<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/NCT02262962</url>
  </required_header>
  <id_info>
    <org_study_id>1R40MC21516</org_study_id>
    <secondary_id>K23HD062677</secondary_id>
    <secondary_id>R40MC21516</secondary_id>
    <nct_id>NCT02262962</nct_id>
  </id_info>
  <brief_title>Well-Child Care Redesign: A New Model of Care for Children in Low-Income Families</brief_title>
  <official_title>Well-Child Care Redesign: A New Model of Care for Children in Low-Income Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Resources and Services Administration (HRSA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to design and test a new model for delivery of well-child&#xD;
      care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators&#xD;
      used an innovative expert panel and community advisory board process to develop this new&#xD;
      model for the delivery of WCC to low-income families in partnership with our partner&#xD;
      community pediatric practices. The new model of care utilizes a trained health educator, or&#xD;
      &quot;Parent Coach&quot; at every well-visit from 0-3 years of age. The Parent Coach provides a range&#xD;
      of services, including health education and guidance, developmental screening, and&#xD;
      psychosocial screening and services. The Parent Coach works with the Primary Care Physician&#xD;
      to ensure that the family's needs are met for that well-visit. As a part of this new model&#xD;
      for well-child care, the parent also uses a web-based tool to help prioritize needs for the&#xD;
      visit and complete any necessary pre-visit screening. Parents receive additional education&#xD;
      and guidance from a text message service and have access to the Parent Coach outside of the&#xD;
      visit.&#xD;
&#xD;
      The randomized controlled trial (RCT) of this new model of care will include 250 families who&#xD;
      will be enrolled at participating clinics if the child is under 1 year of age. Parents will&#xD;
      receive the intervention for 12 months and will complete surveys to collect data on their&#xD;
      experiences of care. Our hypothesis is that this new model of care will be more&#xD;
      patient-centered and more effective in providing recommended preventive care services than&#xD;
      usual care, and that it will be a sustainable and feasible model for the partner practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During Phase 1, we used an innovative expert panel and community advisory board process to&#xD;
      develop a new structural model for delivery of well-child care (WCC) to low-income families.&#xD;
      The new model of care was developed using a WCC Framework that considered alternative&#xD;
      structure for care: non-physician providers (nurses, lay health educators, social workers),&#xD;
      non-traditional formats (group visits, internet, phone), and non-clinical locations (daycare&#xD;
      centers, home visits, grocery stores) for each of six major WCC visits (physical exam,&#xD;
      immunizations/laboratory screening, behavioral/developmental services, anticipatory guidance,&#xD;
      psychosocial screenings, and sick visits/after-hours care), as well as a feasible mechanism&#xD;
      for provider reimbursement. The model that was developed was a Team-Based Care, Parent Coach&#xD;
      Model for WCC.&#xD;
&#xD;
      Recruitment of study participants carried on for approximately six months. We posted flyers&#xD;
      in two Los Angeles pediatric clinics. The flyers instructed parents to contact the study&#xD;
      investigators by phone or email, or alternatively speak with the office receptionist, if&#xD;
      interested in participating. A bilingual (English and Spanish) research associate (RA) was&#xD;
      available 2-3 days per week in each clinic site to answer questions that interested parents&#xD;
      may have had; that person was also available by phone and email 5 days a week to respond to&#xD;
      requests for information. A parent who saw a flyer in the clinic on the day of their visit&#xD;
      could have approached the clinic receptionist, expressed an interest in the study, and then&#xD;
      directed to either speak with the RA in a private room at the clinic. Additionally, when&#xD;
      parents arrived for a visit for a child in the age range specified for the study, they were&#xD;
      handed a 1-page flyer regarding the study during check-in at the receptionist's desk. The&#xD;
      flyers instructed parents to call, email, or speak in person privately with the study RA if&#xD;
      they were interested in participating or needed more information.&#xD;
&#xD;
      Eligible parents were informed of their intervention assignment and were asked for contact&#xD;
      information and to complete a 10 minute survey. All parents were informed that they would be&#xD;
      contacted 6-months and 12-months post-enrollment to complete two additional surveys. Parents&#xD;
      in the intervention group were informed that they may be randomly selected to participate in&#xD;
      an additional component to provide study staff with additional information regarding the&#xD;
      health services that the parent received during the 12 months that he/she was enrolled in the&#xD;
      study.&#xD;
&#xD;
      During enrollment the parents in the intervention group were informed of the additional&#xD;
      services available to them. Parents were able to enroll in a text messaging program which&#xD;
      provides parents with age-tailored health information through texts. The texts are available&#xD;
      in English and Spanish. They contain information such as: car seat safety, dental care for&#xD;
