental Health and Addiction Services MOMS grant application being submitted by MetroHealth Medical Center in collaboration with University Hospitals and several community agencies in Cuyahoga County.

If the grant is awarded, a subcontract between University Hospitals Medical Group (UHMG) and MetroHealth to support 20% of Dr. Delos Reyes’ time to serve in this capacity will be executed.

Should you have any questions or concerns, please do not hesitate to contact me at (216)844-3883.

Sincerely,

Robert J Ronis, MD, MPHDouglas Danford Bond Professor and ChairmanDepartment of PsychiatryUniversity Hospitals Case Medical CenterCWRU School of Medicine

3.5. Recruitment

Currently, MetroHealth and University Hospitals combined see approximately 110

pregnant women with opiate addiction each year. These women are started on methadone when

they seek prenatal care before delivery. The clinical plan for the grant, detailed in the next

section, is to start women on Subutex rather than methadone. The evidence for the choice is

found in a New England Journal of Medicine randomized trial that associated Subutex with

shorter neonatal stays when compared to methadone (from 9.9 days in the hospital to 4.1 days).

(Jones, NEJM, 2010)

The enrollment criteria for the pilot is maternal presentation prior to 24 weeks (3rd

trimester) of pregnancy. We anticipate that not all women will be candidates for Subutex within

the guidelines of the grant or agree to Subutex. Thus, we anticipate 50 women/year will be

candidates and be able to be enrolled between the two sites. Women who are not candidates for

Subutex, refuse Subutex, or who arrive in the third trimester, will be taken care of clinically in

the same manner but with methadone. However, they will not be eligible for ancillary services

to be paid for through the grant and data will not be reported to the grant. Our care coordinators

will follow each patient to be sure that she is keeping up with her appointments. The care

coordinator will also call patients after delivery to be sure that the baby is getting care and to

ensure that mothers continue care.

The grant will educate providers who deliver obstetrical care within the MetroHealth and

University Hospital health care systems about the risks for opiate dependent pregnant women

and urge them to refer these high risk patients to the specialized multidisciplinary clinics. In the

Cleveland area, almost all obstetric providers are associated with a major health care system.

Thus, the above plan should cover most providers seeing pregnant women in the Greater

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Cleveland/ North East Ohio area. By targeting all providers of pregnant women, we should be

able to recruit a racially and ethnically representative group of women into the pilot.

We typically see women early in pregnancy when they find out they are pregnant. Often

women will stop “cold turkey” and go into in acute withdrawal. The second time during

pregnancy we typically see patients is later in pregnancy when they start to show (around 20

weeks) and friends and family find out about the pregnancy and encourage them to seek help.

When women are in acute withdrawal they often come to the hospital. When women are not in

withdrawal and seeking help, they will often go to community organizations that help to treat

addictions. Many of the places that a pregnant addict would approach for help in Cleveland are

affiliated with this pilot. Because the community agencies are in contact with the care

coordinator and social worker on a frequent basis to discuss referrals of new patients from the

grant to the agencies, the affiliated agencies will in turn refer pregnant patients to the grant

program for prenatal care and enrollment in the pilot. Thus, whether a woman first seeks drug

treatment or prenatal care in Cleveland, it is likely that she will be referred to our pilot program.

One of the biggest barriers to getting opiate dependent pregnant women into care is the

woman herself not knowing where to turn to for help. In these cases, women often turn to the

internet to gain information. MetroHealth has a webpage dedicated to the opiate dependent

mothers clinic that provides educational materials as well as information on how to make an

appointment. http://www.MetroHealth.org/mother-and-child-dependency-program. Lastly, a

patient searching Google for information on prenatal care, heroin, and Cleveland will find

multiple news articles referring to the care at MetroHealth as well as the MetroHealth webpage

on the mother and child dependency program. Thus, patients seeking self-referrals will easily

find our program.

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3.6. Clinical Services

Opiate dependent pregnant women typically present in one of three ways: 1) acute

withdrawal, 2) currently using but wishing to get treatment, or 3) currently enrolled in a drug

treatment program and already taking Subutex or methadone. If a woman comes in when she is

not in withdrawal and wishes drug treatment, she will be started in prenatal care and referred to a

community collaborator who will assess and potentially make the transition to Subutex as an

outpatient. If a woman is already enrolled in a Subutex program, only the medical care piece

will be added. The section below describes what happens from the time a woman presents in

acute withdrawal to the time that the baby is a year old when she will be discharged from our

program (though clinical services will continue, care coordination will stop after the infant is one

year of age). However, the major components of care are the same regardless of how she enters

the system.

When a pregnant women presents to the health care system in acute withdrawal, an

obstetric consult will be called. A COWs (clinical opiate withdrawal score) will be performed

and women with a score of 5 or greater, indicating withdrawal, will be admitted to the hospital.

A toxicology screen will be performed as well as a full history and physical. Fetal assessment

will be done as appropriate for the gestational age (including but not limited to ultrasound and

antenatal testing). The patient will be counseled on the risks of opiates in pregnancy as well as

the risks of stopping acutely (miscarriage, preterm birth and stillbirth). Subutex and methadone

will be discussed and the risks and benefits will be reviewed. The criteria for starting Subutex

are:

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1. Diagnosis of opioid dependence

2. Patient interested in Buprenorphine treatment

3. Patient can understand risks and benefits of treatment

4. Patient expected to be able to adhere to treatment plan

5. Patient willing and able to follow safety procedures

6. Patient agrees to treatment after a review of options

7. Needed resources for the patient available ( referrals will be made to our community

collaborators)

8. Patient is psychiatrically stable to a degree that allows participation: not homicidal,

suicidal, or otherwise too mentally ill to participate in treatment

9. Patient is not currently dependent on or abusing alcohol

10. Patient is not currently dependent on benzodiazepines, barbiturates, or other

sedative-hypnotics

11. Patient is at risk for continued opiate use

12. Patient has not had prior adverse reactions to Buprenorphine

13. Patient not taking other medications that may interact with Buprenorphine

14. Patient does not have medical problems that are contraindications to

Buprenorphine treatment

15. Patient lives in an environment supportive of recovery

16. Patient is motivated to change

To be enrolled in the pilot program, the patient must be <24 weeks and be a Subutex

candidate. HIV and Hepatitis C testing will be offered. When the patient show signs of the high-

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end of mild or moderate withdrawal (COWs score >11), they will be started on Subutex. The

patient will be stabilized on a dose of Subutex and additional medical treatment performed as

necessary (treatment of nausea, abscesses, etc.). The patient will see the care coordinator and

social worker the next working day and arrangements will be made for her to follow-up with a

Subutex provider for ongoing Subutex MAT treatment and drug treatment near her house. She

will be asked to sign a form allowing us to share her information with the grant so that her data

can be reported for the grant. She will be discharged from the hospital.

The Subutex provider will do an assessment of the patient the day of or day after

discharge. If they concur that she is a Subutex candidate, they will continue treatment. If they

do not feel comfortable with the patient on Subutex, she will be converted to methadone. In this

case, data would be reported to the grant because the intent was to start her on Subutex and

conversion to methadone is a known possibility (i.e. we will report intent to treat not the ultimate

treatment).

The patient would then report for outpatient prenatal care. She is encouraged to bring the

father, if he is a welcome part of her life, and other family members. As the family structures of

our patients are often unorthodox, anyone the patient brings who she feels is supportive will be

welcome. She will receive routine prenatal care (including but not limited to blood type, rubella,

hepatitis B antigen testing, GC, Chlamydia, VDRL, CBC, urinalysis). If there is any indication

of fetal growth restriction she will receive antenatal testing, but this will not be routinely done

unless there is a standard obstetrical indication. Importantly, routine toxicology screening will

not be done unless there is a medical reason (for example, the patient appears intoxicated,

appears to be having a placental abruption, or is unconscious). The Subutex providers will be

16

doing random drugs screens as part of their treatment, but the medical providers will not perform

them unless medically needed.

As part of prenatal care, patients will be offered nutritional counseling, smoking cessation

counseling (if appropriate), addiction psychiatry consult, liver consult for Hepatitis C (if

appropriate), and Neonatology consult. The Neonatology consult will cover anticipatory

guidance for newborn treatment as well as a tour of the nursery and the NICU.

Childbirth education will also be offered for both mothers and family members. A father’s

educational program, “Daddy Boot Camp,” will be offered by MetroHealth and will be available

at maternity sites across Cleveland, including the jail. Additionally, there are handouts on

prenatal care, delivery and pediatric care that we have specifically developed for opiate

dependent mothers and distribute during prenatal care (see appendix). In the first year of the

grant, we have asked for funds to produce a childbirth education video specifically designed for

opiate dependent pregnant women. The video will have sections on prenatal care, delivery, post

natal care and infant care. The video will be made available on the MetroHealth website so that

women who cannot make it to classes will have a way to get all the information at her

convenience. It will allow her to share the information with family members, and go over a topic

as many times as she would like. Because the video will be on the public website, it will be

available to anyone in the world, not just patients enrolled in the pilot.

Social work will continue to follow the patient through prenatal care and make referrals

for GED, literacy, housing, legal and other services as needed by the patient. Patients who used

illegal substances during pregnancy will be informed that DCFS will be notified upon delivery

and counseled about what that may mean for them. As circumstances are very individualized,

this counseling is tailored to the individual situation.

17

When the patient arrives for delivery, a urine toxicology screen will be done before any

medications are given. The exception to this is when the patient comes in with an obstetrical

emergency requiring immediate delivery. No Nubain or other partial agonists will be given to

the patient. The patient may have an epidural if medically appropriate and other obstetrical care

will be performed as per usual routine.

Postpartum pain will be controlled as per routine. However, no opiates will be given for

home use at discharge when a woman has had an uncomplicated vaginal delivery. If a women

has a cesarean delivery or a complicated vaginal birth, an attempt will be made to find a family

member or friend who can hold the opiates needed for pain control to help insure appropriate

use. Referrals to DCFS will be made as appropriate, keeping mandatory reporting laws in mind

at all times. Mothers will be discharged from the hospital after a discharge class in the hospital

that teaches about infant care; fathers/family are welcome to this class.

Infants of mothers suspected of opiate use will be kept in the normal nursery unless other

medical conditions prevent this (prematurity, anomalies, etc.). Suspected opiate users include

anyone with a positive toxicology screen, track marks, and other behaviors noted as suspicious

by providers (including but not limited to unexplained poor prenatal care, history of drug use in

previous pregnancies, family members reporting use to providers). Neonatal abstinence

syndrome (NAS) scoring will be done by trained professionals on a regular basis. Treatment and

monitoring of NAS will be done according to a standard protocol (see appendix). Babies will go

to the NICU only for medical necessity. Routine monitoring and treatment of NAS will be done

outside of the NICU. Currently, babies are spending on average 20 days in the hospital

(remembering that many of the babies who go to the NICU also have other medical problems

contributing to longer stays). The grant will support either parking or bus ticket, to enable the

18

parents to visit the baby every other day. Additionally, the grant will pay for one meal/day for

the parents (or the mother and another family member depending on the family situation) while

the baby is in the hospital. Currently, transportation and meals are not covered services and

many mothers are limited to how often they can visit their baby in the hospital. Keeping parents

in better contact with the baby in the hospital will help promote bonding as well as teaching

parents how to care for their infant thus helping to keep families intact.

After hospital discharge, mothers will have postpartum follow up as well as follow up

with addiction psychiatry and liver clinic as appropriate. They will continue care with their

Subutex provider and drug treatment provider indefinitely until they have reached treatment

milestones for discharge. Birth control will be discussed at postpartum visits in order to

maximize the chance that future pregnancies can be delayed until the mother is off opiates. If

patients have psychiatrists other than those in our program, they will be encouraged to make

appointments with them instead in order not to interfere with an ongoing therapeutic relationship.

Social work will continue to meet with the patient for up to one year after delivery to make

appropriate referrals for GED, job readiness, housing, etc. as needed. Transportation can be

provided to these services if needed.

For patients who want/need intensive drug treatment, child care will be provided. Two

community organizations will help. Providence House offers free residential care for 60-90 days

for children less than 10 years of age, including infants. Additionally, Merrick House has day

care for infants 6 weeks and older for mothers who are having outpatient drug treatment services.

The grant will pay for up to 10 families to have day care for a year at Merrick House. As drug

treatment is typically shorter lived than one year, we expect multiple families to participate for

shorter periods of time in the daycare at Merrick House.

19

Infants and mothers will be followed by the grant program for up to one year of infant

life. The care coordinator will keep track of infant visits as well as primary care visits by the

mother. Reminders and transportation will be provided if needed. Visits with a pediatric

provider with additional training in addictions will be encouraged, though parents are free to

choose any general pediatrician in the two healthcare systems. Behavioral assessments will be

made at one month and one year of age, with additional visits possible on a clinical basis even

after the grant is over.

