<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/NCT02977858</url>
  </required_header>
  <id_info>
    <org_study_id>2015-9317</org_study_id>
    <nct_id>NCT02977858</nct_id>
  </id_info>
  <brief_title>ISE to Support Constipation Management</brief_title>
  <official_title>Interactive Spaced Education Game to Support Constipation Management in Pediatric Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single site prospective controlled trial assessing two educational&#xD;
      interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses on&#xD;
      collaboratively developed treatment guidelines for pediatric constipation. The study aims to&#xD;
      assess the impact of an Spaced Education game to aid the implementation of the management&#xD;
      guideline. PCP adherence to recommended treatment will be assessed in addition to PCP&#xD;
      satisfaction with the educational methods, constipation knowledge and patient outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary care practices in the Greater Cincinnati region, that are part of the Ohio Valley&#xD;
      Pediatric Care Association (OVPCA) will be recruited to take part in the study. It is&#xD;
      estimated that approximately 170 providers in 40 practices will take part overall. The study&#xD;
      participants will be the PCPs and nurses in their practices.&#xD;
&#xD;
      Prior to the educational intervention (described below), participating PCPs and nurses will&#xD;
      be asked to complete Constipation Action Plan (CAP) forms detailing the treatments they&#xD;
      prescribed to each patient with constipation symptoms at each new visit and the subsequent&#xD;
      follow up visits for constipation. The CAP form will contain a section to describe the&#xD;
      patient's symptoms as well as fields to be checked for each treatment the PCP instructed the&#xD;
      patient to follow.&#xD;
&#xD;
      Practices will be clustered by size (number of providers) and randomly assigned to 1 of 2&#xD;
      educational interventions (Dissemination or Dissemination +Interactive Spaced Education).&#xD;
&#xD;
      Dissemination will include webinars and e-mail distribution of the Constipation Management&#xD;
      Guideline and a slide set containing the evidence-based rationale as well as clinical tips&#xD;
      for advanced management of functional constipation. All PCPs will receive the guideline and&#xD;
      slide set and be offered an opportunity to ask questions of a gastroenterologist.&#xD;
&#xD;
      Participating PCPs and nurses randomized to the Interactive Spaced Education (ISE) arm will&#xD;
      complete an online ISE course assessing their understanding of the constipation guidelines.&#xD;
&#xD;
      Constipation knowledge will be tested via quiz in multiple choice format. Online surveys to&#xD;
      assess satisfaction with the educational intervention, likelihood to change practice, ease of&#xD;
      participation in the SE course (if applicable) and feedback for ways to improve future&#xD;
      educational efforts will be administered at three time-points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2016</start_date>
  <completion_date type="Actual">February 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Referral</measure>
    <time_frame>2 years</time_frame>
    <description>Determine if online ISE reduces referrals of patients with constipation to pediatric gastroenterologists</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved knowledge gains</measure>
    <time_frame>2 years</time_frame>
    <description>Determine if online ISE in addition to dissemination improves knowledge gains by pediatricians and medical staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved adherence to Constipation Management Guideline</measure>
    <time_frame>2 years</time_frame>
    <description>Determine if online ISE in addition to dissemination improves adherence by pediatricians to the Constipation Management Guideline</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Dissemination</arm_group_label>
    <description>Educational practice for HCPs,Dissemination only - Practices who will participate in education for constipation management guidelines via dissemination of webinar alone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dissemination + ISE</arm_group_label>
    <description>Educational practice for HCPs,Spaced Education - Practices who will participate in education for constipation management guidelines via dissemination of webinar along with a web-based format referred to as Interactive Spaced Education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational practice for HCPs,Dissemination only</intervention_name>
    <description>Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments</description>
    <arm_group_label>Dissemination</arm_group_label>
    <arm_group_label>Dissemination + ISE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational practice for HCPs,Spaced Education</intervention_name>
    <description>Study participants are health care professionals (HCPs) who will be provided educational material via a Spaced Education program; participants will subsequently complete knowledge assessments</description>
    <arm_group_label>Dissemination + ISE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care practices in the Greater Cincinnati region, that are part of the Ohio Valley&#xD;
        Pediatric Care Association (OVPCA) will be recruited to take part in the study. It is&#xD;
        estimated that approximately 170 providers in 40 practices will take part overall. The&#xD;
        study participants will be the PCPs and nurses in their practices&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCPs and nurses who are willing and able to complete the education intervention&#xD;
             throughout the study time-frame, as outlined in the protocol (education intervention&#xD;
             does not need to be completed prior to taking part in the study)&#xD;
&#xD;
          -  PCPs and nurses who are willing to complete Constipation Action Plans and submit them&#xD;
             in a timely fashion to the CCHMC Quality Improvement program staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PCPs or nurses who are unwilling and/or unable to follow protocol requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Mallon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT02977858
org study id: 2015-9317
nct id: NCT02977858
lead sponsor: 
has dmc: No
This study is a single site prospective controlled trial assessing two educational
      interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses on
      collaboratively developed treatment guidelines for pediatric constipation. The study aims to
      assess the impact of an Spaced Education game to aid the implementation of the management
      guideline. PCP adherence to recommended treatment will be assessed in addition to PCP
      satisfaction with the educational methods, constipation knowledge and patient outcomes.
Primary care practices in the Greater Cincinnati region, that are part of the Ohio Valley
      Pediatric Care Association (OVPCA) will be recruited to take part in the study. It is
      estimated that approximately 170 providers in 40 practices will take part overall. The study
      participants will be the PCPs and nurses in their practices.

