<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/NCT02190617</url>
  </required_header>
  <id_info>
    <org_study_id>AS1307-05498</org_study_id>
    <nct_id>NCT02190617</nct_id>
  </id_info>
  <brief_title>Guidelines to Practice: Reducing Asthma Health Disparities Through Guideline Implementation</brief_title>
  <acronym>G2P</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Public Health - Seattle and King County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Public Health - Seattle and King County</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary hypothesis the investigators will test is that that improving asthma guideline&#xD;
      implementation and providing patients with a unified asthma management plan using a&#xD;
      multi-component and multilevel intervention will improve patient-centered asthma outcomes&#xD;
      compared to health plan case management, passive guideline dissemination and provider&#xD;
      education.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will use a factorial randomized controlled design to assess the comparative&#xD;
      effectiveness of the following interventions among 8 community health centers and 550&#xD;
      patients with:&#xD;
&#xD;
        -  Health plan enhanced intervention plus traditional provider education: Health plans will&#xD;
           enhance case management support, monitor medication fills, and increase passive&#xD;
           guideline dissemination. Traditional provider education will consist of implementation&#xD;
           of the PACE asthma education program. Note that all participants and clinics will&#xD;
           receive this intervention. In effect, this will be the base active comparator arm of the&#xD;
           study.&#xD;
&#xD;
        -  Home visit intervention: Community health workers will provide in-home tailored asthma&#xD;
           support: assess asthma self-management knowledge and skills, conduct a home&#xD;
           environmental assessment focused on asthma triggers, and conduct follow-up visits to&#xD;
           support patient actions to improve asthma control based on unified asthma management&#xD;
           plan.&#xD;
&#xD;
        -  Enhanced clinic intervention with system integration: Clinics will implement a&#xD;
           multi-component intervention that includes decision support, audit and feedback,&#xD;
           provider and staff education, team-based care, and training and feedback in implementing&#xD;
           office spirometry and allergy testing. EHR enhancements and clinic systems redesign will&#xD;
           support this work. The EHR will also provide a platform for sharing a common asthma&#xD;
           management plan and enhancing communications among care team members (clinicians, CHWs,&#xD;
           plan case managers).&#xD;
&#xD;
      All four intervention groups will receive enhanced health plan intervention + provider&#xD;
      education. The four study arms will receive the following additional different interventions:&#xD;
      (a) usual clinic care; (b) a + home visit, (c) enhanced clinic care + system integration, and&#xD;
      (d) c + home visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>Factorial Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom free days</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire: Days without cough, wheeze, chest tightness, shortness of breath, nocturnal wakening from symptoms or activity limitation due to asthma in past 2 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Asthma control</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire and spirometry. Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Asthma-related Quality of Life</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire.&#xD;
Adults:&#xD;
Mini Asthma Quality of Life Questionnaire&#xD;
Children 7-17:&#xD;
Pediatric Asthma Quality of Life Questionnaire&#xD;
Children 5-6:&#xD;
Pediatric Asthma Caregiver Quality of Life Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nocturnal wakening</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire: Nights wakened in the past two weeks due to asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma exacerbations</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire: Need for oral steroids (3+ day course), hospitalization, ED visit or unscheduled clinic visit for worsening asthma in past 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by spirometry: Post-bronchodilator FEV1 and FEV1 /FVC and change in pre-post bronchodilator FEV1 and FEV1 /FVC182 using EasyOne Diagnostic spirometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FeNO (Fractional exhaled Nitric Oxide)</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by portable handheld device: Online measurement of ppb in exhaled breath at 50 L/s (&lt;25 ppb indicates normal value.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-agonist use</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral steroid use</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Controller use</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by claims data: Controller to total asthma medication ratio &gt; 0.5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma-related urgent health services utilization</measure>
    <time_frame>12 Month</time_frame>
    <description>Measured by questionnaire and administrative data: Urgent clinic visits, emergency department visits, and hospitalizations during past three months and past year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Missed work or school days</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire: Number of school or work days missed in past two weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Health Status</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured by questionnaire:&#xD;
Adults: SF-12 Health Survey Children: SF -10 Health Survey</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">550</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Enhanced Clinic+ Unified Management Plan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in study arm will receive:&#xD;