3.7. Vocational, job placement, and ancillary service provisions

The grant social worker will make assessments at each meeting to see if referrals for job

readiness, GED, literacy, housing, transportation and childcare are needed and will follow up

with mothers to see if they have followed through. The social worker will work with the

community organizations to help prioritize our referrals. We will depend on our community

collaborators to provide actual services. Because most of the community collaborators are not

receiving any support through this grant, this plan is sustainable in the long term and is not grant

dependent. The community agencies receiving support are Merrick House for day care services

and Hitchcock Center for sober housing.

The community collaborators for job readiness, literacy, GED, and childcare are the May

Duggan Center, Seeds of Literacy, Merrick House, and Providence House. Websites are listed

below:

http://www.maydugancenter.org/

http://www.merrickhouse.org/

http://www.provhouse.org/

20

http://www.seedsofliteracy.org/

http://hcfw.org/

The May Duggan Center, Merrick House and Seed of literacy provide job readiness and GED

preparation. Recovery Resources provides vocational training and job placement. Providence

House offers 24/7 residential care of children while mothers are undergoing drug treatment.

Merrick House provides day care at a reduced rate that can be used while mothers are

undergoing intensive drug treatment day programs, GED training, job interviews or other

medical appointments. Services are free at all of the above organizations, with the exception of

day care at Merrick House and sober housing at Hitchcock Center.

3.8. Project plan for success

No one organization can comprehensively meet all the needs of the opiate dependent

pregnant and parenting mother. Thus, collaboration between community organizations is key.

While the medical treatment is housed in large medical centers that have the advantage of

currently being on electronic medical records that allows for coordination between specialties,

managing the relationships and referrals between the medical centers and the smaller community

organizations is critical. We have done several things in setting up the program’s organization

that will allow us to meet these challenges and thrive.

The first key organizational move is that we are not dependent on any one agency for the

success of the grant. There is redundancy for each portion of the pilot services. There are two

major medical centers each with multiple physicians in each major area of treatment: high risk

OB (maternal-fetal medicine), addiction psychiatry, liver/hepatitis C treatment, NICU, general

21

pediatrics, and behavioral pediatrics. There are three providers for Subutex: Community Action

Against Addiction (CAAA), a private practice with multiple providers (Dr. Greg Boehm), and

Rosary Hall. There are multiple providers of drug treatment (in- and out- patient) Recovery

Resources, Dr. Greg Boehm, Rosary Hall, and Hitchcock Center. Furthermore, MetroHealth is

in the process of planning a Subutex program that would include drug treatment and allow

pregnant and parenting women. There are three GED/educational/job readiness programs as

noted in the above section. There are two providers of daycare. Hitchcock Center also provides

low cost sober housing for women with a small child after drug treatment.

We have identified the grant social worker as the day-to-day contact for all organizations.

As there is one central person for contact, relationships can be built and it is not a faceless

“medical center” referral. The social worker will work closely with the care coordinator who can

cross cover for her/him in times of increased demand or time away from work. Dr. Bailit who

has worked in Cleveland for 11 years also has built relationships across the community

collaborators in her work as one of the primary high risk physicians taking care of pregnant

opiate dependent mothers at MetroHealth. As both the medical director and program manager,

she will back up the social worker if any difficulties arise.

Each medical center will use every other week multidisciplinary meetings to review

patients and identify any new or persistent needs. By meeting regularly, any recurrent

difficulties in referrals or agencies can be identified and addressed quickly. These meetings also

allow us to address patients who are not compliant with recommendations and allow the team to

intensify resources for those patients who seem to need more guidance and help accessing

services.

22

Lastly, the leadership team of Dr. Bailit and Dr. Delos Reyes embodies the partnership

between obstetrical care and drug treatment/psychiatry that opiate dependent pregnant women

require. They have both worked in the community for a long time and are well known and

respected in their fields. They both have significant managerial experience and grant

management expertise. Additionally, Dr. Bailit is integral to the leadership team of the Ohio

Perinatal Quality Collaborative and has extensive experience with IHI methods and quality

improvement projects for large complex medical centers. Drs. Bailit and Delos Reyes will be in

frequent communication (speak at least every two weeks) to ensure that operations are flowing

well.

3.9. Participant retention

During the prenatal period, the care coordinator and/or social worker will meet with the

patient at each visit and establish a relationship. As patients often bring their families with them

to visits, the family often becomes an integral part of the healing relationship between provider

and patient. Families come in many different configurations and all are welcome at prenatal

visits. The only exception to that is when it is known or suspected that a patient is in an abusive

relationship, we ask that the abuser leave the room during direct provider-patient interactions.

The care coordinator calls the patient before each visit to remind them of the visit and to be sure

that they have transportation to the visit. If a patient misses a visit, the care coordinator will

reach out to her and help to reschedule.

Patients who are not keeping prenatal appointments or keeping them intermittently are

at risk for relapse. Because there is a patient database, the coordinators will be aware when a

patient is not showing up for care. Extra attention will be paid to contacting these mothers and

23

arranging for reminders for medical appointments to be given when they come to their Subutex

provider. If a mother is using drugs in addition to Subutex, the drug treatment provider has the

choice to change her to methadone or refuse to prescribe further Subutex. If a woman is released

from treatment due to non-compliance, she can be admitted as inpatient for detoxification with

fetal monitoring. This is a treatment of last resort but needs to be reserved in case a patient is a

danger to herself using non-prescribed opiates in addition to Subutex or methadone. While

nothing can be done to force a woman to stop using, the drug use will be reported to DCFS after

delivery and will likely affect her ability to get custody. (DCFS will not take a report of drug use

before delivery.) Assuming that the patient has signed the HIPAA waiver and has not revoked it,

the drug treatment centers will be encouraged to report to the coordinator when a patient has a

positive urine toxicology screen or has stopped coming for care. In these circumstances, the care

coordinator will attempt to reach out to the patient, and if we have prior permission, to her family

to attempt to get her back in care.

Less than one percent of all women in the US deliver babies outside of a hospital. Even

when women do not get prenatal care, they typically come to a hospital for delivery. Thus,

delivery and the subsequent inpatient stay on postpartum is the key to further post-delivery

engagement with the patient. During the inpatient delivery stay, the care coordinator and social

worker will meet with the patient to be sure she is supported during the infant stay. As infants of

opiate dependent mothers almost always stay in the hospital longer than the mother, the ability to

visit the baby, or even board in the hospital, is key to bonding. The coordinator will make sure

that parents have support, if needed, for parking or bus transportation to visit the baby in the

hospital. They will also provide 2 meals a day (one for each parent) to be able to eat at the

hospital during visit, if needed. After discharge, the coordinators will be sure that maternal and

24

infant follow up appointments are at convenient times and that they have transportation. Infants

and other children are always welcome at maternal visits. Additionally, they will be sure that the

patient continues her drug treatment appointments (if the mother is still in the intensive portion

of the treatment) and/ or that she is continuing to attend peer support meetings. Patients have the

choice to discontinue Subutex after delivery, though typically it is not recommended during the

first 6-12 weeks after delivery when the normal stresses of a newborn are overwhelming.

