<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/NCT03037112</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI150731759</org_study_id>
    <nct_id>NCT03037112</nct_id>
  </id_info>
  <brief_title>Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse</brief_title>
  <official_title>Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heartland Primary Care of Sunflower Medical Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Antibiotic overuse and misuse contributes to the development of antibiotic resistant&#xD;
      infections and adverse drug reactions. The majority of all antibiotic prescribing occurs in&#xD;
      outpatient settings; most of which are for respiratory illnesses. It is estimated that 50% of&#xD;
      these prescriptions are unnecessary. The most important factor that leads to overprescribing&#xD;
      is inadequate parent-provider communication. This study will recruit providers and eligible&#xD;
      parents of children 1-5 years of age. Parents in both arms will receive identical brief&#xD;
      antibiotic education via tablet computers. Providers will be randomized to the&#xD;
      parent-provider education or communication skills intervention arm and trained accordingly.&#xD;
      Parent data will be collected via a tablet computer RedCap survey administered in the exam&#xD;
      room prior and immediately following the child's visit. Additional data will be garnered from&#xD;
      the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with&#xD;
      parents (re-visits and adverse drug reactions).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Significance: Antibiotic overuse and misuse contribute to the development of antibiotic&#xD;
      resistant infections that kill at least 23,000 Americans and cause an additional 2 million&#xD;
      infections annually. If left unchecked, antibiotic resistant infections are estimated to&#xD;
      cause 10 million deaths worldwide by 2050. Antibiotic associated adverse drug reactions&#xD;
      (e.g., rash, diarrhea, nausea, and vomiting) also result in over 140,000 Emergency Department&#xD;
      visits annually.&#xD;
&#xD;
      The majority of all antibiotic prescribing occurs in outpatient settings where children&#xD;
      receive 49 million prescriptions annually. Over 70% of these are for respiratory infections&#xD;
      and nearly 8.5 million of these prescriptions are inappropriate (i.e., either an unnecessary&#xD;
      broad-spectrum antibiotic or to treat a viral illness). There are many factors that lead to&#xD;
      overprescribing, but chief among them is inadequate parent-provider communication.&#xD;
&#xD;
      Innovation: This study is the first US multi-site randomized controlled trial comparing the&#xD;
      effectiveness an education vs. communication skills provider intervention to stimulate high&#xD;
      quality parent-provider communication and judicious use of antibiotics.&#xD;
&#xD;
      Approach: 1,600 eligible parents (or caregivers) of children between the ages of 1 and 5 will&#xD;
      be enrolled and exposed to one of the interventions based on the provider they see for their&#xD;
      visit. English and Spanish speaking parents will be recruited from the Children's Mercy&#xD;
      Hospital Primary Care Clinic (CMH PCC) in Kansas City, Missouri and the Heartland Primary&#xD;
      Care Clinics in Kansas City, KS and Lenexa, KS. Parents in both arms will receive identical&#xD;
      brief negatively behavioral framed antibiotic education via tablet computers. Providers will&#xD;
      be randomized to the parent-provider education or communication skills intervention arm and&#xD;
      trained accordingly. The primary outcome is rate of inappropriate antibiotic prescribing.&#xD;
      Secondary outcomes are parental ratings of shared decision-making and satisfaction, re-visits&#xD;
      and adverse drug reactions. Data will be collected via a tablet computer administered RedCap&#xD;
      survey administered in the exam room prior and immediately following the child's visit.&#xD;
      Additional data will be garnered from the medical record (antibiotic prescribing) and a&#xD;
      2-week follow-up telephone call with parents (re-visits and adverse drug reactions).&#xD;
&#xD;
      Public Health Impact: This study could have significant public health implications and meet&#xD;
      the goals outlined in the 2014 Executive Order on Combating Antibiotic Resistance, which&#xD;
      seeks to slow the emergence of resistant bacteria and prevent the spread of resistant&#xD;
      infections through the judicious and appropriate use of antibiotics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</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 (Participant)</masking>
    <masking_description>Providers will be randomly assigned to the education or communication skills intervention study arms. Both groups will receive identical training on the appropriate prescribing of antibiotics for ARTIs, but only those in the communication intervention will receive additional training on communication skills. Once providers have been randomized and trained, eligible patients will be enrolled and exposed to one of the interventions based on the provider they see for their visit. Patients will not be informed of their provider's study arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inappropriate antibiotic use</measure>
    <time_frame>18 months</time_frame>
    <description>Patient medical records will be reviewed 2 weeks after the visit to determine the clinical diagnosis and whether or not antibiotics were given. Determination will be made regarding the appropriateness of the diagnosis and prescribing using current clinical practice guidelines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Revisits</measure>
    <time_frame>18 months</time_frame>
    <description>All parents will be called 2 weeks following the initial visit to determine if any revisits to the same office or to another health care facility were made after the initial visit for either clinical worsening or lack of clinical improvement, or due to an adverse drug reaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse drug reactions</measure>
    <time_frame>18 months</time_frame>
    <description>All parents will be called 2 weeks following the visit to determine if the patient developed an adverse drug reaction to antibiotics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shared decision-making</measure>
