Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)

NCT ID: NCT00114036

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Surgical Procedures Arthroplasty, Replacement Hysterectomy

Keywords

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Antibiotic prophylaxis Surgical wound infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Quality improvement strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hospitals with a minimum number of surgeries per month
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Joint Commission on Accreditation of Healthcare Organizations

OTHER

Sponsor Role collaborator

Society for Healthcare Epidemiology of America

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role lead

Principal Investigators

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Stephen B. Krichevsky, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Barbara I. Braun, PhD

Role: STUDY_DIRECTOR

Joint Commission on Accreditation of Healthcare Organizations

Edward Wong, MD

Role: STUDY_CHAIR

VA Office of Research and Development

Steve Solomon, MD

Role: STUDY_CHAIR

Centers for Disease Control and Prevention

Bryan Simmons, MD

Role: STUDY_CHAIR

Methodist Health System

Andrew J. Bush, PhD

Role: STUDY_CHAIR

University of Tennessee

John Burke, MD

Role: STUDY_CHAIR

LDS Hospital

Michele R. Bozikis, MPH

Role: STUDY_CHAIR

Joint Commission on Accreditation of Healthcare Organizations

Linda Kusek, MPH

Role: STUDY_CHAIR

Joint Commission on Accreditation of Healthcare Organizations

Locations

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Joint Commission on Accreditation of Healthcare Organizations

Oakbrook Terrace, Illinois, United States

Site Status

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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. doi: 10.7326/0003-4819-149-7-200810070-00007.

Reference Type DERIVED
PMID: 18838727 (View on PubMed)

Other Identifiers

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R01HS011331-01A1

Identifier Type: AHRQ

Identifier Source: org_study_id

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