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

Improvement of Care for ICU Patients With Delirium by Early Screening and Treatment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01952899
Acronym
iDECePTIvE
Enrollment
1500
Registered
2013-09-30
Start date
2012-04-30
Completion date
2016-04-30
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Intensive Care Unit, Delirium, Implementation, Guideline

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.

Interventions

None listed

Sponsors

Albert Schweitzer Hospital
CollaboratorOTHER
Ikazia Hospital, Rotterdam
CollaboratorOTHER
IJsselland Hospital
CollaboratorUNKNOWN
Maasstad Hospital
CollaboratorOTHER
Sint Franciscus Gasthuis
CollaboratorOTHER
Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Delirium guideline adherence36 monts1. 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)

Secondary

MeasureTime frameDescription
Economic evaluation1 monthThe economic analysis will be performed from a health care perspective. Investigators 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.

Countries

Netherlands

Contacts

Primary ContactZoran Trogrlic, MSc
z.trogrlic@erasmusmc.nl+31 (0) 10703 0497
Backup ContactErwin W. Ista, Dr
w.Ista@erasmusmc.nl+31 (0) 107037028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026