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).

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.

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.

A validated tool designed to identify patients who may be at risk for adverse outcomes from uncontrolled asthma.

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 .

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.

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?)

The post-study HCP survey asks participants to report the number of patients treated using the PRECISION program.

On the post-study survey, HCPs will be asked to describe the features of the PRECISION program they thought could be improved, features they thought were the most useful, and any other comments or suggestions regarding the PRECISION program.

Descriptive free text responses to the qualitative interviews questions for key site staff and clinicians

Key site staff and clinicians will be 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.

At each touchpoint, site staff will be 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?)

At each touchpoint, site staff will be 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?)

Site staff that participate in the Month 3 optional implementation touchpoint will be 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?)

At each touchpoint, site staff will be 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?)

AIRQ scores range from 0 to 10, where lower scores indicate more well-controlled asthma The 12M AIRQ will be used for the initial study visit, and the 3M AIRQ will be used for follow-up visits.

AIRQ Control level can be categorized as "well controlled", "not-well controlled" or "very poorly controlled" The 12M AIRQ will be used for the initial study visit, and the 3M AIRQ will be used for follow-up visits.

The ACE questionnaire includes 8 items each with Likert scale responses (strongly agree, agree, disagree, strongly disagree).

The final question on the ACE questionnaire asks participants to "Please provide any additional comments you have about your visit or AIRQ."

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)

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)

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

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.

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.

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.

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. Erratum In: J Allergy Clin Immunol Pract. 2021 Jan;9(1):603.