      baby and reminders to schedule child's physicals. The second service available to parents is&#xD;
      a web-based parent tool called the Well Visit Planner (WVP) tool. The tool gives parents the&#xD;
      opportunity to customize their child's upcoming routine physical. The WVP also gives the&#xD;
      parents an opportunity to learn about developmental milestones that their child should be&#xD;
      meeting. Lastly, parents are given the opportunity to choose priorities to discuss with the&#xD;
      physician and the Parent Coach. The data from the pre-visit tool is automatically uploaded to&#xD;
      the electronic health record, where red flags indicate areas of further need.&#xD;
&#xD;
      The Parent Coach is also available to intervention patients at the two participating clinics.&#xD;
      The Parent Coach is a trained child bilingual health education specialist that will be&#xD;
      available at each clinic at least two days a week and over the phone at least one day a week.&#xD;
      She is available to help parents schedule appointments and review flagged items on the Well&#xD;
      Visit Planner tool. The Parent Coach addresses psychosocial, developmental and behavioral&#xD;
      concerns that parents may have. She is also gives parents tips on how parents can help their&#xD;
      baby grow and develop. In addition, she is trained to check if the baby is developing&#xD;
      normally and if there is reason for concern she will bring it to the attention of the&#xD;
      pediatrician at clinic and help parents with referrals for further testing.&#xD;
&#xD;
      Enrollment into the RCT began in June 2013 and ran through December 2013. We enrolled 251&#xD;
      patients over two clinical sites. Half of the participants at each clinic were placed in the&#xD;
      control group (n= 125) and the other half in the intervention group (n=126). Research&#xD;
      associates are available over the phone and in person at to complete parents follow- up&#xD;
      surveys. The 12 month post enrollment surveys are schedule to be completed in December 2014.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2005</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Receipt of Recommended Preventive Care Services</measure>
    <time_frame>At 12 months post enrollment</time_frame>
    <description>This is a composite measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receipt of Recommended Preventive Care Services</measure>
    <time_frame>At 6 months post enrollment</time_frame>
    <description>This is a composite measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">251</enrollment>
  <condition>Preventive Health Services</condition>
  <condition>Health Promotion</condition>
  <arm_group>
    <arm_group_label>Usual Well-Child Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No change in Well-Child Visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Redesigned Well-Child Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Redesigned Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and text messaging services (HealthyTxt).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Redesigned Well-Child Care</intervention_name>
    <description>The Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and HealthyTxt Messaging service.</description>
    <arm_group_label>Redesigned Well-Child Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parent or guardian of an infant who is 12 months of age or younger&#xD;
&#xD;
          2. Speaks English or Spanish&#xD;
&#xD;
          3. Is 18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has plans to move out of Los Angeles county within the next 12 months&#xD;
&#xD;
          2. Has plans to change the primary care location for the index child within the next 12&#xD;
             months.&#xD;
&#xD;
          3. Parent or guardian is an employee of one of the primary care clinics that are part of&#xD;
             the study.&#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>Tumaini Coker, MD/MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA Department of General Pediatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Children's Discovery and Innovation Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.</citation>
    <PMID>24936004</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>June 20, 2016</last_update_submitted>
  <last_update_submitted_qc>June 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Tumaini R Coker</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT02262962
org study id: 1R40MC21516
secondary id: K23HD062677
secondary id: R40MC21516
nct id: NCT02262962
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this research is to design and test a new model for delivery of well-child
      care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators
      used an innovative expert panel and community advisory board process to develop this new
      model for the delivery of WCC to low-income families in partnership with our partner
      community pediatric practices. The new model of care utilizes a trained health educator, or
      "Parent Coach" at every well-visit from 0-3 years of age. The Parent Coach provides a range
      of services, including health education and guidance, developmental screening, and
      psychosocial screening and services. The Parent Coach works with the Primary Care Physician
      to ensure that the family's needs are met for that well-visit. As a part of this new model
      for well-child care, the parent also uses a web-based tool to help prioritize needs for the
      visit and complete any necessary pre-visit screening. Parents receive additional education
      and guidance from a text message service and have access to the Parent Coach outside of the
      visit.

      The randomized controlled trial (RCT) of this new model of care will include 250 families who
      will be enrolled at participating clinics if the child is under 1 year of age. Parents will
      receive the intervention for 12 months and will complete surveys to collect data on their
      experiences of care. Our hypothesis is that this new model of care will be more
      patient-centered and more effective in providing recommended preventive care services than
      usual care, and that it will be a sustainable and feasible model for the partner practices.
During Phase 1, we used an innovative expert panel and community advisory board process to
      develop a new structural model for delivery of well-child care (WCC) to low-income families.
      The new model of care was developed using a WCC Framework that considered alternative
      structure for care: non-physician providers (nurses, lay health educators, social workers),
      non-traditional formats (group visits, internet, phone), and non-clinical locations (daycare
      centers, home visits, grocery stores) for each of six major WCC visits (physical exam,
      immunizations/laboratory screening, behavioral/developmental services, anticipatory guidance,
      psychosocial screenings, and sick visits/after-hours care), as well as a feasible mechanism
      for provider reimbursement. The model that was developed was a Team-Based Care, Parent Coach
      Model for WCC.

      Recruitment of study participants carried on for approximately six months. We posted flyers
      in two Los Angeles pediatric clinics. The flyers instructed parents to contact the study
      investigators by phone or email, or alternatively speak with the office receptionist, if
      interested in participating. A bilingual (English and Spanish) research associate (RA) was
      available 2-3 days per week in each clinic site to answer questions that interested parents
      may have had; that person was also available by phone and email 5 days a week to respond to
      requests for information. A parent who saw a flyer in the clinic on the day of their visit
      could have approached the clinic receptionist, expressed an interest in the study, and then
      directed to either speak with the RA in a private room at the clinic. Additionally, when
      parents arrived for a visit for a child in the age range specified for the study, they were
      handed a 1-page flyer regarding the study during check-in at the receptionist's desk. The
      flyers instructed parents to call, email, or speak in person privately with the study RA if
      they were interested in participating or needed more information.

      Eligible parents were informed of their intervention assignment and were asked for contact
      information and to complete a 10 minute survey. All parents were informed that they would be
      contacted 6-months and 12-months post-enrollment to complete two additional surveys. Parents
      in the intervention group were informed that they may be randomly selected to participate in
      an additional component to provide study staff with additional information regarding the
      health services that the parent received during the 12 months that he/she was enrolled in the
      study.

      During enrollment the parents in the intervention group were informed of the additional
      services available to them. Parents were able to enroll in a text messaging program which
      provides parents with age-tailored health information through texts. The texts are available
      in English and Spanish. They contain information such as: car seat safety, dental care for
      baby and reminders to schedule child's physicals. The second service available to parents is
      a web-based parent tool called the Well Visit Planner (WVP) tool. The tool gives parents the
      opportunity to customize their child's upcoming routine physical. The WVP also gives the
      parents an opportunity to learn about developmental milestones that their child should be
      meeting. Lastly, parents are given the opportunity to choose priorities to discuss with the
      physician and the Parent Coach. The data from the pre-visit tool is automatically uploaded to
      the electronic health record, where red flags indicate areas of further need.

      The Parent Coach is also available to intervention patients at the two participating clinics.
      The Parent Coach is a trained child bilingual health education specialist that will be
      available at each clinic at least two days a week and over the phone at least one day a week.
      She is available to help parents schedule appointments and review flagged items on the Well
      Visit Planner tool. The Parent Coach addresses psychosocial, developmental and behavioral
      concerns that parents may have. She is also gives parents tips on how parents can help their
      baby grow and develop. In addition, she is trained to check if the baby is developing
      normally and if there is reason for concern she will bring it to the attention of the
      pediatrician at clinic and help parents with referrals for further testing.

      Enrollment into the RCT began in June 2013 and ran through December 2013. We enrolled 251
      patients over two clinical sites. Half of the participants at each clinic were placed in the
      control group (n= 125) and the other half in the intervention group (n=126). Research
      associates are available over the phone and in person at to complete parents follow- up
      surveys. The 12 month post enrollment surveys are schedule to be completed in December 2014.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Receipt of Recommended Preventive Care Services
time frame: At 12 months post enrollment
description: This is a composite measure
measure: Receipt of Recommended Preventive Care Services
time frame: At 6 months post enrollment
description: This is a composite measure
arm group label: Usual Well-Child Care
arm group type: No Intervention
description: No change in Well-Child Visits.
arm group label: Redesigned Well-Child Care
arm group type: Experimental
description: The Redesigned Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and text messaging services (HealthyTxt).
intervention type: Other
intervention name: Redesigned Well-Child Care
description: The Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and HealthyTxt Messaging service.
arm group label: Redesigned Well-Child Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tumaini Coker, MD/MBA
role: Principal Investigator
affiliation: UCLA Department of General Pediatrics
facility: 
country: United States
citation: Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.
PMID: 24936004
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Tumaini R Coker
investigator title: Assistant Professor
sharing ipd: No