Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353613
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2006-07-17
Brief Title:
Prevention of Surgical Site Infections
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Prevention of Surgical Site Infections
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RWJ ID57405 | None | None | None |