Sctalk: A Pilot Trial Using Implementation Science to Improve Documentation and Disclosure of Sickle Cell Trait during Infancy
Authors: Schultz Corinna L. , Higgins Kelsey , Taggi Pinto Alison , Thomas Morgan , Pitone Melanie L , Feinson Judith , Lewis Amanda M. , Hossain Jobayer , Smith-Whitley Kim , Hsu Lewis L , Alderfer Melissa A. 
Published: December 2024

Though all US states require newborn screen (NBS) hemoglobinopathy testing, sickle cell trait (SCT) results are not universally disclosed to families despite an ethical imperative. Reliable documentation and disclosure of SCT within infancy (D&D) is one step in ensuring lifetime retention of SCT knowledge and in preventing healthcare and reproductive inequities. Through prior study, we identified gaps in electronic healthcare record (EHR) SCT documentation in a large pediatric health system, pediatrician (PCP) barriers to D&D, and potential strategies to increase D&D. Here we report on a pilot implementation trial of SCTalk, a toolkit to overcome barriers to D&D.

Methods

A two-arm, randomized, interrupted time series trial compared two approaches of toolkit rollout (clinicaltrials.gov NCT05387564). Interested sites in a pediatric health system were randomized to either the “ALL-in” (all components at once) or “ADD-in” arm (one component added every 6 weeks). Components are 1) an EHR “nudge” in the well-child template for 1 and 2 month olds (“Newborn metabolic screen results available in chart? {please add any findings to the problem list, e.g. sickle cell trait}), 2) virtual education video, and 3) printed materials (talking point card, reminder poster). After consent, PCPs completed baseline and 3 follow-up surveys at 6 week intervals of NBS and SCT practices, acceptability and feasibility of toolkit use, and effect on confidence. Nemours IRB approved the study.

Results

Participants

ADD-in arm: 3 sites, 9-12 PCPs per survey (19 eligible)

ALL-in arm: 4 sites, 13-16 PCPs per survey (20 eligible)

Most PCPs identified as female (75%) and white (75%), with 14% Asian, 16% Black, and 14% Hispanic.

Baseline NBS and SCT process: Most PCPs reported reviewing NBS results in the EHR (93%). Some call the NBS program (14%) or log into a portal (10%). The majority often/always check NBS results for a new neonate (96%) but fewer check for a new older infant (64%), child (14%), or adolescent (4%).

All PCPs report discussing SCT in infancy when diagnosed. Fewer discuss again in childhood (28%), adolescence (35%), before sports participation (25%), or transition to adult care (25%). The majority often/always document SCT in the EHR (93%), discuss SCT with family (89%), discuss inheritance (64%), or discuss SCT is benign (61%). Fewer often/always discuss medical complications (46%), reproductive options (36%), or provide reference materials (7%).

EHR Prompt: 85% used the prompt. The majority agreed/strongly agreed (agreed) it was useful (81%), triggered conversations (77%), and increased documentation (73%). &lt;25% agreed it caused clinic delays or was distracting.

20-min Educational Video. 75% watched the video. All agreed they liked and learned from it. Almost all agreed it triggered conversations, was a useful reminder to document SCT, would recommend to others. A minority reported forgetting to watch or having trouble finding it.

Reference Materials: 68% used materials. All agreed they liked and learned from them. The majority agreed they triggered conversations, were a useful reminder to document, would use again and recommend to others. Half reported changing documentation because of them. Others reported forgetting, or not having time.

Effect on Practice and Confidence: Overall, there was improvement from baseline (p&lt;0.05) in self-reported rates of documentation of SCT, discussion of potential medical complications and reproductive options, discussion before transfer to adult care, provision of SCT handouts to families. There was no difference in improvement between arms at any time point.

On a 10 point scale (10, most confident), there was significant improvement in PCP confidence to recognize medical complications (baseline mean 6, SD 2.1) but not to discuss SCT with family (7.8, SD 1.8) or adolescents (7.6, SD 1.8), to discuss inheritance (7.8, SD 2.2) or reproductive options (6, SD 2.5).

Conclusion

A toolkit of 3 implementation strategies was acceptable to PCPs, feasible for use, and increased self-reported practices of D&D of SCT. While most confidence levels did not significantly increase, a larger sample size may be needed given the relatively high baseline. Additional analysis will include review of EHR documentation and caregiver experience with SCT disclosure.

Research supported by the National Institute of General Medical Sciences of the National Institutes of Health, award number P20GM109021