CompletedNot Applicable

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

United States217 participantsStarted 2014-08

Plain-language 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

Who can participate

Age range

99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnosis and Treatment Score

Timeframe: 4 weeks

Trial details

NCT IDNCT02414438

SponsorQure Healthcare, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

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