For up to a year after delivery, the care coordinator and social worker will continue to

follow the patient and baby. Contact will be attempted at least every 2 months to be sure that the

patient is doing well and getting the services that have been recommended to her.

3.10. Monitoring and continuous quality improvement

At the beginning of the grant, MetroHealth will host a meeting of all organizations who

are collaborating on the project. This will allow people to meet each other and put “faces to the

names” so that when patients need care coordination between the agencies, people feel

comfortable reaching out to one another. These meetings will occur yearly throughout the grant,

and more often if needed. If problems do arise with a collaborating agency, Dr. Bailit and/or Dr.

Delos Reyes will meet with the various teams to trouble shoot.

Every other week multidisciplinary meetings will be held at both MetroHealth and

University Hospitals to discuss patients. New patients and patients with ongoing issues in either

medical treatment or drug treatment will be discussed. The care coordinator and social worker,

as well as the medical director for the site, and the NICU, general pediatric, behavioral pediatric,

addiction psychiatry and nurse practitioner will attend the meetings. Because we are collecting

data and keeping track of each patient’s appointments and compliance, we will know quickly

25

whether a patient needs particular attention. This data is kept on secure servers on an Excel

spread sheet. In this way, we will know if issues are arising with individual patients and/or with

coordination with collaborating institutions.

Rapid cycle improvement cycles (PDSA: Plan Do Study Act) will be performed if

problems arise with project operations. Both MetroHealth and University Hospitals are involved

with OPQC (Ohio Perinatal Quality Collaborative) and are quite familiar with how to perform

and improve care using these techniques.

3.11. Data collection and reporting

MetroHealth and University Hospitals commit to providing data for an independent

program evaluation and to the collection of basic data including gestational age and birth weight

for infants and other medical and programmatic data as outlined in the grant announcement

during the program period. Please see the table below for required data items, their source, and

who will collect the data. The data entry associate will input all data for the grantor.

Data item Source of data Person who collectsScreening and care coordinationPrenatal screening and accurate gestational age

Electronic medical record Care coordinator

Behavior health risk assessment

Electronic medical record Care coordinator

BMI and plan of care Electronic medical record Care coordinatorPrenatal visitsFrequency of prenatal care

Electronic medical record Care coordinator

Timeliness of prenatal care (i.e. missed appointments)

Electronic medical record Care coordinator

Postpartum follow-up and care coordination

Electronic medical record Care coordinator

26

Costs of maternal care and support services

Medicaid claims data It is assumed that this will be collected at the State level. On the rare occasion that a non-Medicaid patient is in the program, we will provide charges for the health care from which reimbursement can be modeled. However, charges outside of MetroHealth and University Hospitals may not be available. This is unlikely to be unique to this applicant and is likely true for all parties applying for the grant.

Labor and delivery:maternal and neonatal outcomes/identified ICD9 codes

Electronic medical record Care coordinator

Behavioral Health MeasuresAbstinence

Drug treatment urine toxicology screens

Records of drug screens are typically received by DCFS after delivery from the Subutex provider and will be reported in aggregate for the pilot. This is because individual data are by law not releasable without patient permission

Employment/Education Social work notes in electronic medical record

Social worker

Criminal Justice involvement

Social work notes in electronic medical record

Social worker if patient self discloses, otherwise it is assumed that this will be collected at the State level as they have better access to criminal matters than a health care center. The drug court has agreed to work with the pilot program.

Housing Social work notes inelectronic medical record

Social worker

Retention in treatment Social work notes in electronic medical record

Social worker

Family preservation measures as outlined

DCFS DCFS will report these data in aggregate to MetroHealth for submission to the Grantor

3.12. Cooperation with quality improvement and evidence-based practices

27

MetroHealth and University Hospitals are both deeply enmeshed in quality improvement

initiatives, such as OPQC, and strive to be on the cutting edge of evidenced based care. For

example, we will be following the protocol for neonatal weaning that was developed by the Ohio

Children’s hospitals. This protocol has been shown to decrease length of stay in the NICU. Dr.

Bailit is nationally recognized as an expert in measuring and improving the quality of care. She

is co-author of the chapter on quality and safety in the major textbook for obstetrics, Gabbe:

Obstetrics: Normal and Problem Pregnancies. She is on the leadership committee of OPQC and

helped to select obstetrical quality measures for the State. This background, as well as the

experience of MetroHealth and University Hospitals with OPQC, put this grant leadership team

in an excellent position to lead these types of initiatives through the grant collaborators.

3.13. Implementation work plan

As soon as we receive notice of funding, we will start to interview for the care

coordinator, social worker, data entry and nurse practitioner positions. We anticipate that each

of the new hires will begin employment as of February 1 and participate in employee

orientations at MetroHealth and University Hospitals as well as training in the electronic medical

records of the health care systems. Introductions to the key contacts at each of the community

agencies will be made. As clinics at MetroHealth and University Hospitals are already

established and all of the community agencies are operational, patients will be seen in January

and the new Subutex protocols for women in acute withdrawal will be implemented. Dr. Turkson

will increase his time another 0.1 FTE in January and Dr. Delos Reyes will start 0.2 FTE for the

program in January. Currently, the March of Dimes supports a part-time care coordinator.

Given that we expect 4-5 new patients a month, the current care coordinator should be able to get

28

the patients started in the pilot. As the new hires become trained, they can help with the ongoing

care and postpartum care coordination. Hospital social work, while not currently dedicated

solely to the project, can help get patients started with community referrals, though they cannot

follow postpartum extensively. However, given the requirement that patients be under 24 weeks

at enrollment, we would not expect any deliveries of pilot patients until March. By then, all pilot

staff should be on board and fully trained.

3.14. States support and MOMS project sustainability

The strength of this pilot project is that almost all of the key players are already providing

services and self-sustaining on clinical billing and philanthropy. It is the coordination between

the services that the grant is supporting. State support is requested for four (4) positions (3.0

FTEs) to provide: additional care coordination (currently the March of Dimes is supporting .5

FTE of a care coordinator), additional social work (currently MetroHealth and University

Hospitals provide these services ad hoc but the grant would allow dedicated personnel),

additional time for addiction psychiatry at both MetroHealth and University Hospitals (at

University Hospitals the addiction psychiatry provider is also the medical director), a nurse

practitioner at MetroHealth part-time for follow up care, and part-time data entry support.

