<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833245</url>
  </required_header>
  <id_info>
    <org_study_id>116398</org_study_id>
    <nct_id>NCT03833245</nct_id>
  </id_info>
  <brief_title>Optimizing Pregnancy and Treatment Interventions for Moms 2.0</brief_title>
  <official_title>Optimizing Pregnancy and Treatment Interventions for Moms 2.0</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The US opioid epidemic continues to result in serious health consequences for pregnant and&#xD;
      postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year&#xD;
      reported past month opioid misuse. This study aims to provide rapid and targeted primary&#xD;
      prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to&#xD;
      become linked to and retained in treatment in order to reduce harms to them (including&#xD;
      overdose) and their offspring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Age adjusted rates for overdose among women in the US increased more than six-fold from 1.4&#xD;
      in 1999 to 8.5 in 2016. Examining Pennsylvania (PA) and Utah (UT; the states where&#xD;
      recruitment will happen in this study), these states have some of the highest rates of&#xD;
      overdose among women compared to other US states. Specifically, PA's overdose rate among&#xD;
      women surpassed the national average in 2016, and rates of overdose death in UT among women&#xD;
      have ranged 2-9 times higher than the national rate between 2009 to 2016. Both PA and Utah&#xD;
      are among the states with the highest opioid prescribing to pregnant women, with Utah being&#xD;
      the highest in the nation (41.6%). Prenatal opioid use disorder (OUD) in the US has brought&#xD;
      serious health consequences for mother and infant-including preterm delivery, low birth&#xD;
      weight, NAS, and poor breastfeeding, and includes substantial expenditures of health care&#xD;
      resources. Chances for HIV (OR=20.3, 95% CI = 13.8-29.7) and hepatitis C virus (OR=150.2. 95%&#xD;
      CI = 120.9-186.6) infection among women with OUD are markedly higher than for those without&#xD;
      OUD. Pregnant women with OUD have high rates of psychiatric illnesses, such as depression and&#xD;
      anxiety, and other substance use disorders (SUDs), with particularly high rates of smoking&#xD;
      (&gt;80%). Neonatal abstinence syndrome (NAS), an opioid withdrawal syndrome among neonates, has&#xD;
      also increased substantially from 3.4/1000 births in 2009 to 5.8/1000 births in 2012.&#xD;
      Poly-substance use among pregnant women with OUD has also been associated with higher levels&#xD;
      of needed medications to treat NAS and longer duration of NAS treatment. Smoking combined&#xD;
      with opioid use during pregnancy has likewise been related to longer duration of NAS&#xD;
      treatment, greater NAS severity, and higher levels of medication needed to treat NAS&#xD;
      symptomology. Any prenatal opioid use also has been associated with birth defects, including&#xD;
      neural tube defects, conoventricular septal defects, atrioventricular septal defects,&#xD;
      hypoplastic left heart syndrome, and gastroschisis. Compared with women without any SUDs,&#xD;
      children born to mothers with OUD or OUD plus other SUDs also have been documented to have&#xD;
      lower cognitive functioning as they mature. Problems resulting from illicit and prescription&#xD;
      OUD also result in significant social issues. Pregnant women with OUD have been observed to&#xD;
      have financial and housing instability, challenges related to employment, and involvement&#xD;
      with the legal system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD) Treatment Linkage/Retention</measure>
    <time_frame>36 months</time_frame>
    <description>OUD and other SUD treatment linkage/retention will be assessed through the treatment services review (TSR-6). The TSR-6 is a clinically validated 56-item measure with excellent reliability. We will capture frequency of meetings, sessions, day in OUD and other substance counseling.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid Abstinence</measure>
    <time_frame>36 months</time_frame>
    <description>Opioid abstinence will be accessed using a 14-panel urine toxicology screening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to Medication-Assisted Treatment (MAT)</measure>
    <time_frame>36 months</time_frame>
    <description>Adherence to MAT will be accessed using a 14-panel urine toxicology screening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to Medication-Assisted Treatment (MAT)</measure>
