Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)
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|ClinicalTrials.gov Identifier: NCT00114036|
Recruitment Status : Unknown
Verified June 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was: Active, not recruiting
First Posted : June 14, 2005
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment|
|Cardiovascular Surgical Procedures Arthroplasty, Replacement Hysterectomy||Behavioral: Quality improvement strategies|
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:
- 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;
- identify organizational and system factors associated with error rates;
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)|
|Study Start Date :||August 2002|
|Estimated Study Completion Date :||December 2005|
- Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114036
|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|
|Principal Investigator:||Stephen B. Krichevsky, PhD||Wake Forest University Health Sciences|
|Study Director:||Barbara I. Braun, PhD||Joint Commission on Accreditation of Healthcare Organizations|
|Study Chair:||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|