Clinical trial NCT05059210: Primary Care Implementation and Evaluation of Coach McLungs
Official title: Primary Care Implementation and Evaluation of Coach McLungs, an Asthma Shared Decision-making Intervention, Across a Large Healthcare System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Asthma
Shared Decision Making
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-09-28
Enrollment: 2700
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pragmatic, stepped-wedge cluster randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Decisional impaired or mentally incompetent

Primary outcomes:
measure: Number of Participants with Asthma Exacerbations
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Participants with Asthma Exacerbations
timeFrame: 12 months
measure: Number of Participants with Asthma Exacerbations
timeFrame: 18 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Hazel Tapp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.