CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma

Обзор

Purpose: This study aims to improve asthma care by helping clinicians at community health centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and Reliever Therapy). The investigators will provide training and resources to clinicians, give feedback on prescribing patterns, and offer educational tools for patients and providers. The investigators will roll out these resources in stages across clinics. The study will measure how well the program helps clinicians prescribe SMART therapy and whether it reduces asthma exacerbations in patients.

Подробное описание

CHEST is a type 1 hybrid stepped-wedge cluster randomized trial wherein six federally qualified community health center clinics are randomly and iteratively selected to move in a 1-way crossover from the control group to the SMART implementation group. The primary intervention is an SMART implementation bundle, which contains three components: (1) clinician-level education on SMART with ongoing practice facilitation/supervision, (2) serial clinic- and clinician-level audit and feedback on inhaler prescribing patterns, (3) provision of a paper and online clinician- and patient-centered education aide with a SMART congruent asthma action plan designed for low health literacy patients, and (4) operations committee meetings during the implementation period

The study is conceptually split into three phases: (1) the pre-implementation (control) phase focused on development of implementation materials and baseline data gathering of prescription patterns, (2) the active implementation phase, and (3) post-implementation, which will focus on an assessment of sustainability and dissemination.

1. Pre-implementation phase: The pre-implementation phase (which will last from 12 to 24 months per clinic) is designed to be a baseline for the study. During this phase, no specific interventions will be introduced to the clinicians at participating clinics. This phase will allow the CHEST study team to collect clinic-level data on current asthma care prescription practices and asthma-related outcomes. 2. Active implementation phase: The second phase, which will last from 9 to 24 months per clinic, will begin with the introduction of the SMART implementation bundle to clinicians and staff at participating IHN clinics. 3. Post-implementation phase: The final phase of the study is introduced after the active implementation of the SMART implementation bundle is complete at all participating clinics. In the post-implementation phase, formal assessments will be conducted to evaluate the sustainment of the SMART bundle. Additionally, this phase includes efforts to disseminate the findings of the study. This encompasses analyses of the reach and impact of the dissemination efforts, as well as the practical application and adoption of the findings in the broader medical community.

Вмешательства

• Поведенческое Implementation bundle
  The intervention is a SMART implementation bundle delivered in Federally Qualified Health Centers. Unlike drug trials, no medication is supplied; providers prescribe according to guidelines. The bundle includes three components: (1) clinician education with practice facilitation, (2) audit and feedback on prescribing, (3) patient education tools such as a SMART-aligned asthma action plan and videos tailored for low health literacy, and (4) operations committee meetings during the implementation

Первичные конечные точки

• Patient-level Effectiveness (of the SMART implementation bundle) [Срок оценки: Through study completion, up to 24 months]
• Clinician-level adoption (of the SMART implementation bundle) [Срок оценки: Through study completion, up to 24 months]

Вторичные конечные точки (12)

• Clinic-level reach (of the SMART implementation bundle) [Срок оценки: Through study completion, up to 24 months]
• Clinician-level reach (of the SMART implementation bundle) [Срок оценки: Through study completion, up to 24 months]
• Staff-level reach (of the SMART implementation bundle) [Срок оценки: Through study completion, up to 24 months]
• Patient-level reach of (of the evidence-based practice, i.e., SMART) [Срок оценки: Through study completion, up to 24 months]
• Patient-level effectiveness (of the evidence-based practice, i.e., SMART) [Срок оценки: Through study completion, up to 24 months]
• Patient-level safety (of the evidence-based practice, i.e., SMART) [Срок оценки: Through study completion, up to 24 months]
• Clinician-level effectiveness (of the SMART implementation bundle) [Срок оценки: Through study completion, up to 24 months]
• Qualitative assessment (of the SMART implementation bundle and evidence based practice, i.e., SMART) adoption [Срок оценки: Through study completion, up to 24 months]
• Clinician-level fidelity to the SMART implementation bundle [Срок оценки: Through study completion, up to 24 months]
• Clinician-level fidelity (of the evidence-based practice, SMART) [Срок оценки: Through study completion, up to 24 months]
• Other system-level implementation outcomes (of the SMART implementation bundle and evidence-based practice, i.e., SMART) [Срок оценки: Through study completion, up to 24 months]
• Patient-level sustainment (of the evidence-based practice, i.e., SMART) [Срок оценки: Through study completion, up to 24 months]

Критерии участия

The study population can be viewed from the cluster (clinic), clinician, staff, or patient level.

At the cluster (clinic) level: To be eligible to participate in this study, a cluster (clinic) must meet all the following criteria:

• Active participation in the St. Louis Integrated Health Center Network for Community Academic Partnerships.
• Employment of at least 3 clinicians who commonly manage adult asthma (defined as managing asthma for at least one adult asthma patient, on average, on a weekly basis).
• Data provided to Azara for data queries, and
• Willing and able to receive all components of the SMART implementation bundle (i.e., initial educational outreach visit, ongoing practice facilitation/supervision, audit \& feedback, and provision of education of patient-level education aides and SMART asthma action plans and monthly operations committee meetings).

At the clinician/clinical staff level:

To be eligible to participate in this study, a clinician/clinical staff member must meet all of the following criteria:

• Provision of a signed and dated informed consent form.
• Current state licenses of physician, assistant physician, nurse practitioner, or physician assistant.
• Regularly cares for adults with asthma (which may include those trained in family medicine, internal medicine, obstetrics/gynecology, and/or specialty medicine).
• Willing and able to integrate the SMART implementation bundle into their practice.
• Willing and able to participate for the entire duration of the study, including the pre-implementation, active implementation, and post-implementation periods.
• Willing to provide data on prescribing patterns and asthma patient outcomes for the duration of the study.

At the patient level:

To be eligible to participate in this study, a patient must meet all of the following criteria:

• Age ≥12 years old
• Diagnosis of asthma, of any severity, coded (i.e., International Classification of Diseases \[ICD\]-10-CM: J45\*\*).
• The patient has had ≥2 asthma exacerbations in the last year during which systemic corticosteroids were prescribed, and/or the encounter contains an active prescription for an inhaler that is congruent with medium-dose (or higher) maintenance inhaled corticosteroids (ICS) inhalers or low-dose (or higher) ICS-long-acting β-agonist (LABA) inhalers with concomitant reliever short-acting β-agonist inhalers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Affinia healthcare, 2220 Lemp Ave — St Louis
• Affinia healthcare, 1717 Biddle Street — St Louis
• Affinia healthcare, 4414 North Florissant Avenue — St Louis
• Family Care Heath Center, 4352 Manchester Ave — St Louis
• Washington University in St. Louis School of Medicine — St Louis
• Family Care Heath Center, 401 Holly Hills Ave — St Louis
• Affinia healthcare, 3396 Pershall Road, — St Louis

Публикации

• Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3. PMID 22696318
• Infante AF, Wells C, Loza J, Hobbs K, Jarrett JB, Elmes AT. Be SMART About Asthma Management: Single Maintenance and Reliever Therapy. J Am Board Fam Med. 2024 Jul-Aug;37(4):745-752. doi: 10.3122/jabfm.2023.230456R1. PMID 39455262
• Chapman KR, Barnes NC, Greening AP, Jones PW, Pedersen S. Single maintenance and reliever therapy (SMART) of asthma: a critical appraisal. Thorax. 2010 Aug;65(8):747-52. doi: 10.1136/thx.2009.128504. Epub 2010 Jun 27. PMID 20581409
• Reddel HK, Bateman ED, Schatz M, Krishnan JA, Cloutier MM. A Practical Guide to Implementing SMART in Asthma Management. J Allergy Clin Immunol Pract. 2022 Jan;10(1S):S31-S38. doi: 10.1016/j.jaip.2021.10.011. Epub 2021 Oct 16. PMID 34666208
• Norris MR, Modi S, Al-Shaikhly T. SMART - is it practical in the United States? Curr Opin Pulm Med. 2022 May 1;28(3):245-250. doi: 10.1097/MCP.0000000000000862. Epub 2022 Feb 7. PMID 35131990
• Krings JG, Sekhar TC, Chen V, Blake KV, Sumino K, James AS, Clover AK, Lenze EJ, Brownson RC, Castro M. Beginning to Address an Implementation Gap in Asthma: Clinicians' Views of Prescribing Reliever Budesonide-Formoterol Inhalers and SMART in the United States. J Allergy Clin Immunol Pract. 2023 Sep;11(9):2767-2777. doi: 10.1016/j.jaip.2023.05.023. Epub 2023 May 26. PMID 37245736
• Zaeh SE, Zimmerman ZE, Eakin MN, Chupp G. Adoption and implementation of maintenance and reliever therapy for adults with moderate-to-severe asthma. Ann Allergy Asthma Immunol. 2024 Sep;133(3):318-324. doi: 10.1016/j.anai.2024.06.011. Epub 2024 Jun 17. PMID 38897404

Идентификаторы

NCT: NCT07241117 · 202507167 · 5K23HL171940-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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