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NCT05059210 | Not yet recruiting | Asthma


Primary Care Implementation and Evaluation of Coach McLungs
Sponsor:

Atrium Health

Information provided by (Responsible Party):

Hazel Tapp

Brief Summary:

Here we will evaluate the implementation of Coach McLungsSM, a virtual evidence-based asthma shared decision making (SDM) intervention with built-in asthma education and clinical decision support, into primary care practices across a large healthcare system. All asthma patients aged 5-17 who attend these practices will be assessed for uncontrolled asthma. The goal of this study will be to evaluate the implementation of the Coach McLungsSM SDM intervention into primary care. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes.

Condition or disease

Asthma

Intervention/treatment

Coach McLungs Intervention

Phase

Not Applicable

Detailed Description:

Changing behavior of health providers can be challenging, and significant gaps exist in our knowledge of how to best implement new medical evidence into everyday practice. Numerous individual- and system-level factors contribute to poor asthma outcomes which persist due to the lack of a comprehensive approach for asthma care that is scalable, sustainable, and widely disseminated. Improved asthma outcomes are associated with effective communication strategies between the patient and provider. Shared decision making (SDM) is a patient-centered process in which patients and providers work together to make decisions and select tests, treatments, and care plans based on evidence that balances risks with patient preferences and values. Previous studies, including our PCORI-funded dissemination study, have shown that SDM is associated with improved outcomes for asthma patients in primary care. Here we will evaluate the implementation of Coach McLungsSM, a virtual evidence-based asthma SDM intervention with built-in asthma education and clinical decision support, into primary care practices across a large healthcare system. Atrium Health, the 2nd largest virtually integrated healthcare system in the nation, with over 14 million patient visits per year and the region's largest primary care network, provides an ideal venue to evaluate implementation into primary care. Coach McLungsSM will be fully integrated into the electronic medical record at all primary care practices. All asthma patients aged 5-17 who attend these practices will be assessed for uncontrolled asthma. The goal of this study will be to evaluate the implementation of the Coach McLungsSM SDM intervention into primary care. Implementation will be guided using the Expert Recommendations for Implementing Change (ERIC), a compilation of implementation strategies, and evaluated using the RE-AIM (Reach Effectiveness, Adoption, Implementation, Maintenance) framework. Research questions are: How best can we implement the Coach McLungsSM SDM asthma intervention into primary care? Will use of Coach McLungsSM in primary care improve outcomes for patients with uncontrolled asthma? After convening a Stakeholder Advisory Committee (SAC) composed of providers, researchers, patients, stakeholders with expertise in implementation science, asthma research and advocacy, we will implement the Coach McLungsSM SDM intervention into primary care practices using a stepped wedge randomized control study design. Providers and staff will be trained in SDM communication and use of the Coach McLungsSM tool. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes. The SAC will use an iterative process improvement method and give best practice recommendations back to the practices for implementation improvement. We will disseminate findings through local stakeholders, practice-based research networks, asthma advocacy national organizations, and academic research meetings for healthcare, primary care, and asthma.

Study Type : Interventional
Estimated Enrollment : 2700 participants
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Primary Care Implementation and Evaluation of Coach McLungs, an Asthma Shared Decision-making Intervention, Across a Large Healthcare System
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : August 31, 2026
Arm Intervention/treatment

No Intervention: Control

Coach McLungs not yet implemented in practice

Active Comparator: Intervention

Coach McLungs Implemented in Practice

Ages Eligible for Study: 5 Years to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria Having established mild, moderate, or severe persistent asthma with a diagnosis verified by practice providers. English or Spanish speaking.Exclusion Criteria
  • Decisional impaired or mentally incompetent

Primary Care Implementation and Evaluation of Coach McLungs

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Primary Care Implementation and Evaluation of Coach McLungs

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