Presumably, the substantial data entry component will only be required for the duration of the

grant and would not be needed in the post grant period.

In the long term, the addiction psychiatry, medical directorship of the University

Hospitals site, and the nurse practitioner at MetroHealth will need to be supported through

clinical billing. While they may need to see other patients in addition to the patients in the grant

to sustain long term, this is easily achievable. The hospitals will lose money as a result of

29

shortened lengths of stay by infants in the NICU whereas Medicaid and other insurers will save

money. Thus, assuming that NICU stays are shortened by the pilot, long term it is in the

insurer’s best interest to fund the care coordination and social work resources needed to continue

the program. Similarly, we would ask that they consider patient transportation as a necessary

service component. Our plan is to first demonstrate that our clinic will save the insurers money,

and then approach them to either pay for care coordination on an ongoing basis through

clinically billing or fund those positions directly. The agencies with which we are collaborating

have longstanding history in the Cleveland community and have their own revenue streams for

ongoing support. The only state-supported pilot expenses that may be difficult to sustain are the

costs associated with daycare and sober housing services. However, if we can demonstrate the

value of these services to the achieved outcomes, it may be possible to identify funding streams

(including philanthropy) to cover these relatively modest expenses.

30

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Appendix 1

Educational hand outsNeonatal Weaning Protocol

Drug Dependence and Your Pregnancy

The staff at MetroHealth Medical Center has years of experience in providing healthcare to pregnant women with drug dependency and their babies. Our entire team is dedicated to keeping you and your unborn baby safe during pregnancy and birth.

We believe the more you know about what to expect during your pregnancy and after you give birth, the more you can help yourself and your baby. This handout will give you information you need to care of yourself and your growing baby.

Is Drug Dependence During Pregnancy Common?

Many people suffer with substance abuse in their lifetime. Drug dependence among young women is increasing.6 million women have alcohol problems and more than 5 million currently use street drugs. Almost 800 women are pregnant or parenting in Cuyahoga County with a dependency to drugs like Vicodan, Oxycontin or heroin. So, you certainly are not alone.

How does drug dependence affect my pregnancy?

Drugs such as Vicodan, Percocet, Oxycontin and Heroin can cause drug dependence and withdrawal symptoms when you stop taking them. Symptoms you may have;

� Runny nose� Diarrhea, stomach pain� Shaking, body aches. � Your baby may go through withdrawal inside your body and that can be dangerous. � There is a small risk that you may miscarry or have a stillborn baby if you go through

withdrawal. We don’t want the fetus to go through withdrawal, but we don’t want mothers to keep using drugs either.

Other ways substance abuse can affect your pregnancy:

� The placenta can separate too soon� High blood pressure and seizures� Birth of a small or premature baby� Infections for mother and sometimes baby (especially if you are injecting drugs)� Stillbirth

What can I do to help my pregnancy?

You have taken the first step and have asked for help, not only for yourself but for your growing baby. Make sure you go to each checkup. Getting regular doctor checkups, eating healthy foodsand your physical and mental health are very important. Research shows that good prenatal care improves the health at birth of babies exposed to drugs. With early treatment and care, most babies born to drug dependent mothers have good outcomes.

Treatment and counseling programs can give you the support and help you need during pregnancy. Methadone and Subutex maintenance programs help women with withdrawal symptoms and the desire for drugs. They can prevent withdrawal in the baby before birth. All these things can help you and help your baby to be born healthy.

What should I expect during my pregnancy?

Your doctor will watch you and your baby closely for your entire pregnancy. We will:

� See you often in the office.

� Offer to test you for infections like Hepatitis C which are common in moms who have taken drugs.

� Do ultrasounds to make sure that your baby is growing well.

� Help you feel better with common problems of constipation and heartburn.

� Have you meet a pediatrician to discuss what to expect when the baby is born.

� Schedule Childbirth classes to prepare you for birth and taking care of baby.

� Help you deal with emotional issues that go along with becoming sober (specialists in counseling, drug treatment, social service support)

� Counsel you about healthy foods to eat

� Do a drug screen at birth to help your baby’s doctor decide treatment for your baby.

Will I need to see social work services at MetroHealth?

The social work members of our team are specially trained to work on the special needs of drug dependent pregnant mothers. Social work can help you find services that you are entitled to and with making a safe plan for you and your baby.

Depending on your circumstances, the hospital may be required by law to notify the Department of Children and Family services (DCFS) after childbirth. MetroHealth is completely independent and separate from DCFS. MetroHealth does not control DCFS.

Staying in a drug a treatment program and negative drug screen at birth are often helpful with DCFS. Our social worker will help you figure out whether DCFS will be involved. Remember, the legal requirements to report some things to DCFS are the same at every hospital. Changing hospitals will not change whether or not a report is made to DCFS.

Will I need special pain control in labor?

All pregnant women are concerned about how they will handle the pain of labor and birth. Fear of pain is often a great worry for drug dependent pregnant women. Epidural anesthesia works well in women, regardless of their drug history.

� Like any other pregnant woman, you will be offered an epidural.

� Exceptions to getting an epidural include if you come to the hospital when the baby is about to be born or some rare medical conditions.

� If you have good prenatal care, these medical conditions are known before labor starts.

� A pain management plan is made for you.

� Drugs used for labor pain called Nubain or Stadol will not be given to you because it can put you in acute withdrawal.

� If for some reason you do not give birth at MetroHealth, be sure to tell your delivery provider that you cannot take Nubain or Stadol.

How will I control pain after birth?

We will make sure to give you medicines to control your pain after birth. Most often used pain medications like Motrin work well for cramping and pain after birth. We will try very hard to be sure that you are comfortable after birth. Our postpartum nurses are excellent at helping you find ways to stay comfortable.

Can I breastfeed my baby after birth?

Sometimes drug dependent mothers can breastfeed. It depends on many things including your drug screen at delivery. In general you can breast feed if you are hepatitis C positive except when your viral load for hepatitis C is high and your nipples are cracked if nursing. Women with HIV should not breastfeed. The pediatrician that you meet during pregnancy can help you figure out if you can breast feed.

When will I or my baby go home after birth?

