<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/NCT03037021</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00073506</org_study_id>
    <secondary_id>1U01HL133964-01</secondary_id>
    <nct_id>NCT03037021</nct_id>
  </id_info>
  <brief_title>Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines</brief_title>
  <official_title>Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <brief_summary>
    <textblock>
      The overall goal of this proposed project is to 1) increase co-management between sickle cell&#xD;
      specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which&#xD;
      prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3)&#xD;
      identify and link patients not receiving primary or SCD specialty care to care, and 4) shift&#xD;
      healthcare use from EDs and hospitalizations to primary and specialty co-management. Many&#xD;
      persons with SCD experience a poor quality of life, serious medical complications and&#xD;
      frequent painful events that require treatment from SCD specialty care, primary care and&#xD;
      emergency department (ED) providers. There are two dominating models of care in the United&#xD;
      States; neither are ideal. Many people with SCD have all of their healthcare needs addressed&#xD;
      by sickle cell specialists who do not typically provide primary care and are often&#xD;
      geographically distant from the patients' home. Other sickle cell patients receive all of&#xD;
      their care in EDs. Both models are inadequate and result in an alarmingly high number of ED&#xD;
      visits for many patients. Current care models are neither cost efficient nor promoting&#xD;
      optimal patient outcomes. To improve outcomes, the investigators will implement a new model&#xD;
      of care for SCD using nurse care managers, web based-interactive algorithms, and test if&#xD;
      additional patient provided coaching can improve outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To inform the model, the investigators will conduct an initial in-depth multi-level&#xD;
      assessment of the barriers to care and implementation of the NHLBI &quot;Evidence-Based Management&#xD;
      of Sickle Cell Disease&quot;. With barriers and facilitators identified at the patient, provider,&#xD;
      healthcare organization and community levels, the investigators will develop another study&#xD;
      evaluation interventions that may improve the barriers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2017</start_date>
  <completion_date type="Actual">December 7, 2017</completion_date>
  <primary_completion_date type="Actual">December 7, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Barriers to primary care as measured by Focus Groups./interviews</measure>
    <time_frame>60 Minutes after focus group or interview</time_frame>
    <description>Qualitative analysis will be used to analyze interviews and focus groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to specialty care as measured by Focus Groups./interviews</measure>
    <time_frame>60 Minutes after focus group or interview</time_frame>
    <description>Qualitative analysis will be used to analyze interviews and focus groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to ED care as measured by Focus Groups./interviews</measure>
    <time_frame>60 Minutes after focus group or interview</time_frame>
    <description>Qualitative analysis will be used to analyze interviews and focus groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to primary care as measured by Survey</measure>
    <time_frame>Approximately 30-45 minutes</time_frame>
    <description>Descriptive statistics will be used to summarize the survey data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to specialty care as measured by Survey</measure>
    <time_frame>Approximately 30-45 minutes</time_frame>
    <description>Descriptive statistics will be used to summarize the survey data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to ED care as measured by Survey</measure>
    <time_frame>Approximately 30-45 minutes</time_frame>
    <description>Descriptive statistics will be used to summarize the survey data.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">213</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>SCD Adult Patients</arm_group_label>
    <description>Focus group or individual interview and survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCD Adolescent Patients</arm_group_label>
    <description>Focus group or individual interview and survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCD Healthcare Providers</arm_group_label>
    <description>Focus group or individual interview and survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents of SCD Adolescents</arm_group_label>
    <description>Focus group or individual interview and survey</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The target population includes 15-45 year olds with and SCD, parents of 15-20 year olds&#xD;
        with SCD and healthcare providers of patients with SCD residing in 31 specified counties in&#xD;
        Central North Carolina.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS,&#xD;
        SC, Sβ° or, Sβ+.&#xD;
&#xD;
        and -Parents of 15-20 year old SCD patients in the 31 geographic counties surrounding Duke&#xD;
        with genotypes Hemoglobin SS, SC, Sβ° or Sβ+.&#xD;
&#xD;
        and&#xD;
&#xD;
        -Healthcare providers of sickle cell patients in the 31 geographic counties surrounding&#xD;
        Duke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paula Tanabe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sickle Cell Disease</keyword>
  <keyword>Needs Assessment</keyword>
  <keyword>Barriers to care</keyword>
  <keyword>Access to care</keyword>
  <keyword>Primary care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT03037021
org study id: Pro00073506
secondary id: 1U01HL133964-01
nct id: NCT03037021
lead sponsor: 
collaborator: 
collaborator: 
The overall goal of this proposed project is to 1) increase co-management between sickle cell
      specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which
      prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3)
      identify and link patients not receiving primary or SCD specialty care to care, and 4) shift
      healthcare use from EDs and hospitalizations to primary and specialty co-management. Many
      persons with SCD experience a poor quality of life, serious medical complications and
      frequent painful events that require treatment from SCD specialty care, primary care and
      emergency department (ED) providers. There are two dominating models of care in the United
      States; neither are ideal. Many people with SCD have all of their healthcare needs addressed
      by sickle cell specialists who do not typically provide primary care and are often
      geographically distant from the patients' home. Other sickle cell patients receive all of
      their care in EDs. Both models are inadequate and result in an alarmingly high number of ED
      visits for many patients. Current care models are neither cost efficient nor promoting
      optimal patient outcomes. To improve outcomes, the investigators will implement a new model
      of care for SCD using nurse care managers, web based-interactive algorithms, and test if
      additional patient provided coaching can improve outcomes.
To inform the model, the investigators will conduct an initial in-depth multi-level
      assessment of the barriers to care and implementation of the NHLBI "Evidence-Based Management
      of Sickle Cell Disease". With barriers and facilitators identified at the patient, provider,
      healthcare organization and community levels, the investigators will develop another study
      evaluation interventions that may improve the barriers.
observational model: Other
time perspective: Prospective
measure: Barriers to primary care as measured by Focus Groups./interviews
time frame: 60 Minutes after focus group or interview
description: Qualitative analysis will be used to analyze interviews and focus groups.
measure: Barriers to specialty care as measured by Focus Groups./interviews
time frame: 60 Minutes after focus group or interview
description: Qualitative analysis will be used to analyze interviews and focus groups.
measure: Barriers to ED care as measured by Focus Groups./interviews
time frame: 60 Minutes after focus group or interview
description: Qualitative analysis will be used to analyze interviews and focus groups.
measure: Barriers to primary care as measured by Survey
time frame: Approximately 30-45 minutes
description: Descriptive statistics will be used to summarize the survey data.
measure: Barriers to specialty care as measured by Survey
time frame: Approximately 30-45 minutes
description: Descriptive statistics will be used to summarize the survey data.
measure: Barriers to ED care as measured by Survey
time frame: Approximately 30-45 minutes
description: Descriptive statistics will be used to summarize the survey data.
arm group label: SCD Adult Patients
description: Focus group or individual interview and survey
arm group label: SCD Adolescent Patients
description: Focus group or individual interview and survey
arm group label: SCD Healthcare Providers
description: Focus group or individual interview and survey
arm group label: Parents of SCD Adolescents
description: Focus group or individual interview and survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: No
last name: Paula Tanabe, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell