Universal Type 1 Diabetes Screening in Pediatrics
ConditionType 1 Diabetes (T1D)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorNorthwestern University
About this trial
This study examines how population-based screening for type 1 diabetes (T1D) using islet autoantibodies (i.e., immune system proteins) can be incorporated into pediatric primary care during routine well-child visits. The project evaluates whether this screening approach, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All pediatric primary care clinicians (i.e., physician [MD, DO], nurse practitioner, physician assistant) at participating clinics will be eligible to complete an interview.
All other care team members, including nurses, medical assistants, phlebotomists, and front desk staff at participating clinics will be eligible to complete an interview.
Disqualifiers
None
Trial population
Children and their parents presenting for eligible well-child visits at participating pediatric practices, as well as pediatric clinicians and other care team members at participating practices.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Set of implementation strategies
BehavioralThis is an observational implementation study. The research team does not assign or deliver any clinical interventions. T1D screening orders and blood draws occur as part of routine care at clinician discretion, and the study observes EHR outcomes and collects surveys/interviews. The research team will deliver a set of implementation strategies (clinician education, clinician ordering reminders, and facilitation) to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These strategies will not be randomly assigned.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Feasibility (Clinician Perspective)
Feasibility of screening and implementation strategies will be assessed using items adapted from the Feasibility of Intervention Measure (FIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Time frame
Towards the end of the study (approximately months 12-15)2
Acceptability (Parent Perspective)
Parent perspectives on the acceptability (for both clinician recommendation of screening and undergoing a blood draw for screening; parents who received or completed each element will be asked about actual acceptability and those who didn't will be asked about anticipated acceptability). Survey questions will be adapted from the psychometrically validated Acceptability of Intervention Measure (AIM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Time frame
Throughout study period (15 months)3
Acceptability (Clinician Perspective)
Acceptability of screening and implementation strategies will be assessed using items adapted from the Acceptability of Intervention Measure (AIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Time frame
Towards the end of the study (approximately months 12-15)4
Appropriateness (Parent Perspective)
Parent perspectives on the appropriateness (i.e., relevance of screening; parents who completed screening will be asked about actual appropriateness and those who didn't will be asked about anticipated appropriateness). Survey questions will be adapted from the psychometrically validated Intervention Appropriateness Measure (IAM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Time frame
Throughout study period (15 months)Secondary outcomes
1
Penetration of T1D Screening
Penetration will be calculated from EHR data as proportion of patients who had screening ordered among those who were eligible to be screened
Time frame
15 months preceding study period and 15 months of study period2
Reach of T1D Screening
Reach will be calculated from EHR data as the proportion of patients who completed screening among those eligible to be screened, a definition of reach which aligns with best practices in the literature. As a second, less conservative measure of reach, we will assess the proportion of patients who completed screening among those who had screening ordered for them.
Time frame
15 months preceding study period and 15 months of study period3
Clinical Documentation
Clinical documentation will be measured from EHR data as the proportion of eligible patients with ICD-10 codes documented for early-stage T1D captured through screening (unspecified stage, E10.A0; Stage 1, E10.A1; Stage 2, E10.A2)
Time frame
15 months preceding study period and 15 months of study periodLocations
Sponsors and contacts
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Northwestern University
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov
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