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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sickle Cell Trait

Intervention / Treatment
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* Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient pediatric primary care providers within Nemours and their patients Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: All-in<br>In the all-in arm, pediatric primary care physicians receive all toolkit components at once. | Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)<br>* A toolkit of implementation strategies<br>|
| Active Comparator: Add-in<br>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)<br>* A toolkit of implementation strategies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration | 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. | Every 1 month through study completion, on average 1 year | 
| Acceptability | Acceptability of toolkit components by pediatric primary care providers by survey | Every 3 months through study completion, on average 1 year | 
| Self-efficacy | Increase in the intention and confidence to document/discuss SCT result by pediatric primary care providers by survey | Every 3 months through study completion, on average 1 year | 
| Feasibility of using toolkit components | Percent of pediatric primary care providers who use individual toolkit components by survey | Every 3 months through study completion, on average 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dispersion | Proportion of children over 2 months of age who have SCT newly documented within the electronic health record via chart review | Every 1 month through study completion, on average 1 year | 
| Knowledge | Proportion of caregivers who accurately reported their child's SCT status via survey | Every 1 months through study completion, on average 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic health record, pediatric, newborn screen, implementation