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

Nemours Children's Clinic114 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

114

Conditions

Sickle Cell Trait

Interventions

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.