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

A methodology for scaling patient-centered outcomes research into interoperable, shareable clinical decision support tools that are actively maintained with current evidence and has the potential to close the evidence into practice gap, which can lead to better patient outcomes.

Project Details -
Ongoing

Grant Number

R18 HS028583
Funding Mechanism(s)

Disseminating and Implementing Patient-Centered Outcomes Research (PCOR) Evidence into Practice through Interoperable Clinical Decision Support (R18)
AHRQ Funded Amount

$2,937,874
Principal Investigator(s)

Tignanelli, Christopher J.

Melton-Meaux, Genevieve
Organization

University of Minnesota
Location

Minneapolis

Minnesota
Project Dates

08/05/2022 - 07/31/2025
Technology

Clinical Decision Support System

SMART/FHIR

Patient-Generated Health Data
Care Setting

Academic Medical Center

Hospital
Medical Condition

Thromboembolism

Trauma (Physical)
Population

Adults

Nurse

Pharmacist

Physician

Stakeholder
Type of Care

Acute Care
Health Care Theme

Patient-Reported Outcomes

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.

A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury.

Citation: Tignanelli CJ, Shah S, Vock D, Siegel L, Serrano C, Haut E, Switzer S, Martin CL, Rizvi R, Peta V, Jenkins PC, Lemke N, Thyvalikakath T, Osheroff JA, Torres D, Vawdrey D, Callcut RA, Butler M, Melton GB. A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury. Implement Sci. 2024 Aug 5;19(1):57. doi: 10.1186/s13012-024-01386-4. PMID: 39103955; PMCID: PMC11299263.

Link: https://pubmed.ncbi.nlm.nih.gov/39103955/

Principal Investigator: Tignanelli, Christopher J., Melton-Meaux, Genevieve

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

Document Type: Journal Publication

Research Method: Quantitative, Randomized Controlled Trial (RCT)

Technology: Clinical Decision Support System, SMART/FHIR

Population: Patient

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

Theme:

Optimizing Care Delivery for Clinicians

Subtheme:

Scaling Effective and Interoperable CDS to Improve Care and Decision Making

A methodology for scaling patient-centered outcomes research into interoperable, shareable clinical decision support tools that are actively maintained with current evidence has the potential to close the evidence-into-practice gap, leading to better patient outcomes.

Shareable clinical decision support: patient-centered outcomes research can translate findings into clinical practice

Recognizing that patients are the best source of information about their needs and preferences, patient-centered outcomes research (PCOR) evaluates questions and results through the lens of what is important to patients and caregivers. Despite agreement that PCOR has the potential to empower patients and improve outcomes, translating PCOR findings into clinical practice is challenging. Interoperable clinical decision support (CDS) tools are an indispensable solution to address this issue, but poor design, lack of interoperability, and implementation barriers hinder adoption. Moreover, the current standard in which each healthcare system develops “home-grown” CDS for the same guidelines is not tenable. Interoperable CDS need to be adaptable to local practice and technology dependencies.

Applying CDS may prevent and treat venous thromboembolism

Patients with traumatic brain injuries (TBI) are at high risk for venous thromboembolism (VTE), a serious condition where a blood clot can develop in the leg or arm and either dislodge or block leg or arm blood flow, causing serious illness, disability, and in some cases, death. But VTE is preventable and treatable if discovered early. To reduce VTE events, patients need preventive care, but guidelines for providing preventive VTE care are only followed about 15 percent of the time in the United States. As a trauma critical care surgeon at the University of Minnesota, Dr. Christopher Tignanelli wants to use a CDS system to improve adherence with best practices for preventing VTE by “nudging” providers treating patients with TBI. This interoperable system will apply Fast Healthcare Interoperability Resources (FHIR) standards and will be adapted from Dr. Tignanelli’s previously developed PCOR CDS tool for COVID-19 VTE prevention. Using the Scaling AcceptabLE cDs (SCALED) approach, the researchers will evaluate the effectiveness of the adapted CDS tool across four healthcare systems, measuring guideline adherence and rates of VTE.

“Our goal was, can we develop this decision support system as an app and make it as easy to scale to other hospitals as you would download an app on your phone.” - Dr. Christopher Tignanelli

Collective efforts support widespread adoption of interoperable CDS

Due to the lack of current robust processes around updating CDS tools as new PCOR evidence emerges, the researchers will also develop and pilot what is referred 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 CDS tool for TBI patients to U.S. trauma societies and create an electronic health record-specific ‘playbook’ focused on rapid integration and implementation of PCOR CDS. Researchers hope these collective efforts will help achieve the goal of widespread adoption of these important CDS tools and address the difficulty of implementing PCOR evidence into medical practice.

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