- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05059210
Primary Care Implementation and Evaluation of Coach McLungs
June 28, 2023 updated by: Wake Forest University Health Sciences
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.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
2700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hazel Tapp, PhD
- Phone Number: 704-304-7120
- Email: hazel.tapp@atriumhealth.org
Study Contact Backup
- Name: Thomas Ludden, PhD
- Phone Number: 704-608-2390
- Email: tom.ludden@atriumhealth.org
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Atrium Health
-
Contact:
- Hazel Tapp, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Established mild, moderate, or severe persistent asthma
- English or Spanish speaking.
Exclusion Criteria:
• Decisional impaired or mentally incompetent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Coach McLungs not yet implemented in practice
|
|
Active Comparator: Intervention
Coach McLungs Implemented in Practice
|
Practices have received implementation of Coach McLungs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
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.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hazel Tapp, PhD, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
September 17, 2021
First Submitted That Met QC Criteria
September 17, 2021
First Posted (Actual)
September 28, 2021
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00082608
- 1R01HL151854-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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