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US PRECISION Implementation Study

AstraZeneca logo

AstraZeneca

Status

Completed

Conditions

Asthma

Treatments

Behavioral: Asthma Checklist
Behavioral: AIRQ
Behavioral: PRECISION Program (Educational Resources)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04891978
D2287L00028

Details and patient eligibility

About

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).

Full description

This community program intervention study will examine the process of integrating the AIRQ, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits. Providers use of patients' responses to the AIRQ, Asthma Checklist, and educational resources to guide treatment and asthma work-up and management also will be examined. The study duration is 12-months, with study enrollment lasting nine (9) months for each site (implementation stage), and an additional three (3) months of follow-up to assess the sustainability of using the PRECISION program in clinical practice (sustainability stage). The nine-month implementation stage will allow for the recruitment of approximately 50 patients at each site (maximum of 75 patients at each site) for an initial study visit, plus the potential for follow-up visit(s). The three-month sustainability stage will allow for sites to continue to implement the PRECISION program in their clinical practice and for sites to describe any continued benefits of using the PRECISION program at their site.

Approximately fifteen (15) to twenty (20) clinical sites will be recruited to participate in this study, categorized into the following four practice clusters: (1) primary care site (e.g., private practice, FQHC; (2) specialty care site (pulmonary, asthma/immunology); and (3) novel sites (e.g., pharmacy, nurse practitioners, nurse educators, prescribers and Non-prescribers, telehealth component of Allergy and Asthma Network. While all sites will be able to conduct both in-person and telehealth visits, sites will aim to conduct a minimum of approximately 25% of their initial patient visit using a telehealth platform. Both platforms (in-person and telehealth) can be used for the follow-up visit(s) for all practice types.

Enrollment

857 patients

Sex

All

Ages

13 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >= 13 years of age at the time of enrollment
  • Diagnosis of HCP-confirmed asthma
  • Able to read, understand and speak English or Spanish sufficiently self-complete or be administered the AIRQ via telephone, desktop, or mobile device (e.g., smartphone, iPad)
  • Provide consent (adults/parents/guardians) and assent (age 13-17 years) to participate in the study.

Exclusion criteria

  • Current diagnosis of active COPD or any lower respiratory diagnosis other than asthma
  • Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English or Spanish language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the AIRQ or other study questionnaires

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

857 participants in 1 patient group

AIRQ, Asthma Checklist, and PRECISION Program
Experimental group
Description:
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.
Treatment:
Behavioral: PRECISION Program (Educational Resources)
Behavioral: AIRQ
Behavioral: Asthma Checklist

Trial documents
2

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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