Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable Clinical Decision Support for Venous Thromboembolism Prevention

There is a critical need to reduce the gap between the time that evidence is generated by patient-centered outcomes research (PCOR) and its application into clinical practice. The use of interoperable clinical decision support (CDS) can help to close this gap. The current approach of healthcare systems developing their own “home-grown” CDS is not sustainable, pointing to a need to develop scalable, shareable CDS. The use of Fast Healthcare Interoperability Resources (FHIR) standards to incorporate clinical practice guidelines (CPG), known as CPG-on-FHIR, allows for such a model. The University of Minnesota has extensive experience implementing and scaling user-centered CDS systems by leveraging an implementation strategy called SCALED – Scaling AcceptabLE cDs.

The specific aims of this research study are as follows:

• Conduct a hybrid effectiveness-implementation trial to scale the CDS system across four healthcare systems.
• Evaluate the implementation strategy guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) Implementation.
• Pilot a model for an anticoagulation “Living Guideline.”

Utilizing these aims, the researchers plan to scale and evaluate the implementation of a CDS tool for venous thromboembolism (VTE) prophylaxis in patients with traumatic brain injuries (TBI). First, the research team will modify and adapt their previously developed CPG-on-FHIR CDS tool for VTE prevention in hospitalized COVID-19 patients to patients with TBI. Using the SCALED approach, the researchers will then conduct an effectiveness-implementation trial of the adapted VTE CDS tool across four healthcare systems using a randomized stepped-wedge trial. Guideline adherence and VTE event rates will be primary outcome measures.

In parallel with the effectiveness-implementation trial, researchers will also conduct a mixed-methods assessment guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) Implementation framework to evaluate CDS implementation strategies. The overall goal of this trial is to rigorously evaluate and refine the implementation strategy for scaling interoperable CDS. Lastly, due to the lack of current robust processes around updating CDS tools as new PCOR evidence emerges, the researchers will pilot what they refer to as a “Living Guideline” model: a process used to sustain and update evidence-based decision logic. The researchers plan to widely disseminate this new VTE prophylaxis in TBI tool with U.S. trauma societies and create an electronic health record-specific ‘playbook’ focused on rapid integration and implementation of PCOR CDS. Researchers hope all these collective efforts will help achieve the goal of more widespread adoption of these important CDS tools and close the evidence synthesis into clinical practice implementation gap.