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"Add-in" for Sickle Cell Trait

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks through study completion, on average 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Feasibility of using toolkit components

Penetration

+1 more

Secondary outcome measures

Dispersion

Knowledge

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

17,631 Total Patients Enrolled

Corinna Schultz, MD, MSHPPrincipal InvestigatorNemours

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for enrollment in this trial?

"Indeed, clinicaltrials.gov states that patient recruitment for this study is in progress. The trial was initially posted on December 10th, 2023 and underwent its most recent update on January 4th, 2024."

Answered by AI

What is the total number of individuals currently under research in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is presently seeking eligible candidates. The initial posting of the trial was made on December 10th, 2023, and it was last edited on January 4th, 2024. In order to complete the study successfully, a total of 500 patients are being sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach

2024. "Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05387564.

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