DeliriumNCT05384964
Nurses' Knowledge, Barriers and Practices in the Assessment of Delirium in the Intensive Care Unit
An observational study of Delirium and Health Knowledge, Attitudes, Practice, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Delirium in intensive care patients is a complication associated with many adverse consequences. It negatively affects patient outcomes, is an independent predictor of mortality, prolongs intensive care unit (ICU) stay and causes cognitive impairment. It is estimated that delirium affects up to 80% of ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Health Knowledge, Attitudes, Practice, Critical Care Nursing
- What is being tested?
- Questionnaire
- How many people
- 371 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2022to 28 Feb 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group will include nurses working in an adult intensive care unit.
Who may be able to join
- Nurses,
- ICU staff.
Who cannot join
- Other medical staff,
- children's ICU staff,
- nurses working in other departments.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal and Pediatric Nursing/ Department of Anesthesiology Nursing & Intensive Care
Gdansk, Gdansk/Pomorskie, Poland, 80-211
About this study
Delirium in intensive care patients is a complication associated with many adverse consequences. It negatively affects patient outcomes, is an independent predictor of mortality, prolongs intensive care unit (ICU) stay and causes cognitive impairment. It is estimated that delirium affects up to 80% of ICU patients. Unfortunately, delirium still remains undiagnosed in many cases. Due to the high prevalence of this complication in critically ill patients, it is important to implement an effective management protocol to prevent delirium.
Nurses' knowledge of delirium, learning about nursing practices and identifying barriers to delirium assessment, may be an important basis for early recognition and the creation of procedures for delirium prevention in the intensive care unit.
Read the detailed description
The survey questionnaire is aimed at nurses working in the intensive care unit.
First, respondents are asked to answer questions on socio-demographic data. Then, two questionnaires were used to conduct the study:
- The Nurses' Knowledge of Delirium questionnaire. The questionnaire consists of two parts:
- The first part deals with questions related to the definition of delirium and the tools used to detect specific conditions.
- In the second part, participants are asked to answer questions about delirium and its associated risk factors by ticking respectively "agree", "disagree" or "not sure" to a series of 28 statements. Fourteen of these statements relate to delirium, its symptoms and management, and 14 relate to risk factors for delirium.
- Nursing Practices and Perceptions Towards Delirium in the Intensive Care Unit questionnaire.
The questionnaire consists of two parts:
- The first part consists of questions about sedation and delirium assessment.
- The second part deals with practices/opinions about delirium and its assessment, including identification of potential barriers to delirium assessment
Consents were obtained from the authors for the use of both research tools. Completion of the questionnaire is voluntary, anonymous and equivalent to giving informed consent to participate in the study.
- Being tested
- Questionnaire
- Keywords
- Knowledge, Barriers, Practices, Delirium, ICU nurse, Critical care
- Medical subject headings
- Delirium, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire completed by ICU nurses
| Study group | Role | What they receive |
|---|---|---|
| Nurses | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of delirium
Assessment of nurses' knowledge of delirium in the intensive care unit using The Nurses' Knowledge of Delirium questionnaire.
Measured: 4 month
Barriers to delirium assessment
Identifying barriers to assessment and treatment of delirium in the intensive care unit using The Nursing Practices and Perceptions Towards Delirium in the Intensive Care Unit questionnaire.
Measured: 4 month
Practices and perceptions of delirium
Exploring nurses' practices and perceptions of delirium in the intensive care unit using The Nursing Practices and Perceptions Towards Delirium in the Intensive Care Unit questionnaire.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 May 2022
- Primary completion30 Aug 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Lange, Medical University of Gdansk
- Investigators
- Wioletta Mędrzycka-Dąbrowska, Dr. Habil., Study chair, Medical University of Gdańsk, Department of Anesthesiology Nursing & Intensive CareSandra Lange, MSN, Principal investigator, Medical University of Gdańsk, Department of Internal and Pediatric Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384964
- Sponsor's protocol ID
- NKBBN/267/2022
- Status last verified
- Mar 2023
- First submitted
- 16 May 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lange S, Medrzycka-Da Browska W, Tomaszek L, Wujtewicz M, Krupa S. Nurses' knowledge, barriers and practice in the care of patients with delirium in the intensive care unit in Poland-A cross-sectional study. Front Public Health. 2023 Mar 3;11:1119526. doi: 10.3389/fpubh.2023.1119526. eCollection 2023.
