An interventional study of SCT Documentation and Disclosure Toolkit (SCT-DD) in Sickle Cell Trait, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Health services research
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.
Exclusion Criteria:
In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.
Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)
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)
A toolkit of implementation strategies
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Knowledge
Knowledge of newborn screen results by caregivers via survey.
Time frame: 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.
Invitations were sent to the "physician in charge" of 20 pediatric primary care sites within one hospital system in the mid-Atlantic region. Seven (7) sites were interested in participating in the pilot project and randomized to intervention arms. Clinicians and caregivers at each site were then recruited via email. Each group of participants is designated as a separate time period below: Clinicians, Caregivers from the retrospective period, caregivers from the prospective time.
| Milestone | "All-in" | "Add-in" |
|---|---|---|
| Started | 16 | 12 |
| Completed | 16 | 12 |
| Not completed | 0 | 0 |
| Milestone | "All-in" | "Add-in" |
|---|---|---|
| Started | 22 | 22 |
| Completed | 22 | 22 |
| Not completed | 0 | 0 |
| Milestone | "All-in" | "Add-in" |
|---|---|---|
| Started | 15 | 27 |
| Completed | 15 | 27 |
| Not completed | 0 | 0 |
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.
| Participants | "All-in" | "Add-in" |
|---|---|---|
| Liked the newborn screen EPIC prompt | 11 | 8 |
| Liked the educational module | 11 | 8 |
| Liked the reference materials | 10 | 5 |
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.
| units on a scale (1-10) | "All-in" | "Add-in" |
|---|---|---|
| Confidence to interpret the hemoglobinopathy newborn screen results | 8.55 ± 1.37 | 8.20 ± 1.32 |
| Confidence to discuss hemoglobinopathy results | 8.27 ± 1.35 | 8.8 ± 0.78 |
| Confidence to discuss inheritance of hemoglobinopathies | 8.73 ± 1.42 | 8.89 ± 0.92 |
| Confidence to discuss reproductive options of hemoglobinopathies | 6.18 ± 2.48 | 7.0 ± 2.36 |
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).
| Participants | "All-in" | "Add-in" |
|---|---|---|
| EHR Prompt | 13 | 10 |
| Educational video | 12 | 9 |
| Reference Materials | 11 | 8 |
Knowledge of newborn screen results by caregivers via survey.
| Participants | "All-in" | "Add-in" |
|---|---|---|
| Survey respondents who reported they received newborn screen results - Retrospective | 14 | 15 |
| Survey respondents who reported they received newborn screen results - Prospective | 6 | 18 |
| Survey respondents who reported sickle cell trait on their child's newborn screen -Retrospective | 0 | 2 |
| Survey respondents who reported sickle cell trait on their child's newborn screen -Prospective | 0 | 1 |
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.
| Participants | "All-in" | "Add in" |
|---|---|---|
| Newborn screen available in EPIC - Retrospective | 424 | 303 |
| Newborn screen available in Careeverywhere - Retrospective | 167 | 179 |
| Sickle cell trait on newborn screen - Retrospective | 9 | 13 |
| Sickle cell trait on problem list - Retrospective | 4 | 11 |
| Sickle cell trait documented as disclosed - Retrospective | 4 | 2 |
| Newborn screen available in EPIC - Prospective | 190 | 190 |
| Newborn screen available in Careeverywhere - Prospective | 54 | 70 |
| Sickle cell trait on newborn screen - Prospective | 4 | 9 |
| Sickle cell trait on problem list - Prospective | 3 | 9 |
| Sickle cell trait documented as disclosed - Prospective | 3 | 4 |
Collected over For Physicians: From enrollment until last survey completed (total 18 weeks). Adverse events not evaluated from chart review or caregiver surveys. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| "All-in" | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| "Add-in" | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
Two sets of participants included: 1) Physicians who were the primary target of the intervention, 2) Caregivers who consented and completed surveys. As physicians were the primary interest, demographic characteristics and the majority of study outcomes were based on physicians enrolled.
| Age, Categorical(Participants) | "All-in" | "Add-in" | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 12 | 28 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | "All-in" | "Add-in" | Total |
|---|---|---|---|
| Physicians — Female | 13 | 8 | 21 |
| Physicians — Male | 3 | 4 | 7 |
| Caregivers who completed surveys — Female | 36 | 49 | 85 |
| Caregivers who completed surveys — Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | "All-in" | "Add-in" | Total |
|---|---|---|---|
| Physicians — American Indian or Alaska Native | 0 | 0 | 0 |
| Physicians — Asian | 2 | 2 | 4 |
| Physicians — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Physicians — Black or African American | 0 | 2 | 2 |
| Physicians — White | 13 | 8 | 21 |
| Physicians — More than one race | 0 | 0 | 0 |
| Physicians — Unknown or Not Reported | 1 | 0 | 1 |
| Caregivers who completed surveys — American Indian or Alaska Native | 1 | 1 | 2 |
| Caregivers who completed surveys — Asian | 2 | 1 | 3 |
| Caregivers who completed surveys — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Caregivers who completed surveys — Black or African American | 8 | 27 | 35 |
| Caregivers who completed surveys — White | 21 | 17 | 38 |
| Caregivers who completed surveys — More than one race | 2 | 1 | 3 |
| Caregivers who completed surveys — Unknown or Not Reported | 3 | 2 | 5 |
| Confidence regarding hemoglobinopathies(units on a scale (1-10, 10 'extremely')) | "All-in" | "Add-in" | Total |
|---|---|---|---|
| Confidence to interpret the hemoglobinopathy newborn screen results | 7.33 ± 2.2 | 7.33 ± 2.0 | 7.33 ± 2.1 |
| Confidence to discuss hemoglobinopathy results with family | 8.08 ± 1.83 | 7.5 ± 1.7 | 7.75 ± 1.76 |
| Confidence to discuss inheritance of hemoglobinopathies | 7.19 ± 2.07 | 8.50 ± 2.20 | 7.75 ± 2.19 |
| Confidence to discuss reproductive options for hemoglobinopathies | 5.8 ± 2.21 | 6.25 ± 2.99 | 6.00 ± 2.54 |
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