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MOms in REcovery (MORE) Study: Defining Optimal Care (MORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251208
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sarah E. Lord, Trustees of Dartmouth College

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.


Condition or disease Intervention/treatment
Opioid-Related Disorders NAS Substance Use Disorders Other: Observational Study

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Study Type : Observational
Estimated Enrollment : 523 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MOms in REcovery (MORE): Defining Optimal Care for Pregnant Women and Infants
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : May 1, 2023

Group/Cohort Intervention/treatment
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
No intervention will be administered.

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
No intervention will be administered.




Primary Outcome Measures :
  1. Urine opioid toxicology laboratory report, included in maternal clinical record [ Time Frame: 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). ]
    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).

  2. Presence or absence of MAT medication in medication list, outpatient narrative, or hospital admission notes included in clinical record. [ Time Frame: 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). ]
    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.

  3. Presence or absence of pre-specified perinatal complications in problem list, narrative notes, admission notes in clinical record (Present/Not present). [ Time Frame: at time of delivery ]
    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

  4. Self report (Y/N) of medication assisted treatment (MAT) for opioid use disorder [ Time Frame: Comparison of results at three time points: between 28-36 weeks of pregnancy (third trimester); 3 months after delivery, and 6 months after delivery. ]
    Participant self-report (yes/no) of receiving MAT medicine for opioid use disorder.

  5. Self report on Edinburgh Postnatal Depression Scale (EPDS) (scale) [ Time Frame: 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. ]
    • 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

  6. Self report on Generalized Anxiety Disorders Scale (GAD-7) (scale) [ Time Frame: 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. ]
    • 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

  7. Self report on Post-traumatic Stress Disorder Checklist for Civilians (PCL-C) [ Time Frame: 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. ]
    • 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


Secondary Outcome Measures :
  1. Urine drug/alcohol toxicology laboratory or point of care testing report, included in maternal clinical record [ Time Frame: 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). ]
    : 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).

  2. (Present/Not present). Reference to presence or absence of pre-specified neonatal complications in narrative notes, admission notes in clinical record. [ Time Frame: at time of delivery ]
    Pre-specified neonatal complications include the following conditions: respiratory compromise; infection; neonatal malformation.

  3. Reference to presence or absence of pre-specified neonatal complications in outpatient narrative notes in clinical record (Present/Not present). [ Time Frame: at maternal postpartum outpatient visit ]
    Pre-specified neonatal complications include the following conditions: respiratory compromise; infection; neonatal malformation.

  4. Reference to use of pharmacologic agent to treat neonatal opioid withdrawal in maternal hospital discharge summary or narrative notes (present/absent) [ Time Frame: At delivery hospitalization ]
    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

  5. Reference to use of pharmacologic agent to treat neonatal opioid withdrawal in maternal hospital discharge summary or narrative notes (present/absent) [ Time Frame: At maternal outpatient postpartum visit ]
    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

  6. Change in Child Custody Status: Self report (Y/N) [ Time Frame: compared across two time periods: in the third trimester (between 28-36 weeks of pregnancy); and at 3 and 6 months postpartum ]
    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)

  7. Participants recruited through partner maternity care practices and by snowball sampling throughout New Hampshire, Maine, and Vermont. [ Time Frame: in the third trimester (between 28-36 weeks of pregnancy) ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251208


Contacts
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Contact: Director, Office of Sponsored Projects 603-646-0678 Jill.M.Mortali@dartmouth.edu
Contact: Sarah E Lord, PhD 603-646-7089 Sarah.E.Lord@dartmouth.edu

Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center-OB/GYN Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Daisy J Goodman, DNP       Daisy.J.Goodman@dartmouth.edu   
Sponsors and Collaborators
Trustees of Dartmouth College
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Sarah E Lord, PhD Dartmouth College
Principal Investigator: Daisy Goodman, DNP, MPH Dartmouth-Hitchcock Medical Center
Additional Information:

Publications:
Flavin J. (2002) A Glass Half Full? Harm reduction amongpregnant women who use cocaine. Journal of Drug Issues, 32(3):973-998. https://journals.sagepub.com/doi/10.1177/002204260203200315
Boyd SC, Marcellus L. (2007) With child: substance use during pregnancy, a woman-centered approach. Halifax [N.S.]: Fernwood Pub.
Westfall PH, Tobias RD, Wolfinger RD. Multiple comparisons and multiple tests using SAS. Cary, N.C.: SAS Pub.; 2011
Rosenbaum PR. Springer Series in Statistics: Observational Studies. Second Edition. New York; Berlin; Heidelberg: Springer; 2002, https://link.springer.com/book/10.1007%2F978-1-4757-3692-2
Hedeker DR, Gibbons RD. Wiley Series in Probability and Statistics: Longitudinal Data Analysis. 2006. ISBN-13: 978-0471420279
Molenberghs G, Kenward MG. Missing Data in Clinical Studies. Chichester: Wiley; 2007. ISBN: 978-0-470-84981-1

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Responsible Party: Sarah E. Lord, Assistant Professor of Psychiatry; Director, Dissemination and Implementation, Center for Technology and Behavioral Health, Trustees of Dartmouth College
ClinicalTrials.gov Identifier: NCT04251208    
Other Study ID Numbers: 00031444
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah E. Lord, Trustees of Dartmouth College:
Pregnancy
Infant, Newborn
Buprenorphine
Methadone
Opiate Substitution Treatment
Comparative Effectiveness
Integrated Care
Referral-based Care
Postpartum
Mental health
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders