Reducing Asthma Attacks in Disadvantaged School Children With Asthma

NCT06003569 | Recruiting DMC

• 2 other identifiers: 20-08835UG3HL151297
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Reach

  % 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.

  Up to 48 months

Secondary Outcomes (3)

• Number of episode requiring systemic steroid therapy

  Up to 48 months

• Number of ED/UC visits

  Up to 48 months

• Number of hospitalizations

  Up to 48 months

Other Outcomes (1)

• Effectiveness based on asthma exacerbations

  Up to 48 months

Study Arms (3)

Usual care

NO INTERVENTION

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.

BACK-S

EXPERIMENTAL

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).

Behavioral: BACK-S

BACK-E

EXPERIMENTAL

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.

Behavioral: BACK-E

Interventions

BACK-S BEHAVIORAL

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).

BACK-S

BACK-E BEHAVIORAL

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.

BACK-E

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• students with poor asthma control (or indicators of excess burden on school Asthma Intake Form)
• age 5-12 years of age
• attending one of participating schools in rural Colorado (school selection criteria: high rates of socioeconomic need based on high rates of free-and-reduced lunch or rural status)

You may not qualify if:

• age \< 5 years or \> 12 years
• students with no or controlled asthma

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (13)

Ault-Highland RE-9 school district

Ault, Colorado, 80610, United States

RECRUITING

Colorado Springs 11

Colorado Springs, Colorado, 80907, United States

RECRUITING

Harrison 2 school district

Colorado Springs, Colorado, 80916, United States

RECRUITING

Ellicott 22 school district

Ellicott, Colorado, 80808, United States

RECRUITING

Fountain 8 school district

Fountain, Colorado, 80817, United States

RECRUITING

Granada school district

Granada, Colorado, 81041, United States

RECRUITING

Greeley 6

Greeley, Colorado, 80631, United States

RECRUITING

East Otero R1 school district

La Junta, Colorado, 81050, United States

RECRUITING

Lamar RE2 school district

Lamar, Colorado, 81052, United States

RECRUITING

Las Animas school district

Las Animas, Colorado, 81054, United States

RECRUITING

Manzanola school district

Manzanola, Colorado, 81058, United States

RECRUITING

Weld County RE1

Platteville, Colorado, 80651, United States

RECRUITING

Wiggins RE-50(J)

Wiggins, Colorado, 80654, United States

RECRUITING

Related Publications (21)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 27709456 BACKGROUND

• 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.

  PMID: 25889199 BACKGROUND

• 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.

  PMID: 26249843 BACKGROUND

• 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.

  PMID: 24289295 BACKGROUND

• 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.

  PMID: 30984733 BACKGROUND

• 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.

  PMID: 29300695 BACKGROUND

• 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.

  PMID: 34274004 BACKGROUND

• Huebschmann AG, Wagner NM, Gleason M, Brinton JT, Brtnikova M, Brewer SE, Begum A, Armstrong R, DeCamp LR, McFarlane A, DeKeyser H, Coleman H, Federico MJ, Szefler SJ, Cicutto LC. Reducing asthma attacks in disadvantaged school children with asthma: study protocol for a type 2 hybrid implementation-effectiveness trial (Better Asthma Control for Kids, BACK). Implement Sci. 2024 Aug 15;19(1):60. doi: 10.1186/s13012-024-01387-3.

  PMID: 39148094 DERIVED

Related Links

• SDOH determination
• Consolidated Framework for Implementation Research - Implementation Strategy Matching Tool
• Public school students eligible for free or reduced-price lunch

Study Officials

• Amy G Huebschmann, MD

  Childrens Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaela Brtnikova, PhD

CONTACT

303-724-2643; michaela.brtnikova@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 22, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: August 2027
• Access Criteria: Will be identified later

Locations

US (13)