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

NCT02865967 | Completed

• 1 other identifier: 15-004435
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Decision Support Techniques; Delayed Diagnosis; Natural Language Processing; Geographic Information Systems

Outcome Measures

Primary Outcomes (1)

• Asthma exacerbation

  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.

  up to one year

Secondary Outcomes (4)

• 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 Arms (6)

Block1_Intervention

EXPERIMENTAL

Usual care + a-GPS

Other: Usual care + a-GPS

Block1_Control

OTHER

Usual Care

Other: Usual care

Block2_Intervention

EXPERIMENTAL

Usual care + a-GPS

Other: Usual care + a-GPS

Block2_Control

OTHER

Usual care

Other: Usual care

Block3_Intervention

EXPERIMENTAL

Usual care + a-GPS

Other: Usual care + a-GPS

Block3_Control

OTHER

Usual care

Other: Usual care

Interventions

Usual care + a-GPS OTHER

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_Intervention; Block2_Intervention; Block3_Intervention

Usual care OTHER

The subjects will be treat for their asthma by their physicians according to usual care.

Block1_Control; Block2_Control; Block3_Control

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 34339438 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Young J Juhn

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 15, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)