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Active, Not Recruiting

NCT Number: NCT05059210

Primary Care Implementation and Evaluation of Coach McLungs

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health

Charlotte, North Carolina, 28204, United States

About this study

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 a PCORI-funded dissemination study, have shown that SDM is associated with improved outcomes for asthma patients in primary care. The implementation of Coach McLungsSM, a virtual evidence-based asthma SDM intervention with built-in asthma education and clinical decision support, will be evaluated as it is implemented 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 Coach McLungsSM SDM asthma intervention be implemented 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, the Coach McLungsSM SDM intervention will be implemented 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. Changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes will be evaluated. The SAC will use an iterative process improvement method and give best practice recommendations back to the practices for implementation improvement. Findings will be disseminated through local stakeholders, practice-based research networks, asthma advocacy national organizations, and academic research meetings for healthcare, primary care, and asthma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Established mild, moderate, or severe persistent asthma
  • English or Spanish speaking.

Exclusion criteria

  • Decisional impaired or mentally incompetent

Treatment and study plan

Coach McLungs Intervention

Behavioral

Practices have received implementation of Coach McLungs

Primary outcomes

  1. Number of Participants with Asthma Exacerbations

    Time frame: 6 Months

    Participant utilization data of ED visits and hospitalizations for asthma exacerbations will be extracted from the electronic data warehouse (EDW) for participants who have a diagnosis of asthma (ICD-10 code J45.XXX) irrespective of intervention, allowing measurement of any outcome improvements over the life of the study.

Secondary outcomes

  1. Number of Participants with Asthma Exacerbations

    Time frame: 12 months

    Participant utilization data of ED visits and hospitalizations for asthma exacerbations will be extracted from the electronic data warehouse (EDW) for participants who have a diagnosis of asthma (ICD-10 code J45.XXX) irrespective of intervention, allowing measurement of any outcome improvements over the life of the study.

  2. Number of Participants with Asthma Exacerbations

    Time frame: 18 months

    Participant utilization data of ED visits and hospitalizations for asthma exacerbations will be extracted from the electronic data warehouse (EDW) for participants who have a diagnosis of asthma (ICD-10 code J45.XXX) irrespective of intervention, allowing measurement of any outcome improvements over the life of the study.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Primary Care Implementation and Evaluation of Coach McLungs, an Asthma Shared Decision-making Intervention, Across a Large Healthcare System

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Sep 28, 2021
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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