Outreach: A Programme for Timely Treatment of Critically Ill Patients in a University Hospital - Full Text View

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00306345

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

U.S. FDA Resources

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

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:

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.
Education and training of ward staff in the recognition and basic management of patients developing a critical illness.
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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, Gelderland
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:

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.

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. Erratum in: Lancet. 2005 Oct 1;366(9492):1164.

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. No abstract available.

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. Erratum in: Crit Care Med. 2006 Dec;34(12):3070. Harvey, Maurene [added].

Study ID Numbers:	001, CMO 301
Study First Received:	March 22, 2006
Last Updated:	July 11, 2007
ClinicalTrials.gov Identifier:	NCT00306345
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

Outreach
Major general surgery
Intensive care
Serious adverse events

Study placed in the following topic categories:

Critical Illness

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009