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

NCT ID: NCT05387564

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2024-12-30

Brief Summary

The hemoglobinopathy newborn screen (NBS) performed on all neonates in the U.S. allows for early life-saving medical care for infants with sickle cell disease (SCD), an autosomal recessive genetic disorder. Because of its detection method, the NBS incidentally reveals hemoglobinopathy traits including sickle cell trait (SCT). In an effort to uphold the rights of the newborn to their medical data and preserve autonomy in medical decision making, pediatric and genetic society guidelines recommend disclosure and documentation of SCT results during infancy. Despite this guidance, a large guideline-to-practice gap exists: SCT status is grossly under-documented in the pediatric electronic health record and few adults report knowing their SCT status despite universal screening. We plan to evaluate the effect of a toolkit of SCT Documentation and Disclosure (SCT-DD) strategies on documentation and disclosure of SCT by pediatric primary care providers in a 2-arm randomized interrupted time series trial.

Conditions

Sickle Cell Trait

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

"All-in"

In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.

Group Type: ACTIVE_COMPARATOR

SCT Documentation and Disclosure Toolkit (SCT-DD)

Intervention Type: BEHAVIORAL

A toolkit of implementation strategies

"Add-in"

In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments

Group Type: ACTIVE_COMPARATOR

SCT Documentation and Disclosure Toolkit (SCT-DD)

Intervention Type: BEHAVIORAL

A toolkit of implementation strategies

Interventions

SCT Documentation and Disclosure Toolkit (SCT-DD)

A toolkit of implementation strategies

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Outpatient pediatric primary care providers within Nemours and their patients

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Corinna Schultz

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corinna Schultz, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Nemours

Locations

Nemours Children's Hospital, Delware

Wilmington, Delaware, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

348506

Identifier Type: -

Identifier Source: org_study_id