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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Coach McLungs not yet implemented in practice |
| Intervention | Active comparator | Coach 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.
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)
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
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.
- First posted28 Sep 2021
- Study start1 Feb 2022
- Primary completion1 Sep 2025
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Hazel Tapp, PhD, Principal investigator, Wake Forest University Health Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Implementation and Evaluation of Coach McLungs, an Asthma Shared Decision-making Intervention, Across a Large Healthcare System
- ClinicalTrials.gov ID
- NCT05059210
- Acronym / sponsor ID
- IRB00082608
- Conditions
- Asthma
- Keywords
- Asthma, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic, stepped-wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Coach McLungs not yet implemented in practice |
| Intervention | Active comparator | Behavioral: Coach McLungs InterventionCoach McLungs Implemented in Practice |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Established mild, moderate, or severe persistent asthma
- English or Spanish speaking.
Key exclusion criteria (1 listed)
- Decisional impaired or mentally incompetent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coach McLungs InterventionPractices have received implementation of Coach McLungs | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Number of Participants with Asthma Exacerbations
Time frame: 12 months
Number of Participants with Asthma Exacerbations
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 36333727Ludden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazel Tapp, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
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.