Most women with a vaginal birth can go home after 2 days and with a cesarean after 3-4 days. Babies born to drug dependent mothers will often need to stay in the hospital for at least 7 days to be watched for signs of withdrawal. Some babies may need hospital treatment for drug withdrawal for weeks or months. After birth, the pediatric providers will be your best source of information about your baby. We often have a room in the hospital for you to stay with your

baby even after your discharge. Please speak with your nurse at the time of your discharge to see if we have a room for you to use.

After discharge, you will come back in 6 weeks for a checkup. After that time, we will refer you to a doctor who takes care of non-pregnant women. If you have hepatitis C, we recommend that you follow up with our liver specialists.

Are there other ways I can help my pregnancy?

� Keep all your doctor appointments and stay in a drug treatment program.

� Take care of yourself now and eat healthy to let your baby to grow and develop normally.

� Avoid smoking and passive tobacco smoke. Both will hurt your baby’s health.

� Learn all that you can about a healthy pregnancy so your baby is born healthy.

� Learn all you can about baby care so you can enjoy your baby during the hospital stay

and when you bring your baby home!

Some important contact numbers

Obstetric Clinic: 216-778-5341

Perinatal Center: 216-778-5341

Childbirth Classes: 216-778-3381

Social Work: 216-778-5551

Normal Newborn Nursery: 216-778-4283

Newborn Intensive Care Unit (NICU): 216-6778-5918

Pediatric Outpatient Clinic: 216-778-2222

MetroHealth Medical Center: 216-778-7800

First Call for Help: Dial 211 from anywhere in Cuyahoga County to find help

A Parent’s Guide to Neonatal Abstinence Syndrome (NAS)

Congratulations on the birth of your baby! Our entire team is dedicated to provide the best care we can to you and your baby. Our MetroHealth team has been providing expert healthcare to pregnant women with drug dependence and their babies’ for many years.This booklet will provide you with information that you will need to care for your baby and yourself.

Why is my Baby being evaluated for NAS?

� Many drugs that a mom takes while she is pregnant can pass to her baby,including prescribed or street drugs.

� After you give birth, baby may show signs of drug withdrawal or Neonatal Abstinence Syndrome (NAS).

� The baby may show signs of withdrawal right after birth or it may take days before signs show up.

What withdrawal symptoms will my baby have?

� Jittery or shaky or startle easily� Feel little stiff with tight muscles� Restlessness� High pitch cry or cry a lot� Sleep poorly� Throw up and have watery stools with bad diaper rash� May want something in mouth most times but eat poorly� Lose weight and have a hard time gaining weight� Breathe fast� Stuffy nose and sneezing� Fevers � Seizures (rare)

Almost all babies will have a few of these symptoms but some will have many of these.

� We use a scoring system to tell if your baby is showing signs of withdrawal.� Starting from a few hours after birth, your baby will be scored by our staff about

every 2-4 hours until the baby goes home.� If your baby’s score gets too high, your baby may need to be started on

medications to help stop the withdrawal.� Morphine or Methadone are medicines that we use most often to treat babies

having withdrawal if needed.� If your baby’s scores are low and he or she is showing few signs of withdrawal,

we may not need to start medicines.

How long will my baby stay in the hospital?

� Every baby is different but your baby will be in the hospital for at least 1 week to be watched for signs of withdrawal

� If a medication is started on your baby, he or she will likely be in the hospital for several weeks or even months.

� Once your baby is having less signs of withdrawal, we will very slowly take your baby off the medication.

Where will my baby be?

� Many babies will be able to stay with their mothers while she is in the hospital. � Babies with severe withdrawal or with other medical problems will be taken care

of in the Newborn Intensive Care Unit (NICU). When their problems get better they may then go to the Normal Newborn Nursery to be close to their mothers.

� After a mom goes home, her baby will usually stay in the Newborn Nursery until going home or on the Pediatric Ward.

� We want you to visit and care for your baby as often as you can so that you will feel comfortable and ready when bringing baby home on discharge day.

What can I do to help my baby?

We know this can be a stressful time for you. You might feel sad or unsure of how to care for your baby. Each baby gets better at his or her own pace. Not all babies will have these problems; but most will have some. We will help YOU to help YOUR baby!

Here is how you can to help your baby with some common problems:

SLEEPING PROBLEMS:

� We can all help your baby by moving calmly, talking softly, playing soft music, and turning down the lights.

� You can also help by wrapping your baby snugly, holding or rocking your baby quietly, turning down the radio and TV in your room.

� When your baby is asleep, let your baby sleep.� Your baby grows and gets better during sleep, so let the baby sleep as much as

possible.

FEEDING CONCERNS:Our nurses are very good at helping moms learn the best way to hold and feed their babies. We will help you to become good at feeding your baby:

� Your baby will need to burp often and have quiet feeding times.

� Some babies may tire during their feedings and may need a feeding tube to finish their feedings.

� Some babies will need a special formula.� If you are breast feeding, a breastfeeding specialist will help you with nursing and

to pump your milk for when you are not here.

As your baby grows and gets used to being without drugs, the feedings will get better. Time will help and, although it is often a slow process, you WILL be able to feed your baby by the time your baby goes home!

TREMORS or JITTERS:Wrap your baby snugly and hold close.

STIFFNESS OR INCREASED MUSCLE TONE:Gentle massage, warm baths, or swaddling with blankets help. Physical Therapists can work with your baby to provide muscle stretching, massages, and positioning help. They will be happy to show you some exercises that you can do with your baby.

RECOGNIZING WHEN MY BABY MAY OR MAY NOT BE STRESSED:All babies like to play, be held, and talked to but some babies with withdrawal may need longer quiet and sleep time. Knowing when your baby may be stressed and ways to comfort him or her may help you to enjoy your baby without over-doing it.

� Baby is not likely to be stressed if she/he has good color, breathes evenly, holdsyour finger, turns to noises, is quiet but alert and may look at you.

� Baby might be stressed if he or she looks pale, floppy, will not make eyecontact, spreads fingers out, has hiccups, coughs, sneezes or yawns, gags or spits, shakes, roll eyes or breathes differently.

SOME COMFORTING TIPS WHEN BABY MIGHT BE STRESSED:

� Let baby rest in a quiet area; dim the lights; try playing quiet/soft music; wrap baby snugly in blankets and or hold close to you.

� Try only one thing at a time such as holding your baby but not rocking him or her. Some babies eat well when being held quietly, but not when being talked to and rocked at the same time.

� Offer your baby a pacifier if he or she is fussy.� Feed your baby small, frequent feedings; change your baby’s diaper before

feeding; burp often.

Over time you will get to know your baby and be able to tell if your baby is ready to play or needs to rest.

Are there other ways I can help my baby?

