xml: <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/NCT06003569</url>
    </required_header>
    <id_info>
      <org_study_id>20-0883</org_study_id>
      <secondary_id>5UG3HL151297</secondary_id>
      <nct_id>NCT06003569</nct_id>
    </id_info>
    <brief_title>Reducing Asthma Attacks in Disadvantaged School Children With Asthma</brief_title>
    <official_title>Reducing Asthma Attacks in Disadvantaged School Children With Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Colorado, Denver</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>
        Our UH3 clinical trial, &quot;Reducing Asthma Attacks in Disadvantaged School Children with&#xD;
        Asthma,&quot; seeks broad-scale implementation of our effective school-based approach to improve&#xD;
        asthma disparities for children, ages 5-12 years, in low-income communities. The&#xD;
        investigators will contextualize dissemination and implementation (D&amp;I) of our Colorado&#xD;
        school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school&#xD;
        days, while also addressing social determinants of health. Our Better Asthma Control for Kids&#xD;
        (BACK) Program will evaluate key metrics identified by diverse stakeholders during this&#xD;
        dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial&#xD;
        includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S)&#xD;
        and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two&#xD;
        strategies are designed for sustainable delivery by school asthma navigators and school&#xD;
        nurses who coordinate with primary care and community resources. The Exploration,&#xD;
        Preparation, Implementation, Sustainment (EPIS) D&amp;I framework was applied with community&#xD;
        partners during the UG3 planning phase to tailor implementation plans that meet local&#xD;
        community needs, resources and priorities (EPIS Phases 1 &amp; 2). BACK-S and BACK-E will be&#xD;
        delivered from years 1-3 with data collection for implementation and effectiveness outcomes&#xD;
        in 4 Colorado regions. In year 4, the investigators will collect data for sustainment&#xD;
        outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine&#xD;
        our &quot;dissemination playbook&quot; that guides adoption by other school systems (EPIS Phase 4). Our&#xD;
        primary implementation hypothesis is: Reach will be greater among students when delivered&#xD;
        using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be&#xD;
        more effective than usual care at reducing asthma exacerbations. The BACK playbook includes&#xD;
        training materials and a calculation of return on investment. The investigators are targeting&#xD;
        schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial&#xD;
        includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of&#xD;
        Colorado with attention to sustainability. Collectively, our approach will accelerate&#xD;
        dissemination of BACK nationally to communities experiencing health inequities in pediatric&#xD;
        asthma care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Asthma disproportionately affects children living in disadvantaged communities. The&#xD;
        well-documented disparities in asthma outcomes for minorities, including death, worse asthma&#xD;
        control, greater likelihood of emergency room visits, and higher rates of school absenteeism&#xD;
        are partly related to unmet SDOH for low-income families. Many SDOH contribute to&#xD;
        uncontrolled asthma for low-income families, such as lack of insurance and transportation.&#xD;
        For the child with asthma, this leads to reduced preventive care visits leading to more&#xD;
        emergency visits and hospitalizations. Poor asthma control contributes to lower school&#xD;
        performance due to missed school days and/fatigue and poorer concentration due to poor sleep&#xD;
        quality. As a result, asthma is one of seven educationally relevant health disparities that&#xD;
        school leaders seek to address to bend the widening achievement gap between low-income and&#xD;
        higher income students. While some measures of health equity improved in the last decade,&#xD;
        socio-economic disparities in asthma care have been stubbornly persistent.&#xD;
  &#xD;
        A recent Cochrane review along with other reports identify key benefits of school-based&#xD;
        asthma management programs, including reduced acute/urgent care health care use and days of&#xD;
        restricted activity for students. Additionally, our work in this area for more than 15 years&#xD;
        demonstrates improvements in self-management behaviors, quality of life, and school&#xD;
        absenteeism. Core elements of our existing Colorado school-based asthma program (Col-SBAP)&#xD;
        are concordant with those identified as effective in a Cochrane review, including education&#xD;
        and counseling strategies to improve asthma knowledge and self-management skills to&#xD;
        successfully control asthma. To date, these core Col-SBAP elements have been implemented in&#xD;
        six school districts by school nurses and project funded asthma navigators (ANavs) - each&#xD;
        ANav serves 40-65 children with uncontrolled asthma across one or more schools. A lesson&#xD;
        learned during Col-SBAP implementation from our CABs is that the investigators need to&#xD;
        address families' SDOH. Thus, the investigators developed a two-step intervention program,&#xD;
        Col-SBAP combined with SDOH assessment/referral, termed Better Asthma Control for Kids&#xD;
        (BACK). Our ANavs have had great success in identifying and addressing SDOH that directly&#xD;
        impact asthma care, including inadequate insurance coverage, transportation, and difficulty&#xD;
        affording medications. The core components of BACK are highly pragmatic and acceptable, as&#xD;
        evidenced by the Denver Public School system sustaining Col-SBAP for 3 years with no external&#xD;
        funding.&#xD;
  &#xD;
        The investigators have developed, refined and piloted a program that is feasible to&#xD;
        implement, and that has been sustained without external funding in one school district, but&#xD;
        requires ongoing funding in other school districts. Support has largely come from public&#xD;
        health agencies with limited engagement of Medicaid and other funders. To date, ours and&#xD;
        others' work in school-based asthma care is also limited by the lack of generalizability to&#xD;
        rural and smaller urban areas, and by the fact that our implementation guide does not help&#xD;
        schools tailor implementation strategies to their community/site needs, resources, and&#xD;
        priorities. Thus, the key next step to scale out BACK more broadly to use tools from the D&amp;I&#xD;
        field to prepare us for primetime dissemination and scalability. The UG3 award has allowed us&#xD;
        to: 1) work purposively with multi-sectoral partners (including public health funders and&#xD;
        insurers) in regions across Colorado where the investigators have not yet implemented our&#xD;
        program to identify local needs, priorities and resources for BACK, and 2) tailor BACK&#xD;
        implementation strategies to local factors. In the UH3 trial, the investigators will evaluate&#xD;
        the effects of implementing BACK in diverse areas of Colorado, including rural regions with&#xD;
        two different implementation packages, and will also identify different contextual factors&#xD;
        that predict RE-AIM outcomes. Briefly, the investigators will identify how and why&#xD;
        implementation strategies critical for local uptake and sustainability vary in their impact.&#xD;
        Lessons learned will support the co-development of our BACK dissemination playbook with our&#xD;
        partners so diverse and disadvantaged communities across the nation can feasibly implement&#xD;
        BACK in a way that addresses local factors critical for success and sustainability.&#xD;
  &#xD;
        Multi-sectoral engagement, including funders: The EPIS framework encourages the involvement&#xD;
        of partners across multiple socioecological levels to support implementation. For BACK this&#xD;
        includes patients/families, school health staff, primary care clinics, and community SDOH&#xD;
        representatives that are part of our CABs. The investigators have also worked to engage&#xD;
        health insurers and public health departments to ensure our implementation strategies&#xD;
        consider payer perspectives and state public health integration.&#xD;
  &#xD;
        Development Process for our Dissemination Playbook: The principles of &quot;Designing for&#xD;
        Dissemination&quot; hold that it is critical to design evidence-based programs (EBPs) as a&#xD;
        &quot;product&quot; that specifies not just core components, but details how to deliver the &quot;product&quot;&#xD;
        within a site's usual way of practice. EPIS has been used previously to engage stakeholders&#xD;
        to effectively package EBPs to tailor how implementation to address local needs and&#xD;
        priorities. A key next step for future BACK dissemination is an innovative playbook to assist&#xD;
        potential adopters to pick the types of &quot;plays&quot; needed to deliver the program with fidelity&#xD;
        to core components but in a way that permits localized sustainability.&#xD;
  &#xD;
        The investigators anticipate that typologies of context exist for each school site, such as&#xD;
        the number of children eligible for BACK, needs and priorities for BACK, or the size of the&#xD;
        school health team, that will influence implementation. Thus, the investigators propose to&#xD;
        use our Aim 3a mixed methods evaluation to co-create a dissemination playbook prototype for&#xD;
        implementation with our multi-sectoral partners, to help future adopters select&#xD;
        implementation strategies tailored to their contextual typologies.&#xD;
  &#xD;
        Innovative design of our playbook: Our dissemination playbook is innovative and extends the&#xD;
        work of others by being interactive and allowing for site-specific tailoring through site&#xD;
        self-evaluation assessments with immediate feedback identifying and suggesting relevant&#xD;
        implementation strategies. It will permit tailoring to site to consider the general RE-AIM&#xD;
        outcomes of BACK, including Reach to students and implementation costs. In addition, the&#xD;
        playbook will allow school leaders to consider any significant variability of impact of BACK&#xD;
        for different typologies of schools/communities (e.g., rural vs. urban, school nurse on-site&#xD;
        yes/no). It will also highlight opportunities for reimbursement, including a bill to support&#xD;
        community health worker reimbursement that was drafted by the Colorado House/Senate&#xD;
        legislature in 2023.&#xD;
  &#xD;
        Our specific aims for the UH3 trial phase are:&#xD;
  &#xD;
        Aim 1: Among n=60 school nurses, their schools and students with poorly controlled asthma&#xD;
        randomized to BACK-S vs. BACK-E in 4 regions of Colorado compare the reach (primary outcome),&#xD;
        student retention, adoption, costs to future adopters, and sustainment.&#xD;
  &#xD;
        Hypothesis 1a (Primary): Reach will be significantly greater among students with poorly&#xD;
        controlled asthma when delivered using the BACK -E implementation package as compared to&#xD;
        BACK-S package.&#xD;
  &#xD;
        Aim 2: Determine and compare annual asthma exacerbation rates (i.e., exacerbations/year) in&#xD;
        children with uncontrolled asthma randomized to either usual care (control) or the BACK&#xD;
        intervention (using either the BACK-S or BACK-E implementation package).&#xD;
  &#xD;
        Hypothesis 2: BACK will be more effective than usual care at reducing annual asthma&#xD;
        exacerbations.&#xD;
  &#xD;
        Aim 3a: Identify factors that predict student reach and retention, school-level adoption,&#xD;
        costs to future adopters (schools), and sustainment for BACK-S or BACK-E.&#xD;
  &#xD;
        Aim 3b: Based on the evaluation of Aims 1, 2 and 3a, adapt the current Denver based Col-SBAP,&#xD;
        Asthma COMP implementation guide into a multi-media BACK dissemination playbook to guide the&#xD;
        future dissemination of BACK (EPIS phase 4) Engagement of Multi-sectoral partners for Aims&#xD;
        1-3 Table 3 details the organization and membership in our partner groups. Drs. Szefler,&#xD;
        Cicutto, Huebschmann, McFarlane and De Camp and Ms. Gleason formed community advisory boards&#xD;
        (CAB) in 5 Colorado regions that met 3-4 times yearly in the UG3 phase and will continue to&#xD;
        meet semi-annually in the UH3 phase. Our team will continue to work closely with the&#xD;
        non-investigator elected chair to maintain engagement and effective group processes.&#xD;
  &#xD;
        SCHOOL SITE RECRUITMENT:&#xD;
  &#xD;
        Among the 5 school regions the investigators engaged with in the UG3 Phase, the investigators&#xD;
        have successfully identified school nurses from four of the 5 regions for UH3 study&#xD;
        participation. The 4 participating regions for the UH3 phase are the Lower Arkansas Valley&#xD;
        (LAV), Delta/Mesa, Greeley/Weld/Fort Morgan, and Pikes Peak regions. The Montezuma/La Plata&#xD;
        region was unable to engage with school districts to participate in the UH3 trial, but the&#xD;
        investigators are maintaining the CAB in this region in anticipation of future BACK&#xD;
        implementation.&#xD;
  &#xD;
        School sites recruited serve socioeconomically diverse communities in rural and mid-size&#xD;
        urban areas, representing ethnically/racially diverse populations that have SDOH&#xD;
        characteristics placing them at higher risk of asthma burden. These include rural populations&#xD;
        (e.g., the Lower Arkansas Valley, Morgan and Delta counties) and small-to-mid-size urban&#xD;
        populations (e.g., Mesa County, Greeley), and large urban populations (Colorado Springs/Pikes&#xD;
        Peak). The schools the investigators selected within each of the regions have &gt;32% rates of&#xD;
        free and reduced lunch, have a large proportion of minority children, and higher risk SDOH&#xD;
        characteristics. The investigators will provide services in English and Spanish and employ&#xD;
        bilingual ANavs.&#xD;
  &#xD;
        APPROACH FOR AIMS 1-2 (UH3) Overarching objective: This research is guided by the Reach,&#xD;
        Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and its emphasis on&#xD;
        equity and representativeness. The investigators will study diverse and rural schools across&#xD;
        four regions of Colorado and students with poor asthma control. In Aim 1, the investigators&#xD;
        will compare reach and other implementation outcomes among schools and students with&#xD;
        randomization at the school nurse level (n=~60) to deliver either the BACK-standard vs.&#xD;
        BACK-enhanced implementation package. Separately, in Aim 2, the investigators will compare&#xD;
        the effectiveness of the BACK intervention when delivered as either BACK-standard or&#xD;
        BACK-enhanced, as compared to usual care. See Section 3D for specific aims.&#xD;
  &#xD;
        PRAGMATIC UH3 STUDY DESIGN The investigators will conduct a pragmatic type 2 hybrid&#xD;
        implementation-effectiveness trial; randomized at the level of school nurses, involving an&#xD;
        open cohort, parallel cluster randomized trial where intervention conditions are phased in&#xD;
        over two years. The investigators will compare the implementation outcomes of BACK-S and&#xD;
        BACK-E with each other and will also compare the effectiveness outcomes (asthma&#xD;
        exacerbations) of BACK-S/BACK-E with control arm.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">May 2027</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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reach</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>% of eligible students enrolled Numerator of Reach = number students consented with confirmed Asthma Intake Form (AIF) eligibility Denominator of Reach = number of eligible students&#xD;
  o This denominator includes all students presumed eligible based on AIF at school registration, minus any students determined to NOT be eligible by AIF once the navigator called to confirm eligibility.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of episode requiring systemic steroid therapy</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>A reported number of episodes of systemic steroid therapy due to asthma, either orally or parenterally per year.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of ED/UC visits</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>A reported number of Emergency Department (ED) and Urgent Care (UC) visits due to asthma per year.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of hospitalizations</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>A reported number of hospitalizations due to asthma per year.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Effectiveness based on asthma exacerbations</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Number of asthma exacerbations per year - defined as the number of asthma exacerbations requiring systemic steroid therapy, either orally or parenterally, following an ED visit, urgent care visit, hospitalization, or as directed by their clinician</description>
    </other_outcome>
    <other_outcome>
      <measure>Effectiveness based on missed school days</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Number of school days missed due to asthma per year</description>
    </other_outcome>
    <other_outcome>
      <measure>Adoption at a setting level</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>% of eligible schools randomized to a study arm.</description>
    </other_outcome>
    <other_outcome>
      <measure>Planned Adoption at a staff level</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>% of school nurses employed in an eligible school who agree to support the study intervention</description>
    </other_outcome>
    <other_outcome>
      <measure>Actual Adoption at a staff level</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>% of school nurses employed in an eligible school who began supporting the study intervention</description>
    </other_outcome>
    <other_outcome>
      <measure>Fidelity to the intervention</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Fidelity to the intervention will be assessed as the percentage of participants that receive an adequate dose of the intervention, as defined by at least 2 of 3 planned intervention visits with students and at least 2 of 3 planned intervention visits with caregivers.</description>
    </other_outcome>
    <other_outcome>
      <measure>Implementation costs</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Total US dollar amount for the cost of the intervention materials and required resources</description>
    </other_outcome>
    <other_outcome>
      <measure>Maintenance</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Number of schools that continue to offer the intervention at 6-12 months after completion of active implementation support.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sustainability</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Sustainability will be assessed in schools that have implemented the intervention with the Short Clinical Sustainability Assessment Tool (CSAT).&#xD;
  Minimum value: 1&#xD;
  Maximum value: 7&#xD;
  Interpretation guide: Higher scores mean a better outcome</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Asthma in Children</condition>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>School nurses/schools randomized to usual care will continue to receive their usual care from school nurses and then subsequently provide the intervention given their asthma remains poorly controlled at the start of the next school year following enrollment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BACK-S</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BACK-E</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>BACK-S</intervention_name>
      <description>BACK = Better Asthma Control for Kids:&#xD;
  The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).</description>
      <arm_group_label>BACK-S</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>BACK-E</intervention_name>
      <description>The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.</description>
      <arm_group_label>BACK-E</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  students with poor asthma control (or indicators of excess burden on school Asthma&#xD;
               Intake Form)&#xD;
  &#xD;
            -  age 5-12 years of age&#xD;
  &#xD;
            -  attending one of participating schools in rural Colorado (school selection criteria:&#xD;
               high rates of socioeconomic need based on high rates of free-and-reduced lunch or&#xD;
               rural status)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt; 5 years or &gt; 12 years&#xD;
  &#xD;
            -  students with no or controlled asthma&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stanley Szefler, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Childrens Hospital Colorado</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michaela Brtnikova, PhD</last_name>
      <phone>303-724-2643</phone>
      <email>michaela.brtnikova@cuanschutz.edu</email>
    </overall_contact>
    <link>
      <url>https://health.gov/healthypeople/priority-areas/social-determinants-health</url>
      <description>SDOH determination</description>
    </link>
    <link>
      <url>https://cfirguide.org/choosing-strategies/</url>
      <description>Consolidated Framework for Implementation Research - Implementation Strategy Matching Tool</description>
    </link>
    <link>
      <url>https://nces.ed.gov/FastFacts/display.asp?id=898</url>
      <description>Public school students eligible for free or reduced-price lunch</description>
    </link>
    <reference>
      <citation>Szefler SJ, Cicutto L, Brewer SE, Gleason M, McFarlane A, DeCamp LR, Brinton JT, Huebschmann AG. Applying dissemination and implementation research methods to translate a school-based asthma program. J Allergy Clin Immunol. 2022 Sep;150(3):535-548. doi: 10.1016/j.jaci.2022.04.029. Epub 2022 May 13.</citation>
      <PMID>35569568</PMID>
    </reference>
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      <citation>Cicutto L, Gleason M, Haas-Howard C, White M, Hollenbach JP, Williams S, McGinn M, Villarreal M, Mitchell H, Cloutier MM, Vinick C, Langton C, Shocks DJ, Stempel DA, Szefler SJ. Building Bridges for Asthma Care Program: A School-Centered Program Connecting Schools, Families, and Community Health-Care Providers. J Sch Nurs. 2020 Jun;36(3):168-180. doi: 10.1177/1059840518805824. Epub 2018 Oct 18.</citation>
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      <PMID>28726584</PMID>
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    </reference>
    <reference>
      <citation>Szefler SJ, Cloutier MM, Villarreal M, Hollenbach JP, Gleason M, Haas-Howard C, Vinick C, Calatroni A, Cicutto L, White M, Williams S, McGinn M, Langton C, Shocks D, Mitchell H, Stempel DA. Building Bridges for Asthma Care: Reducing school absence for inner-city children with health disparities. J Allergy Clin Immunol. 2019 Feb;143(2):746-754.e2. doi: 10.1016/j.jaci.2018.05.041. Epub 2018 Jul 25.</citation>
      <PMID>30055181</PMID>
    </reference>
    <reference>
      <citation>Cicutto L, To T, Murphy S. Cicutto, To, and Murphy respond: a randomized controlled trial of a public health nurse-delivered asthma program to elementary schools. J Sch Health. 2014 Jun;84(6):350. doi: 10.1111/josh.12163. No abstract available.</citation>
      <PMID>24749915</PMID>
    </reference>
    <reference>
      <citation>Liptzin DR, Gleason MC, Cicutto LC, Cleveland CL, Shocks DJ, White MK, Faino AV, Szefler SJ. Developing, Implementing, and Evaluating a School-Centered Asthma Program: Step-Up Asthma Program. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):972-979.e1. doi: 10.1016/j.jaip.2016.04.016. Epub 2016 Jun 7.</citation>
      <PMID>27283054</PMID>
    </reference>
    <reference>
      <citation>Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.</citation>
      <PMID>18468362</PMID>
    </reference>
    <reference>
      <citation>Gleason M, Cicutto L, Haas-Howard C, Raleigh BM, Szefler SJ. Leveraging Partnerships: Families, Schools, and Providers Working Together to Improve Asthma Management. Curr Allergy Asthma Rep. 2016 Oct;16(10):74. doi: 10.1007/s11882-016-0655-0.</citation>
      <PMID>27709456</PMID>
    </reference>
    <reference>
      <citation>Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.</citation>
      <PMID>25889199</PMID>
    </reference>
    <reference>
      <citation>Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK, Kirchner JE. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015 Aug 7;10:109. doi: 10.1186/s13012-015-0295-0.</citation>
      <PMID>26249843</PMID>
    </reference>
    <reference>
      <citation>Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139.</citation>
      <PMID>24289295</PMID>
    </reference>
    <reference>
      <citation>Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.</citation>
      <PMID>30984733</PMID>
    </reference>
    <reference>
      <citation>Glasgow RE, Estabrooks PE. Pragmatic Applications of RE-AIM for Health Care Initiatives in Community and Clinical Settings. Prev Chronic Dis. 2018 Jan 4;15:E02. doi: 10.5888/pcd15.170271.</citation>
      <PMID>29300695</PMID>
    </reference>
    <reference>
      <citation>Malone S, Prewitt K, Hackett R, Lin JC, McKay V, Walsh-Bailey C, Luke DA. The Clinical Sustainability Assessment Tool: measuring organizational capacity to promote sustainability in healthcare. Implement Sci Commun. 2021 Jul 17;2(1):77. doi: 10.1186/s43058-021-00181-2.</citation>
      <PMID>34274004</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will preserve and share all data generated in this project except data that cannot be shared safely because it is identifiable. We will put these data on the Open Science Framework (https://osf.io/) and embargo it. Additionally, during publication, we will make data available to share with reviewers.</ipd_description>
      <ipd_time_frame>August 2027</ipd_time_frame>
      <ipd_access_criteria>Will be identified later</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 9, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT06003569/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003569
  org study id: 20-0883
  secondary id: 5UG3HL151297
  nct id: NCT06003569
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with
        Asthma," seeks broad-scale implementation of our effective school-based approach to improve
        asthma disparities for children, ages 5-12 years, in low-income communities. The
        investigators will contextualize dissemination and implementation (D&I) of our Colorado
        school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school
        days, while also addressing social determinants of health. Our Better Asthma Control for Kids
        (BACK) Program will evaluate key metrics identified by diverse stakeholders during this
        dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial
        includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S)
        and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two
        strategies are designed for sustainable delivery by school asthma navigators and school
        nurses who coordinate with primary care and community resources. The Exploration,
        Preparation, Implementation, Sustainment (EPIS) D&I framework was applied with community
        partners during the UG3 planning phase to tailor implementation plans that meet local
        community needs, resources and priorities (EPIS Phases 1 & 2). BACK-S and BACK-E will be
        delivered from years 1-3 with data collection for implementation and effectiveness outcomes
        in 4 Colorado regions. In year 4, the investigators will collect data for sustainment
        outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine
        our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our
        primary implementation hypothesis is: Reach will be greater among students when delivered
        using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be
        more effective than usual care at reducing asthma exacerbations. The BACK playbook includes
        training materials and a calculation of return on investment. The investigators are targeting
        schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial
        includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of
        Colorado with attention to sustainability. Collectively, our approach will accelerate
        dissemination of BACK nationally to communities experiencing health inequities in pediatric
        asthma care.
  Asthma disproportionately affects children living in disadvantaged communities. The
        well-documented disparities in asthma outcomes for minorities, including death, worse asthma
        control, greater likelihood of emergency room visits, and higher rates of school absenteeism
        are partly related to unmet SDOH for low-income families. Many SDOH contribute to
        uncontrolled asthma for low-income families, such as lack of insurance and transportation.
        For the child with asthma, this leads to reduced preventive care visits leading to more
        emergency visits and hospitalizations. Poor asthma control contributes to lower school
        performance due to missed school days and/fatigue and poorer concentration due to poor sleep
        quality. As a result, asthma is one of seven educationally relevant health disparities that
        school leaders seek to address to bend the widening achievement gap between low-income and
        higher income students. While some measures of health equity improved in the last decade,
        socio-economic disparities in asthma care have been stubbornly persistent.
  
