NCT07486362

Brief Summary

Patients are commonly discharged from the Emergency Department(ED) with pending blood culture results. Blood cultures can take up to 48 hours to become positive which is why it is important to notify patients with true positive cultures as soon as possible. Delay in notification can lead to other serious complications such as sepsis, septic shock, and death. The American College of Emergency Physicians states pharmacists serve a critical role in ensuring efficient, safe, and effective medication use in the ED and advocates for health systems to support dedicated roles for pharmacists within the ED. Pharmacists help to decrease the workload on the healthcare team, especially in the ED where there is high volume and acuity.Emergency medicine pharmacist (EMP) play a significant role in the optimization of therapy, medication safety, and reducing costs. There is strong evidence for the positive impact EMPs have on microbiological culture review. Overall, pharmacist review of late cultures results in higher rates of appropriate antimicrobial therapy and decreased missed interventions.These prior studies focused on the review of microbiological tests, including sexually transmitted infections, urine, and wound cultures; however, there was limited data to support the role of pharmacists evaluating late blood culture results.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2024Jan 2028

Study Start

First participant enrolled

January 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
2 years until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

March 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

March 26, 2024

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time from an actionable positive blood culture to the time of review and/or patient notification. ult.

    Time to patient notification is defined as time until the first attempt to contact the patient regarding the actionable positive res

    18 months

Study Arms (2)

Emergency medicine pharmacist (EMPs)

EMPs, utilizing a Collaborative practice agreements(CPA), will be associated with a significantly shorter time to patient review and notification of positive blood culture compared to a CN-physician review.

Other: No Intervention

Charge nurse (CN's)

To determine the effect of EMPs, utilizing a CPA, on the appropriateness of antibiotic selection upon return admission for bacteremia, reasons for patient return to hospital (i.e., return due to call - expectant, worsening of symptoms - non-expectant, other) compared to the standard CN-physician facilitated process, and rates of inappropriate call backs for reassessment or admissions (i.e., contaminant call backs).

Other: No Intervention

Interventions

No Intervention

Charge nurse (CN's)Emergency medicine pharmacist (EMPs)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a positive blood culture result, collected during the initial ED visit and who were discharged from the ED to the outpatient/long-term care setting prior to a critical blood Groupsculture result.

You may qualify if:

  • Patients with a positive blood culture result, collected during the initial ED visit and who were discharged from the ED to the outpatient/long-term care setting prior to a critical blood Groups culture result.

You may not qualify if:

  • Patients admitted to inpatient and patients transferred from ED to another acute care facility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute Methodist Health System

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Karpisek, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

March 20, 2026

Study Start

January 31, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

March 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations