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Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)
This study is ongoing, but not recruiting participants.
Study NCT00114036   Information provided by Agency for Healthcare Research and Quality (AHRQ)
First Received: June 13, 2005   Last Updated: June 23, 2005   History of Changes

June 13, 2005
June 23, 2005
August 2002
 
Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.
Same as current
Complete list of historical versions of study NCT00114036 on ClinicalTrials.gov Archive Site
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.
Same as current
 
Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)
Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)

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.

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.

 
Interventional
Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Cardiovascular Surgical Procedures
  • Arthroplasty, Replacement
  • Hysterectomy
Behavioral: Quality improvement strategies
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
December 2005
 

Inclusion Criteria:

  • Hospitals with a minimum number of surgeries per month
 
 
 
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00114036
 
RO1 HS11331-01A1
Agency for Healthcare Research and Quality (AHRQ)
  • Joint Commission on Accreditation of Healthcare Organizations
  • Society for Healthcare Epidemiology of America
  • Centers for Disease Control and Prevention
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
Agency for Healthcare Research and Quality (AHRQ)
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP