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

Nemours Children's Health

Status: Completed

Conditions: Sickle Cell Trait

Treatments: Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)

Study type: Interventional

Funder types: Other

Identifiers

NCT05387564

348506

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient pediatric primary care providers within Nemours and their patients

Exclusion criteria

• none

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

"All-in"

Active Comparator group

Description:

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

Treatment:

Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)

"Add-in"

Active Comparator group

Description:

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

Treatment:

Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)