        A recent Cochrane review along with other reports identify key benefits of school-based
        asthma management programs, including reduced acute/urgent care health care use and days of
        restricted activity for students. Additionally, our work in this area for more than 15 years
        demonstrates improvements in self-management behaviors, quality of life, and school
        absenteeism. Core elements of our existing Colorado school-based asthma program (Col-SBAP)
        are concordant with those identified as effective in a Cochrane review, including education
        and counseling strategies to improve asthma knowledge and self-management skills to
        successfully control asthma. To date, these core Col-SBAP elements have been implemented in
        six school districts by school nurses and project funded asthma navigators (ANavs) - each
        ANav serves 40-65 children with uncontrolled asthma across one or more schools. A lesson
        learned during Col-SBAP implementation from our CABs is that the investigators need to
        address families' SDOH. Thus, the investigators developed a two-step intervention program,
        Col-SBAP combined with SDOH assessment/referral, termed Better Asthma Control for Kids
        (BACK). Our ANavs have had great success in identifying and addressing SDOH that directly
        impact asthma care, including inadequate insurance coverage, transportation, and difficulty
        affording medications. The core components of BACK are highly pragmatic and acceptable, as
        evidenced by the Denver Public School system sustaining Col-SBAP for 3 years with no external
        funding.
  
        The investigators have developed, refined and piloted a program that is feasible to
        implement, and that has been sustained without external funding in one school district, but
        requires ongoing funding in other school districts. Support has largely come from public
        health agencies with limited engagement of Medicaid and other funders. To date, ours and
        others' work in school-based asthma care is also limited by the lack of generalizability to
        rural and smaller urban areas, and by the fact that our implementation guide does not help
        schools tailor implementation strategies to their community/site needs, resources, and
        priorities. Thus, the key next step to scale out BACK more broadly to use tools from the D&I
        field to prepare us for primetime dissemination and scalability. The UG3 award has allowed us
        to: 1) work purposively with multi-sectoral partners (including public health funders and
        insurers) in regions across Colorado where the investigators have not yet implemented our
        program to identify local needs, priorities and resources for BACK, and 2) tailor BACK
        implementation strategies to local factors. In the UH3 trial, the investigators will evaluate
        the effects of implementing BACK in diverse areas of Colorado, including rural regions with
        two different implementation packages, and will also identify different contextual factors
        that predict RE-AIM outcomes. Briefly, the investigators will identify how and why
        implementation strategies critical for local uptake and sustainability vary in their impact.
        Lessons learned will support the co-development of our BACK dissemination playbook with our
        partners so diverse and disadvantaged communities across the nation can feasibly implement
        BACK in a way that addresses local factors critical for success and sustainability.
  
