Intellectual Disability Clinical Trial
Official title:
Establishing the Clinical Utility of First StepDx PLUS and NextStepDx PLUS Study
Verified date | April 2015 |
Source | Qure Healthcare, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 217 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Provide consent to participate in the study 2. Currently practicing board-certified physician in the following specialty areas: 1. Pediatric neurologists 2. Developmental pediatricians 3. General pediatricians 3. Have practiced as a board-certified physician for greater than 2 but less than 30 years. 4. English-speaking 5. Community / non-academic based practice setting 6. =30 pediatric patients under care annually 7. Access to the internet Exclusion Criteria: 1. Not board certified in their respective area of care 2. Academic-based practice 3. Have previously used FirstStepDx PLUS and/or NextStepDx PLUS in their care delivery 4. Have practiced as a board-certified physician for less than 2 or greater than 30 years. 5. Follow <30 pediatric patients annually 6. Non-English speaking 7. Unable to access the internet |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | QURE Healthcare | San Rafael | California |
Lead Sponsor | Collaborator |
---|---|
Qure Healthcare, LLC | Lineagen |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis and Treatment Score | Differences in CPV diagnosis/treatment domain score post-intervention versus baseline for the intervention and control group physicians). | 4 weeks | No |
Secondary | Overall CPV score | Differences in overall CPV score post-intervention versus baseline for the intervention and control group physicians). | 4 weeks | No |
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