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Establishing the Clinical Utility of First StepDx PLUS and NextStepDx PLUS Study

NCT02414438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2026-02-27

No results posted yet for this study

Summary

The study uses a randomized controlled study design of pediatric neurologists and developmental pediatricians and front-line (primary care) pediatricians to determine if use of FirstStepDx PLUS and Next StepDx PLUS are associated with higher clinical quality, less variability in clinical practice, and lower costs from decreased resource utilization. The Clinical Performance and Value Vignettes (CPV) used in this study simulate a clinical encounter for individuals with an atypical phenotype and clinical presentation indicative of a possible genetic disorder. We will measure the difference in combined diagnostic and treatment CPV® domain score post-intervention versus baseline comparing intervention and control groups

Conditions

  • Intellectual Disability
  • Developmental Delay

Interventions

OTHER

FirstStepDX PLUS and NextStepDX PLUS Test Results

Physicians receive a prompt to order and download FirstStepDX PLUS and NextStepDX PLUS Test Results

OTHER

FirstStepDX PLUS and NextStepDX PLUS Webinar

A pre-recorded 20-minute webinar on FirstStepDX PLUS and NextStepDX PLUS

Sponsors & Collaborators

  • Lineagen

    collaborator UNKNOWN

  • Qure Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • John W Peabody, MD PhD · QURE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414438 on ClinicalTrials.gov