NCT00306345

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 12, 2007

Status Verified

February 1, 2007

First QC Date

March 22, 2006

Last Update Submit

July 11, 2007

Conditions

Patient Centered CarePostoperative CareCritical Illness

Keywords

OutreachMajor general surgeryIntensive careSerious adverse events

Interventions

OutreachBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not able to communicate in the Dutch language.
  • Younger than 18 years old.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud Universiteit Nijmegen Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

Related Publications (4)

  • Bellomo R, Goldsmith D, Uchino S, Buckmaster J, Hart G, Opdam H, Silvester W, Doolan L, Gutteridge G. Prospective controlled trial of effect of medical emergency team on postoperative morbidity and mortality rates. Crit Care Med. 2004 Apr;32(4):916-21. doi: 10.1097/01.ccm.0000119428.02968.9e.

    PMID: 15071378BACKGROUND

  • Hillman K, Chen J, Cretikos M, Bellomo R, Brown D, Doig G, Finfer S, Flabouris A; MERIT study investigators. Introduction of the medical emergency team (MET) system: a cluster-randomised controlled trial. Lancet. 2005 Jun 18-24;365(9477):2091-7. doi: 10.1016/S0140-6736(05)66733-5.

    PMID: 15964445BACKGROUND

  • DeVita MA, Bellomo R, Hillman K. Introduction to the rapid response systems series. Jt Comm J Qual Patient Saf. 2006 Jul;32(7):359-60. doi: 10.1016/s1553-7250(06)32046-6. No abstract available.

    PMID: 16884121BACKGROUND

  • Devita MA, Bellomo R, Hillman K, Kellum J, Rotondi A, Teres D, Auerbach A, Chen WJ, Duncan K, Kenward G, Bell M, Buist M, Chen J, Bion J, Kirby A, Lighthall G, Ovreveit J, Braithwaite RS, Gosbee J, Milbrandt E, Peberdy M, Savitz L, Young L, Harvey M, Galhotra S. Findings of the first consensus conference on medical emergency teams. Crit Care Med. 2006 Sep;34(9):2463-78. doi: 10.1097/01.CCM.0000235743.38172.6E.

    PMID: 16878033BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Community-Institutional Relations

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Public RelationsOrganization and AdministrationHealth Services Administration

Study Officials

  • Hans van der Hoeven, Professor

    UMCN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerrit Bloo, Master

CONTACT

0031 24 3665011g.bloo@caiocb.umcn.nl

Ton Haans, Master

CONTACT

0031 24 3665012a.haans@ic.umcn.nl

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 23, 2006

Study Start

January 1, 2006

Study Completion

December 1, 2008

Last Updated

July 12, 2007

Record last verified: 2007-02

Locations

NL(1)