MOms in REcovery (MORE) Study: Defining Optimal Care

Substance Use Disorders Clinical Trial

— MORE  

Official title:

MOms in REcovery (MORE): Defining Optimal Care for Pregnant Women and Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251208
• Other study ID #: 00031444
• Status: Completed
• Start date: July 30, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2024
• Source: Trustees of Dartmouth College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Northern New England has among the highest rates of opioid dependence in the U.S, with prevalence highest and growing among those of between the ages of 18-35 years. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with opioid use disorder. In northern New England (Maine, New Hampshire, & Vermont), 5-8% of newborns have mothers with an opioid use disorder (OUD), greatly increasing the risk of poor outcomes, including preterm birth and long hospitalization for neonatal withdrawal and other newborn complications. For pregnant women with OUD, medication assisted treatment (MAT) significantly reduces these risks. However, it is sometimes difficult for pregnant women to find MAT providers. As a result, many maternity care providers have begun to prescribe MAT in their own practices. Other practices have maintained the longstanding evidence-based standard of care, referral of patients with OUD to specialty MAT treatment program. Most pregnant women with OUD have other psychosocial needs, ranging from lack of housing and untreated mental health conditions, to need for parenting education and support. There is variability among practices in terms of types of other services provided to patients, whether the practice has integrated MAT or relies on referral. Although pregnancy is a time when women are highly motivated to start MAT, many women are also likely to discontinue MAT postpartum due to loss of insurance coverage, difficulty transitioning to another provider, loss of motivation for treatment, or competing demands on time and resources as a new parent.

The challenge for patients, providers, and other stakeholders is to understand the relative advantage of the two MAT models (receiving MAT as part of maternity care or at a specialty program) for improving key outcomes for baby & mother. A second challenge is to understand the relative contributions of onsite services such as mental health care, care coordination, & parenting education to improved outcomes. This question is important to patients & families who may have a choice of where they receive their maternity care. It is even more important in rural areas, such as northern New England, where obstetric practices & specialty care services are limited. Patients, providers & other stakeholders need guidance in choosing the optimal models for building new programs to provide maternity care for women with OUD.

Description:

Northern New England has among the highest rates of opioid dependence in the U.S, with prevalence highest and growing among those aged 18-35 years. Regional rates of perinatal opioid use disorders (OUD) reflect this public health crisis; Northern New England region has the highest incidence of opioid-related births in the nation. Perinatal opioid use disorders impact 5-8% of pregnancies in Maine, New Hampshire, and Vermont, three states that have been severely impacted by the current opioid epidemic. Consequences of inadequately treated OUD include premature delivery and other perinatal complications, prolonged newborn hospitalization for neonatal abstinence (NAS), and maternal morbidity and mortality from infectious disease and overdose. In 2013, costs associated with NAS treatment in the U.S. reached $1.5 billion. The epidemic has grown multifold since 2013.

Medication assisted treatment (MAT) with either methadone or buprenorphine is the recommended standard of care during pregnancy. Professionals, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics, the Society for Maternal-Fetal Medicine, and the American Society for Addiction Medicine, have called to adopt care models that promote early identification and treatment for pregnant women with OUD. Referral to specialty programs for MAT has been the accepted standard of care, with demonstrated safety for women and their infants. However, in response to the escalating opioid crisis, the ACOG began offering buprenorphine training programs to its members. Consequently, a number of maternity care practices throughout Northern New England now provide integrated MAT services. But even where such integrated programs exist, questions persist on the optimal care model for providing MAT to pregnant women with OUD.

There are patient- and provider- factors associated with variability in effectiveness of what MAT model works best for whom. For women, advantages of buprenorphine over methadone include a lower risk of overdose, fewer drug interactions, the accessibility of office-based treatment delivery in the context of maternity care and demonstrated shorter NAS course. The disadvantages of buprenorphine relative to methadone include potential hepatic dysfunction, lack of long-term data on consequences of fetal exposure for infants, potential limited efficacy in patients with high addiction severity, requirement of moderate withdrawal symptoms prior to initiation to avoid iatrogenic withdrawal, and an increased risk of diversion (i.e., sharing or sale). Despite buprenorphine's demonstrated neonatal advantages, it is not effective for all women. The structure of methadone treatment (daily meeting) may also better align with support needs for some women. For providers, the choice of what medication-assisted approach to offer to patients is often restricted by availability and access to specialty care services.

There is limited literature comparing the effectiveness of integrated versus referral MAT care models for postpartum retention in treatment and women's experiences in these two models. In particular, women with high levels of addiction severity or co-occurring mental health conditions may have prenatal care needs from women with less complex behavioral health concerns. Studies have also not assessed the impact of maternal opioid addiction severity on newborn outcomes and maternal long-term recovery. The best neonatal outcomes will be achieved by providing the most appropriate and effective treatment for mothers.

The challenge for patients, providers, and other stakeholders is determining the optimal approach for delivering MAT during pregnancy and after delivery to improve outcomes. Currently, regional obstetrical practices provide either: (1) Integrated care, in which MAT and associated psychosocial services are delivered on site with obstetrical care, and (2) Referral-based care, in which women receive MAT and obstetrical care in separate, specialized locations. Both models have different potential advantages and disadvantages for mothers with OUD and their babies regarding access, availability, acceptability and quality of MAT, obstetrics and other needed services, and long term follow up and treatment after delivery. While pregnancy motivates women to initiate MAT, relapse to use of opioids and cessation of MAT frequently occur during the first postpartum year, placing both mother and infant at significant risk. Payers and policymakers are also seeking answers about where to invest healthcare resources to increase access to treatment for pregnant women, especially in the current opioid crisis. A disproportionate number of women with OUD are insured through the Medicaid system; Medicaid policy affects women's access to a wide range of services, from reimbursement for same-day services or care coordination, to whether a woman continues to be eligible for benefits after delivery.

Study Aims: This study aims to answer these important patient, provider, and policy questions by comparing the real-world effectiveness of two models of MAT delivery currently in clinical use in Maine, New Hampshire, and Vermont with respect to patient experience of care and perinatal, neonatal, and longer-term substance use treatment outcomes.

Two main Comparative Effectiveness Research (CER) Patient-Centered Outcomes Research Institute (PCORI) priority questions will be addressed:

1. Do clinical and patient-reported outcomes for pregnant and parenting women differ between integrated and referral-based MAT practice models?

2. Within models, which psychosocial services are most associated with MAT continuation, and for which groups of patients?

To answer these questions, the following specific aims will be addressed:

Aim 1 (Clinical Outcomes). To use clinical record data to evaluate the comparative effectiveness of Integrated and Referral-Based MAT care models on maternal and neonatal outcomes.

Aim 2 (Patient-reported Outcomes). To use patient reported data to evaluate the comparative effectiveness of Integrated and Referral -Based care models on patient-centered outcomes.

Aim 3 (Heterogeneity of Effects). To examine differences in treatment retention within condition by subgroups of patients based on (1) psychiatric comorbidity, (2) type of medication used for MAT and (3) addiction severity.

Aim 4 (Specification of Services). To determine which services (psychosocial services, care coordination, parenting education) are associated with better maternal and neonatal outcomes.

Aim 5 (Provider). To explore how provider attitudes about MAT and care of patients with OUD vary by care model and are associated with maternal outcomes.

Study Description: This study will collaboratively engage 21 practices providing maternity care across Northern New England, with examples of both integrated care and referral-based models. The study population is pregnant women who receive prenatal care from any of these practices and who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for an opioid use disorder. A cluster-based, prospective observational mixed-methods design will be used to compare outcomes for pregnant women with opioid use disorder receiving prenatal care in obstetric practices that offer MAT through one of two delivery models: Integrated or Referral-based. Clinical records data (n=2000) from pregnant women with OUD receiving prenatal care at a partner practice will be used to examine Aim 1. Aim 2 will be addressed with a patient-report subsample cohort (n=532) recruited in the 3rd trimester of care and followed to 6 months postpartum. Aim 3 will use both kinds of data to explore heterogeneity of treatment effects. For Aim 4, practice-level data will be collected yearly to evaluate services provided across Integrated and Referral-based practices. In Aim 5, survey and qualitative interviews with providers will lend perspective on facilitators and barriers to MAT in both Integrated and Referral-based practice settings. The analytic strategy will account for clustering and patient baseline differences to compare outcomes across assessment points. Whether the effect of treatment type differs according to psychiatric status, type of MAT patients access, or addiction severity will also be tested. Analysis of qualitative data will inform our interpretation of quantitative results and enhance our understanding of patient experience, as well as barriers and facilitators to receiving care within these care models. Patient representatives, practice-partners, state and regional stakeholders, and scientific advisors will actively guide all stages of this study and dissemination of results to relevant partner networks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 16 year and older,

• Identified opioid use disorder,

• Receiving prenatal care for current pregnancy at partner practice,

• Clinic-recorded diagnosis of opioid use disorder,

• Willing and able to provide informed consent.

Exclusion Criteria:

• Ward of the State

Related Conditions & MeSH terms

• NAS
• Opioid-Related Disorders
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Observational Study
No intervention will be administered.

