NCT01746888

Brief Summary

Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist. These patients often have atypical presentations which can complicate diagnosis and treatment. The development of an antimicrobial stewardship program for Emergency Department older adult patients can ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This research study involves data collection from enrolled subjects and treating physicians. The data will be collected using a patient interview which will be answered directly by the patient or caregiver. Additional surveys will be administered to the Emergency Department treating physician and subsequent physician. Additional data will be abstracted from the Emergency Department chart and from additional charts that often accompanies the patient to the Emergency Department. A physician adjudication process will occur if there is disagreement in diagnosis between the treating Emergency Department physician and succeeding physician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
437

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

October 23, 2012

Last Update Submit

November 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of infection while in the Emergency Department

    participants will be followed for the duration of hospital stay, an expected average of 4 days.

Study Arms (1)

Older Adults

Adults 65 years and older who present to the Emergency Department.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults 65 years of age and older who present to the Emergency Department.

You may qualify if:

  • years of age

You may not qualify if:

  • Patient incarcerated
  • Chief complaint of suicidal or homicidal ideation
  • Patient primarily evaluated by the trauma team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wexner Medical Center at The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Jeffrey M Caterino, MD, MPH

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 23, 2012

First Posted

December 11, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations