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

NCT02414438 | Completed

• 1 other identifier: 01-LIN-2014
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Diagnosis and Treatment Score

  Differences in CPV diagnosis/treatment domain score post-intervention versus baseline for the intervention and control group physicians).

  4 weeks

Secondary Outcomes (1)

• Overall CPV score

  4 weeks

Study Arms (3)

Current Practice Arm

NO INTERVENTION

Physicians follow current care procedures

FirstStep and NextStep Information

EXPERIMENTAL

Providers receive informational webinar regarding FirstStepDx PLUS and NextStepDx PLUS between rounds and are able to order test results in Round 2

Other: FirstStepDX PLUS and NextStepDX PLUS Webinar

FirstStep and NextStep Results

EXPERIMENTAL

Providers receive informational webinar regarding FirstStepDx PLUS and NextStepDx PLUS between rounds and are specifically prompted to order test results in Round 2

Other: FirstStepDX PLUS and NextStepDX PLUS Webinar; Other: FirstStepDX PLUS and NextStepDX PLUS Test Results

Interventions

FirstStepDX PLUS and NextStepDX PLUS Webinar OTHER

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

FirstStep and NextStep Information; FirstStep and NextStep Results

FirstStepDX PLUS and NextStepDX PLUS Test Results OTHER

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

FirstStep and NextStep Results

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide consent to participate in the study
• Currently practicing board-certified physician in the following specialty areas:
• Pediatric neurologists
• Developmental pediatricians
• General pediatricians
• Have practiced as a board-certified physician for greater than 2 but less than 30 years.
• English-speaking
• Community / non-academic based practice setting
• ≥30 pediatric patients under care annually
• Access to the internet

You may not qualify if:

• Not board certified in their respective area of care
• Academic-based practice
• Have previously used FirstStepDx PLUS and/or NextStepDx PLUS in their care delivery
• Have practiced as a board-certified physician for less than 2 or greater than 30 years.
• Follow \<30 pediatric patients annually
• Non-English speaking
• Unable to access the internet

Sponsors & Collaborators

• Lineagen: collaborator
• Qure Healthcare, LLC: lead

Study Sites (1)

QURE Healthcare

San Rafael, California, 94901, United States

Location

Related Publications (1)

• Peabody JW, Luck J, Glassman P, Jain S, Hansen J, Spell M, Lee M. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004 Nov 16;141(10):771-80. doi: 10.7326/0003-4819-141-10-200411160-00008.

  PMID: 15545677 BACKGROUND

MeSH Terms

Conditions

Intellectual Disability; Learning Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders

Study Officials

• John W Peabody, MD PhD

  QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)