Enhanced Clinic Intervention&#xD;
Enhanced Health Plan&#xD;
Unified Management Plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHW Home Visit Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in study arm will receive:&#xD;
CHW Home Visit&#xD;
Usual clinic care with enhanced health plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Clinic+ Unified Plan+ CHW</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in study arm will receive:&#xD;
CHW Home Visit&#xD;
Enhanced Clinic intervention&#xD;
Enhanced health plan&#xD;
Unified asthma management plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>-Usual clinic care with enhanced healthplan</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Clinic+ Unified Plan + CHW</intervention_name>
    <description>Unified asthma management plan and asthma support team coordination: A support team will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan.&#xD;
Home visit intervention: Community health workers will provide in-home tailored asthma support and conduct follow-up to support patient actions to improve asthma control based on unified asthma management plan.&#xD;
Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign.</description>
    <arm_group_label>Enhanced Clinic+ Unified Plan+ CHW</arm_group_label>
    <other_name>-Enhanced Clinic</other_name>
    <other_name>-CHW Home Visits</other_name>
    <other_name>-Unified Management plan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Clinic+ Unified Management Plan</intervention_name>
    <description>Unified asthma management plan and asthma support team coordination: A support team (clinicians, CHWs and plan care managers) will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan and enhancing communications among care team.&#xD;
Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign.</description>
    <arm_group_label>Enhanced Clinic+ Unified Management Plan</arm_group_label>
    <other_name>-Unified Management Plan</other_name>
    <other_name>-Enhanced Clinic Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CHW Home Visit Only</intervention_name>
    <description>-Home visit intervention: Community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan.</description>
    <arm_group_label>CHW Home Visit Only</arm_group_label>
    <other_name>-CHW Home Visit Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 5-75&#xD;
&#xD;
          -  Provider-verified diagnosis of asthma&#xD;
&#xD;
          -  Have uncontrolled asthma&#xD;
&#xD;
          -  Primary language of English,Spanish or Vietnamese&#xD;
&#xD;
          -  Patient of Neighborcare or HealthPoint Health&#xD;
&#xD;
          -  Insured by Molina Healthcare or Community Health Plan of Washington&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient planning to leave Neighborcare or Healthpoint Health within the next 12 months&#xD;
&#xD;
          -  Household appearing to be unsafe for a visit by a community health worker&#xD;
&#xD;
          -  Co-existing medical conditions that make asthma control a low priority for patient&#xD;
             management or that confound outcome measurement or that preclude participation in&#xD;
             self-management&#xD;
&#xD;
          -  Participation in another asthma research study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Stout, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Public Health -- Seattle &amp; King County</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>May 8, 2015</last_update_submitted>
  <last_update_submitted_qc>May 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Guidelines</keyword>
  <keyword>Community Health Worker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT02190617
org study id: AS1307-05498
nct id: NCT02190617
lead sponsor: 
collaborator: 
has dmc: Yes
The primary hypothesis the investigators will test is that that improving asthma guideline
      implementation and providing patients with a unified asthma management plan using a
      multi-component and multilevel intervention will improve patient-centered asthma outcomes
      compared to health plan case management, passive guideline dissemination and provider
      education.
The study will use a factorial randomized controlled design to assess the comparative
      effectiveness of the following interventions among 8 community health centers and 550
      patients with:

        -  Health plan enhanced intervention plus traditional provider education: Health plans will
           enhance case management support, monitor medication fills, and increase passive
           guideline dissemination. Traditional provider education will consist of implementation
           of the PACE asthma education program. Note that all participants and clinics will
           receive this intervention. In effect, this will be the base active comparator arm of the
           study.

        -  Home visit intervention: Community health workers will provide in-home tailored asthma
           support: assess asthma self-management knowledge and skills, conduct a home
           environmental assessment focused on asthma triggers, and conduct follow-up visits to
           support patient actions to improve asthma control based on unified asthma management
           plan.

        -  Enhanced clinic intervention with system integration: Clinics will implement a
           multi-component intervention that includes decision support, audit and feedback,
           provider and staff education, team-based care, and training and feedback in implementing
           office spirometry and allergy testing. EHR enhancements and clinic systems redesign will
           support this work. The EHR will also provide a platform for sharing a common asthma
           management plan and enhancing communications among care team members (clinicians, CHWs,
           plan case managers).