    <time_frame>36 months</time_frame>
    <description>Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Linkage/Retention in Psychosocial Services</measure>
    <time_frame>36 months</time_frame>
    <description>Linkage/retention in psychosocial services will be accessed through medical record review.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adequacy of Prenatal Care</measure>
    <time_frame>36 months</time_frame>
    <description>Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Needle use and safe sex frequency</measure>
    <time_frame>36 months</time_frame>
    <description>The Risk Behavior Survey (RBA) will be used to access HIV/Hepatitis C virus (HCV) risk behaviors. The RBA is a self-report, 22-item assessment provides the highest 30-day reliability among standardized instruments for HIV/HCV-risk behaviors among drug users.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of depression and anxiety</measure>
    <time_frame>36 months</time_frame>
    <description>The patient health questionnaire (PHQ) will be used to assess mental health. The PHQ is an 11-item mental health assessment with demonstrated criterion validity and reliability. The PHQ accesses depression, suicide ideation, anxiety, somatoform, eating and alcohol use disorders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child and mother bond following delivery</measure>
    <time_frame>36 months</time_frame>
    <description>Child and mother indicators will be accessed through the Maternal-Fetal Attachment survey.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Pregnancy, High Risk</condition>
  <condition>Opioid-Related Disorders</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The standard care condition includes brief case management and referral. The brief case management involves the participant speaking to a hospital social worker who conducts a patient needs assessment in the areas of behavioral health and social services. All patients will be referred to MAT and any identified behavioral health or social service needs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Navigation</intervention_name>
    <description>The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact.</description>
    <arm_group_label>Patient Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥18 years)&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Pregnant women (pregnancy status verified by gestational age &gt;6 weeks from last&#xD;
             menstrual period confirmed by ultrasound)&#xD;
&#xD;
          -  OUD verified by examination of medical records for an OUD diagnosis, urine toxicology,&#xD;
             and the Diagnostic and Statistical Manual of Mental Disorders (DSM) Checklist&#xD;
             (modified from the DSM-IV to confirm current diagnosis for substance use disorders)&#xD;
&#xD;
          -  Plan to carry their babies to delivery verified by patient self report&#xD;
&#xD;
        Participant Exclusion Criteria&#xD;
&#xD;
          -  Experienced a psychotic or a manic episode in the last 30 days documented in their&#xD;
             medical record&#xD;
&#xD;
          -  Beyond the 25th week of gestation&#xD;
&#xD;
          -  Cannot provide collateral contact information of 2 persons,&#xD;
&#xD;
          -  Cannot provide a reliable phone number,&#xD;
&#xD;
          -  Plan to move from the area within 2 months of their delivery will or 6 months after&#xD;
             not be included in the study&#xD;
&#xD;
          -  Inability or unwillingness of subject or legal guardian/representative to give written&#xD;
             informed consent.&#xD;
&#xD;
          -  Other factors that would cause harm or increased risk to the participant or close&#xD;
             contacts, or preclude the participant's full adherence with or completion of the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerald Cochran, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee Women's Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Jerry Cochran</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833245
org study id: 116398
nct id: NCT03833245
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The US opioid epidemic continues to result in serious health consequences for pregnant and
      postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year
      reported past month opioid misuse. This study aims to provide rapid and targeted primary
      prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to
      become linked to and retained in treatment in order to reduce harms to them (including
      overdose) and their offspring.
