Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care (iAnemia)

Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care: Feasibility & Validation Study

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.

Study Overview

• Status: Unknown
• Conditions: Anemia; Decision Support Systems
• Intervention / Treatment: Device: iAnemia Decision Support System

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Anesthesiologist: anesthesiologists, resident/fellow physician anesthesiologists.

Exclusion Criteria:

• Unfinished questionnaire.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management.
Clinical Decision Support Group; Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management helped by dedicated clinical decision support systems for patient blood management (iAnemia, Intelligence Anesthesia).	Device: iAnemia Decision Support System; iAnemia permits to display the appropriate guideline using several inputs about a patient: age, type and delay of the surgery, gender, hemoglobin level, and iron deficiency status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average global score obtained for the two groups.	The mean number of correct answers (out of possible 10);	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average subcategories score obtained for the two groups.	The mean number of correct answers (out of possible 10);	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Intelligence Anesthesia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Clinical Decision Support Systems; Patient Blood Management; Preoperative Anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: IRB 00010254-2020-131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No