Pediatric Asthma
Conditions
Keywords
Pediatric Asthma, Early Detection, Screening, Passive Digital Marker, Risk Factors
Brief summary
Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used in practice. The objective of the study is to determine the usability, acceptability, feasibility, and preliminary efficacy of the childhood asthma passive digital marker (PDM) among pediatricians. The study will include practicing pediatricians within the IU Health Network.
Interventions
OTHERChildhood Asthma Passive Digital Marker
A childhood asthma Passive Digital Marker (PDM) is an ML algorithm that is able to retrieve and synthesize pre-existing "passively" collected mother/child dyad prognostic data in "digital" electronic health record (EHR) to provide an objective and quantifiable "marker" of a child's risk (probability) and associated pathophysiological phenotype to inform clinician decision-making at point-of-care.
Sponsors
Indiana University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Practicing pediatricians within the IU Health Network
Exclusion criteria
• Non-practicing pediatricians within the IU Health Network
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived PDM Acceptance | 8 to 12 months | Mean Perceived PDM acceptance measured using a Behavioral Intention scale (BIS) with a score Likert scale score of 0-5. Here, higher score values represent a higher acceptability of the PDM (i.e., better outcome). |
| Perceived PDM Usability | 8 to 12 months | Mean Perceived Usability measured using a modified Simplified System Usability Scale (SUS) with a score Likert scale of 0-5. Here, higher score values represent a higher perceived usability of the PDM (i.e., better outcome). |
| Study Feasibility | 8 to 12 months | Percent of successful study enrollment of eligible clinicians (\>80%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prognostic Accuracy | 3 to 12 months | Clinician prognostic accuracy was defined as the proportion of correctly classified vignettes. Accuracy was calculated as: correct vignette classifications ÷ total vignettes evaluated. Values ranged from 0 to 1, with higher values indicating greater prognostic accuracy. Each clinician assessed 10 vignettes (5 cases and 5 controls) and classified them as either high or low risk. A correct classification was high risk for a case and low risk for a control vignette. |
Countries
United States
Participant flow
Recruitment details
Practicing pediatricians were recruited from clinics in Indiana over a 6-month recruitment period.
Pre-assignment details
Eligible participants were board-certified or board-eligible pediatricians providing outpatient pediatric care. No restrictions were applied regarding years of experience, practice setting, or demographic characteristics.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Race/Ethnicity, Customized Count of White Participants | 4 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 9 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 4 | 0 / 9 | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 4 | 0 / 9 | 0 / 10 | 0 / 11 |
Outcome results
None listed