xml: <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/NCT05993689</url>
    </required_header>
    <id_info>
      <org_study_id>PRO00047801</org_study_id>
      <nct_id>NCT05993689</nct_id>
    </id_info>
    <brief_title>Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE</brief_title>
    <acronym>BUNDLE</acronym>
    <official_title>Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical College of Wisconsin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical College of Wisconsin</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The BUNDLE study is a prospective mixed-methods study focused on the early integration of&#xD;
        community doula into prenatal care. The study will have three phases: Phase 1 is the&#xD;
        qualitative phase of conducting focus groups with Black/African American (AA) birthing people&#xD;
        and with medical and community healthcare providers to elicit feedback on how best to&#xD;
        integrate community-based doulas and obstetricians into one united model of prenatal care to&#xD;
        promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the&#xD;
        newly developed model on healthcare engagement, trust, and adverse maternal outcomes using&#xD;
        randomized control trial of 412 Black/AA pregnant participants. Phase 3 is dissemination of&#xD;
        BUNDLE findings in scholarly and community-based forums, including with healthcare leaders&#xD;
        and policy makers in Wisconsin, advocating for doula coverage and health system&#xD;
        sustainability of the integrated model.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The BUNDLE study is a prospective mixed-methods study focused on the early integration of&#xD;
        community doula into prenatal care. The investigators will pursue the following aims using a&#xD;
        multidisciplinary team of experts in health disparities, community engagement, qualitative&#xD;
        research, maternal-fetal medicine, and doula support:&#xD;
  &#xD;
        Aim 1: Develop an integrated prenatal care model of medical providers and community doulas in&#xD;
        Southeastern Wisconsin Approach: The investigators will conduct six focus groups with 30&#xD;
        Black/AA birthing people (currently pregnant or recently postpartum) and 30 prenatal&#xD;
        healthcare providers (obstetricians, midwives, doulas, social workers, prenatal care&#xD;
        coordinators, nurses, mental health providers, and obstetric unit leaders) to elicit feedback&#xD;
        on models of doula/medical provider integration with the overarching aim of building trust&#xD;
        and improving maternal health outcomes. Focus group findings will be reviewed with a&#xD;
        community advisory panel (CAP) developed as part of the Community Partnership of the MCW U54&#xD;
        center, to gain the CAP's input on intervention development.&#xD;
  &#xD;
        Aim 2: Compare the effectiveness of the integrated prenatal care model to standard prenatal&#xD;
        care in improving healthcare engagement and trust and reducing adverse maternal outcomes&#xD;
        Approach: In a two-arm randomized controlled trial conducted at Froedtert and MCW, the&#xD;
        investigators will randomize 412 Black/AA pregnant people to BUNDLE or standard prenatal&#xD;
        care. Primary outcome is healthcare engagement (starting prenatal care in 1st trimester,&#xD;
        attending at least 70% of the recommended visits, attending the postpartum visit, and receipt&#xD;
        of recommended vaccination during pregnancy). Secondary outcomes include medical mistrust&#xD;
        measured by trust in provider scale, perceived discrimination, and frequencies of severe&#xD;
        maternal morbidity as defined by the Centers for Disease Control.&#xD;
  &#xD;
        Aim 3: Disseminate findings to scholarly and community-based forums and actively pursue&#xD;
        opportunities for systems- and policy-level change Approach: The investigators will&#xD;
        disseminate findings regularly in scholarly (conference, grand rounds) and community-based&#xD;
        (listening session, town hall) forums. The investigators will leverage the existing&#xD;
        partnerships with policymakers, healthcare organizations, and community leaders to implement&#xD;
        strategies to sustain successful program outcomes through policy changes at the system and&#xD;
        statewide level by advocating for doula coverage and healthcare system sustainability of the&#xD;
        integrated prenatal care model.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2030</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2030</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Perinatal Healthcare Engagement</measure>
      <time_frame>From study enrollment and until 12 months postpartum</time_frame>
      <description>A composite of the following variables to assess perinatal healthcare engagement: 1) Attended at least ~75% of the recommended prenatal visits; 2) Attended postpartum visit; 3) Received recommended vaccination during pregnancy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Trust in Provider</measure>
      <time_frame>Baseline; third trimester, and postpartum</time_frame>
      <description>A validated 11-item instrument used to measure patients' trust in the provider regarding dependability, confidence, and confidentiality of information.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reported Discrimination</measure>
      <time_frame>Baseline, third trimester and postpartum</time_frame>
      <description>Measured with a validated survey of patient self-report on how often in the past 12 months, individuals felt treated poorly due to race.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress</measure>