    <time_frame>18 months</time_frame>
    <description>Parents will rate the quality of the shared decision-making using validated survey instruments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Satisfaction with visit</measure>
    <time_frame>18 months</time_frame>
    <description>Parents will rate the their satisfaction with the visit using validated measures.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1600</enrollment>
  <condition>Communication</condition>
  <condition>Anti-Bacterial Agents</condition>
  <condition>Decision Making</condition>
  <condition>Personal Satisfaction</condition>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All providers will receive identical training on the appropriate prescribing of antibiotics for ARTIs in a 20 minute presentation. Follow up refresher video clips will also be available for all providers to view at their convenience throughout the study. Parents in both arms will receive identical high quality education on the pros and cons of antibiotics and tips for communicating with their provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Communication Skills</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Providers randomized to the communication intervention will receive additional training on communication skills in a 40 minute communication skills training session. This training session will include good and bad communication examples, training on positive and negative behavioral framing, and education regarding key drivers of patient satisfaction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>The first intervention is an educational intervention regarding appropriate diagnosis and treatment of common respiratory infections. This education will be delivered in an interactive lecture format for providers with follow up short informational video clips available over the course of the project.</description>
    <arm_group_label>Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Communication Skills</intervention_name>
    <description>The second intervention is an education plus communication skills training intervention. This training session will include identical antibiotic education training, good and bad communication examples, training on negative behavioral framing, and education regarding key drivers of patient satisfaction. Additionally providers will be informed of parent's desire for antibiotics rating prior to their consultation with the patient.</description>
    <arm_group_label>Communication Skills</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: \&#xD;
&#xD;
          -  Parent or guardian of a child 1-5 years of age with suspected respiratory tract&#xD;
             infection who are English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents of children who require hospitalization&#xD;
&#xD;
          -  Received antibiotics in the last 30 days&#xD;
&#xD;
          -  Have concurrent bacterial infection, an immune compromising condition or chronic&#xD;
             medical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathy Goggin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Childrens Mercy Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jason G. Newland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heartland Primary Care</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Primary Care</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Pediatric Care Clinic</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>June 25, 2019</last_update_submitted>
  <last_update_submitted_qc>June 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Kathy Goggin</investigator_full_name>
    <investigator_title>Ernest L. Glasscock, MD, Chair in Pediatric Education and Research</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the final year of funding. Prior to data sharing, we will remove or convert all identifying information (date of birth will be converted to age and other identifiers will be removed). There may remain the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users under a data-sharing agreement.</ipd_description>
  </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/NCT03037112
org study id: PCORI150731759
nct id: NCT03037112
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Antibiotic overuse and misuse contributes to the development of antibiotic resistant
      infections and adverse drug reactions. The majority of all antibiotic prescribing occurs in
      outpatient settings; most of which are for respiratory illnesses. It is estimated that 50% of
      these prescriptions are unnecessary. The most important factor that leads to overprescribing
      is inadequate parent-provider communication. This study will recruit providers and eligible
      parents of children 1-5 years of age. Parents in both arms will receive identical brief
      antibiotic education via tablet computers. Providers will be randomized to the
      parent-provider education or communication skills intervention arm and trained accordingly.
      Parent data will be collected via a tablet computer RedCap survey administered in the exam
      room prior and immediately following the child's visit. Additional data will be garnered from
      the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with
      parents (re-visits and adverse drug reactions).
Significance: Antibiotic overuse and misuse contribute to the development of antibiotic
      resistant infections that kill at least 23,000 Americans and cause an additional 2 million
      infections annually. If left unchecked, antibiotic resistant infections are estimated to
      cause 10 million deaths worldwide by 2050. Antibiotic associated adverse drug reactions
      (e.g., rash, diarrhea, nausea, and vomiting) also result in over 140,000 Emergency Department
      visits annually.

      The majority of all antibiotic prescribing occurs in outpatient settings where children
      receive 49 million prescriptions annually. Over 70% of these are for respiratory infections
      and nearly 8.5 million of these prescriptions are inappropriate (i.e., either an unnecessary
      broad-spectrum antibiotic or to treat a viral illness). There are many factors that lead to
      overprescribing, but chief among them is inadequate parent-provider communication.

