Developing and Implementing Asthma-Guidance and Prediction System (a-GPS) for Better Asthma Management



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 17
Updated:11/11/2018
Start Date:August 2016
End Date:December 2019

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Enhancing Asthma Care and Outcome Through the Implementation of Asthma-Guidance and Prediction System (a-GPS) on Asthma Management Program: A Randomized Block Design

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.

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.

Inclusion Criteria for Children in Block 1:

- Must be enrolled in AMP at the time of enrollment.

Inclusion Criteria for Children in Block 2:

- 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.

Inclusion Criteria for Children in Block 3:

- 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 (All Blocks):

- Non-Olmsted County residents

- 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
We found this trial at
1
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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