Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
Primary Purpose
Sickle Cell Trait
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SCT Documentation and Disclosure Toolkit (SCT-DD)
Sponsored by
About this trial
This is an interventional health services research trial for Sickle Cell Trait focused on measuring electronic health record, pediatric, newborn screen, implementation
Eligibility Criteria
Inclusion Criteria:
- Outpatient pediatric primary care providers within Nemours and their patients
Exclusion Criteria:
- none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
"All-in"
"Add-in"
Arm Description
In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.
In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 3 month increments
Outcomes
Primary Outcome Measures
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.
Acceptability
Acceptability of toolkit components by pediatric primary care providers by survey
Self-efficacy
Increase in the intention and confidence to document/discuss SCT result by pediatric primary care providers by survey
Feasibility of using toolkit components
Percent of pediatric primary care providers who use individual toolkit components by survey
Secondary Outcome Measures
Dispersion
Proportion of children over 2 months of age who have SCT newly documented within the electronic health record via chart review
Knowledge
Proportion of caregivers who accurately reported their child's SCT status via survey
Full Information
NCT ID
NCT05387564
First Posted
May 17, 2022
Last Updated
September 5, 2023
Sponsor
Nemours Children's Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05387564
Brief Title
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
Official Title
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Trait
Keywords
electronic health record, pediatric, newborn screen, implementation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"All-in"
Arm Type
Active Comparator
Arm Description
In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.
Arm Title
"Add-in"
Arm Type
Active Comparator
Arm Description
In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 3 month increments
Intervention Type
Behavioral
Intervention Name(s)
SCT Documentation and Disclosure Toolkit (SCT-DD)
Intervention Description
A toolkit of implementation strategies
Primary Outcome Measure Information:
Title
Penetration
Description
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.
Time Frame
Every 1 month through study completion, on average 1 year
Title
Acceptability
Description
Acceptability of toolkit components by pediatric primary care providers by survey
Time Frame
Every 3 months through study completion, on average 1 year
Title
Self-efficacy
Description
Increase in the intention and confidence to document/discuss SCT result by pediatric primary care providers by survey
Time Frame
Every 3 months through study completion, on average 1 year
Title
Feasibility of using toolkit components
Description
Percent of pediatric primary care providers who use individual toolkit components by survey
Time Frame
Every 3 months through study completion, on average 1 year
Secondary Outcome Measure Information:
Title
Dispersion
Description
Proportion of children over 2 months of age who have SCT newly documented within the electronic health record via chart review
Time Frame
Every 1 month through study completion, on average 1 year
Title
Knowledge
Description
Proportion of caregivers who accurately reported their child's SCT status via survey
Time Frame
Every 1 months through study completion, on average 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatient pediatric primary care providers within Nemours and their patients
Exclusion Criteria:
none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corinna Schultz, MD, MSHP
Phone
3023313088
Email
corinna.schultz@nemours.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinna Schultz, MD, MSHP
Organizational Affiliation
Nemours
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
We'll reach out to this number within 24 hrs