      All four intervention groups will receive enhanced health plan intervention + provider
      education. The four study arms will receive the following additional different interventions:
      (a) usual clinic care; (b) a + home visit, (c) enhanced clinic care + system integration, and
      (d) c + home visit.
allocation: Randomized
intervention model: Factorial Assignment
masking: None (Open Label)
measure: Symptom free days
time frame: 12 Months
description: Measured by questionnaire: Days without cough, wheeze, chest tightness, shortness of breath, nocturnal wakening from symptoms or activity limitation due to asthma in past 2 weeks.
measure: Asthma control
time frame: 12 Months
description: Measured by questionnaire and spirometry. Asthma Control Adults: Asthma Control Test and EPR3 categories Asthma Control Children: cACT and EPR3 categories
measure: Asthma-related Quality of Life
time frame: 12 Months
description: Measured by questionnaire.
Adults:
Mini Asthma Quality of Life Questionnaire
Children 7-17:
Pediatric Asthma Quality of Life Questionnaire
Children 5-6:
Pediatric Asthma Caregiver Quality of Life Scale
measure: Nocturnal wakening
time frame: 12 Months
description: Measured by questionnaire: Nights wakened in the past two weeks due to asthma.
measure: Asthma exacerbations
time frame: 12 Months
description: Measured by questionnaire: Need for oral steroids (3+ day course), hospitalization, ED visit or unscheduled clinic visit for worsening asthma in past 12 months
measure: Pulmonary function
time frame: 12 Months
description: Measured by spirometry: Post-bronchodilator FEV1 and FEV1 /FVC and change in pre-post bronchodilator FEV1 and FEV1 /FVC182 using EasyOne Diagnostic spirometer
measure: FeNO (Fractional exhaled Nitric Oxide)
time frame: 12 Months
description: Measured by portable handheld device: Online measurement of ppb in exhaled breath at 50 L/s (<25 ppb indicates normal value.)
measure: Beta-agonist use
time frame: 12 Months
description: Measured by questionnaire and claims data: Days using Beta-agonist medication in past 2 weeks
measure: Oral steroid use
time frame: 12 Months
description: Measured by questionnaire and claims data: Courses of steroids (3+ day course) in past 12 months
measure: Controller use
time frame: 12 Months
description: Measured by claims data: Controller to total asthma medication ratio > 0.5
measure: Asthma-related urgent health services utilization
time frame: 12 Month
description: Measured by questionnaire and administrative data: Urgent clinic visits, emergency department visits, and hospitalizations during past three months and past year
measure: Missed work or school days
time frame: 12 Months
description: Measured by questionnaire: Number of school or work days missed in past two weeks.
measure: General Health Status
time frame: 12 Months
description: Measured by questionnaire:
Adults: SF-12 Health Survey Children: SF -10 Health Survey
arm group label: Enhanced Clinic+ Unified Management Plan
arm group type: Active Comparator
description: Patients in study arm will receive:
Enhanced Clinic Intervention
Enhanced Health Plan
Unified Management Plan
arm group label: CHW Home Visit Only
arm group type: Active Comparator
description: Patients in study arm will receive:
CHW Home Visit
Usual clinic care with enhanced health plan
arm group label: Enhanced Clinic+ Unified Plan+ CHW
arm group type: Active Comparator
description: Patients in study arm will receive:
CHW Home Visit
Enhanced Clinic intervention
Enhanced health plan
Unified asthma management plan
arm group label: Usual Care
arm group type: No Intervention
description: -Usual clinic care with enhanced healthplan
intervention type: Behavioral
intervention name: Enhanced Clinic+ Unified Plan + CHW
description: Unified asthma management plan and asthma support team coordination: A support team will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan.
Home visit intervention: Community health workers will provide in-home tailored asthma support and conduct follow-up to support patient actions to improve asthma control based on unified asthma management plan.
Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign.
arm group label: Enhanced Clinic+ Unified Plan+ CHW
other name: -Enhanced Clinic
other name: -CHW Home Visits
other name: -Unified Management plan
intervention type: Behavioral
intervention name: Enhanced Clinic+ Unified Management Plan
description: Unified asthma management plan and asthma support team coordination: A support team (clinicians, CHWs and plan care managers) will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan and enhancing communications among care team.
Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign.
arm group label: Enhanced Clinic+ Unified Management Plan
other name: -Unified Management Plan
other name: -Enhanced Clinic Intervention
intervention type: Behavioral
intervention name: CHW Home Visit Only
description: -Home visit intervention: Community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan.
arm group label: CHW Home Visit Only
other name: -CHW Home Visit Intervention
criteria: 
gender: All
minimum age: 5 Years
maximum age: 75 Years
healthy volunteers: No
last name: James Stout, MD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma