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| Sponsor: | Agency for Healthcare Research and Quality (AHRQ) |
|---|---|
| Collaborators: |
Joint Commission on Accreditation of Healthcare Organizations Society for Healthcare Epidemiology of America Centers for Disease Control and Prevention |
| Information provided by: | Agency for Healthcare Research and Quality (AHRQ) |
| ClinicalTrials.gov Identifier: | NCT00114036 |
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) |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | December 2005 |
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:
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.
EligibilityInclusion Criteria:
Contacts and 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 | |
| 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
| 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 |
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Antibiotic prophylaxis Surgical wound infections |
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Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |