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Documentation and Disclosure Toolkit for Sickle Cell Trait

N/A
Waitlist Available
Led By Corinna Schultz, MD, MSHP
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Outpatient pediatric primary care providers within Nemours and their patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks through study completion, on average 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to evaluate the impact of a set of strategies on documenting and disclosing sickle cell trait (SCT) by pediatric primary care providers. The hemoglobinopathy newborn screen (NBS)

Who is the study for?
This trial is for outpatient pediatric primary care providers within Nemours and their patients. It aims to improve how sickle cell trait (SCT) status is recorded and shared with patients, addressing the gap between guidelines and practice.
What is being tested?
The study tests a toolkit called SCT Documentation and Disclosure Toolkit (SCT-DD). Providers are randomly assigned to use this toolkit or not, to see if it helps in better recording and sharing SCT status from newborn screenings.
What are the potential side effects?
Since this trial involves implementing a documentation strategy rather than a medical treatment, there are no direct physical side effects. However, there may be implications for privacy or data management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks through study completion, on average 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks through study completion, on average 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Feasibility of using toolkit components
Penetration
+1 more
Secondary study objectives
Dispersion
Knowledge

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: "Add-in"Active Control1 Intervention
In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments
Group II: "All-in"Active Control1 Intervention
In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
127 Previous Clinical Trials
17,923 Total Patients Enrolled
Corinna Schultz, MD, MSHPPrincipal InvestigatorNemours
~273 spots leftby Nov 2025
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