      Prior to the educational intervention (described below), participating PCPs and nurses will
      be asked to complete Constipation Action Plan (CAP) forms detailing the treatments they
      prescribed to each patient with constipation symptoms at each new visit and the subsequent
      follow up visits for constipation. The CAP form will contain a section to describe the
      patient's symptoms as well as fields to be checked for each treatment the PCP instructed the
      patient to follow.

      Practices will be clustered by size (number of providers) and randomly assigned to 1 of 2
      educational interventions (Dissemination or Dissemination +Interactive Spaced Education).

      Dissemination will include webinars and e-mail distribution of the Constipation Management
      Guideline and a slide set containing the evidence-based rationale as well as clinical tips
      for advanced management of functional constipation. All PCPs will receive the guideline and
      slide set and be offered an opportunity to ask questions of a gastroenterologist.

      Participating PCPs and nurses randomized to the Interactive Spaced Education (ISE) arm will
      complete an online ISE course assessing their understanding of the constipation guidelines.

      Constipation knowledge will be tested via quiz in multiple choice format. Online surveys to
      assess satisfaction with the educational intervention, likelihood to change practice, ease of
      participation in the SE course (if applicable) and feedback for ways to improve future
      educational efforts will be administered at three time-points.
observational model: Case-Control
time perspective: Prospective
measure: Patient Referral
time frame: 2 years
description: Determine if online ISE reduces referrals of patients with constipation to pediatric gastroenterologists
measure: Improved knowledge gains
time frame: 2 years
description: Determine if online ISE in addition to dissemination improves knowledge gains by pediatricians and medical staff
measure: Improved adherence to Constipation Management Guideline
time frame: 2 years
description: Determine if online ISE in addition to dissemination improves adherence by pediatricians to the Constipation Management Guideline
arm group label: Dissemination
description: Educational practice for HCPs,Dissemination only - Practices who will participate in education for constipation management guidelines via dissemination of webinar alone.
arm group label: Dissemination + ISE
description: Educational practice for HCPs,Spaced Education - Practices who will participate in education for constipation management guidelines via dissemination of webinar along with a web-based format referred to as Interactive Spaced Education.
intervention type: Other
intervention name: Educational practice for HCPs,Dissemination only
description: Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments
arm group label: Dissemination
arm group label: Dissemination + ISE
intervention type: Other
intervention name: Educational practice for HCPs,Spaced Education
description: Study participants are health care professionals (HCPs) who will be provided educational material via a Spaced Education program; participants will subsequently complete knowledge assessments
arm group label: Dissemination + ISE
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Mallon, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Constipation
sharing ipd: No