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AsthmaNCT05059210

Primary Care Implementation and Evaluation of Coach McLungs

A study testing Coach McLungs Intervention in people with Asthma, run by Wake Forest University Health Sciences at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Asthma
What is being tested?
Coach McLungs Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
1 Feb 2022to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • Decisional impaired or mentally incompetent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Atrium Health

    Charlotte, North Carolina, 28204

Other trials in United States

About this study

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

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.

Read the 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 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.

Conditions
Asthma
Being tested
Coach McLungs Intervention
Keywords
Asthma, Shared Decision Making
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coach McLungs InterventionBehavioural

    Practices have received implementation of Coach McLungs

Study groups in NCT05059210
Study groupRoleWhat they receive
ControlNo interventionCoach McLungs not yet implemented in practice
InterventionActive comparatorCoach McLungs Implemented in Practice
Receives: Behavioral: Coach McLungs Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Asthma Exacerbations

    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.

    Measured: 6 Months

Secondary outcomes (2)
  1. Number of Participants with Asthma Exacerbations

    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.

    Measured: 12 months

  2. Number of Participants with Asthma Exacerbations

    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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2021
  2. Study start1 Feb 2022
  3. Primary completion1 Sep 2025
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Pragmatic, stepped-wedge cluster randomized controlled trial
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05059210
Sponsor's protocol ID
IRB00082608
Other IDs
1R01HL151854-01A1
Status last verified
Apr 2026
First submitted
17 Sep 2021
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ludden T, O'Hare K, Shade L, Reeves K, Patterson CG, Tapp H. Implementation of Coach McLungsSM into primary care using a cluster randomized stepped wedge trial design. BMC Med Inform Decis Mak. 2022 Nov 4;22(1):285. doi: 10.1186/s12911-022-02030-1.

    PubMed 36333727

Questions about this trial

What is this clinical trial studying?

A study testing Coach McLungs Intervention in people with Asthma, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Asthma Exacerbations (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05059210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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