AMAZE™ Asthma Implementation QI Study

Study Overview
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Brief Summary
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The primary study objective is to generate evidence as to the feasibility, usability, perceived value, and potential benefits of implementing the AMAZE™ platform into clinical practice.

Detailed Description
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AstraZeneca has developed the AMAZE™ disease management platform to be used across multiple disease indications to provide a unified experience for the management of patients throughout their patient care journey. AMAZE™ integrates multiple systems, including a patient mobile application where patients can enter daily symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials. Implementation of AMAZE™ within clinical practice has not yet been evaluated. The results from this study will be used to inform any changes or modifications that need to be made to the technology platform, its implementation process, and explore impact on clinical outcomes.

Official Title
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AMAZE™ Asthma Implementation Quality Improvement Study

Conditions
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Asthma

Intervention / Treatment
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* Device: AMAZE™ Disease Management Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age at the time of enrollment Clinically confirmed diagnosis of asthma Access to a smartphone with internet access with the following requirements: iOS (Operating System iOS 13 or newer and Devices iPhone 8 or newer) or Android (Operating System 8.0 or newer) Able to understand and speak English sufficiently to be able to use the AMAZE™ patient App Willingness to participate in a telephone interview and be audio-recorded Consenting to participate in the study Exclusion Criteria: Current diagnosis of active chronic obstructive pulmonary disease (COPD) or any pulmonary diagnosis other than asthma; Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the ACT™

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quality Initiative<br>Each participant will be asked to complete the symptoms log daily for up to 6 months. Additional surveys will be completed throughout the study by participants and GAA clinical staff. | Device: AMAZE™ Disease Management Platform<br>* The disease management platform includes a patient mobile application where patients can enter daily symptoms, communicate with their healthcare providers, and access educational materials. Additionally, the healthcare providers will have access to a dashboard that is integrated with the EMR and patient app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient App Usage | Patient app usage will be measured as the number of days the patient engages (i.e., completes daily log, sends a message) with the app at least once a day during the study period. | Up to 6 months | 
| Clinician Dashboard Usage | Clinician dashboard usage will be measured as the mean number of days per week/month that the clinical site staff accessed the AMAZE™ dashboard over the 6-month period. | Up to 6 months | 
| Daily Asthma status | Patient daily asthma status (bad, okay, good) reported on the app will be described weekly during Month 1, and then per month from Month 1 through Month 6 pending availability of data after Month 1. | Up to 6 months | 
| Symptoms and Triggers | Frequency of symptoms and frequency of triggers (for those that reported symptoms) reported on the app will be described weekly during Months 1, and then per month from Month 1 through Month 6 pending availability of data after Month 1. | Up to 6 months | 
| Self-Reported Rescue Medication usage | The number of times per month a patient used rescue medication as well as visited the emergency room or urgent care as reported on the app will be described from Month 1 through Month 6. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of AMAZE™ on patient visits | The impact of AMAZE™ on patient visits will be measured as the frequency of patients who select agree or strongly agree in response to the 9-items in the patient visit experience survey. | Up to 6 months | 
| ER visits and Hospitalization avoidance | The impact of AMAZE™ on ER and hospitalizations will be measured as the frequency of patients who report agree or strongly agree with the item The visit helped avoid an ER or Urgent Care center visit or hospitalization from the patient visit experience survey | Up to 6 months | 
| Patient Perception of Appointment Discussions and Taking Part in Asthma Decisions | The impact of AMAZE™ on improved patient communication with their provider will be measured as the frequency of patients who report agree or strongly agree with the items the app helped me discuss my asthma with my healthcare provider(s) during my most recent visit and I was included in making decisions about my asthma treatment during my most recent visit on the patient visit experience survey. | Up to 6 months | 
| Patient Perception of Usability and Design of Mobile app | The usability of the AMAZE™ app will be measured by the frequency of patients who rate the app excellent (SUS score >80.3), good (68-80.3), okay (68), poor (51-68), or awful (<51) at months 1 and 6 | Up to 6 months | 
| Clinical Staff Perception of Usability and Design of Dashboard | The usability of the AMAZE™ dashboard will be measured by the frequency of clinical staff who rate the app excellent (SUS score >80.3), good (68-80.3), okay (68), poor (51-68), or awful (<51) at months 1 and 6 | Up to 6 months | 
| Evaluate ease of implementation of AMAZE™ in clinical setting | The ease of implementation of AMAZE™ will be measured by the frequency of clinical staff who report very easy or somewhat easy to the question How would you rate the overall ease of implementing AMAZE™ on a platform into your clinical practice? in the post-study survey at month 6. | Up to 6 months | 
| Evaluate impact of AMAZE™ on managing patients | The impact of AMAZE™ on managing patients will be measured by the frequency of clinical staff who report moderately or very well to the question Did the AMAZE™ help you manage your patients? in the post-study survey at month 6. | Up to 6 months | 
| Evaluate Perceived Benefit of AMAZE™ in clinical setting | The perceived benefit of AMAZE™ will be evaluated by the frequency of clinical staff who endorse different perceived benefits based on the item what did you find the most useful about the AMAZE™ platform? in the post-study survey at month 6. | Up to 6 months | 
| Evaluate Perceived Disadvantages of AMAZE™ in clinical setting | The perceived disadvantages of AMAZE™ will be evaluated by the frequency of clinical staff who endorse different perceived disadvantages based on the item what did you find the least useful or cumbersome about the AMAZE™ platform? in the post-study survey at month 6. | Up to 6 months | 
| Evaluate patient satisfaction with healthcare experience | Patient satisfaction with their healthcare experience will be evaluated using the PSQ-18 items and subscale scores (General Satisfaction, Technical Quality, Interpersonal Manner, Communication, Financial Aspects, Time Spent with Doctor, Accessibility and Convenience) at Month 6. | Up to 6 months | 
| Evaluate patient satisfaction with app | Satisfaction with the app features will be measured by the frequency of patients who report satisfaction on a scale of 1 (lowest satisfaction) to 5 (highest satisfaction) at months 1, 3, and 6. | Up to 6 months |