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Primary Care Implementation and Evaluation of Coach McLungs

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coach McLungs Intervention
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Asthma, Shared Decision Making

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• Decisional impaired or mentally incompetent

Sites / Locations

  • Atrium HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention

Arm Description

Coach McLungs not yet implemented in practice

Coach McLungs Implemented in Practice

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 17, 2021
Last Updated
June 28, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05059210
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Shared Decision Making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pragmatic, stepped-wedge cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Coach McLungs not yet implemented in practice
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Coach McLungs Implemented in Practice
Intervention Type
Behavioral
Intervention Name(s)
Coach McLungs Intervention
Intervention Description
Practices have received implementation of Coach McLungs
Primary Outcome Measure Information:
Title
Number of Participants with Asthma Exacerbations
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Participants with Asthma Exacerbations
Description
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.
Time Frame
12 months
Title
Number of Participants with Asthma Exacerbations
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established mild, moderate, or severe persistent asthma English or Spanish speaking. Exclusion Criteria: • Decisional impaired or mentally incompetent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hazel Tapp, PhD
Phone
704-304-7120
Email
hazel.tapp@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Ludden, PhD
Phone
704-608-2390
Email
tom.ludden@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazel Tapp, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazel Tapp, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36333727
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.
Results Reference
derived

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Primary Care Implementation and Evaluation of Coach McLungs

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