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| Tracking Information | |||||||||||||||||||||||||||||||||||||
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| First Received Date ICMJE | June 13, 2005 | ||||||||||||||||||||||||||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||||||||||||||||||||||||||
| Start Date ICMJE | August 2002 | ||||||||||||||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes. | ||||||||||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00114036 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||||||||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||||||
| Brief Title ICMJE | Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE) | ||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE) | ||||||||||||||||||||||||||||||||||||
| Brief 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. |
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| Detailed 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:
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. |
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| Study Phase | |||||||||||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||||||||||||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Quality improvement strategies | ||||||||||||||||||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||||||||||||||||||
| Publications * | 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. | ||||||||||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||||||||||||||||||
| Enrollment ICMJE | |||||||||||||||||||||||||||||||||||||
| Completion Date | December 2005 | ||||||||||||||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Ages | |||||||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | |||||||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||||||
| NCT ID ICMJE | NCT00114036 | ||||||||||||||||||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||||||||||||||||||
| Study ID Numbers ICMJE | RO1 HS11331-01A1 | ||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Agency for Healthcare Research and Quality (AHRQ) | ||||||||||||||||||||||||||||||||||||
| Verification Date | June 2005 | ||||||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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