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

Delirium Clinical Trial

— iDECePTIvE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01952899
• Other study ID #: 80-82315-97-12025
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2013
• Last updated: September 30, 2013
• Start date: April 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2013
• Source: Erasmus Medical Center
• Contact: Zoran Trogrlic, MSc
• Phone: +31 (0) 10703 0497
• Email: z.trogrlic[@]erasmusmc.nl
• Is FDA regulated: No
• Health authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Netherlands	Erasmus MC Academic Medica Center Rotterdam	Rotterdam	South Holland

Sponsors (6)

Lead Sponsor	Collaborator
Erasmus Medical Center	Albert Schweitzer Hospital, IJsselland Hospital, Ikazia Hospital, Rotterdam, Maasstad Hospital, Sint Franciscus Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium guideline adherence	Current practices; Barriers and facilitators for guideline adherence; Tailored implementation strategy; Percentage of adherence to the guideline (early screening, prevention and treatment of delirium); process evaluation in terms of relevant clinical outcomes, economic assessment, delirium incidence.; Re-validation of delirium screening tools (CAM-ICU and ICDSC)	36 monts	No
Secondary	Economic evaluation	The 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.	1 month	No