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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Erasmus Medical Center
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
ClinicalTrials.gov Identifier:
NCT01952899
First received: September 25, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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
Delirium

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Delirium guideline adherence [ Time Frame: 36 monts ] [ Designated as safety issue: No ]
    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:
  • Economic evaluation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Albert Schweitzer Hospital
Erasmus MC Academic Hospital
Ikazia Hospital
IJsselland Hospital
Maasstad Hospital
Sint Franciscus Gasthuis Hospital

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952899

Contacts
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
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
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
  More Information

No publications provided

Responsible Party: Z. Trogrlic, MSc / PhD-Student, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01952899     History of Changes
Other Study ID Numbers: 80-82315-97-12025
Study First Received: September 25, 2013
Last Updated: September 30, 2013
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

Keywords provided by Erasmus Medical Center:
Intensive Care Unit
Delirium
Implementation
Guideline

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014