PubMed 36935691
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses' Knowledge, Barriers and Practices in the Assessment of Delirium in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05384964
- Acronym / sponsor ID
- NKBBN/267/2022
- Keywords
- Knowledge, Barriers, Practices, Delirium, ICU nurse, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 May 2022 (actual)
- 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.
Delirium in intensive care patients is a complication associated with many adverse consequences. It negatively affects patient outcomes, is an independent predictor of mortality, prolongs intensive care unit (ICU) stay and causes cognitive impairment. It is estimated that delirium affects up to 80% of ICU patients. Unfortunately, delirium still remains undiagnosed in many cases. Due to the high prevalence of this complication in critically ill patients, it is important to implement an effective management protocol to prevent delirium.
Nurses' knowledge of delirium, learning about nursing practices and identifying barriers to delirium assessment, may be an important basis for early recognition and the creation of procedures for delirium prevention in the intensive care unit.
Detailed description
The survey questionnaire is aimed at nurses working in the intensive care unit.
First, respondents are asked to answer questions on socio-demographic data. Then, two questionnaires were used to conduct the study:
- The Nurses' Knowledge of Delirium questionnaire. The questionnaire consists of two parts:
- The first part deals with questions related to the definition of delirium and the tools used to detect specific conditions.
- In the second part, participants are asked to answer questions about delirium and its associated risk factors by ticking respectively "agree", "disagree" or "not sure" to a series of 28 statements. Fourteen of these statements relate to delirium, its symptoms and management, and 14 relate to risk factors for delirium.
- Nursing Practices and Perceptions Towards Delirium in the Intensive Care Unit questionnaire.
The questionnaire consists of two parts:
- The first part consists of questions about sedation and delirium assessment.
- The second part deals with practices/opinions about delirium and its assessment, including identification of potential barriers to delirium assessment
Consents were obtained from the authors for the use of both research tools. Completion of the questionnaire is voluntary, anonymous and equivalent to giving informed consent to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurses | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will include nurses working in an adult intensive care unit.
Key inclusion criteria (2 listed)
- Nurses,
- ICU staff.
Key exclusion criteria (3 listed)
- Other medical staff,
- children's ICU staff,
- nurses working in other departments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire completed by ICU nurses | Other | Nurses |
Primary outcome
Knowledge of delirium
Time frame: 4 month
Assessment of nurses' knowledge of delirium in the intensive care unit using The Nurses' Knowledge of Delirium questionnaire.
Barriers to delirium assessment
Time frame: 4 month
Identifying barriers to assessment and treatment of delirium in the intensive care unit using The Nursing Practices and Perceptions Towards Delirium in the Intensive Care Unit questionnaire.
Practices and perceptions of delirium
Time frame: 4 month
Exploring nurses' practices and perceptions of delirium in the intensive care unit using The Nursing Practices and Perceptions Towards Delirium in the Intensive Care Unit questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 36935691Lange S, Medrzycka-Da Browska W, Tomaszek L, Wujtewicz M, Krupa S. Nurses' knowledge, barriers and practice in the care of patients with delirium in the intensive care unit in Poland-A cross-sectional study. Front Public Health. 2023 Mar 3;11:1119526. doi: 10.3389/fpubh.2023.1119526. eCollection 2023.
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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.
Wioletta Mędrzycka-Dąbrowska, Dr. Habil. study chair
Medical University of Gdańsk, Department of Anesthesiology Nursing & Intensive Care
Sandra Lange, MSN principal investigator
Medical University of Gdańsk, Department of Internal and Pediatric Nursing
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 and Health Knowledge, Attitudes, Practice, run by Medical University of Gdansk at 1 site in Poland.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 14 Mar 2023. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of delirium (time frame: 4 month). The study lists 3 primary outcomes in all. 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 NCT05384964, which also lists 1 linked publication.
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 14 Mar 2023.