<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/NCT03296774</url>
  </required_header>
  <id_info>
    <org_study_id>University Pittsburgh</org_study_id>
    <nct_id>NCT03296774</nct_id>
  </id_info>
  <brief_title>Healthy Beyond Pregnancy: Improving Postpartum Care</brief_title>
  <official_title>Healthy Beyond Pregnancy: A Pilot Usability and Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</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>
      Minority women and women of lower socioeconomic status are at significantly increased risk of&#xD;
      unintended pregnancies, short inter-pregnancy interval, and short duration of breastfeeding.&#xD;
      The consequences of poorly timed pregnancies and short duration of breastfeeding for the&#xD;
      health of mothers, infants and children are well documented.&#xD;
&#xD;
      To decrease rates of poorly timed pregnancies, increase breastfeeding duration and address&#xD;
      other postpartum concerns women must be engaged in their postpartum care outside of the&#xD;
      traditional postpartum visit. In addition to contraceptive counseling and breastfeeding&#xD;
      support, providers discuss a number of important maternal and child health issues at the&#xD;
      postpartum visit. These include (1) screening and referral for postpartum mood disorders (2)&#xD;
      screening for cardiometabolic consequences of pregnancy complications, (3) discussing&#xD;
      inter-conception care and (4) connecting women with a primary care provider. Thus, as&#xD;
      recommended by numerous professional societies, the standard postpartum visit at 4 to 6 weeks&#xD;
      after delivery has considerable value to women's postpartum care.&#xD;
&#xD;
      Attendance rates for the postpartum visit are markedly lower for women with limited resources&#xD;
      contributing to racial and economic health disparities. Despite receiving excellent prenatal&#xD;
      care, only 40% of the economically disadvantaged women who receive prenatal care at the Magee&#xD;
      outpatient clinic return for their postpartum visit. These parallel national trends, where&#xD;
      60% of women with Medicaid insurance return for a postpartum checkup compared with over 82%&#xD;
      of women with private insurance. Medicaid programs serve pregnant women who are particularly&#xD;
      vulnerable to poor health outcomes and thus this gap is critical. Additionally, minority&#xD;
      women disproportionally receive Medicaid and thus interventions that focus on Medicaid&#xD;
      recipients have the potential to address racial as well as economic disparities. These data&#xD;
      demonstrate that the current care model does not engage all women to make good health care&#xD;
      decision postpartum and is disproportionately failing our most vulnerable moms and babies.&#xD;
&#xD;
      Empirically derived concepts from behavioral economics can be leveraged to design&#xD;
      interventions that support participants to make better health decisions and may be&#xD;
      particularly useful for postpartum care.&#xD;
&#xD;
      The feasibility trial will focus on four tenants of behavioral economics-bounded rationality&#xD;
      (information overload), status quo bias (lack of self-control), hovering (limited attention),&#xD;
      and framed incentives-- that have been successfully used to tackle stubborn health problems&#xD;
      such as smoking and obesity. Importantly, unlike tobacco cessation or weight loss, many&#xD;
      aspects of postpartum care such as compliance with the visit or uptake of LARC, do not&#xD;
      require on-going action on part of the patient and thus may be particularly amenable to the&#xD;
      lessons of behavioral economics.&#xD;
&#xD;
      Specific Aim 1: To conduct a pilot trial evaluating the feasibility and acceptability of a&#xD;
      future randomized trial to determine the efficacy of Healthy Beyond Pregnancy on adherence&#xD;
      with the postpartum visit.&#xD;
&#xD;
      Specific Aim 2: To determine the impact of Healthy Beyond Pregnancy on adherence with the&#xD;
      postpartum visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">February 15, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of eligible participants who consent and complete study intervention</measure>
    <time_frame>1-4 days postpartum</time_frame>
    <description>Assess the feasibility of a larger randomized controlled trial</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence with postpartum visit- number of participants who return for postpartum visit.</measure>
    <time_frame>21-56 days after delivery</time_frame>
    <description>Did participant come for postpartum visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Postpartum Care</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual postpartum care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Beyond Pregnancy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Web-based program for postpartum care and education and scheduling. Incentive for committing and returning for postpartum care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Beyond Pregnancy</intervention_name>
    <description>Web-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care.</description>
    <arm_group_label>Healthy Beyond Pregnancy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postpartum 6-72 hours from delivery, aged 18-50, receipt of prenatal care through the&#xD;
             Magee-Womens Hospital outpatient clinic and UPMC for You Medicaid insurance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Delivery less than 24 weeks, fetal or neonatal death, non-English speaking, no&#xD;
             text-enabled phone&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnancy based study</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Francesca Facco, MD</investigator_full_name>
    <investigator_title>Assistant Professor of medicine</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03296774
org study id: University Pittsburgh
nct id: NCT03296774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Minority women and women of lower socioeconomic status are at significantly increased risk of
      unintended pregnancies, short inter-pregnancy interval, and short duration of breastfeeding.
      The consequences of poorly timed pregnancies and short duration of breastfeeding for the
      health of mothers, infants and children are well documented.