� Learning all that you can about your baby’s care so that you can enjoy your baby

during the hospital stay and when you bring the baby home!

� Maintain good health and nutrition so you can care for and enjoy your baby.

� Avoid smoking and passive tobacco smoke. Both will hurt your baby’s health.

� Keep all yours and your baby’s health care appointments after you are both home.

Some important contact numbers

Normal Newborn Nursery: 216-778-4283

Newborn Intensive Care Unit (NICU): 216-6778-5918

Pediatric Outpatient Clinic: 216-778-2222

Obstetric Clinic: 216-7778-5341

Perinatal Center: 216-778-5341

Social Work: 216-778-5551

MetroHealth Medical Center: 216-778-7800

First Call for Help: Dial 211 from anywhere in Cuyahoga County to find help

Ohio Children’s’ Hospitals Neonatal Research ConsortiumEnteral Morphine or Methadone Protocol for

Neonatal Abstinence Syndrome (NAS) from Maternal Exposure

Introduction:The protocols are a synthesis of the best available, although limited evidence, and an analysis of practice variation across the state of Ohio in a cohort of 553 term infants with maternal narcotic exposure. These are viewed as potentially better protocols that humanely and safely wean infants off narcotics over a 2-3 week period.

Each center should pick either Morphine or Methadone as their standard and use this for ALL NAS infants treated in that center.

Overview of Stages of treatment

1. Scoring: All Infants will be scored every 3 hours prior to a feeding with the modified Finnegan Scoring System. Begin scoring at every 3 hrs, when weaning phase begins, if not waking to feed until 4 hrs may score every 4 hrs.1a. Some experts recommend using the average of NAS scores over a 24 hour period in

the stabilization and weaning phase to minimize the impact of minor variations on dosing.

1b. Adjust trigger scores when > 3 weeks old: Research has shown that NAS scores increase over time as the infant matures so > 21 days all Trigger thresholds should be increased by 2. (For example: now would wean if average of scores in 24 hours are < 11).(REF: Zimmerman-Bauer U et al. Finnegan neonatal abstinence scoring system: normal values for the first 3 days and weeks 5-6 in non-addicted infants. Addiction 2010 March. 105: 524-528.)

1c. Centers should develop a plan for periodic refresher training for all nurses on NAS modified scoring system using the D’Apolito Reliability Training system, and a training system for on-boarding new nursing staff.

2. Non-Pharmacologic Treatments:

Final Aug 22 2013Walsh 1

a. All infants with NAS will be treated with a bundle of non-pharmacologic interventions including decreased stimulation, swaddling, and continuous holdingand frequent feeds.

b. Feedings: Each institution should develop a policy for the use of Mother’s Own Milk. Consideration of supporting breast feeding may be given if the mother isactive in a treatment program and mother’s addiction specialist supports breast feeding. If MBM is not used, consider frequent feeds with an increased caloric density non-lactose containing formula at 22cal/oz. The higher calorie formula is designed to meet the exceptional caloric needs and combat the documented weight loss seen in NAS infants. Additional calories may not be needed once the infant is a week or more into the course and weight loss is < 10% of birthweight. 22 Calorie formula may be discontinued when weight gain is established firmly.

c. See references at end for resources on Non-pharmacologic interventions.

Final Aug 22 2013Walsh 2

3. Pharmacologic Treatment - Morphine: (see page 6 for Methadone)

Treatment should be initiated if an infant has 2 consecutive scores > 8 OR 1 score > 12.

Treatment is divided into the following phases: Initiation, Escalation, Stabilization, Wean

a. Initiation Phase- most infants can be treated with oral medication.:

Morphine**PO 0.05mg/kg/dose q3hIV 0.02 mg/kg/dose q3h

(**IV morphine and enteral morphine doses are not equivalent)

b. Escalation Phase:

MorphinePO 0.03mg/kg/dose q3hIV 0.01 mg/kg/dose q3h

Increase dose every 3 hrs until controlled (average NAS � 8 in 24 hours)

*Rescue Dose*: If infant has 1 score of > 12, double the previous dose given (enteral or IV) x 1 and then adjust accordingly:� If NAS score now < 12: make the scheduled maintenance dose (MD) the same as

the rescue dose that was just administered. The first higher MD should be given at the next scheduled care/feed.

� If NAS score still > 12: increase next dose by 50% of the prior dose. Continue to do so until score is < 12.

Second Drug: PhenobarbitalConsider starting phenobarbital if:� Polysubstance exposure (benzodiazepines, barbiturates, antipsychotics,

antidepressants, other sedatives/hypnotics, tobacco) is suspected/confirmed � AND CNS findings (tremors, increased muscle tone, etc) rather than GI findings

predominate on NAS sub scale score � AND Morphine dose exceeds 0.3 mg/kg/dose with score remaining > 8; OR

unable to wean for 2 consecutive days.

Loading dose: 10 mg/kg/dose po q12hr x 2 doses PO OR20 mg/kg/ dose IV x1. (Enteral formulation contains 10% alcohol. Dividing dosePO may decrease risk of emesis and/or sedation.)Maintenance dose: 5 mg/kg/dose po once daily (do not weight adjust)

Final Aug 22 2013Walsh 3

Phenobarbitol Wean: Two approaches may be used. (Neither has been directly studied.) Each center should pick one method.

A. Discontinue when on second to last step of morphine wean to assess for tolerance of discontinuation. Given long half life of phenobarbitol this will wear off gradually over 4 days.

B. Discharging infant home on phenobarbital with subsequent weaning to be done either in Neo Clinic or by infant’s PCP. (Given the high alcohol concentration limiting exposure may be the best practice.Hypnotic or nicotine withdrawal occurs rapidly and generally is completed by day 5- thus longer phenobarbitol exposure may not be needed.)

c. Stabilization: ������������� ���� for minimum 48 hours. 72 hours of stabilization may be used if infant has had to increase above 0.4 mg/kg dose or if phenobarbitol added.

d. Morphine Weaning Phase: Once stabilized on same dose for 48 hours, use this dose as the starting point of the wean. Begin weaning the dose by 10% (of the original dose when the first wean was started) every 24 hours. Drug may be discontinued when a single dose is < 0.02 mg/kg/dose. Please see below for example.

*Ad lib infants*: Given the shorter duration of action of enteral morphine, it is best suited to be dosed on a q3hr schedule. Infants should be allowed to ad lib feed but kept on a q3hr drug schedule.

