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Clinical Trials/NCT02865967
NCT02865967
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country185 target enrollmentAugust 2016
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Mayo Clinic
Enrollment
185
Locations
1
Primary Endpoint
Asthma exacerbation
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Juhn

M.D.

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Asthma exacerbation

Time Frame: 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 Outcomes

  • Clinicians' workload(When collecting data listed in A-GPS with and without A-GPS)
  • Health care cost(T0 (baseline) and T4 (when the study ends, approximately up to one year))
  • Asthma control status(up to one year)
  • Timeliness of asthma follow-up care after asthma exacerbation(T0 (baseline) and T4 (when the study ends, approximately up to one year))

Study Sites (1)

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