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

NCT05387564 | Completed Results DMC

• 1 other identifier: 348506
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Keywords

electronic health record; pediatric; newborn screen; implementation

Outcome Measures

Primary Outcomes (4)

• Acceptability

  Acceptability of toolkit components by pediatric primary care providers by survey at the end of the study (i.e. 18 weeks after initial roll-out of interventions). Reported as the number who answered Agree or Strongly Agree on a 4-point Likert scale that they liked the toolkit component. Likert scale options included strong disagree, disagree, agree, strongly agree.

  At conclusion of study: 18 weeks after initial roll-out of interventions

• Self-efficacy

  Confidence to document/discuss SCT result by pediatric primary care providers by survey. Scale 1 to 10: 1 = not confident at all, 10 = extremely confident.

  At conclusion of study (18 weeks after initial roll-out of interventions)

• Feasibility of Using Toolkit Components

  Number of pediatric primary care providers who used individual toolkit components in the last 6 weeks of the study (week 12-18) as indicated by answering "yes" to questions about whether individual toolkit components were used on a survey at the end of the study (18 weeks after roll-out of interventions).

  Survey at end of study: 18 weeks after roll-out of interventions

• Penetration

  The number of newborns with newborn screen results visible in the electronic healthcare record and presence of documentation of abnormal newborn screen results. By chart review.

  Chart review for retrospective patients was done before intervention roll-out. Chart review for prospective patients was done on a rolling basis at 2 months of age for any newborn patient seen during the 18 week intervention period

Secondary Outcomes (1)

• Knowledge

  Survey for retrospective patients was sent before intervention roll-out. Survey for prospective patients were sent on a rolling basis at 2 months of age for any newborn patient seen during the 18 week intervention period.

Study Arms (2)

"All-in"

ACTIVE COMPARATOR

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

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

"Add-in"

ACTIVE COMPARATOR

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

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

Interventions

SCT Documentation and Disclosure Toolkit (SCT-DD) BEHAVIORAL

A toolkit of implementation strategies

"Add-in"; "All-in"

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient pediatric primary care providers within Nemours and their patients

You may not qualify if:

• none

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Hospital, Delware

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Sickle Cell Trait

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Very small number of caregivers of children with sickle cell trait responded to survey requests.

Results Point of Contact

• Title: Corinna Schultz
• Organization: Nemours Children's Health

corinna.schultz@nemours.org

302-651-5500

Study Officials

• Corinna Schultz, MD, MSHP

  Nemours

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: January 18, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 30, 2024
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)