Clinical trial NCT04891978: US PRECISION Implementation Study
Official title: Implementation of the US PRECISION AIRQ™, Asthma Checklist, and Educational Resources (PRECISION Program) Into Clinical Practice Using Telehealth and In-Person Platforms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 857
Sex: ALL
Minimum age (years): 13
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of responses for each of the categorical items on the post-study survey
timeFrame: 1 year
measure: Mean number of patients treated using the PRECISION Program
timeFrame: 1 year
measure: Descriptive free-text responses to open-ended questions on the post-study survey
timeFrame: 1 year
measure: Descriptive free text responses to the qualitative interviews questions for key site staff and clinicians
timeFrame: 1 year
measure: Descriptive free-text responses to the implementation touchpoint questions
timeFrame: Month 1
measure: Descriptive free-text responses to the implementation touchpoint questions
timeFrame: Month 2
measure: Descriptive free-text responses to the implementation touchpoint questions
timeFrame: Month 3
measure: Descriptive free-text responses to the implementation touchpoint questions
timeFrame: Month 6
Secondary outcomes:
measure: Change in AIRQ score from baseline to follow-up visits.
timeFrame: Baseline and Follow-up, average of 3 months
measure: Change in AIRQ control level from baseline to follow-up visit
timeFrame: Baseline and Follow-up, average of 3 months
measure: Proportion of responses for each of the 8 categorical items on the ACE Questionnaire
timeFrame: Baseline
measure: Descriptive free-text responses to the ACE questionnaire open-ended question
timeFrame: Baseline
Other outcomes:
measure: Change in frequency of OCS
timeFrame: 12 months pre-baseline vs. 12 months
measure: Change in frequency of ER/unplanned visits
timeFrame: 12 months pre-baseline vs. 12 months
measure: Change in frequency of hospitalizations
timeFrame: 12 months pre-baseline vs. 12 months
measure: Change in mean cost of asthma care
timeFrame: 12 months pre-baseline vs 12 months
measure: Correlation between AIRQ scores and practice patterns by practice cluster
timeFrame: Baseline
measure: Correlation between AIRQ scores and practice patterns by practice cluster
timeFrame: Follow-up, average of 3 months
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Leesburg
country: United States
facility: Research Site
state: Florida
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Tewksbury
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Cornwall
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Vienna
country: United States
facility: Research Site
state: Virginia
city: Charleston
country: United States
facility: Research Site
state: West Virginia
Study officials:
References:
citation: Murphy KR, Chipps B, Beuther DA, Wise RA, McCann W, Gilbert I, Eudicone JM, Gandhi HN, Harding G, Coyne KS, Zeiger RS; US PRECISION Advisory Board. Development of the Asthma Impairment and Risk Questionnaire (AIRQ): A Composite Control Measure. J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2263-2274.e5. doi: 10.1016/j.jaip.2020.02.042. Epub 2020 May 6.