- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02414438
Establishing the Clinical Utility of First StepDx PLUS and NextStepDx PLUS Study
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
The study is an interventional longitudinal study design of physician practice. 225 specialist and general pediatricians without previous exposure to FirstStepDx PLUS or NextStepDx PLUS will be selected from a nationally representative list of approximately 25,000 board-certified pediatricians and 5,000 specialists. These physicians will be randomized into one of three arms: to receive information regarding FirstStepDx PLUS ("Intervention A"), to receive information about FirstStepDx PLUS and NextStepDx PLUS ("Intervention B") for use in clinical practice, and controls not receiving any intervention. Specifically we will test the hypotheses:
- Clinical practice, specifically decisions around treatment of individuals with disorders postnatal development including DD, ASD, and ID will vary widely among all physician types. This documentation of variation in practice will demonstrate the need for a new diagnostic service that FirstStepDx PLUS and NextStepDx PLUS would fulfill
- FirstStepDx PLUS and NextStepDx PLUS will improve the quality and appropriateness of care and therapeutic plans, as measured by the number of physicians that correctly act on the results of the assay
A Physician Questionnaire will be administered to all physicians. This questionnaire will assess physician, patient and practice characteristics. Data gathered from this set of questions will become part of the baseline (pre-intervention) assessment and used for analysis. At the baseline assessment, Clinical Performance and Value (CPVs) Vignettes, a validated tool to measure physician performance and behavior will be used. CPV vignettes have been used to establish clinical utility in the molecular diagnostic space.
The CPV vignettes used in this study will simulate a clinical encounter for a patient with an atypical clinical presentation indicative of a possible genetic developmental disorder. Each physician will provide open-ended responses regarding clinical care. These responses are scored in five domains (taking a medical history, performing a physical examination, ordering appropriate tests, making a diagnosis and prescribing treatment against explicit evidence and criteria as determined by the literature and by expert physicians. Results are presented as percentage correct controlling for primacy effects using case within pair randomization. Each case will take approximately 15-20 minutes to complete. All case responses will be completed electronically online and confidential. No physician or practice names are used when reporting the results of the study.
The CPVs will be randomly assigned to physicians for each to complete 3 CPVs™ (one from each type). Each of the CPVs will be scored by physicians for changes in clinical practice including treatment changes, frequency of follow up, laboratory tests and imaging studies ordered - see for scoring sheet.
The objective of this study is to assess how FirstStepDx PLUS (and NextStepDx PLUS) testing affects the variability of clinical practice and resultant impact.
Primary Endpoint Differences in CPV diagnosis/treatment domain score post-intervention versus baseline for the intervention and control group physicians).
Secondary Endpoints
- Difference in utilization of appropriate treatment including indicated versus unnecessary therapy pre- and post-intervention between intervention and control groups
- Difference in utilization of laboratory testing such as fluorescence in situ hybridization (FISH) analyses, global assessment, and utilization of other laboratory tests pre- and post-intervention, between intervention and control groups
- Difference in overall Clinical Performance and Value Vignettes (CPV®) scores post-intervention versus baseline between intervention and control groups
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
San Rafael, California, Förenta staterna, 94901
- QURE Healthcare
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
- ≥30 pediatric patients under care annually
- Access to the internet
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Current Practice Arm
Physicians follow current care procedures
|
|
Experimentell: FirstStep and NextStep Information
Providers receive informational webinar regarding FirstStepDx PLUS and NextStepDx PLUS between rounds and are able to order test results in Round 2
|
A pre-recorded 20-minute webinar on FirstStepDX PLUS and NextStepDX PLUS
|
Experimentell: FirstStep and NextStep Results
Providers receive informational webinar regarding FirstStepDx PLUS and NextStepDx PLUS between rounds and are specifically prompted to order test results in Round 2
|
A pre-recorded 20-minute webinar on FirstStepDX PLUS and NextStepDX PLUS
Physicians receive a prompt to order and download FirstStepDX PLUS and NextStepDX PLUS Test Results
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Diagnosis and Treatment Score
Tidsram: 4 weeks
|
Differences in CPV diagnosis/treatment domain score post-intervention versus baseline for the intervention and control group physicians).
|
4 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall CPV score
Tidsram: 4 weeks
|
Differences in overall CPV score post-intervention versus baseline for the intervention and control group physicians).
|
4 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: John W Peabody, MD PhD, QURE Healthcare
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 01-LIN-2014
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