Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114036
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-06-13
Brief Title:
Trial to Reduce Antimicrobial Prophylaxis Errors TRAPE
Sponsor:
Agency for Healthcare Research and Quality AHRQ
Organization:
Agency for Healthcare Research and Quality AHRQ
Study Overview
Official Title:
Trial to Reduce Antimicrobial Prophylaxis Errors TRAPE
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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:
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
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
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