Developing and Implementing Asthma-Guidance and Prediction System (a-GPS) for Better Asthma Management
- Conditions
- Asthma
- Interventions
- Other: Usual careOther: Usual care + a-GPS
- Registration Number
- NCT02865967
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Asthma is the most common chronic condition in children and one of the five most burdensome diseases in the United States. Despite this, research and care for childhood asthma are limited by inefficient utilization of electronic medical records (EMRs) to facilitate large-scale studies and care.
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
Despite the availability of evidence-based guidelines for asthma management and effective asthma therapies, asthma continues to cause a significant morbidity and burden to our society. Growing deployments of Electronic Health Records (EHRs) systems have established large practice-based longitudinal datasets, which allow for the identification of patient cohorts for epidemiological investigations and population-based management. Natural Language Processing (NLP; automated chart review using computer program) has received great attention and has played a critical role in secondary use of EHRs for clinical care and translational research. For example, we recently developed an NLP algorithm for the Predetermined Asthma Criteria (PAC) that can ascertain asthma status without manual chart review.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Block2_Control Usual care Usual care Block1_Control Usual care Usual Care Block2_Intervention Usual care + a-GPS Usual care + a-GPS Block3_Intervention Usual care + a-GPS Usual care + a-GPS Block3_Control Usual care Usual care Block1_Intervention Usual care + a-GPS Usual care + a-GPS
- Primary Outcome Measures
Name Time Method Asthma exacerbation up to one year Asthma exacerbation will be defined as the number of emergency department visits/ hospitalization for asthma (asthma symptoms) or unscheduled visit for asthma (asthma symptoms) requiring oral corticosteroid. This outcome will be retrieved from the electronic health record for the subjects.
- Secondary Outcome Measures
Name Time Method Clinicians' workload When collecting data listed in A-GPS with and without A-GPS Clinicians' workload in duration of time to collect and review clinical data from EHRs for making a clinical decision
Health care cost T0 (baseline) and T4 (when the study ends, approximately up to one year) A total cost of health care (regardless of asthma) per study subject for the 1 year before the study starts and during the study period will be calculated and assessed.
Asthma control status up to one year A quarterly asthma control status will be measured by administering Asthma Control Test (ACT) or Test for Respiratory and Asthma Control in Kids (TRACK) by an asthma care coordinator, care team or study coordinator over the phone or online ACT questionnaire with a reminding system. Good asthma control will be defined as \>ACT score of 19 for children ≥ 4 years or \<TRACK score of 80 for children \<4 years. Patient''s asthma control status will be determined as good vs. bad control.
Timeliness of asthma follow-up care after asthma exacerbation T0 (baseline) and T4 (when the study ends, approximately up to one year) Documented any asthma care either via clinic visit or by asthma care coordinator's contact after asthma-related adverse events (ie, ER/Hospitalization for asthma, or asthma exacerbation requiring oral corticosteroid use) and time gap (in days) will be retrieved and assessed.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States