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

NCT04484233 | Unknown FDA Device

• 1 other identifier: IRB 00010254-2020-131
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Decision Support Systems; Anemia

Keywords

Clinical Decision Support Systems; Patient Blood Management; Preoperative Anemia

Outcome Measures

Primary Outcomes (1)

• Average global score obtained for the two groups.

  The mean number of correct answers (out of possible 10);

  Up to 24 weeks

Secondary Outcomes (1)

• Average subcategories score obtained for the two groups.

  Up to 24 weeks

Study Arms (2)

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

Interventions

iAnemia Decision Support System DEVICE

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.

Clinical Decision Support Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Anesthesiologist: anesthesiologists, resident/fellow physician anesthesiologists.

You may not qualify if:

• Unfinished questionnaire.

Sponsors & Collaborators

• Intelligence Anesthesia: lead

Related Publications (3)

• 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.

  PMID: 30860564 BACKGROUND

• 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.

  PMID: 17302768 BACKGROUND

• 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.

  PMID: 21502229 BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yassine Moussali, MD

CONTACT

+33620858135; y.moussali@intelligenceanesthesia.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 23, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07