US PRECISION Implementation Study

Implementation of the US PRECISION AIRQ, Asthma Checklist, and Educational Resources (PRECISION Program) Into Clinical Practice Using Telehealth and In-Person Platforms

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).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: AIRQ; Behavioral: Asthma Checklist; Behavioral: PRECISION Program (Educational Resources)

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.

• Study Type: Interventional
• Enrollment (Actual): 857
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Research Site
  • Florida
    • Leesburg, Florida, United States, 34748
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46802
      • Research Site
  • Massachusetts
    • Tewksbury, Massachusetts, United States, 01876
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Research Site
  • New York
    • Cornwall, New York, United States, 12518
      • Research Site
    • Rochester, New York, United States, 14607
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19148
      • Research Site
  • Texas
    • San Antonio, Texas, United States, 78249
      • Research Site
  • Virginia
    • Vienna, Virginia, United States, 22182
      • Research Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 130 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: AIRQ; A validated tool designed to identify patients who may be at risk for adverse outcomes from uncontrolled asthma.; Behavioral: Asthma Checklist; 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 .; Behavioral: PRECISION Program (Educational Resources); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The post-study HCP survey includes questions regarding the implementation of the PRECISION program (e.g., how would you rate the overall ease of implementing the AIRQ into your clinical practice using the telehealth platform?)	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).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to How Much the AIRQ Helped Manage Patients	The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ help you manage your patients?)	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).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Whether the AIRQ Helped Identify Patients at Risk for Adverse Asthma Health Outcomes	The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ help you identify patients who were at risk for adverse health outcomes from their asthma that you would have otherwise missed?)	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).
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Most and Least Helpful Parts of AIRQ	The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., What did you find most useful about AIRQ?)	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).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Frequency of Referring to a Specialist or Practice Type Different Than Their Own While Using the AIRQ	The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., While using AIRQ how often did you refer to a specialist or practice type different than your own?)	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).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Components of Care Improved by AIRQ	The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ improve any of the following?)	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).
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Importance of Using Different Components of the PRECISION Program	The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., How important was it for you to use the Assess component of the Asthma Checklist (page 1) with the AIRQ?).	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).
Average Number of Patients Treated Using the PRECISION Program at Each Site as Reported by Site HCPs by Site Type	The post-study HCP survey asks sites to report the number of patients treated using the PRECISION program at their site. One HCP per site reported on the number of patients treated using the PRECISION program at their site. The mean presented is the number of patients at each site as reported by site HCPs divided by the number of sites.	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).
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Primary Care Sites	On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were the most useful and could be improved when implemented at their site	Post-study survey was completed between 32.9 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.
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Specialty Care Sites	On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were most useful and could be improved when implemented at their site	Post-study survey was completed between 22.1 weeks and 50.4 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Novel Care Site	On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were most useful and could be improved when implemented at their site	Post-study survey was completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites	Site clinicians were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.	Post-study clinician interviews were completed between -2 weeks (interviews completed a little sooner than end of follow-up) and 52.4 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites	Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.	Post-study key site staff interviews were completed between -2 weeks (interviews completed a little sooner than end of follow-up) and 43 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites	Site clinicians were asked to respond to several open-ended interview questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.	Post-study clinician interviews were completed between -6.3 weeks (interviews completed a little sooner than end of follow-up) and 23 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites	Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.	Post-study site staff interviews were completed between -6.3 weeks (interviews completed a little sooner than end of follow-up) and 4.7 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text HCP Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site	Site HCPs were asked to respond to several open-ended interview questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.	Post-study HCP interviews were completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site	Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.	Post-study key site staff interviews were completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 1)	At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)	Month 1 after start of implementation
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 2)	At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)	Month 2 after start of implementation
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Specialty Care Sites (Month 1)	At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)	Month 1 after start of implementation
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Novel Care Site (Month 2)	At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)	Month 2 after start of implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean and Standard Deviation at Each Visit	AIRQ scores range from 0 to 10, where lower scores indicate more well-controlled asthma The AIRQ was used for the initial study visit, and a follow-up AIRQ that employs the same 10 questions as the AIRQ but for the 3 risk questions where exacerbation history covers a 3 month look-back period instead of a 12 month look-back period was used for follow-up visits.	Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean Difference and Confidence Interval	AIRQ scores range from 0 to 10, where lower scores indicate more well-controlled asthma The AIRQ was used for the initial study visit, and a follow-up AIRQ that employs the same 10 questions as the AIRQ but for the 3 risk questions where exacerbation history covers a 3 month look-back period instead of a 12 month look-back period was used for follow-up visits.	Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Change in Patient AIRQ Control Level From Baseline to Follow-up Visit	AIRQ Control level can be categorized as "well controlled", "not-well controlled" or "very poorly controlled" The AIRQ was used for the initial study visit, and a follow-up AIRQ that employs the same 10 questions as the AIRQ but for the 3 risk questions where exacerbation history covers a 3 month look-back period instead of a 12 month look-back period was used for follow-up visits.	Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Percentage of Endorsement of Responses for Each of the 8 Categorical Items on the ACE Questionnaire	The ACE questionnaire includes 8 items each with Likert scale responses (strongly agree, agree, disagree, strongly disagree). Participants completed this measure via a patient web survey.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of OCS	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs. 12 months
Change in frequency of ER/unplanned visits	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs. 12 months
Change in frequency of hospitalizations	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs. 12 months
Change in mean cost of asthma care	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs 12 months
Correlation between AIRQ scores and practice patterns by practice cluster	AIRQ scores range from 0 to 10, where lower scores indicate more well controlled asthma. Practice patterns will be evaluated based on the assess component of the Asthma Checklist (step-up/step down/no change in therapy; referral to specialist; initiation of biologic)	Baseline
Correlation between AIRQ scores and practice patterns by practice cluster	AIRQ scores range from 0 to 10, where lower scores indicate more well controlled asthma. Practice patterns will be evaluated based on the assess component of the Asthma Checklist (step-up/step down/no change in therapy; referral to specialist; initiation of biologic)	Follow-up, average of 3 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: D2287L00028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No