Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: "All-in" In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once. |
Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)
A toolkit of implementation strategies
|
| Active Comparator: "Add-in" In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 3 month increments |
Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)
A toolkit of implementation strategies
|
Outcome Measures
Primary Outcome Measures
- Penetration [Every 1 month through study completion, on average 1 year]
Rate of documentation and disclosure of NBS and SCT by 2 months of age within the medical history section of the electronic health record by chart review.
- Acceptability [Every 3 months through study completion, on average 1 year]
Acceptability of toolkit components by pediatric primary care providers by survey
- Self-efficacy [Every 3 months through study completion, on average 1 year]
Increase in the intention and confidence to document/discuss SCT result by pediatric primary care providers by survey
- Feasibility of using toolkit components [Every 3 months through study completion, on average 1 year]
Percent of pediatric primary care providers who use individual toolkit components by survey
Secondary Outcome Measures
- Dispersion [Every 1 month through study completion, on average 1 year]
Proportion of children over 2 months of age who have SCT newly documented within the electronic health record via chart review
- Knowledge [Every 1 months through study completion, on average 1 year]
Proportion of caregivers who accurately reported their child's SCT status via survey
Eligibility Criteria
Criteria
Inclusion Criteria:
- Outpatient pediatric primary care providers within Nemours and their patients
Exclusion Criteria:
- none
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nemours Children's Clinic
Investigators
- Principal Investigator: Corinna Schultz, MD, MSHP, Nemours
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 348506