NCT00114036

Brief Summary

The specific aims are to determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies across a heterogeneous sample of hospitals; identify organizational and practitioner factors associated with error rates, and evaluate the effectiveness of a multifaceted intervention in reducing prophylaxis error rates compared to written feedback alone in a sample of 44 hospitals enrolled in the study using a rigorous group-randomized design.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2005

First QC Date

June 13, 2005

Last Update Submit

June 23, 2005

Conditions

Keywords

Antibiotic prophylaxisSurgical wound infections

Outcome Measures

Primary Outcomes (1)

  • Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.

Secondary Outcomes (1)

  • Change in performance on appropriate selection of drug, appropriate duration, appropriate number of doses pre-op, appropriate use of beta-lactams in patients with allergies.

Interventions

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitals with a minimum number of surgeries per month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Joint Commission on Accreditation of Healthcare Organizations

Oakbrook Terrace, Illinois, 60181, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

University of Tennessee

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Kritchevsky SB, Braun BI, Bush AJ, Bozikis MR, Kusek L, Burke JP, Wong ES, Jernigan J, Davis CC, Simmons B; TRAPE Study Group. The effect of a quality improvement collaborative to improve antimicrobial prophylaxis in surgical patients: a randomized trial. Ann Intern Med. 2008 Oct 7;149(7):472-80, W89-93. doi: 10.7326/0003-4819-149-7-200810070-00007.

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen B. Krichevsky, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
  • Barbara I. Braun, PhD

    Joint Commission on Accreditation of Healthcare Organizations

    STUDY DIRECTOR
  • Edward Wong, MD

    VA Office of Research and Development

    STUDY CHAIR
  • Steve Solomon, MD

    Centers for Disease Control and Prevention

    STUDY CHAIR
  • Bryan Simmons, MD

    Methodist Health System

    STUDY CHAIR
  • Andrew J. Bush, PhD

    University of Tennessee

    STUDY CHAIR
  • John Burke, MD

    LDS Hospital

    STUDY CHAIR
  • Michele R. Bozikis, MPH

    Joint Commission on Accreditation of Healthcare Organizations

    STUDY CHAIR
  • Linda Kusek, MPH

    Joint Commission on Accreditation of Healthcare Organizations

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 13, 2005

First Posted

June 14, 2005

Study Start

August 1, 2002

Study Completion

December 1, 2005

Last Updated

June 24, 2005

Record last verified: 2005-06

Locations