US PRECISION Implementation Study

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891978
• Other study ID #: D2287L00028
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 857
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Asheville	North Carolina
United States	Research Site	Birmingham	Alabama
United States	Research Site	Charleston	West Virginia
United States	Research Site	Cornwall	New York
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Leesburg	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Rochester	New York
United States	Research Site	San Antonio	Texas
United States	Research Site	Tewksbury	Massachusetts
United States	Research Site	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in frequency of OCS	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs. 12 months
Other	Change in frequency of ER/unplanned visits	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs. 12 months
Other	Change in frequency of hospitalizations	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs. 12 months
Other	Change in mean cost of asthma care	Evaluation of available exacerbation data from selected sites	12 months pre-baseline vs 12 months
Other	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
Other	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
Primary	Proportion of responses for each of the categorical items on the post-study survey	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?)	1 year
Primary	Mean number of patients treated using the PRECISION Program	The post-study HCP survey asks participants to report the number of patients treated using the PRECISION program.	1 year
Primary	Descriptive free-text responses to open-ended questions on the post-study survey	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.	1 year
Primary	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.	1 year
Primary	Descriptive free-text responses to the implementation touchpoint questions	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?)	Month 1
Primary	Descriptive free-text responses to the implementation touchpoint questions	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?)	Month 2
Primary	Descriptive free-text responses to the implementation touchpoint questions	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?)	Month 3
Primary	Descriptive free-text responses to the implementation touchpoint questions	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?)	Month 6
Secondary	Change in AIRQ score from baseline to follow-up visits.	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.	Baseline and Follow-up, average of 3 months
Secondary	Change in 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 12M AIRQ will be used for the initial study visit, and the 3M AIRQ will be used for follow-up visits.	Baseline and Follow-up, average of 3 months
Secondary	Proportion 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).	Baseline
Secondary	Descriptive free-text responses to the ACE questionnaire open-ended question	The final question on the ACE questionnaire asks participants to "Please provide any additional comments you have about your visit or AIRQ."	Baseline