      Innovation: This study is the first US multi-site randomized controlled trial comparing the
      effectiveness an education vs. communication skills provider intervention to stimulate high
      quality parent-provider communication and judicious use of antibiotics.

      Approach: 1,600 eligible parents (or caregivers) of children between the ages of 1 and 5 will
      be enrolled and exposed to one of the interventions based on the provider they see for their
      visit. English and Spanish speaking parents will be recruited from the Children's Mercy
      Hospital Primary Care Clinic (CMH PCC) in Kansas City, Missouri and the Heartland Primary
      Care Clinics in Kansas City, KS and Lenexa, KS. Parents in both arms will receive identical
      brief negatively behavioral framed antibiotic education via tablet computers. Providers will
      be randomized to the parent-provider education or communication skills intervention arm and
      trained accordingly. The primary outcome is rate of inappropriate antibiotic prescribing.
      Secondary outcomes are parental ratings of shared decision-making and satisfaction, re-visits
      and adverse drug reactions. Data will be collected via a tablet computer administered RedCap
      survey administered in the exam room prior and immediately following the child's visit.
      Additional data will be garnered from the medical record (antibiotic prescribing) and a
      2-week follow-up telephone call with parents (re-visits and adverse drug reactions).

      Public Health Impact: This study could have significant public health implications and meet
      the goals outlined in the 2014 Executive Order on Combating Antibiotic Resistance, which
      seeks to slow the emergence of resistant bacteria and prevent the spread of resistant
      infections through the judicious and appropriate use of antibiotics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
masking description: Providers will be randomly assigned to the education or communication skills intervention study arms. Both groups will receive identical training on the appropriate prescribing of antibiotics for ARTIs, but only those in the communication intervention will receive additional training on communication skills. Once providers have been randomized and trained, eligible patients will be enrolled and exposed to one of the interventions based on the provider they see for their visit. Patients will not be informed of their provider's study arm.
measure: Inappropriate antibiotic use
time frame: 18 months
description: Patient medical records will be reviewed 2 weeks after the visit to determine the clinical diagnosis and whether or not antibiotics were given. Determination will be made regarding the appropriateness of the diagnosis and prescribing using current clinical practice guidelines.
measure: Revisits
time frame: 18 months
description: All parents will be called 2 weeks following the initial visit to determine if any revisits to the same office or to another health care facility were made after the initial visit for either clinical worsening or lack of clinical improvement, or due to an adverse drug reaction.
measure: Adverse drug reactions
time frame: 18 months
description: All parents will be called 2 weeks following the visit to determine if the patient developed an adverse drug reaction to antibiotics.
measure: Shared decision-making
time frame: 18 months
description: Parents will rate the quality of the shared decision-making using validated survey instruments
measure: Parent Satisfaction with visit
time frame: 18 months
description: Parents will rate the their satisfaction with the visit using validated measures.
arm group label: Education
arm group type: Active Comparator
description: All providers will receive identical training on the appropriate prescribing of antibiotics for ARTIs in a 20 minute presentation. Follow up refresher video clips will also be available for all providers to view at their convenience throughout the study. Parents in both arms will receive identical high quality education on the pros and cons of antibiotics and tips for communicating with their provider.
arm group label: Communication Skills
arm group type: Active Comparator
description: Providers randomized to the communication intervention will receive additional training on communication skills in a 40 minute communication skills training session. This training session will include good and bad communication examples, training on positive and negative behavioral framing, and education regarding key drivers of patient satisfaction.
intervention type: Behavioral
intervention name: Education
description: The first intervention is an educational intervention regarding appropriate diagnosis and treatment of common respiratory infections. This education will be delivered in an interactive lecture format for providers with follow up short informational video clips available over the course of the project.
arm group label: Education
intervention type: Behavioral
intervention name: Communication Skills
description: The second intervention is an education plus communication skills training intervention. This training session will include identical antibiotic education training, good and bad communication examples, training on negative behavioral framing, and education regarding key drivers of patient satisfaction. Additionally providers will be informed of parent's desire for antibiotics rating prior to their consultation with the patient.
arm group label: Communication Skills
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathy Goggin, PhD
role: Principal Investigator
affiliation: Childrens Mercy Hospital
last name: Jason G. Newland, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Kathy Goggin
investigator title: Ernest L. Glasscock, MD, Chair in Pediatric Education and Research
sharing ipd: Yes
ipd description: We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the final year of funding. Prior to data sharing, we will remove or convert all identifying information (date of birth will be converted to age and other identifiers will be removed). There may remain the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users under a data-sharing agreement.