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	Behavior: Quality improvement strategies

Further Study Details: 

Primary Outcomes: 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: 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.

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.

Criteria

Inclusion Criteria:

• Hospitals with a minimum number of surgeries per month

Illinois
      Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace,  Illinois,  60181,  United States
North Carolina
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157,  United States
Tennessee
      University of Tennessee, Memphis,  Tennessee,  38105,  United States

Study chairs or principal investigators

Stephen B. Krichevsky, PhD,  Principal Investigator,  Wake Forest School of Medicine   
Barbara I. Braun, PhD,  Study Director,  Joint Commission on Accreditation of Healthcare Organizations   
Edward Wong, MD,  Study Chair,  Department of Veterans Affairs   
Steve Solomon, MD,  Study Chair,  Centers for Disease Control and Prevention   
Bryan Simmons, MD,  Study Chair,  Methodist Health System   
Andrew J. Bush, PhD,  Study Chair,  University of Tennessee   
John Burke, MD,  Study Chair,  LDS Hospital   
Michele R. Bozikis, MPH,  Study Chair,  Joint Commission on Accreditation of Healthcare Organizations   
Linda Kusek, MPH,  Study Chair,  Joint Commission on Accreditation of Healthcare Organizations   

Study ID Numbers:  RO1 HS11331-01A1
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 13, 2005
ClinicalTrials.gov Identifier:  NCT00114036
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05