US PRECISION Implementation Study

Not Applicable

Completed

Conditions: Asthma

Registration Number: NCT04891978

Lead Sponsor: AstraZeneca

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 857

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	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).	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?)
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	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).	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?)
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	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).	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?)
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	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).	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?)
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	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).	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?)
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Components of Care Improved by 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).	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?)
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	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).	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?).
Average Number of Patients Treated Using the PRECISION Program at Each Site as Reported by Site HCPs by Site Type	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).	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.
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Primary Care Sites	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.	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
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Specialty Care Sites	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.	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
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Novel Care 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.	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
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites	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.	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.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites	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.	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.
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites	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.	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.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites	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.	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.
Descriptive Free-text HCP Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site	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.	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.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site	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.	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.
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 1)	Month 1 after start of implementation	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?)
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 2)	Month 2 after start of implementation	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?)
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Specialty Care Sites (Month 1)	Month 1 after start of implementation	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?)
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Novel Care Site (Month 2)	Month 2 after start of implementation	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?)

Secondary Outcome Measures

Name	Time	Method
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean and Standard Deviation at Each Visit	Mean (SD) time to follow-up was 3.3 (SD = 1.4) months	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.
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean Difference and Confidence Interval	Mean (SD) time to follow-up was 3.3 (SD = 1.4) months	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.
Change in Patient AIRQ Control Level From Baseline to Follow-up Visit	Mean (SD) time to follow-up was 3.3 (SD = 1.4) months	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.
Percentage of Endorsement of Responses for Each of the 8 Categorical Items on the ACE Questionnaire	Baseline	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.