The ICU DElirium in Clinical PracTice Implementation Evaluation Study Screening and Treatment

NCT ID: NCT01952899

Last Updated: 2013-10-01

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

2012-04-30

Study Completion Date

2016-04-30

Brief Summary

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Objective: Delirium is an important and frequently occurring complication in intensive care patients. However, screening and treatment of delirium is not in accordance with current national and international guidelines. The first objective of this prospective study is to describe the barriers and facilitators for guideline adherence. Second, investigators will develop a tailored implementation strategy. Finally, investigators will describe the effects of the tailored implementation on the adherence of the guideline in a pilot study. Design: Current practices, attitudes and deviations from a national (Dutch) delirium guideline will be assessed in a prospective before-measurement. Barriers and facilitators will be identified with surveys and focus group interviews. Adherence to the guideline will be studied in a before-after study in 7 ICUs in the Southwest of the Netherlands. Further, the effect of a multifaceted implementation strategy-guided implementation will be assessed with regard to important clinical outcomes, such as mortality and delirium incidence. Population: Professionals (Physicians/intensivists, nurses' and psychiatrists) and ICU patients. Intervention: The delirium guideline of the Netherlands Society of Intensive Care (NVIC) is implemented in this study. Implementation strategies: Barriers and facilitators will be determined in focus group interviews (n=7) with health care professionals resulting in a tailored guideline implementation strategy. In the development of the strategies specific attention will be paid to sustaining the guideline adherence. Main outcome: 1. Current practices; 2. Barriers and facilitators for guideline adherence; 3. Tailored implementation strategy; 4. Percentage of adherence to the guideline (early screening, prevention and treatment of delirium); 5. Effects of implementation on outcomes (economic, mortality, delirium incidence). Data analysis / power: The main effects, guideline adherence, will be evaluated by comparing the before and after measurements. Calculating from 90% power,2-sided alpha=0.01, 231 patients per periods will be sufficient to test the proposed adherence of 85%. Economic evaluation: The economic analysis will be performed from a health care perspective. Investigator will calculate and compare the direct medical costs of usual care (before) and care after implementation of the guideline. Additionally, the cost of the tailored guideline implementation process will be calculated. The economic analysis will be a cost-minimalization analysis.

Detailed Description

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Conditions

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Delirium

Keywords

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Intensive Care Unit Delirium Implementation Guideline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Albert Schweitzer Hospital

No interventions assigned to this group

Erasmus MC Academic Hospital

No interventions assigned to this group

Ikazia Hospital

No interventions assigned to this group

IJsselland Hospital

No interventions assigned to this group

Maasstad Hospital

No interventions assigned to this group

Sint Franciscus Gasthuis Hospital

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Screening delirium by all patients
* Measuring of guide line adherence for all professionals working on the ICU
* Implementation guideline: all professionals

Exclusion Criteria

* no
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Schweitzer Hospital

OTHER

Sponsor Role collaborator

Ikazia Hospital, Rotterdam

OTHER

Sponsor Role collaborator

IJsselland Hospital

UNKNOWN

Sponsor Role collaborator

Maasstad Hospital

OTHER

Sponsor Role collaborator

Sint Franciscus Gasthuis

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Z. Trogrlic

MSc / PhD-Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erwin W. Ista, Dr

Role: STUDY_DIRECTOR

Erasmus MC University Medical Center Rotterdam/ ZonMw

Mathieu van der Jagt, MD, PhD

Role: STUDY_DIRECTOR

Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands

Zoran Trogrlic, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands

Locations

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Erasmus MC Academic Medica Center Rotterdam

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Zoran Trogrlic, MSc

Role: CONTACT

Phone: +31 (0) 10703 0497

Email: [email protected]

Erwin W. Ista, Dr

Role: CONTACT

Phone: +31 (0) 107037028

Email: [email protected]

Facility Contacts

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Zoran Trogrlic, MSc

Role: primary

References

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Smit L, Wiegers EJA, Trogrlic Z, Gommers D, Ista E, van der Jagt M. Risk factors for transitions and outcomes of subsyndromal delirium in the ICU: Post-hoc analysis of a prospective multicenter cohort study. J Crit Care. 2025 Aug;88:155041. doi: 10.1016/j.jcrc.2025.155041. Epub 2025 Mar 6.

Reference Type DERIVED
PMID: 40054074 (View on PubMed)

Smit L, Wiegers EJA, Trogrlic Z, Rietdijk WJR, Gommers D, Ista E, van der Jagt M. Prognostic significance of delirium subtypes in critically ill medical and surgical patients: a secondary analysis of a prospective multicenter study. J Intensive Care. 2022 Dec 20;10(1):54. doi: 10.1186/s40560-022-00644-1.

Reference Type DERIVED
PMID: 36539913 (View on PubMed)

Ista E, Trogrlic Z, Bakker J, Osse RJ, van Achterberg T, van der Jagt M. Improvement of care for ICU patients with delirium by early screening and treatment: study protocol of iDECePTIvE study. Implement Sci. 2014 Oct 2;9:143. doi: 10.1186/s13012-014-0143-7.

Reference Type DERIVED
PMID: 25273854 (View on PubMed)

Other Identifiers

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80-82315-97-12025

Identifier Type: -

Identifier Source: org_study_id