Clinical trial NCT04484233: Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care
Official title: Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care: Feasibility & Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Decision Support Systems
Anemia
Keywords: Clinical Decision Support Systems
Patient Blood Management
Preoperative Anemia
Lead sponsor: Intelligence Anesthesia
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anesthesiologist:

* Less than one year experience in anesthesia
* 2 to 5 years of experience
* 5 to 10 years of experience
* 10 to 20 years of experience
* More than 20 years of experience

Brief summary: Anemia need to be diagnosed and treated, following several guidelines. However, the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion.

In order to improve practices and regarding the complexity of the guidelines, the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia.

Detailed description: The World Health Organization defines anemia as a hemoglobin level of less than 13 g/dL in adult men and less than 12 g/dL in women.

The cause of these anemias is most often deficient with 17% iron deficiency. This deficiency is related to age, inflammatory diseases, blood loss, and absorption disorders mainly. Anemia must be diagnosed preoperatively and treated.

To reduce transfusion in the perioperative period there are various possibilities: increase of the preoperative erythrocyte mass, reduction of losses, use of the blood that has been applied.

The impact of these preoperative strategies can be considerable. In their work, Beattie and al demonstrates that transfusion is associated with an increase in mortality at 90 days, proportional to the volume transfused, with certainly a higher risk in fragile subjects. More recently, an American registry of more than 220,000 patients showed that 30% had preoperative anemia. This anemia not only significantly increased mortality, but all causes of comorbidity were aggravated in an anemic patient.

However, the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion.

In order to improve practices and regarding the complexity of the guidelines, the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia.

Eligibility criteria: Inclusion Criteria:

* Anesthesiologist: anesthesiologists, resident/fellow physician anesthesiologists.

Exclusion Criteria:

* Unfinished questionnaire.

Primary outcomes:
measure: Average global score obtained for the two groups.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Average subcategories score obtained for the two groups.
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.
citation: Rothschild JM, McGurk S, Honour M, Lu L, McClendon AA, Srivastava P, Churchill WH, Kaufman RM, Avorn J, Cook EF, Bates DW. Assessment of education and computerized decision support interventions for improving transfusion practice. Transfusion. 2007 Feb;47(2):228-39. doi: 10.1111/j.1537-2995.2007.01093.x.
citation: Adams ES, Longhurst CA, Pageler N, Widen E, Franzon D, Cornfield DN. Computerized physician order entry with decision support decreases blood transfusions in children. Pediatrics. 2011 May;127(5):e1112-9. doi: 10.1542/peds.2010-3252. Epub 2011 Apr 18.