*Backslide*: If infant has 2 consecutive NAS scores >8, during the weaning process, assure that non-pharmacological measures are optimized (i.e.: swaddling, holding, decreased stimuli, etc) before going back to previous dose at which patient was stable. If infant’s scores continue to be elevated (even after physical exam to ensure nothing else is wrong/bothering the infant), either weight adjust medication and/or continue to back up in a stepwise fashion until patient’s scores are �8. Once stabilized on new dose for minimum 48 hrs, resume 10% wean but consider weaning at less frequent intervals.

e. Discharge: Observe in-house x 48 hours off of morphine before discharge.

Example:Infant X (wt: 3.2 kg) required 2 dose increases of his morphine to get his NAS scores consistently � 8. He has now been on the dose of 0.32 mg (0.1 mg/kg/dose) po q3hr for 72 hours. Team would like to begin weaning. As long as ������������� ��� ���� ����� 8, please decrease by 10% every 24hrs.

Day 1: 0.29 mg q3hr (0.09 mg/kg)Day 2: 0.26 mg q3hr (0.08 mg/kg)Day 3: 0.22 mg q3hr (0.07 mg/kg)Day 4: 0.19 mg q3hr (0.06 mg/kg)Day 5: 0.16 mg q3hr (0.05 mg/kg)Day 6: 0.13 mg q3hr (0.04 mg/kg)

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Day 7: 0.1 mg q3hr (0.03 mg/kg)Day 8: 0.06 mg q3hr (0.02 mg/kg) x 24hr

and then stop

Monitor in-house for minimum of 48hrs prior to discharge.

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METHADONE3. Pharmacologic Treatment with Methadone (see page 3 for Morphine):Treatment should be initiated if an infant has 2 consecutive scores > 8 OR 1 score > 12Treatment is divided into the following phases: Initiation, Escalation, Stabilization, Wean

A. Initiation Phase- all treatments are with oral medication.

MethadonePO 0.05mg/kg/dose q6h

B. Escalation Phase:1. Increase dose if NAS still > 8 after 3 doses of methadone

MethadonePO 0.1mg/kg/dose q6h

2. If 3 doses later NAS still > 8 increase to 0.15 mg/kg/dose q6h

3. Second Drug: PhenobarbitalConsider starting phenobarbital if:� Polysubstance exposure (benzodiazepines, barbiturates, antipsychotics,

antidepressants, other sedatives/hypnotics, tobacco) is suspected/confirmed � AND CNS findings (tremors, increased muscle tone, etc) rather than GI findings

predominate on NAS sub scale score � AND Methadone dose exceeds 0.2 mg/kg/dose with score remaining > 8; OR

unable to wean for 2 consecutive days.

Loading dose: 10 mg/kg/dose po q12hr x 2 doses PO OR20 mg/kg/ dose IV x1. (Enteral formulation contains 10% alcohol. Dividing dose PO may decrease risk of emesis and/or sedation.)Maintenance dose: 5 mg/kg/dose po once daily (do not weight adjust)

Phenobarbital Wean: Two approaches may be used. (Neither has been directly studied.)

A. Discontinue when on second to last step of methadone wean to assess for tolerance of discontinuation. Given long half life of phenobarbitol this will wear off gradually over 4 days.B. Discharging infant home on phenobarbital for 30 days with subsequent weaning

to be done either in Neo Clinic or by infant’s PCP. (Given the high alcohol concentration limiting exposure may be the best practice. Hypnotic or nicotine withdrawal occurs rapidly and generally is completed by day 5- thus longer phenobarbitol exposure may not be needed.)

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C. Stabilization:All scores remain < 8 for minimum 48 hours. 72 hours of stabilization may be used if infant has had to increase above 0.4 mg/kg dose or if phenobarbitol added.

D. Weaning Phase: Once stabilized on same dose for 48 hours, use this dose as the starting point of the wean. Begin weaning the dose by 10% (of the original dose when the first wean was started) every 24 hours. Drug may be discontinued when a single dose is < 0.02 mg/kg/dose. Please see below for example.

*Ad lib infants*: Infants should be allowed to ad lib feed but kept on a q6hr drug schedule.

*Backslide*: If infant has 2 consecutive NAS scores for >8, during the weaning process, assure that non-pharmacological measures are optimized (i.e.: swaddling, holding, decreased stimuli, etc) before going back to previous dose at which patientwas stable. If infant’s scores continue to be elevated (even after physical exam to ensure nothing else is wrong/bothering the infant), either weight adjust medication and/or continue to back up in a stepwise fashion until patient’s scores are <8. Once stabilized on new dose for minimum 48 hrs, resume 10% weans but consider weaning at less frequent intervals.

e. Discharge: Observe in-house x 72 hours off of methadone before discharge.

EXAMPLE:

Step Dose/kg Interval1 0.05 mg/kg q 6 hrs * 4

1a- escalate to obtain NAS score <8. Once stable for 24 hrs, begin wean back to 0.05mg/kgby weaning daily by 0.025 mg/kg/dose.2 0.04 mg/kg q 6 hrs * 43 0.03 mg/kg q 6 hrs * 44 0.02 mg/kg q 6 hrs * 45 0.02 mg/kg q 8 hrs * 46 0.02 mg/kg q 12 hrs * 47 0.01 mg/kg q 12 hrs * 48 0.01 mg/kg q 24 hrs * 4Observe for 72 hours off methadone before discharge.

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REFERENCES:1. Vermont Oxford Network; “Nurture the Mother-Nurture the Child”; A Virtual Video

Visit. Vermont Oxford Network; 2013.2. McGrath JM, Samra HA, Kenner C. Family centered care in the NICU and Research:

what will the next century bring. J Perinat Neonatal Nurs. 2011 Apr-Jun;25(2):165-70.3. Finnegan LP, Conaughton JF Jr, Kron RE, Emich JP. Neonatal abstinence syndrome:

Assessment and management. Addict Dis.1975;2(1):141-158.4. Zimmerman-Baer U; Notzli U, Rentsch K, Bucher HU. Finnegan Neonatal abstinence

scoring system: normal values for first 3 days and weeks 5-6 in non-addicted infants. Addiction 2010: 105: 524-8.

5. Osborn DA, Jeffery HE, Cole MJ. Opiate treatment for opiate withdrawal in newborn infants. Cochrane Database of Systematic Reviews 2010; 10: CD 002059.

6. Osborn DA, Jeffery HE, Cole MJ. Sedatives for opiate withdrawal in newborn infants. Cochrane Database of Systematic Reviews 2010; 10: CD 002053.

7. Nationwide Children’s Hospital Neonatal Abstinence Management Protocol. 20138. Cincinnati Children’s Hospital Neonatal Abstinence Management Protocol. 2013

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