        Multi-sectoral engagement, including funders: The EPIS framework encourages the involvement
        of partners across multiple socioecological levels to support implementation. For BACK this
        includes patients/families, school health staff, primary care clinics, and community SDOH
        representatives that are part of our CABs. The investigators have also worked to engage
        health insurers and public health departments to ensure our implementation strategies
        consider payer perspectives and state public health integration.
  
        Development Process for our Dissemination Playbook: The principles of "Designing for
        Dissemination" hold that it is critical to design evidence-based programs (EBPs) as a
        "product" that specifies not just core components, but details how to deliver the "product"
        within a site's usual way of practice. EPIS has been used previously to engage stakeholders
        to effectively package EBPs to tailor how implementation to address local needs and
        priorities. A key next step for future BACK dissemination is an innovative playbook to assist
        potential adopters to pick the types of "plays" needed to deliver the program with fidelity
        to core components but in a way that permits localized sustainability.
  
        The investigators anticipate that typologies of context exist for each school site, such as
        the number of children eligible for BACK, needs and priorities for BACK, or the size of the
        school health team, that will influence implementation. Thus, the investigators propose to
        use our Aim 3a mixed methods evaluation to co-create a dissemination playbook prototype for
        implementation with our multi-sectoral partners, to help future adopters select
        implementation strategies tailored to their contextual typologies.
  
        Innovative design of our playbook: Our dissemination playbook is innovative and extends the
        work of others by being interactive and allowing for site-specific tailoring through site
        self-evaluation assessments with immediate feedback identifying and suggesting relevant
        implementation strategies. It will permit tailoring to site to consider the general RE-AIM
        outcomes of BACK, including Reach to students and implementation costs. In addition, the
        playbook will allow school leaders to consider any significant variability of impact of BACK
        for different typologies of schools/communities (e.g., rural vs. urban, school nurse on-site
        yes/no). It will also highlight opportunities for reimbursement, including a bill to support
        community health worker reimbursement that was drafted by the Colorado House/Senate
        legislature in 2023.
  
        Our specific aims for the UH3 trial phase are:
  
        Aim 1: Among n=60 school nurses, their schools and students with poorly controlled asthma
        randomized to BACK-S vs. BACK-E in 4 regions of Colorado compare the reach (primary outcome),
        student retention, adoption, costs to future adopters, and sustainment.
  
        Hypothesis 1a (Primary): Reach will be significantly greater among students with poorly
        controlled asthma when delivered using the BACK -E implementation package as compared to
        BACK-S package.
  
        Aim 2: Determine and compare annual asthma exacerbation rates (i.e., exacerbations/year) in
        children with uncontrolled asthma randomized to either usual care (control) or the BACK
        intervention (using either the BACK-S or BACK-E implementation package).
  
        Hypothesis 2: BACK will be more effective than usual care at reducing annual asthma
        exacerbations.
  
        Aim 3a: Identify factors that predict student reach and retention, school-level adoption,
        costs to future adopters (schools), and sustainment for BACK-S or BACK-E.
  
        Aim 3b: Based on the evaluation of Aims 1, 2 and 3a, adapt the current Denver based Col-SBAP,
        Asthma COMP implementation guide into a multi-media BACK dissemination playbook to guide the
        future dissemination of BACK (EPIS phase 4) Engagement of Multi-sectoral partners for Aims
        1-3 Table 3 details the organization and membership in our partner groups. Drs. Szefler,
        Cicutto, Huebschmann, McFarlane and De Camp and Ms. Gleason formed community advisory boards
        (CAB) in 5 Colorado regions that met 3-4 times yearly in the UG3 phase and will continue to
        meet semi-annually in the UH3 phase. Our team will continue to work closely with the
        non-investigator elected chair to maintain engagement and effective group processes.
  
        SCHOOL SITE RECRUITMENT:
  
        Among the 5 school regions the investigators engaged with in the UG3 Phase, the investigators
        have successfully identified school nurses from four of the 5 regions for UH3 study
        participation. The 4 participating regions for the UH3 phase are the Lower Arkansas Valley
        (LAV), Delta/Mesa, Greeley/Weld/Fort Morgan, and Pikes Peak regions. The Montezuma/La Plata
        region was unable to engage with school districts to participate in the UH3 trial, but the
        investigators are maintaining the CAB in this region in anticipation of future BACK
        implementation.
  