Age adjusted rates for overdose among women in the US increased more than six-fold from 1.4
      in 1999 to 8.5 in 2016. Examining Pennsylvania (PA) and Utah (UT; the states where
      recruitment will happen in this study), these states have some of the highest rates of
      overdose among women compared to other US states. Specifically, PA's overdose rate among
      women surpassed the national average in 2016, and rates of overdose death in UT among women
      have ranged 2-9 times higher than the national rate between 2009 to 2016. Both PA and Utah
      are among the states with the highest opioid prescribing to pregnant women, with Utah being
      the highest in the nation (41.6%). Prenatal opioid use disorder (OUD) in the US has brought
      serious health consequences for mother and infant-including preterm delivery, low birth
      weight, NAS, and poor breastfeeding, and includes substantial expenditures of health care
      resources. Chances for HIV (OR=20.3, 95% CI = 13.8-29.7) and hepatitis C virus (OR=150.2. 95%
      CI = 120.9-186.6) infection among women with OUD are markedly higher than for those without
      OUD. Pregnant women with OUD have high rates of psychiatric illnesses, such as depression and
      anxiety, and other substance use disorders (SUDs), with particularly high rates of smoking
      (>80%). Neonatal abstinence syndrome (NAS), an opioid withdrawal syndrome among neonates, has
      also increased substantially from 3.4/1000 births in 2009 to 5.8/1000 births in 2012.
      Poly-substance use among pregnant women with OUD has also been associated with higher levels
      of needed medications to treat NAS and longer duration of NAS treatment. Smoking combined
      with opioid use during pregnancy has likewise been related to longer duration of NAS
      treatment, greater NAS severity, and higher levels of medication needed to treat NAS
      symptomology. Any prenatal opioid use also has been associated with birth defects, including
      neural tube defects, conoventricular septal defects, atrioventricular septal defects,
      hypoplastic left heart syndrome, and gastroschisis. Compared with women without any SUDs,
      children born to mothers with OUD or OUD plus other SUDs also have been documented to have
      lower cognitive functioning as they mature. Problems resulting from illicit and prescription
      OUD also result in significant social issues. Pregnant women with OUD have been observed to
      have financial and housing instability, challenges related to employment, and involvement
      with the legal system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD) Treatment Linkage/Retention
time frame: 36 months
description: OUD and other SUD treatment linkage/retention will be assessed through the treatment services review (TSR-6). The TSR-6 is a clinically validated 56-item measure with excellent reliability. We will capture frequency of meetings, sessions, day in OUD and other substance counseling.
measure: Opioid Abstinence
time frame: 36 months
description: Opioid abstinence will be accessed using a 14-panel urine toxicology screening.
measure: Adherence to Medication-Assisted Treatment (MAT)
time frame: 36 months
description: Adherence to MAT will be accessed using a 14-panel urine toxicology screening.
measure: Adherence to Medication-Assisted Treatment (MAT)
time frame: 36 months
description: Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section.
measure: Linkage/Retention in Psychosocial Services
time frame: 36 months
description: Linkage/retention in psychosocial services will be accessed through medical record review.
measure: Adequacy of Prenatal Care
time frame: 36 months
description: Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received.
measure: Needle use and safe sex frequency
time frame: 36 months
description: The Risk Behavior Survey (RBA) will be used to access HIV/Hepatitis C virus (HCV) risk behaviors. The RBA is a self-report, 22-item assessment provides the highest 30-day reliability among standardized instruments for HIV/HCV-risk behaviors among drug users.
measure: Incidence of depression and anxiety
time frame: 36 months
description: The patient health questionnaire (PHQ) will be used to assess mental health. The PHQ is an 11-item mental health assessment with demonstrated criterion validity and reliability. The PHQ accesses depression, suicide ideation, anxiety, somatoform, eating and alcohol use disorders.
measure: Child and mother bond following delivery
time frame: 36 months
description: Child and mother indicators will be accessed through the Maternal-Fetal Attachment survey.
arm group label: Control
arm group type: No Intervention
description: The standard care condition includes brief case management and referral. The brief case management involves the participant speaking to a hospital social worker who conducts a patient needs assessment in the areas of behavioral health and social services. All patients will be referred to MAT and any identified behavioral health or social service needs.
arm group label: Patient Navigation
arm group type: Experimental
description: The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention.
intervention type: Behavioral
intervention name: Patient Navigation
description: The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact.
arm group label: Patient Navigation
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gerald Cochran, PhD
role: Principal Investigator
affiliation: University of Utah
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Jerry Cochran
investigator title: Associate Professor
mesh term: Opioid-Related Disorders
sharing ipd: No