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 — BEHAVIORAL
    A validated tool designed to identify patients who may be at risk for adverse outcomes from uncontrolled asthma.
  • Asthma Checklist — BEHAVIORAL
    A 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) — BEHAVIORAL
    Educational 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 Program
    All 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)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35209-
Research SiteLeesburgFlorida34748-
Research SiteHonoluluHawaii96819-
Research SiteFort WayneIndiana46802-
Research SiteTewksburyMassachusetts01876-
Research SiteAnn ArborMichigan48109-
Research SiteCornwall-on-HudsonNew York12518-
Research SiteRochesterNew York14607-
Research SiteAshevilleNorth Carolina28801-
Research SitePhiladelphiaPennsylvania19148-
Research SiteSan AntonioTexas78249-
Research SiteViennaVirginia22182-
Research SiteCharlestonWest Virginia25304-

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