R44LM014736

Guidedor: A real-time medication safety software platform for the operating room - Guidedor: A real-time medication safety software platform for the operating room.

Medication administration in the operating room (OR) bypasses many of the standard safety checks that exist throughout the rest of the hospital.

For example, due to the fast-paced clinical environment, high acuity and rapidly changing patient condition in the OR, medications are typically administered without prospective medication orders, double-checks by second providers, or electronic clinical decision support to warn of medication errors.

As a result, about 4-10% of medication administrations, or almost every second operation, involves a medication error.

About half of these errors lead to observed patient harm, and the remainder have the potential for patient harm.

The cost of the harm due to errors is $5.3 billion annually in the US alone, and more than two-thirds of the harm is serious or life-threatening.

Guidedor is a novel OR clinical decision support software platform that is integrated with the electronic health record (EHR) and uses real-time data to display patient-specific information and alerts on the OR computer monitor to prevent errors.

Briefly, the barcode on a medication syringe label is scanned immediately prior to medication administration.

The scan triggers Guidedor to display a dosing window containing the dose, time administered, route, and/or alert(s) when necessary to prevent a medication error prior to the medication being administered.

The clinician simply confirms the dose or enters an alternative dose if needed.

After the medication passes through Guidedor’s algorithms, the medication data are sent to the EHR in real-time for automated documentation.

In an RCT, the Guidedor prototype substantially outperformed standard medication use workflows by improving clinician workflow efficiency (clinicians saved > 20% of their time) and quality of care metrics including tighter blood pressure control, more accurate medication dosing and better pain management.

In addition, on first-time use of Guidedor, clinicians rated its usability double that of existing EHRs.

Through iterative feedback sessions with key customer and company stakeholders, we have identified the following additional critical functionality that is required to achieve commercialization and widespread adoption of Guidedor: support for local anesthetic systemic toxicity, glucose management and perioperative antibiotic management.

In Phase I of this SBIR fast-track project, we will identify user requirements and functional requirements for this critical new functionality, and deploy the new algorithms to Epic’s testing tool at Mass General Brigham.

In Phase II, we will iteratively identify usability challenges and implement solutions.

We will then perform end-to-end testing of Guidedor, including building a noninteractive “silent mode” that we will use to evaluate algorithm behavior in live surgical cases.

With the addition of the proposed critical functionality, Guidedor will transform the field of medication safety, making surgery and anesthesia safer for patients, more efficient for clinicians, and more cost-effective for hospitals and payors.

Guided Clinical Solutions

NOT APPLICABLE

93.879 - Medical Library Assistance

National Library of Medicine (NLM) [HHS - NIH]

Brookline, Massachusetts 024455931 United States

Single Zip Code

PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-23-230)

Amendment Since initial award the End Date has been extended from 11/30/25 to 06/30/28 and the total obligations have increased 346% from $313,819 to $1,399,225.