      <time_frame>Baseline, third trimester and postpartum</time_frame>
      <description>Measured with Cohen's Perceived Stress Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Baseline, third trimester and postpartum</time_frame>
      <description>Measured with the Patient Health Questionnaire-9 (PHQ-9)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cesarean birth</measure>
      <time_frame>At study completion</time_frame>
      <description>Cesarean birth for any indication other than prior cesarean</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Unplanned healthcare utilization</measure>
      <time_frame>Up to 12 months postpartum</time_frame>
      <description>Prenatal or postpartum (up to 12 weeks postpartum) unplanned emergency room visits or hospitalizations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severe Maternal Morbidity</measure>
      <time_frame>Up to 12 months postpartum</time_frame>
      <description>Composite outcome of the following diagnoses using ICD-10 codes: acute myocardial infarction, aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, disseminated intravascular coagulation, eclampsia, heart failure, puerperal cerebrovascular disorders, pulmonary edema, severe anesthesia complications, sepsis, shock, sickle cell disease with crisis, air and thrombotic embolism blood products transfusion, hysterectomy, temporary tracheostomy, ventilation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Breastfeeding Initiation</measure>
      <time_frame>Up to 12 months postpartum</time_frame>
      <description>Rates of breastfeeding initiation prior to discharge from the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Group-Based Medical Mistrust Scale</measure>
      <time_frame>Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum)</time_frame>
      <description>A 12-item validated survey focused on healthcare provided in the social context of racism and discrimination.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">412</enrollment>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>BUNDLE Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Proposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>BUNDLE</intervention_name>
      <description>An integrated model of community-based doulas and clinical obstetric providers</description>
      <arm_group_label>BUNDLE Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>Standard of care for pregnancy and pregnancy-related issues by the obstetric provider</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Self-reported Black or African American&#xD;
  &#xD;
            -  Pregnant with singleton gestation&#xD;
  &#xD;
            -  Has an established OBGY at Froedtert &amp; the Medical College of Wisconsin (F&amp;MCW) Health&#xD;
               System&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Planning to deliver outside of F&amp;MCW Health System&#xD;
  &#xD;
            -  Receiving support beyond routing prenatal care, such as group prenatal care or has&#xD;
               their own doula&#xD;
  &#xD;
            -  Inability or unwillingness to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Anna Palatnik, MD</last_name>
      <phone>(414) 805-6624</phone>
      <email>apalatnik@mcw.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joni S Williams, MD, MPH</last_name>
      <phone>(414) 955-8827</phone>
      <email>jswilliams@mcw.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
      <investigator_full_name>Anna Palatnik, MD</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993689
  org study id: PRO00047801
  nct id: NCT05993689
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The BUNDLE study is a prospective mixed-methods study focused on the early integration of
        community doula into prenatal care. The study will have three phases: Phase 1 is the
        qualitative phase of conducting focus groups with Black/African American (AA) birthing people
        and with medical and community healthcare providers to elicit feedback on how best to
        integrate community-based doulas and obstetricians into one united model of prenatal care to
        promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the
        newly developed model on healthcare engagement, trust, and adverse maternal outcomes using
        randomized control trial of 412 Black/AA pregnant participants. Phase 3 is dissemination of
        BUNDLE findings in scholarly and community-based forums, including with healthcare leaders
        and policy makers in Wisconsin, advocating for doula coverage and health system
        sustainability of the integrated model.
  The BUNDLE study is a prospective mixed-methods study focused on the early integration of
        community doula into prenatal care. The investigators will pursue the following aims using a
        multidisciplinary team of experts in health disparities, community engagement, qualitative
        research, maternal-fetal medicine, and doula support:
  
        Aim 1: Develop an integrated prenatal care model of medical providers and community doulas in
        Southeastern Wisconsin Approach: The investigators will conduct six focus groups with 30
        Black/AA birthing people (currently pregnant or recently postpartum) and 30 prenatal
        healthcare providers (obstetricians, midwives, doulas, social workers, prenatal care
        coordinators, nurses, mental health providers, and obstetric unit leaders) to elicit feedback
        on models of doula/medical provider integration with the overarching aim of building trust
        and improving maternal health outcomes. Focus group findings will be reviewed with a
        community advisory panel (CAP) developed as part of the Community Partnership of the MCW U54
        center, to gain the CAP's input on intervention development.
