Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill

NCT04755777 | Completed

• 1 other identifier: 20-007528
• Study Type: observational
• Target: 138
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.

Conditions

Sepsis; Critical Illness

Keywords

pharmacokinetics; therapeutic drug monitoring; mixed methods; implementation science; beta-lactam antibiotic

Outcome Measures

Primary Outcomes (2)

• Frequency of drug level testing recommended

  Indication of how many critically ill patients treated with beta-lactams should receive TDM.

  Baseline

• Nature of drug level testing recommended

  Indication of which types of critically ill patients treated with beta-lactams should receive TDM

  Baseline

Secondary Outcomes (1)

• Determinants of beta-lactam TDM implementation

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be obtained from ICU clinicians at three hospitals with distinct beta-lactam dosing and monitoring practices: Royal Brisbane and Women's Hospital in Queensland Australia, University of Florida Health Shands Hospital, Gainesville, Florida, United States, and the Mayo Clinic Hospital in Rochester, Minnesota, United States. The sampling frame will include key clinician stakeholders likely to be involved with beta-lactam TDM in the intensive care unit (i.e., pharmacists, intensivists, infectious diseases experts, medical/surgical trainees, and advanced practice providers).

You may qualify if:

• Providers involved with beta-lactam TDM for critically ill patients

You may not qualify if:

• None

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

UF Health Shands

Gainesville, Florida, 32610, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Related Publications (3)

• Ausman S, Boehmer K, et al. Open Forum Infectious Diseases. 2022;9(Supplement 2):ofac492.034.

  BACKGROUND

• Barreto EF, Chitre PN, Pine KH, Shepel KK, Rule AD, Alshaer MH, Abdul Aziz MH, Roberts JA, Scheetz MH, Ausman SE, Moreland-Head LN, Rivera CG, Jannetto PJ, Mara KC, Boehmer KR. Why is the Implementation of Beta-Lactam Therapeutic Drug Monitoring for the Critically Ill Falling Short? A Multicenter Mixed-Methods Study. Ther Drug Monit. 2023 Aug 1;45(4):508-518. doi: 10.1097/FTD.0000000000001059. Epub 2023 Mar 21.

  PMID: 37076424 DERIVED

• Barreto EF, Rule AD, Alshaer MH, Roberts JA, Abdul Aziz MH, Scheetz MH, Mara KC, Jannetto PJ, Gajic O, O'Horo JC, Boehmer KR. Provider perspectives on beta-lactam therapeutic drug monitoring programs in the critically ill: a protocol for a multicenter mixed-methods study. Implement Sci Commun. 2021 Mar 24;2(1):34. doi: 10.1186/s43058-021-00134-9.

  PMID: 33762025 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Erin Barreto, Pharm. D.,R.Ph.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 16, 2021
• Study Start: October 22, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

AU (1); US (2)