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Outreach: A Programme for Timely Treatment of Critically Ill Patients in a University Hospital

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Radboud University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306345
First Posted: March 23, 2006
Last Update Posted: July 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
  Purpose

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.


Condition Intervention
Patient Centered Care Postoperative Care Critical Illness Behavioral: Outreach

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Outreach: A Programme for Early Recognition, Quick Response and Timely Treatment of Critically Ill Patients in a University Hospital

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 1500
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major general surgery.
  • Admitted to the hospital 48 hours after surgical intervention

Exclusion Criteria:

  • Not able to communicate in the Dutch language.
  • Younger than 18 years old.
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306345


Contacts
Contact: Gerrit Bloo, Master 0031 24 3665011 g.bloo@caiocb.umcn.nl
Contact: Ton Haans, Master 0031 24 3665012 a.haans@ic.umcn.nl

Locations
Netherlands
Radboud Universiteit Nijmegen Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Gerrit Bloo, Master    0031 24 3665011    g.bloo@caiocb.umcn.nl   
Contact: Ton Haans, Master    0031 24 3665012    a.haans@ic.umcn.nl   
Principal Investigator: Hans van der Hoeven, Professor         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Hans van der Hoeven, Professor UMCN
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00306345     History of Changes
Other Study ID Numbers: 001
CMO 301
First Submitted: March 22, 2006
First Posted: March 23, 2006
Last Update Posted: July 12, 2007
Last Verified: February 2007

Keywords provided by Radboud University:
Outreach
Major general surgery
Intensive care
Serious adverse events

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes


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