  
        Aim 2: Compare the effectiveness of the integrated prenatal care model to standard prenatal
        care in improving healthcare engagement and trust and reducing adverse maternal outcomes
        Approach: In a two-arm randomized controlled trial conducted at Froedtert and MCW, the
        investigators will randomize 412 Black/AA pregnant people to BUNDLE or standard prenatal
        care. Primary outcome is healthcare engagement (starting prenatal care in 1st trimester,
        attending at least 70% of the recommended visits, attending the postpartum visit, and receipt
        of recommended vaccination during pregnancy). Secondary outcomes include medical mistrust
        measured by trust in provider scale, perceived discrimination, and frequencies of severe
        maternal morbidity as defined by the Centers for Disease Control.
  
        Aim 3: Disseminate findings to scholarly and community-based forums and actively pursue
        opportunities for systems- and policy-level change Approach: The investigators will
        disseminate findings regularly in scholarly (conference, grand rounds) and community-based
        (listening session, town hall) forums. The investigators will leverage the existing
        partnerships with policymakers, healthcare organizations, and community leaders to implement
        strategies to sustain successful program outcomes through policy changes at the system and
        statewide level by advocating for doula coverage and healthcare system sustainability of the
        integrated prenatal care model.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Perinatal Healthcare Engagement
  time frame: From study enrollment and until 12 months postpartum
  description: A composite of the following variables to assess perinatal healthcare engagement: 1) Attended at least ~75% of the recommended prenatal visits; 2) Attended postpartum visit; 3) Received recommended vaccination during pregnancy.
  measure: Trust in Provider
  time frame: Baseline; third trimester, and postpartum
  description: A validated 11-item instrument used to measure patients' trust in the provider regarding dependability, confidence, and confidentiality of information.
  measure: Reported Discrimination
  time frame: Baseline, third trimester and postpartum
  description: Measured with a validated survey of patient self-report on how often in the past 12 months, individuals felt treated poorly due to race.
  measure: Perceived Stress
  time frame: Baseline, third trimester and postpartum
  description: Measured with Cohen's Perceived Stress Scale
  measure: Depression
  time frame: Baseline, third trimester and postpartum
  description: Measured with the Patient Health Questionnaire-9 (PHQ-9)
  measure: Cesarean birth
  time frame: At study completion
  description: Cesarean birth for any indication other than prior cesarean
  measure: Unplanned healthcare utilization
  time frame: Up to 12 months postpartum
  description: Prenatal or postpartum (up to 12 weeks postpartum) unplanned emergency room visits or hospitalizations.
  measure: Severe Maternal Morbidity
  time frame: Up to 12 months postpartum
  description: Composite outcome of the following diagnoses using ICD-10 codes: acute myocardial infarction, aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, disseminated intravascular coagulation, eclampsia, heart failure, puerperal cerebrovascular disorders, pulmonary edema, severe anesthesia complications, sepsis, shock, sickle cell disease with crisis, air and thrombotic embolism blood products transfusion, hysterectomy, temporary tracheostomy, ventilation.
  measure: Breastfeeding Initiation
  time frame: Up to 12 months postpartum
  description: Rates of breastfeeding initiation prior to discharge from the hospital
  measure: Group-Based Medical Mistrust Scale
  time frame: Baseline; Week 27 up to birth (third trimester); Birth up to Week 40 (Postpartum)
  description: A 12-item validated survey focused on healthcare provided in the social context of racism and discrimination.
  arm group label: BUNDLE Intervention
  arm group type: Experimental
  description: Proposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction.
  arm group label: Usual Care
  arm group type: Active Comparator
  description: Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.
  intervention type: Other
  intervention name: BUNDLE
  description: An integrated model of community-based doulas and clinical obstetric providers
  arm group label: BUNDLE Intervention
  intervention type: Other
  intervention name: Usual Care
  description: Standard of care for pregnancy and pregnancy-related issues by the obstetric provider
  arm group label: Usual Care
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Anna Palatnik, MD
  phone: (414) 805-6624
  email: apalatnik@mcw.edu
  last name: Joni S Williams, MD, MPH
  phone: (414) 955-8827
  email: jswilliams@mcw.edu
  responsible party type: Principal Investigator
  investigator affiliation: Medical College of Wisconsin
  investigator full name: Anna Palatnik, MD
  investigator title: Associate Professor