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

July 11, 2007 updated by: Radboud University Medical Center

Outreach: A Programme for Early Recognition, Quick Response and Timely Treatment of Critically Ill Patients in a University Hospital

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Recruiting
        • Radboud Universiteit Nijmegen Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hans van der Hoeven, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Hans van der Hoeven, Professor, UMCN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

March 22, 2006

First Submitted That Met QC Criteria

March 22, 2006

First Posted (Estimate)

March 23, 2006

Study Record Updates

Last Update Posted (Estimate)

July 12, 2007

Last Update Submitted That Met QC Criteria

July 11, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)
  • CMO 301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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