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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
S-PATH clinical decision support system
Other interventionAccess to the S-PATH electronic health record (EHR)-integrated clinical decision support system
Usual care
Other interventionIncluding use of the conventional Maximum Surgical Blood Ordering Schedule (MSBOS)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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
Other outcomes
Viewing S-PATH predictions (Implementation outcome)
Clinician-level measure of the frequency of viewing S-PATH predictions, retrieved from EHR audit log data
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
Cost assessment
Estimate of the cost savings associated with S-PATH use
Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator