Sickle Cell TraitNCT05387564
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
A study testing SCT Documentation and Disclosure Toolkit (SCT-DD) in people with Sickle Cell Trait, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Trait
- What is being tested?
- SCT Documentation and Disclosure Toolkit (SCT-DD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatient pediatric primary care providers within Nemours and their patients
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Hospital, Delware
Wilmington, Delaware, 19803
About this study
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
- Being tested
- SCT Documentation and Disclosure Toolkit (SCT-DD)
- Keywords
- electronic health record, pediatric, newborn screen, implementation
- Medical subject headings
- Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT Documentation and Disclosure Toolkit (SCT-DD)Behavioural
A toolkit of implementation strategies
| Study group | Role | What they receive |
|---|---|---|
| "All-in" | Active comparator | In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once. Receives: 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 Receives: Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Knowledge of newborn screen results by caregivers via survey.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start18 Jan 2024
- Primary completion31 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell TraitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corinna Schultz, Nemours Children's Clinic
- Investigators
- Corinna Schultz, MD, MSHP, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387564
- Sponsor's protocol ID
- 348506
- Status last verified
- Jan 2026
- First submitted
- 17 May 2022
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
- ClinicalTrials.gov ID
- NCT05387564
- Acronym / sponsor ID
- 348506
- Conditions
- Sickle Cell Trait
- Keywords
- electronic health record, pediatric, newborn screen, implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "All-in" | Active comparator | Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once. |
| "Add-in" | Active comparator | 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatient pediatric primary care providers within Nemours and their patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCT Documentation and Disclosure Toolkit (SCT-DD)A toolkit of implementation strategies | Behavioural | "Add-in", "All-in" |
Primary outcome
Acceptability
Time frame: At conclusion of study: 18 weeks after initial roll-out of interventions
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.
Self-efficacy
Time frame: At conclusion of study (18 weeks after initial roll-out of interventions)
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.
Feasibility of Using Toolkit Components
Time frame: Survey at end of study: 18 weeks after roll-out of interventions
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).
Penetration
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
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.
1 secondary outcome
Knowledge
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinna Schultz, MD, MSHP principal investigator
Nemours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCT Documentation and Disclosure Toolkit (SCT-DD) in people with Sickle Cell Trait, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: At conclusion of study: 18 weeks after initial roll-out of interventions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.