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| Descriptive Information Fields | |||||||||
| Brief Title † | Prevention of Surgical Site Infections | ||||||||
| Official Title † | Prevention of Surgical Site Infections | ||||||||
| Brief Summary | The primary research question is whether interventions to prevent caregiver and system errors will increase the proportion of laparotomy patients who receive recommended measures to prevent surgical site infections. |
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| Detailed Description | Background: Surgical site infections (SSIs) cause significant and largely preventable morbidity, mortality, and resource use due to failure to comply with evidence-based guidelines. Quality improvement programs report increased compliance with these guidelines, but are subject to a variety of biases. Hypothesis: The primary hypothesis is that a targeted intervention program will increase the proportion of patients in a county hospital who receive recommended interventions to prevent SSIs, when assessed in the most rigorous feasible clinical trial. The specific aims of the trial are to establish practical surveillance measures to determine the percentage of patients whose care complies with 5 major guidelines to prevent SSIs; to use chart review, direct observation, attitude surveys, and focus groups to identify, quantify, and address latent and active errors linked to non-compliance, and to develop, implement, and assess the effectiveness of an intervention program to increase guideline compliance. Study Design: An innovative trial design will be performed with 3 staggered phases in the two major county hospitals in Houston, TX. This design allows for adjustment for temporal trends and hospital differences in assessing the intervention program in a large, high-risk, disadvantaged urban population. Based on a compliance goal of 95%, this design has adequate power to detect even a small absolute increase ( >= 5%) above baseline in the percentage of patients receiving all 5 recommended preventive measures. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Condition † | Surgical Wound Infection | ||||||||
| Intervention † | Behavioral: Package of targeted interventions to reduce error | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Robert Wood Johnson Physician Faculty Scholars bio page  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 900 | ||||||||
| Start Date † | March 2007 | ||||||||
| Completion Date | June 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00353613 | ||||||||
| Organization ID | HSC-MS-050570 | ||||||||
| Secondary IDs †† | RWJ ID#57405 | ||||||||
| Study Sponsor † | The University of Texas Health Science Center, Houston | ||||||||
| Collaborators †† | Robert Wood Johnson Foundation | ||||||||
| Investigators † |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||||||
| Verification Date | November 2008 | ||||||||
| First Received Date † | July 17, 2006 | ||||||||
| Last Updated Date | November 6, 2008 | ||||||||
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