Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)

Hysterectomy Clinical Trial

Official title:

Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00114036
• Other study ID #: RO1 HS11331-01A1
• Status: Active, not recruiting
• Phase: N/A
• First received: June 13, 2005
• Last updated: June 23, 2005
• Start date: August 2002
• Est. completion date: December 2005

Study information

• Verified date: June 2005
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: December 2005
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospitals with a minimum number of surgeries per month

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Arthroplasty, Replacement
• Cardiovascular Surgical Procedures
• Hysterectomy

Intervention

Behavioral:
• Quality improvement strategies

Locations

Country	Name	City	State
United States	University of Tennessee	Memphis	Tennessee
United States	Joint Commission on Accreditation of Healthcare Organizations	Oakbrook Terrace	Illinois
United States	Wake Forest University School of Medicine	Winston Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Agency for Healthcare Research and Quality (AHRQ)	Centers for Disease Control and Prevention, Joint Commission on Accreditation of Healthcare Organizations, Society for Healthcare Epidemiology of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.