        School sites recruited serve socioeconomically diverse communities in rural and mid-size
        urban areas, representing ethnically/racially diverse populations that have SDOH
        characteristics placing them at higher risk of asthma burden. These include rural populations
        (e.g., the Lower Arkansas Valley, Morgan and Delta counties) and small-to-mid-size urban
        populations (e.g., Mesa County, Greeley), and large urban populations (Colorado Springs/Pikes
        Peak). The schools the investigators selected within each of the regions have >32% rates of
        free and reduced lunch, have a large proportion of minority children, and higher risk SDOH
        characteristics. The investigators will provide services in English and Spanish and employ
        bilingual ANavs.
  
        APPROACH FOR AIMS 1-2 (UH3) Overarching objective: This research is guided by the Reach,
        Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and its emphasis on
        equity and representativeness. The investigators will study diverse and rural schools across
        four regions of Colorado and students with poor asthma control. In Aim 1, the investigators
        will compare reach and other implementation outcomes among schools and students with
        randomization at the school nurse level (n=~60) to deliver either the BACK-standard vs.
        BACK-enhanced implementation package. Separately, in Aim 2, the investigators will compare
        the effectiveness of the BACK intervention when delivered as either BACK-standard or
        BACK-enhanced, as compared to usual care. See Section 3D for specific aims.
  
        PRAGMATIC UH3 STUDY DESIGN The investigators will conduct a pragmatic type 2 hybrid
        implementation-effectiveness trial; randomized at the level of school nurses, involving an
        open cohort, parallel cluster randomized trial where intervention conditions are phased in
        over two years. The investigators will compare the implementation outcomes of BACK-S and
        BACK-E with each other and will also compare the effectiveness outcomes (asthma
        exacerbations) of BACK-S/BACK-E with control arm.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Reach
  time frame: Up to 48 months
  description: % of eligible students enrolled Numerator of Reach = number students consented with confirmed Asthma Intake Form (AIF) eligibility Denominator of Reach = number of eligible students
  o This denominator includes all students presumed eligible based on AIF at school registration, minus any students determined to NOT be eligible by AIF once the navigator called to confirm eligibility.
  measure: Number of episode requiring systemic steroid therapy
  time frame: Up to 48 months
  description: A reported number of episodes of systemic steroid therapy due to asthma, either orally or parenterally per year.
  measure: Number of ED/UC visits
  time frame: Up to 48 months
  description: A reported number of Emergency Department (ED) and Urgent Care (UC) visits due to asthma per year.
  measure: Number of hospitalizations
  time frame: Up to 48 months
  description: A reported number of hospitalizations due to asthma per year.
  measure: Effectiveness based on asthma exacerbations
  time frame: Up to 48 months
  description: Number of asthma exacerbations per year - defined as the number of asthma exacerbations requiring systemic steroid therapy, either orally or parenterally, following an ED visit, urgent care visit, hospitalization, or as directed by their clinician
  measure: Effectiveness based on missed school days
  time frame: Up to 48 months
  description: Number of school days missed due to asthma per year
  measure: Adoption at a setting level
  time frame: Up to 48 months
  description: % of eligible schools randomized to a study arm.
  measure: Planned Adoption at a staff level
  time frame: Up to 48 months
  description: % of school nurses employed in an eligible school who agree to support the study intervention
  measure: Actual Adoption at a staff level
  time frame: Up to 48 months
  description: % of school nurses employed in an eligible school who began supporting the study intervention
  measure: Fidelity to the intervention
  time frame: Up to 48 months
  description: Fidelity to the intervention will be assessed as the percentage of participants that receive an adequate dose of the intervention, as defined by at least 2 of 3 planned intervention visits with students and at least 2 of 3 planned intervention visits with caregivers.
  measure: Implementation costs
  time frame: Up to 48 months
  description: Total US dollar amount for the cost of the intervention materials and required resources
  measure: Maintenance
  time frame: Up to 48 months
  description: Number of schools that continue to offer the intervention at 6-12 months after completion of active implementation support.
  measure: Sustainability
  time frame: Up to 48 months
  description: Sustainability will be assessed in schools that have implemented the intervention with the Short Clinical Sustainability Assessment Tool (CSAT).
  Minimum value: 1
  Maximum value: 7
  Interpretation guide: Higher scores mean a better outcome
  arm group label: Usual care
  arm group type: No Intervention
  description: School nurses/schools randomized to usual care will continue to receive their usual care from school nurses and then subsequently provide the intervention given their asthma remains poorly controlled at the start of the next school year following enrollment.
  arm group label: BACK-S
  arm group type: Experimental
  description: The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).
  arm group label: BACK-E
  arm group type: Experimental
  description: The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.
  intervention type: Behavioral
  intervention name: BACK-S
  description: BACK = Better Asthma Control for Kids:
  The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).
  arm group label: BACK-S
  intervention type: Behavioral
  intervention name: BACK-E
  description: The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.
  arm group label: BACK-E
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Stanley Szefler, MD
  role: Principal Investigator
  affiliation: Childrens Hospital Colorado
  last name: Michaela Brtnikova, PhD
  phone: 303-724-2643
  email: michaela.brtnikova@cuanschutz.edu
  url: https://health.gov/healthypeople/priority-areas/social-determinants-health
  description: SDOH determination
  url: https://cfirguide.org/choosing-strategies/
  description: Consolidated Framework for Implementation Research - Implementation Strategy Matching Tool
  url: https://nces.ed.gov/FastFacts/display.asp?id=898
  description: Public school students eligible for free or reduced-price lunch
  citation: Szefler SJ, Cicutto L, Brewer SE, Gleason M, McFarlane A, DeCamp LR, Brinton JT, Huebschmann AG. Applying dissemination and implementation research methods to translate a school-based asthma program. J Allergy Clin Immunol. 2022 Sep;150(3):535-548. doi: 10.1016/j.jaci.2022.04.029. Epub 2022 May 13.
  PMID: 35569568
  citation: Cicutto L, Gleason M, Haas-Howard C, White M, Hollenbach JP, Williams S, McGinn M, Villarreal M, Mitchell H, Cloutier MM, Vinick C, Langton C, Shocks DJ, Stempel DA, Szefler SJ. Building Bridges for Asthma Care Program: A School-Centered Program Connecting Schools, Families, and Community Health-Care Providers. J Sch Nurs. 2020 Jun;36(3):168-180. doi: 10.1177/1059840518805824. Epub 2018 Oct 18.
  PMID: 30336726
  citation: Cicutto L, Gleason M, Haas-Howard C, Jenkins-Nygren L, Labonde S, Patrick K. Competency-Based Framework and Continuing Education for Preparing a Skilled School Health Workforce for Asthma Care: The Colorado Experience. J Sch Nurs. 2017 Aug;33(4):277-284. doi: 10.1177/1059840516675931. Epub 2016 Nov 30.
  PMID: 28726584
  citation: Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.
  PMID: 31036028
  citation: Kneale D, Harris K, McDonald VM, Thomas J, Grigg J. Effectiveness of school-based self-management interventions for asthma among children and adolescents: findings from a Cochrane systematic review and meta-analysis. Thorax. 2019 May;74(5):432-438. doi: 10.1136/thoraxjnl-2018-211909. Epub 2019 Jan 27.
  PMID: 30686788
  citation: Walter H, Sadeque-Iqbal F, Ulysse R, Castillo D, Fitzpatrick A, Singleton J. Effectiveness of school-based family asthma educational programs in quality of life and asthma exacerbations in asthmatic children aged five to 18: a systematic review. JBI Database System Rev Implement Rep. 2016 Nov;14(11):113-138. doi: 10.11124/JBISRIR-2016-003181.
  PMID: 27941517
  citation: Akinbami LJ, Moorman JE, Simon AE, Schoendorf KC. Trends in racial disparities for asthma outcomes among children 0 to 17 years, 2001-2010. J Allergy Clin Immunol. 2014 Sep;134(3):547-553.e5. doi: 10.1016/j.jaci.2014.05.037. Epub 2014 Aug 1.
  PMID: 25091437
  citation: Cicutto L, Murphy S, Coutts D, O'Rourke J, Lang G, Chapman C, Coates P. Breaking the access barrier: evaluating an asthma center's efforts to provide education to children with asthma in schools. Chest. 2005 Oct;128(4):1928-35. doi: 10.1378/chest.128.4.1928.
  PMID: 16236837
  citation: Cicutto L, To T, Murphy S. A randomized controlled trial of a public health nurse-delivered asthma program to elementary schools. J Sch Health. 2013 Dec;83(12):876-84. doi: 10.1111/josh.12106.
  PMID: 24261522
  citation: Szefler SJ, Cloutier MM, Villarreal M, Hollenbach JP, Gleason M, Haas-Howard C, Vinick C, Calatroni A, Cicutto L, White M, Williams S, McGinn M, Langton C, Shocks D, Mitchell H, Stempel DA. Building Bridges for Asthma Care: Reducing school absence for inner-city children with health disparities. J Allergy Clin Immunol. 2019 Feb;143(2):746-754.e2. doi: 10.1016/j.jaci.2018.05.041. Epub 2018 Jul 25.
  PMID: 30055181
  citation: Cicutto L, To T, Murphy S. Cicutto, To, and Murphy respond: a randomized controlled trial of a public health nurse-delivered asthma program to elementary schools. J Sch Health. 2014 Jun;84(6):350. doi: 10.1111/josh.12163. No abstract available.
  PMID: 24749915
  citation: Liptzin DR, Gleason MC, Cicutto LC, Cleveland CL, Shocks DJ, White MK, Faino AV, Szefler SJ. Developing, Implementing, and Evaluating a School-Centered Asthma Program: Step-Up Asthma Program. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):972-979.e1. doi: 10.1016/j.jaip.2016.04.016. Epub 2016 Jun 7.
  PMID: 27283054
  citation: Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.
  PMID: 18468362
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  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: Yes
  ipd description: We will preserve and share all data generated in this project except data that cannot be shared safely because it is identifiable. We will put these data on the Open Science Framework (https://osf.io/) and embargo it. Additionally, during publication, we will make data available to share with reviewers.
  ipd time frame: August 2027
  ipd access criteria: Will be identified later
  provided document: 