AI-driven Clinical Decision Support for Perioperative Blood Orders

ConditionSurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

20 million patients have surgery in the United States every year, with approximately 1 million of those patients requiring life-saving blood transfusion. Presurgical preparation for transfusion is important to allow for safe and timely transfusion during surgery; however, excessive preparation is unfortunately common, costly, and contributes to blood waste. This study aims to evaluate an intelligent clinical decision support system that helps clinicians prepare blood for patients who are likely to need it, while avoiding excessive preparation for patients who don't, potentially improving patient safety while reducing blood waste and healthcare costs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Clinician (resident physician or advanced practice provider) who works at a preoperative assessment clinic

None

Scheduled for surgery in one of the main operating room areas (non-remote) at Barnes Jewish Hospital

Evaluated in-person at one of the preoperative assessment clinics affiliated with BJC Healthcare

Trial design

Design model

Crossover

Treatments tested in this trial

  • S-PATH clinical decision support system

    Other intervention

    Access to the S-PATH electronic health record (EHR)-integrated clinical decision support system

  • Usual care

    Other intervention

    Including use of the conventional Maximum Surgical Blood Ordering Schedule (MSBOS)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Usual careActive comparator 1 intervention
Group B: S-PATHExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of patients with a type and screen order placed during the preoperative clinic assessment visit

This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Placement of a type and screen order during the preoperative clinic assessment visit will be evaluated at the patient / surgical case level. This includes orders placed and collected during the preoperative clinic assessment visit, as well as orders signed during the preoperative clinic assessment visit or subsequent follow up care and held to be drawn on the day of surgery.

Time frame
Decision made during the preoperative assessment clinic visit

Secondary outcomes

1

Frequency of a valid type and screen order at the start of surgery

This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Valid type and screen order at the start of surgery (defined as resulted prior to 1h after anesthesia start). The 1 hour buffer is used to account for orders that were drawn prior to surgery but may not have resulted by the time the patient enters the operating room. This will include orders placed by the clinicians working in preoperative assessment clinic and any orders that may be placed by the day of surgery anesthesia or surgical teams. This will not include type and screen orders that have expired by the start of surgery. This is a secondary efficacy outcome that reflects type and screen ordering decisions by all members of the patient's care team.

Time frame
Start of surgery (1 hour after Anesthesia Start)
2

Frequency of red cell transfusion during surgery

This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Administration of allogeneic packed red blood cells during surgery will be retrieved from the electronic health record. Documentation of transfusion is mandatory and the electronic health record scan is used to confirm the correct patient. This is a secondary efficacy outcome, as lack of a type and screen may prevent discretionary intraoperative transfusion.

Time frame
During surgery
3

Frequency of emergency release blood use during surgery

This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Administration of emergency release allogeneic packed red blood cells will be retrieved from the electronic health record. These are either documented as volumes under the MTP tab or individually scanned as uncrossmatched red cells. This is the primary safety outcome of the study as emergency release blood may be administered if red cell transfusion is urgently indicated but a type and screen is not available. The frequency of this outcome will be reported overall across both groups, and stratified by whether the patient had an active type and screen at the start of surgery.

Time frame
During surgery
4

Frequency of red cell transfusion during surgery without an active type and screen at the start of surgery

This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. This is the secondary safety outcome intended to capture false negative results, i.e., patients who required transfusion during surgery but did not have a preoperative type and screen. This outcome will be collected electronically from the EHR and will capture patients for whom the type and screen was resulted after the start of surgery (i.e., after 1h after anesthesia start), suggesting it was collected after the patient entered the operating room

Time frame
During surgery

Other outcomes

1

Viewing S-PATH predictions (Implementation outcome)

Clinician-level measure of the frequency of viewing S-PATH predictions, retrieved from EHR audit log data

Time frame
Through study completion, an average of 1 year
2

Acceptance of S-PATH recommendation (Implementation outcome)

Clinician-level measure of the frequency of the clinician's blood order during the preoperative clinic visit (1' outcome) matching S-PATH's recommendation

Time frame
Through study completion, an average of 1 year
3

Cost assessment

Estimate of the cost savings associated with S-PATH use

Time frame
Through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator