Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306345
Status:
UNKNOWN
Last Update Posted:
2007-07-12
First Post:
2006-03-22
Brief Title:
Outreach A Programme for Timely Treatment of Critically Ill Patients in a University Hospital
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Outreach A Programme for Early Recognition Quick Response and Timely Treatment of Critically Ill Patients in a University Hospital
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
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 identification of patients with potential early organ failure is the key in preventing admission or readmission to a critical care facility The primary goal of the Outreach Project is to ensure that all patients with threatening organ failure receive appropriate and timely treatment in a suitable area avoid admission to the intensive care unit ICU and share ICU skills by a partnership in education The objectives of the study are to determine whether the introduction of an intensive care unit based medical emergency team responding to hospital-wide preset criteria of physiologic instability will decrease the number of predefined serious adverse events SAEs and to investigate the effects on quality of life and costs in a general surgery population
Study Hypothesis The Outreach intervention will decrease the number of predefined serious adverse events increase quality of life and decrease costs
Study Hypothesis The Outreach intervention will decrease the number of predefined serious adverse events increase quality of life and decrease costs
Detailed Description:
DESIGN A multi centre longitudinal intervention trial with a before and after design in a university hospital
The INTERVENTION consists of three parts
1 The introduction of a hospital-wide intensive care unit based medical emergency team to evaluate and treat patients deemed at risk for developing an adverse outcome
2 Education and training of ward staff in the recognition and basic management of patients developing a critical illness
3 The development of an intensive care nurse and physician staffed consultancy service for general wards
STUDY POPULATION The population for this study consists of patients undergoing major general surgery with an admission stay of more than 48 hours It includes patients undergoing central or peripheral vascular surgery major oncological surgery lung surgery major abdominal surgery and trauma surgery
MEASUREMENTS AND OUTCOMES In total 1500 patients will be included 750 Patients in the control period and 750 patients in the intervention period Measurements include the incidence of Serious Adverse Events HRQoL Quality of life EQ-5D costs of care and ICU logistics
TIME-SCHEDULE Data collection starts January 1 2006 and stops no later than three months after the inclusion of 1500 patients or April 1 2008 The final report of the study will be in December 2008
The INTERVENTION consists of three parts
1 The introduction of a hospital-wide intensive care unit based medical emergency team to evaluate and treat patients deemed at risk for developing an adverse outcome
2 Education and training of ward staff in the recognition and basic management of patients developing a critical illness
3 The development of an intensive care nurse and physician staffed consultancy service for general wards
STUDY POPULATION The population for this study consists of patients undergoing major general surgery with an admission stay of more than 48 hours It includes patients undergoing central or peripheral vascular surgery major oncological surgery lung surgery major abdominal surgery and trauma surgery
MEASUREMENTS AND OUTCOMES In total 1500 patients will be included 750 Patients in the control period and 750 patients in the intervention period Measurements include the incidence of Serious Adverse Events HRQoL Quality of life EQ-5D costs of care and ICU logistics
TIME-SCHEDULE Data collection starts January 1 2006 and stops no later than three months after the inclusion of 1500 patients or April 1 2008 The final report of the study will be in December 2008
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 |
|---|---|---|---|
| CMO 301 | None | None | None |