MOms in REcovery (MORE) Study: Defining Optimal Care

NCT04251208 | Completed

• 1 other identifier: 00031444
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Opioid-Related Disorders; NAS; Substance Use Disorders

Keywords

Pregnancy; Infant, Newborn; Buprenorphine; Methadone; Opiate Substitution Treatment; Comparative Effectiveness; Integrated Care; Referral-based Care; Postpartum; Mental health

Outcome Measures

Primary Outcomes (7)

• 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).

• 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).

• 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

• 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.

• 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.

• 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.

• 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 Outcomes (7)

• Urine drug/alcohol toxicology laboratory or point of care testing report, included in maternal clinical record

  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).

• (Present/Not present). Reference to presence or absence of pre-specified neonatal complications in narrative notes, admission notes in clinical record.

  at time of delivery

• Reference to presence or absence of pre-specified neonatal complications in outpatient narrative notes in clinical record (Present/Not present).

  at maternal postpartum outpatient visit

• Reference to use of pharmacologic agent to treat neonatal opioid withdrawal in maternal hospital discharge summary or narrative notes (present/absent)

  At delivery hospitalization

• Reference to use of pharmacologic agent to treat neonatal opioid withdrawal in maternal hospital discharge summary or narrative notes (present/absent)

  At maternal outpatient postpartum visit

Study Arms (2)

Integrated Care

This is an observational study and no intervention will be administered. The Integrated Cohort consists of pregnant women with identified opioid use disorder who are receiving prenatal care in a maternity setting that provides medication assisted treatment for opioid use.

Other: Observational Study

Referral-Based Care

This is an observational study and no intervention will be administered. The Referral-Based Cohort consists of pregnant women with identified opioid use disorder who are receiving prenatal care in a maternity setting and are referred to substance use treatment at a specialty care setting.

Other: Observational Study

Interventions

Observational Study OTHER

No intervention will be administered.

Integrated Care; Referral-Based Care

Eligibility Criteria

• Age: 16 Years - 50 Years
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from our 21 partner maternity care practices located throughout our northeastern New England region: New Hampshire, Maine, and Vermont.

You may qualify if:

• 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.

You may not qualify if:

• Ward of the State

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (10)

Maine General Hospital

Augusta, Maine, 04330, United States

Location

Eastern Maine Medical Center/Northern Light

Bangor, Maine, 04401, United States

Location

Dartmouth Hitchcock Keene/Cheshire Medical Center OB-GYN

Keene, New Hampshire, 03431, United States

Location

Dartmouth-Hitchcock Medical Center-OB/GYN

Lebanon, New Hampshire, 03756, United States

Location

Dartmouth Hitchcock Addiction Treatment, Moms in Recovery

Lebanon, New Hampshire, 03766, United States

Location

Dartmouth Hitchcock Bedford/Manchester

Manchester, New Hampshire, 03101, United States

Location

Dartmouth Hitchcock Nashua OB-GYN

Nashua, New Hampshire, 03060, United States

Location

Southwestern Vermont Medical Center OB-GYN

Bennington, Vermont, 05201, United States

Location

Central Vermont Medical Center

Berlin Corners, Vermont, 05602, United States

Location

Brattleboro Memorial Hospital OB-GYN

Brattleboro, Vermont, 05301, United States

Location

Related Publications (81)

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Related Links

• Maine Department of Health and Human Services (DHHS): DHHS to announce the expansion of Medication Assisted Treatment services statewide
• American College of Obstetricians and Gynecologists. Medical Education: Responding to a national crisis: Opioid Trainings and Clinical Guidance
• Norris L. Maine and Affordable Care Act's (ACA) Medicaid Expansion. 2017
• The Henry J. Kaiser Family Foundation. Delivery System Reform Incentive Payment Program (DSRIP) Waivers in Place. 2017
• Substance Use and Mental Health Services Administration. Behavioral Health Barometer: United States, 2015. Rockville, Maryland: Substance Abuse and Mental Health Services Administration, 2015
• Vandonsel A, Livingston, S., Searle, J. Opioids in Vermont: Prevalence, use, and impact. Vermont Department of Health, 2016
• Maternal Mortality Review Team. Richmond, Virginia: Virginia Department of Health;2015
• American College of Obstetrics and Gynecologists. Statement on Opioid Use During Pregnancy. May 26, 2016
• 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
• 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
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MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Psychological Well-Being

Interventions

Observation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Sarah E Lord, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Daisy Goodman, DNP, MPH

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Biomedical Data Science and Pediatrics; Director, Dissemination and Implementation Core, Center for Technology and Behavioral Health

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: January 31, 2020
• Study Start: July 30, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)