US PRECISION Implementation Study
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- AstraZeneca
- Study ID
- NCT04891978
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- AIRQ — BEHAVIORALA validated tool designed to identify patients who may be at risk for adverse outcomes from uncontrolled asthma.
- Asthma Checklist — BEHAVIORALA validated, 3-page tool, based on GINA and NAEPP guidelines to assist providers with recognition, evaluation, and optimization of all patients with asthma. In this study, healthcare providers will be required to complete the assess component (page 1) of the Asthma Checklist .
- PRECISION Program (Educational Resources) — BEHAVIORALEducational resources accessible to all providers in the study. There are provider-facing and patient-facing educational materials that can be accessed during the patient visit or as resources for before/after visits. Resources can be downloaded and sent to patients per the discretion of providers.
Study Details
The primary objective of this community program intervention study is to assess the process and potential benefits of integrating the AIRQ®, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits. The secondary objectives are to assess asthma patients' clinic visit experiences when the AIRQ, the Asthma Checklist, and educational resources (PRECISION program) are utilized as part of a telehealth or in-person visit with their HCP, and to explore change in AIRQ scores from the initial visit to follow-up visit(s) (when available).
Key Dates
- Start date
- Apr 20, 2021
- Status verified
- Jun 2025
- Primary completion
- Apr 30, 2023
- Completion
- Apr 30, 2023
Study Design
- Enrollment
- 857 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: AIRQ, Asthma Checklist, and PRECISION ProgramAll participants in the trial will be given the behavioral interventions which include the AIRQ tool, the Asthma Checklist tool, and the PRECISION program educational resources.
Primary Outcome Measure
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice. [ Time Frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site). ]
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | - |
| Research Site | Leesburg | Florida | 34748 | - |
| Research Site | Honolulu | Hawaii | 96819 | - |
| Research Site | Fort Wayne | Indiana | 46802 | - |
| Research Site | Tewksbury | Massachusetts | 01876 | - |
| Research Site | Ann Arbor | Michigan | 48109 | - |
| Research Site | Cornwall-on-Hudson | New York | 12518 | - |
| Research Site | Rochester | New York | 14607 | - |
| Research Site | Asheville | North Carolina | 28801 | - |
| Research Site | Philadelphia | Pennsylvania | 19148 | - |
| Research Site | San Antonio | Texas | 78249 | - |
| Research Site | Vienna | Virginia | 22182 | - |
| Research Site | Charleston | West Virginia | 25304 | - |
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