Primary Care Implementation and Evaluation of Coach McLungs

NCT05059210 | Active Not Recruiting DMC

• 2 other identifiers: IRB000826081R01HL151854-01A1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Shared Decision Making

Outcome Measures

Primary Outcomes (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.

  6 Months

Secondary Outcomes (2)

• Number of Participants with Asthma Exacerbations

  12 months

• Number of Participants with Asthma Exacerbations

  18 months

Study Arms (2)

Control

NO INTERVENTION

Coach McLungs not yet implemented in practice

Intervention

ACTIVE COMPARATOR

Coach McLungs Implemented in Practice

Behavioral: Coach McLungs Intervention

Interventions

Coach McLungs Intervention BEHAVIORAL

Practices have received implementation of Coach McLungs

Intervention

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Decisional impaired or mentally incompetent

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Related Publications (1)

• 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.

  PMID: 36333727 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hazel Tapp, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, stepped-wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: February 1, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)