Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Joint Commission on Accreditation of Healthcare Organizations
Society for Healthcare Epidemiology of America
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00114036
First received: June 13, 2005
Last updated: June 23, 2005
Last verified: June 2005
  Purpose

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.


Condition Intervention
Cardiovascular Surgical Procedures
Arthroplasty, Replacement
Hysterectomy
Behavioral: Quality improvement strategies

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Study Start Date: August 2002
Estimated Study Completion Date: December 2005
Detailed Description:

Numerous studies have shown that many surgical site infections (SSI) are preventable with appropriately timed antimicrobial prophylaxis. Patients receiving prophylaxis either well-before or well after surgery are up to 5 times more likely to develop an SSI than those receiving appropriate therapy (Classen et al, 1992). Unfortunately, errors in antimicrobial prophylaxis timing are extremely common with error rates typically reported to be between 35 and 40%. Given that errors in antimicrobial prophylaxis are common and the consequences of error so grave, identifying methods to assist hospitals in improving prophylaxis must be a high priority. TRAPE will evaluate a multifaceted, theory-based intervention to assist hospitals in progressing through stages of organizational change to improve the prophylaxis process. We will test the impact of the intervention using a rigorous group-randomized, nested, pretest-posttest design (Murray, 1998).

Our specific aims over the 4 year project period are:

  1. determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies in 44 hospitals recruited to participate in the study;
  2. identify organizational and system factors associated with error rates;
  3. randomize the 44 hospitals to evaluate the effectiveness of a multifaceted intervention.

The interventions consist of: a) the promotion of specific process changes likely to reduce error rates, b) a site-visit, c) customized process feedback, d) facilitated benchmarking, and e) peer consultation. The 22 intervention hospitals will be compared to 22 hospitals that receive written feedback of their error rates only. The study has 80% power to detect a 12-15% improvement in the timing of prophylaxis in the full intervention group compared to the written feedback only group. Data collection will be done at each participating hospital, and the medical records of 100 surgical patients before and after the intervention will be abstracted at each hospital to establish performance rates. Changes in the processes of care, and the evolution through stages of organizational change will also be assessed.

  Eligibility

Criteria

Inclusion Criteria:

  • Hospitals with a minimum number of surgeries per month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114036

Locations
United States, Illinois
Joint Commission on Accreditation of Healthcare Organizations
Oakbrook Terrace, Illinois, United States, 60181
United States, North Carolina
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Joint Commission on Accreditation of Healthcare Organizations
Society for Healthcare Epidemiology of America
Investigators
Principal Investigator: Stephen B. Krichevsky, PhD Wake Forest School of Medicine
Study Director: Barbara I. Braun, PhD Joint Commission on Accreditation of Healthcare Organizations
Study Chair: Edward Wong, MD Department of Veterans Affairs
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
  More Information

No publications provided by Agency for Healthcare Research and Quality (AHRQ)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00114036     History of Changes
Other Study ID Numbers: RO1 HS11331-01A1
Study First Received: June 13, 2005
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Antibiotic prophylaxis
Surgical wound infections

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014