US PRECISION Implementation Study
- Conditions
- Asthma
- Interventions
- Behavioral: AIRQBehavioral: Asthma ChecklistBehavioral: PRECISION Program (Educational Resources)
- 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
- >= 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.
- 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
- Arm && Interventions
Group Intervention Description AIRQ, Asthma Checklist, and PRECISION Program AIRQ 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. AIRQ, Asthma Checklist, and PRECISION Program Asthma Checklist 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. AIRQ, Asthma Checklist, and PRECISION Program PRECISION Program (Educational Resources) 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.
- Primary Outcome Measures
Name Time Method Proportion of responses for each of the categorical items on the post-study survey 1 year 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?)
Descriptive free-text responses to open-ended questions on the post-study survey 1 year 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.
Mean number of patients treated using the PRECISION Program 1 year The post-study HCP survey asks participants to report the number of patients treated using the PRECISION program.
Descriptive free text responses to the qualitative interviews questions for key site staff and clinicians 1 year 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.
Descriptive free-text responses to the implementation touchpoint questions Month 6 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?)
- Secondary Outcome Measures
Name Time Method Change in AIRQ score from baseline to follow-up visits. Baseline and Follow-up, average of 3 months 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.Change in AIRQ control level from baseline to follow-up visit Baseline and Follow-up, average of 3 months 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.Proportion 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).
Descriptive free-text responses to the ACE questionnaire open-ended question Baseline The final question on the ACE questionnaire asks participants to "Please provide any additional comments you have about your visit or AIRQ."
Trial Locations
- Locations (1)
Research Site
🇺🇸Charleston, West Virginia, United States