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

NCT01952899 | Unknown

• 1 other identifier: 80-82315-97-12025
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium

Keywords

Intensive Care Unit; Delirium; Implementation; Guideline

Outcome Measures

Primary Outcomes (1)

• Delirium guideline adherence

  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. process evaluation in terms of relevant clinical outcomes, economic assessment, delirium incidence. 6. Re-validation of delirium screening tools (CAM-ICU and ICDSC)

  36 monts

Secondary Outcomes (1)

• Economic evaluation

  1 month

Study Arms (6)

Albert Schweitzer Hospital

Erasmus MC Academic Hospital

Ikazia Hospital

IJsselland Hospital

Maasstad Hospital

Sint Franciscus Gasthuis Hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients and professionals

You may qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Albert Schweitzer Hospital: collaborator
• Ikazia Hospital, Rotterdam: collaborator
• IJsselland Hospital: collaborator
• Maasstad Hospital: collaborator
• Sint Franciscus Gasthuis: collaborator

Study Sites (1)

Erasmus MC Academic Medica Center Rotterdam

Rotterdam, South Holland, 3000 CA, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 40054074 DERIVED

• 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.

  PMID: 36539913 DERIVED

• 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.

  PMID: 25273854 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Erwin W. Ista, Dr

  Erasmus MC University Medical Center Rotterdam/ ZonMw

  STUDY DIRECTOR

• Mathieu van der Jagt, MD, PhD

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

  STUDY DIRECTOR

• Zoran Trogrlic, MSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoran Trogrlic, MSc

CONTACT

+31 (0) 10703 0497; z.trogrlic@erasmusmc.nl

Erwin W. Ista, Dr

CONTACT

+31 (0) 107037028; w.Ista@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc / PhD-Student

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: April 1, 2016
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

NL (1)