Locations

Country	Name	City	State
United States	Maine General Hospital	Augusta	Maine
United States	Eastern Maine Medical Center/Northern Light	Bangor	Maine
United States	Southwestern Vermont Medical Center OB-GYN	Bennington	Vermont
United States	Central Vermont Medical Center	Berlin	Vermont
United States	Brattleboro Memorial Hospital OB-GYN	Brattleboro	Vermont
United States	Dartmouth Hitchcock Keene/Cheshire Medical Center OB-GYN	Keene	New Hampshire
United States	Dartmouth Hitchcock Addiction Treatment, Moms in Recovery	Lebanon	New Hampshire
United States	Dartmouth-Hitchcock Medical Center-OB/GYN	Lebanon	New Hampshire
United States	Dartmouth Hitchcock Bedford/Manchester	Manchester	New Hampshire
United States	Dartmouth Hitchcock Nashua OB-GYN	Nashua	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Trustees of Dartmouth College	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 81 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine opioid toxicology laboratory report, included in maternal clinical record	Each clinical record describes the care of the patient over the course of her pregnancy. Urine opioid toxicology results will be reviewed in laboratory reports from each of three time periods. Data collection will include the presence/absence of nonprescribed opioids or metabolites during that time period and measure tracks the change in illicit opioid use across three time periods. Time periods include: third trimester (between 28-36 weeks of pregnancy); delivery episode (between 36-41 weeks of pregnancy); and at the last outpatient postpartum visit (occurring 2-6 weeks after delivery).	Comparison of results at three time points: between 28-36 weeks of pregnancy (third trimester); 36-41 weeks of pregnancy (delivery episode); and at the last documented outpatient postpartum visit (occurring 2-6 weeks after delivery).
Primary	Presence or absence of MAT medication in medication list, outpatient narrative, or hospital admission notes included in clinical record.	Measure is designed to track change in MAT treatment participation by tracking MAT medication use across three time periods- pregnancy, delivery, and postpartum. MAT treatment medications include: buprenorphine, buprenorphine/naloxone, methadone, naltrexone.	Comparison of results at three time points: between 28-36 weeks of pregnancy (third trimester); 36-41 weeks of pregnancy (delivery episode); and at the last documented outpatient postpartum visit (occurring 2-6 weeks after delivery).
Primary	Presence or absence of pre-specified perinatal complications in problem list, narrative notes, admission notes in clinical record (Present/Not present).	Pre-specified perinatal complications include the following: Hyperemesis, pre-eclampsia, gestational diabetes, prenatal diagnosis of fetal growth restriction, miscarriage, fetal demise, second or third trimester bleeding, placental abruption, maternal mortality, or severe maternal morbidity indicators as defined by CDC: https://www.cdc.gov/reproductivehealth/maternalinfanthealth/smm/severe-morbidity-ICD.htm	at time of delivery
Primary	Self report (Y/N) of medication assisted treatment (MAT) for opioid use disorder	Participant self-report (yes/no) of receiving MAT medicine for opioid use disorder.	Comparison of results at three time points: between 28-36 weeks of pregnancy (third trimester); 3 months after delivery, and 6 months after delivery.
Primary	Self report on Edinburgh Postnatal Depression Scale (EPDS) (scale)	Full unabbreviated scale name: Edinburgh Postnatal Depression Scale; Maximum and minimum scores: 0-30, higher indicates more severe symptoms; Scoring and interpretation of values: A cumulative score of > 10 on the EPDS or any response > 0 for question 10 is considered positive for serious postnatal depression: https://www.knowppd.com/wp-content/uploads/2019/02/edinburgh-postnatal-depression-scale-en.pdf	Comparison of numeric scores at three time points: between 28-36 weeks of pregnancy (third trimester); 3 months after delivery, and 6 months after delivery.
Primary	Self report on Generalized Anxiety Disorders Scale (GAD-7) (scale)	Full unabbreviated scale name: Generalized Anxiety Disorders Scale- 7; Maximum and minimum scores: 0-21, higher indicates more severe symptoms; Scoring and interpretation of values: 7-item scale with each item scored from 0 (not at all) to 3 (nearly every day), results are summed to calculate overall score. Score >=10 is considered clinically significant anxiety: https://www.mdcalc.com/gad-7-general-anxiety-disorder-7	Comparison of numeric scores at three time points: between 28-36 weeks of pregnancy (third trimester); 3 months after delivery, and 6 months after delivery.
Primary	Self report on Post-traumatic Stress Disorder Checklist for Civilians (PCL-C)	Full unabbreviated scale name: Post traumatic Stress Disorder Checklist for Civilians (PCL-C); Maximum and minimum scores: 17-85; higher indicates more severe symptoms.; Scoring and interpretation of values: Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale. Responses range from 1 Not at All - 5 Extremely. Scoring consists of adding up all items for a total severity score: https://www.mirecc.va.gov/docs/visn6/3_ptsd_checklist_and_scoring.pdf	Comparison of numeric scores at three time points: between 28-36 weeks of pregnancy (third trimester); 3 months after delivery, and 6 months after delivery.
Secondary	Urine drug/alcohol toxicology laboratory or point of care testing report, included in maternal clinical record	: Each clinical record describes the care of the patient over the course of her pregnancy. Urine toxicology results will be reviewed in laboratory/point of care testing reports from each of three time periods. Data collection will include the presence/absence of nonprescribed drugs, alcohol, or associated metabolites during that time period and measure tracks the change in illicit drug/alcohol use across three time periods. Time periods include: third trimester (between 28-36 weeks of pregnancy); delivery episode (between 36-41 weeks of pregnancy); and at the last outpatient postpartum visit (occurring 2-6 weeks after delivery).	Comparison of results at three time points: between 28-36 weeks of pregnancy (third trimester); 36-41 weeks of pregnancy (delivery episode); and at the last documented outpatient postpartum visit (occurring 2-6 weeks after delivery).
Secondary	(Present/Not present). Reference to presence or absence of pre-specified neonatal complications in narrative notes, admission notes in clinical record.	Pre-specified neonatal complications include the following conditions: respiratory compromise; infection; neonatal malformation.	at time of delivery
Secondary	Reference to presence or absence of pre-specified neonatal complications in outpatient narrative notes in clinical record (Present/Not present).	Pre-specified neonatal complications include the following conditions: respiratory compromise; infection; neonatal malformation.	at maternal postpartum outpatient visit
Secondary	Reference to use of pharmacologic agent to treat neonatal opioid withdrawal in maternal hospital discharge summary or narrative notes (present/absent)	The presence or absence of notes indicating the use of one of three medications for pharmacologic treatment for opioid withdrawal in newborns: morphine, methadone, or phenobarbitol	At delivery hospitalization
Secondary	Reference to use of pharmacologic agent to treat neonatal opioid withdrawal in maternal hospital discharge summary or narrative notes (present/absent)	The presence or absence of notes indicating the use of one of three medications for pharmacologic treatment for opioid withdrawal in newborns: morphine, methadone, or phenobarbitol	At maternal outpatient postpartum visit
Secondary	Change in Child Custody Status: Self report (Y/N)	Retention of child custody (Referral-based practices compared to Integrated care practices; practices with designed care coordinator to practices without designated care coordinator; practices that offer or compared to practices that do not offer psychosocial services; and practices that do not offer parenting education compared to practices that offer parenting education)	compared across two time periods: in the third trimester (between 28-36 weeks of pregnancy); and at 3 and 6 months postpartum
Secondary	Participants recruited through partner maternity care practices and by snowball sampling throughout New Hampshire, Maine, and Vermont.	Pregnant person age 16 or older Identified diagnosis of OUD Receiving prenatal care for current pregnancy at partner practice Willing and able to provide informed consent; Exclusion Criteria: Under State guardianship, including foster care Incarcerated	in the third trimester (between 28-36 weeks of pregnancy)

