Developing and Implementing Asthma-Guidance and Prediction System (a-GPS) for Better Asthma Management
NCT ID: NCT02865967
Last Updated: 2020-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
185 participants
INTERVENTIONAL
2016-08-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary goal of this clinical trial is to implement the asthma-Guidance and Prediction System (a-GPS) on the Asthma Management Program (AMP, a current care coordination program for asthma care of children aged 5-17 years at Mayo Clinic). Primary hypothesis: The implementation of a-GPS in the current care is logistically feasible.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary goals of this proposed clinical trial are 1) to implement the asthma-Guidance and Prediction System (a-GPS) on Asthma Management Program (AMP, a current care coordination program for asthma care of children aged 5-17 years at Mayo Clinic) and 2) assess the impact of a-GPS on the primary and secondary end points for a one-year study period. These goals will be accomplished by conducting a randomized clinical trial with block design for three groups of children as the groups (blocks) of children are significantly heterogeneous in terms of receiving asthma care.
The a-GPS program includes 1) natural language processing (NLP) capabilities (i.e., automated EHR review to identify asthma status (yes vs. no) and monitor asthma activity (onset, remission, and relapse) in real time), 2) temporal and geospatial trends analysis of asthma outcome and care, and 3) asthma care optimization through predictive analytics.
The primary end points include asthma outcome using quarterly measured age-appropriate asthma control questionnaire (ie, Asthma Control Test (ACT; validated for children aged ≥ 4 years) scores for children ≥ 4 years: a total duration of ACT scores \> 19, or Test for Respiratory and Asthma Control in Kids (TRACK; validated for children under 5 years) scores for children \<4 years: a total duration of TRACK scores \< 80), care quality (timely care in response to asthma-related events), and costs (total costs per member). For those in Block 3, the rate of a physician diagnosis of asthma during the study will be also compared between the intervention and control groups as a measure for quality care.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Block1_Intervention
Usual care + a-GPS
Usual care + a-GPS
Clinicians will be provided a-GPS data on a regular basis for intervention group, but not control group such as their risk factors for asthma, quality of care, and asthma outcomes.
Block1_Control
Usual Care
Usual care
The subjects will be treat for their asthma by their physicians according to usual care.
Block2_Intervention
Usual care + a-GPS
Usual care + a-GPS
Clinicians will be provided a-GPS data on a regular basis for intervention group, but not control group such as their risk factors for asthma, quality of care, and asthma outcomes.
Block2_Control
Usual care
Usual care
The subjects will be treat for their asthma by their physicians according to usual care.
Block3_Intervention
Usual care + a-GPS
Usual care + a-GPS
Clinicians will be provided a-GPS data on a regular basis for intervention group, but not control group such as their risk factors for asthma, quality of care, and asthma outcomes.
Block3_Control
Usual care
Usual care
The subjects will be treat for their asthma by their physicians according to usual care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Usual care + a-GPS
Clinicians will be provided a-GPS data on a regular basis for intervention group, but not control group such as their risk factors for asthma, quality of care, and asthma outcomes.
Usual care
The subjects will be treat for their asthma by their physicians according to usual care.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Physician diagnosis of persistent asthma by NLP program for the list of physician diagnoses referring to persistent asthma, and/or
* Persistent asthma equivalent condition by either the Healthcare Effectiveness Data and Information Set (HEDIS); (e.g., ER visit or hospitalization for asthma during the past 12 months) or the National Asthma Education and Prevention Program (NAEPP); (e.g., ≥2 exacerbations requiring oral systemic corticosteroids in the past 6 months for children aged 0-4 years and 12 months for those aged ≥5 years), and/or
* Physician diagnosis of asthma with controller medication (e.g., inhaled corticosteroid) documented in the past 12 months, but they were not enrolled in AMP at the time of enrollment or during run-in period.
\- Children must meet the criteria for asthma delineated in Table 1 in protocol for asthma and recurrent asthma-like symptoms, but do not have a documentation of a diagnosis of asthma in medical records aged 0-17 years.
Exclusion Criteria
* Children who are not enrolled in Mayo Clinic downtown pediatric practice
* No research authorization for using medical records for research
* Immunosuppressive therapy
* Conditions making asthma ascertainment difficult for Block 3 (pulmonary function tests that showed forced expiratory volume at one second (FEV1) to be consistently below 50% predicted or diminished diffusion capacity, tracheobronchial foreign body at or about the incidence date of asthma, wheezing occurring only in response to anesthesia or medications, bullous emphysema or pulmonary fibrosis on chest radiograph, homozygous alpha 1-protease inhibitor deficiency (PiZZ) alpha1-antitrypsin, cystic fibrosis, other major chest disease such as severe kyphoscoliosis or bronchiectasis)
* Children and their caregivers who decline to participate in the study
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Young Juhn
M.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Young J Juhn
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Seol HY, Shrestha P, Muth JF, Wi CI, Sohn S, Ryu E, Park M, Ihrke K, Moon S, King K, Wheeler P, Borah B, Moriarty J, Rosedahl J, Liu H, McWilliams DB, Juhn YJ. Artificial intelligence-assisted clinical decision support for childhood asthma management: A randomized clinical trial. PLoS One. 2021 Aug 2;16(8):e0255261. doi: 10.1371/journal.pone.0255261. eCollection 2021.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15-004435
Identifier Type: -
Identifier Source: org_study_id