Clinical Decision Support, Genetic Disease, Pediatrics, Predictive Model
Conditions
Brief summary
This study will evaluate the effectiveness of SIGHT as a clinical support system to prompt provider/patient discussion and shared decision making regarding the need for genetic testing in the form of a chromosomal microarray. Identifying patients at high predicted probability of needing a test in clinical settings will be examined to determine if it decreases the duration of time to testing and increases diagnostic yield. SIGHT requires only data already collected in routine clinical encounters and is calculated prior to a clinical visit at VUMC.
Interventions
DEVICESIGHT Prompted Provider Message
Among patients surpassing a 0.30 probability threshold that have a scheduled visit to pediatric primary care at VUMC, 500 will be randomized to the intervention and a SIGHT-prompted provider message will be generated.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
There will be no blinding of participants or physicians as patients and providers will follow standard of care. Providers may dismiss the SIGHT - prompted provider message and not act on its recommendations at any time. No other intervention is planned. Patients would be unaware of the providers' decisions in that case unless the provider chooses independently to discuss the SIGHT score with them. A sample size re-estimation will be conducted after 250 patients have been randomized to account for uncertainty in the initial test-referral rate used in the sample size calculation. An independent analyst, who will be blinded to the randomization assignment, will calculate the observed test-referral rate across all patients.
Intervention model description
1:1 allocation by predicted probability to either the intervention group, receiving a SIGHT-prompted provider message, or the control group, receiving standard care without the SIGHT-prompted message. The randomization process will be integrated into the routine clinical workflow, with SIGHT scores generated before regularly scheduled patient visits in pediatric primary care at VUMC.
Eligibility
Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* All patients \> 1 year old, \< 20 years of age with a scheduled visit to the VUMC pediatric primary care.
Exclusion criteria
* Patients who have been programmatically excluded due to having already received a chromosomal microarray at VUMC and patients \> 20 years of age or \< 1 year of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Diagnoses in the intervention arm compared to the control arm | 2 years | Number of patients diagnosed via a Chromosomal Microarray. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to test | 2 years | Duration of time to genetic testing. Time to event, measured from the initial patient visit to the time genetic testing is conducted. |
| Abnormal CMA | 2 years | Number of patients flagged by SIGHT who's CMA result returned abnormal but in the absence of diagnostic findings. |
| Rate of genetic testing | 2 years | Rates of genetic testing ordered by providers after a pediatric visit. |
| Diagnosis via any test (molecular confirmation) | 2 years | Number of patients flagged by SIGHT who receive a diagnosis via any molecular test. |
Countries
United States
Outcome results
None listed