External Links

•   American College of Obstetricians and Gynecologists. Medical Education: Responding to a national crisis: Opioid Trainings and Clinical Guidance
•   American College of Obstetrics and Gynecologists. Statement on Opioid Use During Pregnancy. May 26, 2016
•   Maine Department of Health and Human Services (DHHS): DHHS to announce the expansion of Medication Assisted Treatment services statewide
•   Maternal Mortality Review Team. Richmond, Virginia: Virginia Department of Health;2015
•   Norris L. Maine and Affordable Care Act's (ACA) Medicaid Expansion. 2017
•   Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70(1):41-55
•   SAS Institute Inc. SAS/STAT User's Guide, version 9.4. Cary, NC: SAS Institute Inc.; 2015
•   Stone R. Pregnant women and substance use: fear, stigma, and barriers to care. Health Justice. 2015;3(1)
•   Substance Use and Mental Health Services Administration. A collaborative approach to the treatment of women with opioid use disorders. Rockville, Maryland: Substance Abuse and Mental Health Services Administration; 2016
•   Substance Use and Mental Health Services Administration. Behavioral Health Barometer: United States, 2015. Rockville, Maryland: Substance Abuse and Mental Health Services Administration, 2015
•   The American College of Obstetricians and Gynecologists Statement on Opioid Use During Pregnancy. May 26, 2016
•   The Henry J. Kaiser Family Foundation. Delivery System Reform Incentive Payment Program (DSRIP) Waivers in Place. 2017
•   Vandonsel A, Livingston, S., Searle, J. Opioids in Vermont: Prevalence, use, and impact. Vermont Department of Health, 2016
•   Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, eds. Developing a Protocol for Observational Comparative Effectiveness Research. Washington, DC: United States Department of Health and Human Services; 2013. AHRQ, ed.
•   World Health Organization Guidelines Review Committee. Guidelines for the identification and management of substance use and substance use disorders in pregnancy. World Health Organization 2014