The ICU DElirium in Clinical PracTice Implementation Evaluation Study Screening and Treatment
Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delirium
Phase: N/A
Status: Recruiting
Sponsored by: Erasmus Medical Center Official(s) and/or principal investigator(s):
Erwin W. Ista, Dr, Study Director, Affiliation: Erasmus MC University Medical Center Rotterdam/ ZonMw
Mathieu van der Jagt, MD, PhD, Study Director, Affiliation: Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands
Zoran Trogrlic, MSc, Principal Investigator, Affiliation: Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands
Overall contact:
Zoran Trogrlic, MSc, Phone: +31 (0) 10703 0497, Email: z.trogrlic@erasmusmc.nl
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.
Clinical Details
Official title: Improvement of Care for ICU Patients With Delirium by Early Screening and Treatment
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Delirium guideline adherence
Secondary outcome: Economic evaluation
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Zoran Trogrlic, MSc, Phone: +31 (0) 10703 0497, Email: z.trogrlic@erasmusmc.nl
Erasmus MC Academic Medica Center Rotterdam, Rotterdam, South Holland 3000 CA, Netherlands; Recruiting
Zoran Trogrlic, MSc, Phone: +30 (0) 10 7030497, Email: z.trogrlic@erasmusmc.nl
Additional Information
Starting date: April 2012
Last updated: September 30, 2013
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