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

NCT ID: NCT00306345

Last Updated: 2007-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient Centered Care Postoperative Care Critical Illness

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Outreach

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Hans van der Hoeven, Professor

Role: PRINCIPAL_INVESTIGATOR

UMCN

Locations

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Radboud Universiteit Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Gerrit Bloo, Master

Role: CONTACT

0031 24 3665011

Ton Haans, Master

Role: CONTACT

0031 24 3665012

Facility Contacts

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Gerrit Bloo, Master

Role: primary

0031 24 3665011

Ton Haans, Master

Role: backup

0031 24 3665012

References

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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.

Reference Type BACKGROUND
PMID: 15071378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15964445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16884121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16878033 (View on PubMed)

Other Identifiers

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CMO 301

Identifier Type: -

Identifier Source: secondary_id

001

Identifier Type: -

Identifier Source: org_study_id