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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01952899
Recruitment Status : Unknown
Verified September 2013 by Z. Trogrlic, Erasmus Medical Center.
Recruitment status was:  Recruiting
First Posted : September 30, 2013
Last Update Posted : October 1, 2013
Sponsor:
Collaborators:
Albert Schweitzer Hospital
Ikazia Hospital, Rotterdam
IJsselland Hospital
Maasstad Hospital
Sint Franciscus Gasthuis
Information provided by (Responsible Party):
Z. Trogrlic, Erasmus Medical Center

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.

Condition or disease
Delirium

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Improvement of Care for ICU Patients With Delirium by Early Screening and Treatment
Study Start Date : April 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
Albert Schweitzer Hospital
Erasmus MC Academic Hospital
Ikazia Hospital
IJsselland Hospital
Maasstad Hospital
Sint Franciscus Gasthuis Hospital



Primary Outcome Measures :
  1. Delirium guideline adherence [ Time Frame: 36 monts ]
    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)


Secondary Outcome Measures :
  1. Economic evaluation [ Time Frame: 1 month ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ICU patients and professionals
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952899


Contacts
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Contact: Zoran Trogrlic, MSc +31 (0) 10703 0497 z.trogrlic@erasmusmc.nl
Contact: Erwin W. Ista, Dr +31 (0) 107037028 w.Ista@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Academic Medica Center Rotterdam Recruiting
Rotterdam, South Holland, Netherlands, 3000 CA
Contact: Zoran Trogrlic, MSc    +30 (0) 10 7030497    z.trogrlic@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
Albert Schweitzer Hospital
Ikazia Hospital, Rotterdam
IJsselland Hospital
Maasstad Hospital
Sint Franciscus Gasthuis
Investigators
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Study Director: 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
Principal Investigator: Zoran Trogrlic, MSc Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Z. Trogrlic, MSc / PhD-Student, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01952899    
Other Study ID Numbers: 80-82315-97-12025
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013
Keywords provided by Z. Trogrlic, Erasmus Medical Center:
Intensive Care Unit
Delirium
Implementation
Guideline
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders