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

September 30, 2013 updated by: Z. Trogrlic, Erasmus Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3000 CA
        • Recruiting
        • Erasmus MC Academic Medica Center Rotterdam
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients and professionals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
36 monts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Albert Schweitzer Hospital
Maasstad Hospital
Sint Franciscus Gasthuis
Ikazia Hospital, Rotterdam
IJsselland Hospital

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (ESTIMATE)

September 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80-82315-97-12025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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