AsthmaNCT02865967
Developing and Implementing Asthma-Guidance and Prediction System (a-GPS) for Better Asthma Management
A study of Asthma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Asthma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Usual care + a-GPS, Usual care
- Keywords
- Decision Support Techniques, Delayed Diagnosis, Natural Language Processing, Geographic Information Systems
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care + a-GPSOther
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 careOther
The subjects will be treat for their asthma by their physicians according to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Block1_Intervention | Experimental | Usual care + a-GPS Receives: Other: Usual care + a-GPS |
| Block1_Control | Other | Usual Care Receives: Other: Usual care |
| Block2_Intervention | Experimental | Usual care + a-GPS Receives: Other: Usual care + a-GPS |
| Block2_Control | Other | Usual care Receives: Other: Usual care |
| Block3_Intervention | Experimental | Usual care + a-GPS Receives: Other: Usual care + a-GPS |
| Block3_Control | Other | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one year
Secondary outcomes (4)
Clinicians' workload
Clinicians' workload in duration of time to collect and review clinical data from EHRs for making a clinical decision
Measured: When collecting data listed in A-GPS with and without A-GPS
Health care cost
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.
Measured: T0 (baseline) and T4 (when the study ends, approximately up to one year)
Asthma control status
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.
Measured: up to one year
Timeliness of asthma follow-up care after asthma exacerbation
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.
Measured: T0 (baseline) and T4 (when the study ends, approximately up to one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Juhn, Mayo Clinic
- Investigators
- Young J Juhn, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865967
- Sponsor's protocol ID
- 15-004435
- Status last verified
- Nov 2020
- First submitted
- 20 Jul 2016
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD.
Publications
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.
PubMed 34339438
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Asthma Care and Outcome Through the Implementation of Asthma-Guidance and Prediction System (a-GPS) on Asthma Management Program: A Randomized Block Design
- ClinicalTrials.gov ID
- NCT02865967
- Acronym / sponsor ID
- 15-004435
- Conditions
- Asthma
- Keywords
- Decision Support Techniques, Delayed Diagnosis, Natural Language Processing, Geographic Information Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Block1_Intervention | Experimental | Other: Usual care + a-GPSUsual care + a-GPS |
| Block1_Control | Other | Other: Usual careUsual Care |
| Block2_Intervention | Experimental | Other: Usual care + a-GPSUsual care + a-GPS |
| Block2_Control | Other | Other: Usual careUsual care |
| Block3_Intervention | Experimental | Other: Usual care + a-GPSUsual care + a-GPS |
| Block3_Control | Other | Other: Usual careUsual care |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care + a-GPSClinicians 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. | Other | Block1_Intervention, Block2_Intervention, Block3_Intervention |
| Usual careThe subjects will be treat for their asthma by their physicians according to usual care. | Other | Block1_Control, Block2_Control, Block3_Control |
Primary outcome
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.
4 secondary outcomes
Clinicians' workload
Time frame: When collecting data listed in A-GPS with and without A-GPS
Health care cost
Time frame: T0 (baseline) and T4 (when the study ends, approximately up to one year)
Asthma control status
Time frame: up to one year
Timeliness of asthma follow-up care after asthma exacerbation
Time frame: T0 (baseline) and T4 (when the study ends, approximately up to one year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Derived from this study: PubMed 34339438Seol 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young J Juhn principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Asthma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma exacerbation (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.