DeliriumiDECePTIvENCT01952899
The ICU DElirium in Clinical PracTice Implementation Evaluation Study Screening and Treatment
An observational study of Delirium, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delirium
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to Apr 2016
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: ICU patients and professionals
Who may be able to join
- Screening delirium by all patients
- Measuring of guide line adherence for all professionals working on the ICU
- Implementation guideline: all professionals
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC Academic Medica Center Rotterdam
Rotterdam, South Holland, 3000 CA
Zoran Trogrlic, MSc, +30 (0) 10 7030497, z.trogrlic@erasmusmc.nl
About this study
Official title: 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.
- Conditions
- Delirium
- Keywords
- Intensive Care Unit, Delirium, Implementation, Guideline
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Albert Schweitzer Hospital | Not described | |
| Erasmus MC Academic Hospital | Not described | |
| Ikazia Hospital | Not described | |
| IJsselland Hospital | Not described | |
| Maasstad Hospital | Not described | |
| Sint Franciscus Gasthuis Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 monts
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Schweitzer Hospital, Ikazia Hospital, Rotterdam, IJsselland Hospital, Maasstad Hospital, Sint Franciscus Gasthuis
- Responsible party
- Principal investigator, Z. Trogrlic, Erasmus Medical Center
- Investigators
- Erwin W. Ista, Dr, Study director, Erasmus MC University Medical Center Rotterdam/ ZonMwMathieu van der Jagt, MD, PhD, Study director, Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, NetherlandsZoran Trogrlic, MSc, Principal investigator, Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952899
- Sponsor's protocol ID
- 80-82315-97-12025
- Acronym
- iDECePTIvE
- Status last verified
- Sep 2013
- First submitted
- 25 Sep 2013
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Smit L, Wiegers EJA, Trogrlic Z, Gommers D, Ista E, van der Jagt M. Risk factors for transitions and outcomes of subsyndromal delirium in the ICU: Post-hoc analysis of a prospective multicenter cohort study. J Crit Care. 2025 Aug;88:155041. doi: 10.1016/j.jcrc.2025.155041. Epub 2025 Mar 6.
PubMed 40054074Smit L, Wiegers EJA, Trogrlic Z, Rietdijk WJR, Gommers D, Ista E, van der Jagt M. Prognostic significance of delirium subtypes in critically ill medical and surgical patients: a secondary analysis of a prospective multicenter study. J Intensive Care. 2022 Dec 20;10(1):54. doi: 10.1186/s40560-022-00644-1.
PubMed 36539913Ista E, Trogrlic Z, Bakker J, Osse RJ, van Achterberg T, van der Jagt M. Improvement of care for ICU patients with delirium by early screening and treatment: study protocol of iDECePTIvE study. Implement Sci. 2014 Oct 2;9:143. doi: 10.1186/s13012-014-0143-7.
PubMed 25273854
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Care for ICU Patients With Delirium by Early Screening and Treatment
- ClinicalTrials.gov ID
- NCT01952899
- Acronym / sponsor ID
- iDECePTIvE / 80-82315-97-12025
- Conditions
- Delirium
- Keywords
- Intensive Care Unit, Delirium, Implementation, Guideline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Albert Schweitzer Hospital, Ikazia Hospital, Rotterdam, IJsselland Hospital, Maasstad Hospital, Sint Franciscus Gasthuis
- Study start
- Apr 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Albert Schweitzer Hospital | – | – |
| Erasmus MC Academic Hospital | – | – |
| Ikazia Hospital | – | – |
| IJsselland Hospital | – | – |
| Maasstad Hospital | – | – |
| Sint Franciscus Gasthuis Hospital | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patients and professionals
Key inclusion criteria (3 listed)
- Screening delirium by all patients
- Measuring of guide line adherence for all professionals working on the ICU
- Implementation guideline: all professionals
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Economic evaluation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
- Derived from this study: PubMed 40054074Smit L, Wiegers EJA, Trogrlic Z, Gommers D, Ista E, van der Jagt M. Risk factors for transitions and outcomes of subsyndromal delirium in the ICU: Post-hoc analysis of a prospective multicenter cohort study. J Crit Care. 2025 Aug;88:155041. doi: 10.1016/j.jcrc.2025.155041. Epub 2025 Mar 6.
- Derived from this study: PubMed 36539913Smit L, Wiegers EJA, Trogrlic Z, Rietdijk WJR, Gommers D, Ista E, van der Jagt M. Prognostic significance of delirium subtypes in critically ill medical and surgical patients: a secondary analysis of a prospective multicenter study. J Intensive Care. 2022 Dec 20;10(1):54. doi: 10.1186/s40560-022-00644-1.
- Derived from this study: PubMed 25273854Ista E, Trogrlic Z, Bakker J, Osse RJ, van Achterberg T, van der Jagt M. Improvement of care for ICU patients with delirium by early screening and treatment: study protocol of iDECePTIvE study. Implement Sci. 2014 Oct 2;9:143. doi: 10.1186/s13012-014-0143-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin W. Ista, Dr study director
Erasmus MC University Medical Center Rotterdam/ ZonMw
Mathieu van der Jagt, MD, PhD study director
Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands
Zoran Trogrlic, MSc principal investigator
Department of Intensive Care, Erasmus MC - University Medical Center Rotterdam, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoran Trogrlic, MSc (+31 (0) 10703 0497, z.trogrlic@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium guideline adherence (time frame: 36 monts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952899, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.