      To decrease rates of poorly timed pregnancies, increase breastfeeding duration and address
      other postpartum concerns women must be engaged in their postpartum care outside of the
      traditional postpartum visit. In addition to contraceptive counseling and breastfeeding
      support, providers discuss a number of important maternal and child health issues at the
      postpartum visit. These include (1) screening and referral for postpartum mood disorders (2)
      screening for cardiometabolic consequences of pregnancy complications, (3) discussing
      inter-conception care and (4) connecting women with a primary care provider. Thus, as
      recommended by numerous professional societies, the standard postpartum visit at 4 to 6 weeks
      after delivery has considerable value to women's postpartum care.

      Attendance rates for the postpartum visit are markedly lower for women with limited resources
      contributing to racial and economic health disparities. Despite receiving excellent prenatal
      care, only 40% of the economically disadvantaged women who receive prenatal care at the Magee
      outpatient clinic return for their postpartum visit. These parallel national trends, where
      60% of women with Medicaid insurance return for a postpartum checkup compared with over 82%
      of women with private insurance. Medicaid programs serve pregnant women who are particularly
      vulnerable to poor health outcomes and thus this gap is critical. Additionally, minority
      women disproportionally receive Medicaid and thus interventions that focus on Medicaid
      recipients have the potential to address racial as well as economic disparities. These data
      demonstrate that the current care model does not engage all women to make good health care
      decision postpartum and is disproportionately failing our most vulnerable moms and babies.

      Empirically derived concepts from behavioral economics can be leveraged to design
      interventions that support participants to make better health decisions and may be
      particularly useful for postpartum care.

      The feasibility trial will focus on four tenants of behavioral economics-bounded rationality
      (information overload), status quo bias (lack of self-control), hovering (limited attention),
      and framed incentives-- that have been successfully used to tackle stubborn health problems
      such as smoking and obesity. Importantly, unlike tobacco cessation or weight loss, many
      aspects of postpartum care such as compliance with the visit or uptake of LARC, do not
      require on-going action on part of the patient and thus may be particularly amenable to the
      lessons of behavioral economics.

      Specific Aim 1: To conduct a pilot trial evaluating the feasibility and acceptability of a
      future randomized trial to determine the efficacy of Healthy Beyond Pregnancy on adherence
      with the postpartum visit.

      Specific Aim 2: To determine the impact of Healthy Beyond Pregnancy on adherence with the
      postpartum visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of eligible participants who consent and complete study intervention
time frame: 1-4 days postpartum
description: Assess the feasibility of a larger randomized controlled trial
measure: Adherence with postpartum visit- number of participants who return for postpartum visit.
time frame: 21-56 days after delivery
description: Did participant come for postpartum visit
arm group label: Usual Care
arm group type: Placebo Comparator
description: Usual postpartum care
arm group label: Healthy Beyond Pregnancy
arm group type: Experimental
description: Web-based program for postpartum care and education and scheduling. Incentive for committing and returning for postpartum care.
intervention type: Behavioral
intervention name: Healthy Beyond Pregnancy
description: Web-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care.
arm group label: Healthy Beyond Pregnancy
intervention type: Behavioral
intervention name: Usual Care
arm group label: Usual Care
criteria: 
gender: Female
gender based: Yes
gender description: pregnancy based study
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Francesca Facco, MD
investigator title: Assistant Professor of medicine
sharing ipd: Undecided