<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/NCT03253211</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00076048</org_study_id>
    <nct_id>NCT03253211</nct_id>
  </id_info>
  <brief_title>Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina</brief_title>
  <official_title>Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</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>Duke University</source>
  <brief_summary>
    <textblock>
      This project will improve the efficiency and quality of healthcare for persons with sickle&#xD;
      cell disease, an under-served and at risk population by implementing a co-management model of&#xD;
      care. Many patients with sickle cell disease (SCD) receive care primarily from specialty&#xD;
      physicians and emergency departments (ED), thus resulting in a lack of primary care and a&#xD;
      high number of ED visits and hospitalizations. The goal is to improve PCP and SCD specialist&#xD;
      co-management. The overall purpose of this dissemination project is to evaluate utilization&#xD;
      data, as well as patient and provider reported outcomes associated with the dissemination of&#xD;
      a toolbox of decision support tools to PCP's and ED providers across NC and SC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will achieve the goals stated above through three aims.&#xD;
&#xD;
        1. Examine the effects of decision support tools on study outcomes during the 12 months&#xD;
           prior to project start and across the 3.5 years of the project in NC and SC. The&#xD;
           investigators will also determine which patient and practice level characteristics&#xD;
           predict study outcomes.&#xD;
&#xD;
        2. Evaluate individual provider-reported awareness, use and preference of health&#xD;
           maintenance tables and algorithms amongst PCPs and ED providers in NC and SC at project&#xD;
           start and yearly across the project. Additionally, the investigators will explore&#xD;
           patient reported awareness of and satisfaction with co-management model of care in NC&#xD;
           and SC.&#xD;
&#xD;
        3. The investigators will conduct an exploratory cost analysis of the dissemination and&#xD;
           implementation of the SCD co-management model and its effect on healthcare resource&#xD;
           utilization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HU refills</measure>
    <time_frame>12 months</time_frame>
    <description>number of hydroxyurea prescription refills per patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Co-management visits</measure>
    <time_frame>12 months</time_frame>
    <description>number of co-management visits per patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ED visits</measure>
    <time_frame>12 months</time_frame>
    <description>number of visits to the emergency department per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-patient hospitalizations</measure>
    <time_frame>12 months</time_frame>
    <description>number of in-patient hospitalizations per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-admission to hospital within 30 days</measure>
    <time_frame>12 months</time_frame>
    <description>number of re-admissions per patient over the course of one year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary care visits</measure>
    <time_frame>12 months</time_frame>
    <description>number of visits to primary care provider per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specialty visits</measure>
    <time_frame>12 months</time_frame>
    <description>number of specialty care visits per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcranial doppler screening</measure>
    <time_frame>12 months</time_frame>
    <description>number of transcranial doppler screenings per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid prescription fills</measure>
    <time_frame>12 months</time_frame>
    <description>number of opioid prescription fill days per patient</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">4392</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>State</arm_group_label>
    <description>North Carolina</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCD Patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Providers</arm_group_label>
    <description>Primary care and emergency department clinicians</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Year</arm_group_label>
    <description>Baseline, year 2, year 3</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of sickle cell disease (not trait) are eligible for inclusion.&#xD;
        Additionally, we will survey primary care and emergency department clinicians. Patients&#xD;
        must be from North Carolina or Georgetown, SC. Clinicians must practice in NC or SC.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with diagnosis of sickle cell disease, emergency department clinician, or&#xD;
             primary care clinician in the state of NC or part of SC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking, non-resident of NC or SC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>Community Care of North Carolina</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Co-management model of care</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Specialty Care</keyword>
  <keyword>Decision support tools</keyword>
  <keyword>Emergency Department Clinicians</keyword>
  <keyword>Co-management</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/NCT03253211
org study id: PRO00076048
nct id: NCT03253211
lead sponsor: 
collaborator: 
This project will improve the efficiency and quality of healthcare for persons with sickle
      cell disease, an under-served and at risk population by implementing a co-management model of
      care. Many patients with sickle cell disease (SCD) receive care primarily from specialty
      physicians and emergency departments (ED), thus resulting in a lack of primary care and a
      high number of ED visits and hospitalizations. The goal is to improve PCP and SCD specialist
      co-management. The overall purpose of this dissemination project is to evaluate utilization
      data, as well as patient and provider reported outcomes associated with the dissemination of
      a toolbox of decision support tools to PCP's and ED providers across NC and SC.
The investigators will achieve the goals stated above through three aims.

        1. Examine the effects of decision support tools on study outcomes during the 12 months
           prior to project start and across the 3.5 years of the project in NC and SC. The
           investigators will also determine which patient and practice level characteristics
           predict study outcomes.

        2. Evaluate individual provider-reported awareness, use and preference of health
           maintenance tables and algorithms amongst PCPs and ED providers in NC and SC at project
           start and yearly across the project. Additionally, the investigators will explore
           patient reported awareness of and satisfaction with co-management model of care in NC
           and SC.

        3. The investigators will conduct an exploratory cost analysis of the dissemination and
           implementation of the SCD co-management model and its effect on healthcare resource
           utilization.
observational model: Cohort
time perspective: Prospective
measure: HU refills
time frame: 12 months
description: number of hydroxyurea prescription refills per patient
measure: Co-management visits
time frame: 12 months
description: number of co-management visits per patient
measure: ED visits
time frame: 12 months
description: number of visits to the emergency department per patient
measure: In-patient hospitalizations
time frame: 12 months
description: number of in-patient hospitalizations per patient
measure: Re-admission to hospital within 30 days
time frame: 12 months
description: number of re-admissions per patient over the course of one year
measure: Primary care visits
time frame: 12 months
description: number of visits to primary care provider per patient
measure: Specialty visits
time frame: 12 months
description: number of specialty care visits per patient
measure: Transcranial doppler screening
time frame: 12 months
description: number of transcranial doppler screenings per patient
measure: Opioid prescription fills
time frame: 12 months
description: number of opioid prescription fill days per patient
arm group label: State
description: North Carolina
arm group label: SCD Patients
arm group label: Providers
description: Primary care and emergency department clinicians
arm group label: Year
description: Baseline, year 2, year 3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
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