<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/NCT03774797</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00126810</org_study_id>
    <nct_id>NCT03774797</nct_id>
  </id_info>
  <brief_title>Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation</brief_title>
  <official_title>Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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 objective of this study is to test and disseminate tools that drive successful immediate&#xD;
      postpartum Long-Acting Reversible Contraception (LARC) implementation. The long-term goal is&#xD;
      to reduce unintended pregnancy soon after childbirth by increasing access to immediate&#xD;
      postpartum LARC for women who desire it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on previous work, the investigators have generated a toolkit to guide the integration&#xD;
      of immediate postpartum LARC services into widespread clinical practice. In the proposed&#xD;
      work, this toolkit will be used to initiate immediate postpartum LARC services in a single&#xD;
      site with low baseline immediate postpartum LARC uptake (Michigan Medicine). The&#xD;
      investigators will conduct a feasibility study using mixed methods to assess acceptability&#xD;
      and appropriateness of toolkit items; patient experience of care; immediate postpartum LARC&#xD;
      utilization rate; and prenatal contraceptive counseling rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">August 16, 2020</completion_date>
  <primary_completion_date type="Actual">August 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient experience of care</measure>
    <time_frame>Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of care process - patients</measure>
    <time_frame>Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>Online survey assessing experience of care, acceptability and appropriateness of implementation tools</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appropriateness of care process - patients</measure>
    <time_frame>Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>Online survey assessing experience of care, acceptability and appropriateness of implementation tools</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of implementation process - study site maternity care providers</measure>
    <time_frame>Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appropriateness of implementation process - study site maternity care providers</measure>
    <time_frame>Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of implementation toolkit items - patients</measure>
    <time_frame>Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>30-minute follow-up in-person interview of subgroup of patients who completed surveys</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appropriateness of implementation toolkit items - patients</measure>
    <time_frame>Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>30-minute follow-up in-person interview of subgroup of patients who completed surveys</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of implementation toolkit items - providers</measure>
    <time_frame>Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>30-minute follow-up in-person interview of subgroup of providers who completed survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appropriateness of implementation toolkit items - providers</measure>
    <time_frame>Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care</time_frame>
    <description>30-minute follow-up in-person interview of subgroup of providers who completed survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perinatal contraceptive counseling rate</measure>
    <time_frame>Measured monthly, up to 24 months after toolkit implementation</time_frame>
    <description>Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate postpartum LARC provision rate</measure>
    <time_frame>Measured monthly, up to 24 months after toolkit implementation</time_frame>
    <description>Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">592</enrollment>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Pre-Implementation Patients</arm_group_label>
    <description>Enrolled patients will take online surveys following a prenatal or a postpartum visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Implementation Patients</arm_group_label>
    <description>All enrolled patients will take online surveys following a prenatal or a postpartum visit. A subset will be interviewed after the postpartum survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Implementation Providers</arm_group_label>
    <description>All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implementation Toolkit</intervention_name>
    <description>Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.</description>
    <arm_group_label>Post-Implementation Patients</arm_group_label>
    <arm_group_label>Post-Implementation Providers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes women receiving prenatal care and maternity providers working at&#xD;
        the study site. The patient populations includes approximately 5000 women annually. The&#xD;
        provider population includes approximately 400 maternity providers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female (patients)&#xD;
&#xD;
          -  Pregnant (patients)&#xD;
&#xD;
          -  Receiving obstetrical care at Michigan Medicine (patients)&#xD;
&#xD;
          -  L&amp;D provider at Michigan Medicine (providers)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-English speaking&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle H. Moniz, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vanessa K. Dalton, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michelle Heisler, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michigan Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Michelle H. Moniz</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>contraception</keyword>
  <keyword>long-acting reversible contraception</keyword>
  <keyword>postpartum</keyword>
  <keyword>toolkit</keyword>
  <keyword>implementation</keyword>
  <keyword>feasibility</keyword>
  <!-- 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/NCT03774797
org study id: HUM00126810
nct id: NCT03774797
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to test and disseminate tools that drive successful immediate
      postpartum Long-Acting Reversible Contraception (LARC) implementation. The long-term goal is
      to reduce unintended pregnancy soon after childbirth by increasing access to immediate
      postpartum LARC for women who desire it.
Based on previous work, the investigators have generated a toolkit to guide the integration
      of immediate postpartum LARC services into widespread clinical practice. In the proposed
      work, this toolkit will be used to initiate immediate postpartum LARC services in a single
      site with low baseline immediate postpartum LARC uptake (Michigan Medicine). The
      investigators will conduct a feasibility study using mixed methods to assess acceptability
      and appropriateness of toolkit items; patient experience of care; immediate postpartum LARC
      utilization rate; and prenatal contraceptive counseling rate.
observational model: Other
time perspective: Cross-Sectional
measure: Patient experience of care
time frame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
description: Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit
measure: Acceptability of care process - patients
time frame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
description: Online survey assessing experience of care, acceptability and appropriateness of implementation tools
measure: Appropriateness of care process - patients
time frame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
description: Online survey assessing experience of care, acceptability and appropriateness of implementation tools
measure: Acceptability of implementation process - study site maternity care providers
time frame: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
description: Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
measure: Appropriateness of implementation process - study site maternity care providers
time frame: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
description: Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
measure: Acceptability of implementation toolkit items - patients
time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
description: 30-minute follow-up in-person interview of subgroup of patients who completed surveys
measure: Appropriateness of implementation toolkit items - patients
time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
description: 30-minute follow-up in-person interview of subgroup of patients who completed surveys
measure: Acceptability of implementation toolkit items - providers
time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
description: 30-minute follow-up in-person interview of subgroup of providers who completed survey
measure: Appropriateness of implementation toolkit items - providers
time frame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
description: 30-minute follow-up in-person interview of subgroup of providers who completed survey
measure: Perinatal contraceptive counseling rate
time frame: Measured monthly, up to 24 months after toolkit implementation
description: Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception
measure: Immediate postpartum LARC provision rate
time frame: Measured monthly, up to 24 months after toolkit implementation
description: Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device
arm group label: Pre-Implementation Patients
description: Enrolled patients will take online surveys following a prenatal or a postpartum visit.
arm group label: Post-Implementation Patients
description: All enrolled patients will take online surveys following a prenatal or a postpartum visit. A subset will be interviewed after the postpartum survey.
arm group label: Post-Implementation Providers
description: All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.
intervention type: Other
intervention name: Implementation Toolkit
description: Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
arm group label: Post-Implementation Patients
arm group label: Post-Implementation Providers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle H. Moniz, MD, MSc
role: Principal Investigator
affiliation: University of Michigan
last name: Vanessa K. Dalton, MD, MPH
role: Principal Investigator
affiliation: University of Michigan
last name: Michelle Heisler, MD, MPH
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Michelle H. Moniz
investigator title: Assistant Professor