SafetyNCT05910918
Intensive Care Nurses' Training Package on the Safety Culture of Geriatric Patients
A study testing Intensive Care Nurses' Training Package in people with Safety, run by Alexandria University at 2 sites in Egypt.
Trial summary
This study aims to determine the effect of intensive care nurses' training package on the safety culture of critically ill geriatric patients. Study hypothesis: Intensive care nurses who receive the proposed training package exhibit higher scores on critically ill geriatric patients' safety culture awareness than… Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- Intensive Care Nurses' Training Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Nov 2022to 10 Feb 2023
- Phase
- Interventional
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 20 years and above.
- provide direct care for critically ill geriatric patients.
- work for at least 1 month in the unit.
Who cannot join
- not involved in patient care.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Intensive Care Nurses' Training Package on the Safety Culture of Critically Ill Geriatric Patients:Findings and Implications for Clinical Practice
This study aims to determine the effect of intensive care nurses' training package on the safety culture of critically ill geriatric patients.
Study hypothesis:
Intensive care nurses who receive the proposed training package exhibit higher scores on critically ill geriatric patients' safety culture awareness than those who do not receive it.
Read the detailed description
The researchers will prepare the proposed nurses' training package program. The program will be planned to be carried out in 10 sessions that will be classified into; sessions regarding knowledge about the age-related changes affecting elderly patients that should be considered while caring for them and how to care for and maintain the safety of the critically ill geriatric patients. The researchers will prepare an illustrative PowerPoint presentation of each study program's session.
- Conditions
- Safety
- Being tested
- Intensive Care Nurses' Training Package
- Keywords
- Geriatric Patients, Critically ill
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Care Nurses' Training PackageBehavioural
For the study group, the researcher will explain the method of the training package program application to critical care nurses as follows; firstly, the researchers will assess the nurses' roster, then the researchers will classify the subjects into groups in order to conduct the training package for a group of them while the other subjects taking care of the patients in the intensive care units and repeat the same session to the others in the same manner.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care Nurses' Training Package | Experimental | For the study group, the researcher will explain the method of the training package program application to critical care nurses as follows; firstly, the researchers will assess the nurses' roster, then the researchers will classify the subjects into groups in order to conduct the training package for a group of them while the other subjects taking care of the patients in the intensive care units and repeat the same session to the others in the same manner. Receives: Behavioral: Intensive Care Nurses' Training Package |
| comparison group | Active comparator | for the comparison group receive the general intensive care rules manual for routine care. Receives: Behavioral: Intensive Care Nurses' Training Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Nurses' Awareness of the Critically Ill Geriatric Patients' Safety Culture Questionnaire
This tool will assess the intensive care nurses' awareness of critically ill geriatric patients' safety culture. It will include items that will be categorized into four subscales namely, intensive care nurses' knowledge, attitude, and practices of caring for critically ill geriatric patients and the critical care unit work environment. The nurses have to respond to the items using a 3-point Likert scale. The total score of the items will be summed and higher scores will indicate greater nurses' awareness of critically ill geriatric patients' safety culture.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start30 Nov 2022
- Primary completion15 Jan 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha salah elsayed eweida, Alexandria University
- Investigators
- Eman Taha, Study chair, Egypt Faculty of Nursing Alexandria, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910918
- Sponsor's protocol ID
- 1522102022
- Status last verified
- Jun 2023
- First submitted
- 19 Feb 2023
- Last updated
- 20 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen YL, Angus DC, Boumendil A, Guidet B. The challenge of admitting the very elderly to intensive care. Ann Intensive Care. 2011 Aug 1;1(1):29. doi: 10.1186/2110-5820-1-29.
PubMed 21906383Laake JH, Dybwik K, Flaatten HK, Fonneland IL, Kvale R, Strand K. Impact of the post-World War II generation on intensive care needs in Norway. Acta Anaesthesiol Scand. 2010 Apr;54(4):479-84. doi: 10.1111/j.1399-6576.2009.02170.x. Epub 2009 Nov 23.
PubMed 19930244Bagshaw SM, Webb SA, Delaney A, George C, Pilcher D, Hart GK, Bellomo R. Very old patients admitted to intensive care in Australia and New Zealand: a multi-centre cohort analysis. Crit Care. 2009;13(2):R45. doi: 10.1186/cc7768. Epub 2009 Apr 1.
PubMed 19335921Boumendil A, Somme D, Garrouste-Orgeas M, Guidet B. Should elderly patients be admitted to the intensive care unit? Intensive Care Med. 2007 Jul;33(7):1252. doi: 10.1007/s00134-007-0621-3. Epub 2007 Apr 3.
PubMed 17404703
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Care Nurses' Training Package on the Safety Culture of Critically Ill Geriatric Patients:Findings and Implications for Clinical Practice
- ClinicalTrials.gov ID
- NCT05910918
- Acronym / sponsor ID
- 1522102022
- Conditions
- Safety
- Keywords
- Geriatric Patients, Critically ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 20 Jun 2023 (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.
This study aims to determine the effect of intensive care nurses' training package on the safety culture of critically ill geriatric patients.
Study hypothesis:
Intensive care nurses who receive the proposed training package exhibit higher scores on critically ill geriatric patients' safety culture awareness than those who do not receive it.
Detailed description
The researchers will prepare the proposed nurses' training package program. The program will be planned to be carried out in 10 sessions that will be classified into; sessions regarding knowledge about the age-related changes affecting elderly patients that should be considered while caring for them and how to care for and maintain the safety of the critically ill geriatric patients. The researchers will prepare an illustrative PowerPoint presentation of each study program's session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Nurses' Training Package | Experimental | Behavioral: Intensive Care Nurses' Training PackageFor the study group, the researcher will explain the method of the training package program application to critical care nurses as follows; firstly, the researchers will assess the nurses' roster, then the researchers will classify the subjects into groups in order to conduct the training package for a group of them while the other subjects taking care of the patients in the intensive care units and repeat the same session to the others in the same manner. |
| comparison group | Active comparator | Behavioral: Intensive Care Nurses' Training Packagefor the comparison group receive the general intensive care rules manual for routine care. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 20 years and above.
- provide direct care for critically ill geriatric patients.
- work for at least 1 month in the unit.
Key exclusion criteria (1 listed)
- not involved in patient care.
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 |
|---|---|---|
| Intensive Care Nurses' Training PackageFor the study group, the researcher will explain the method of the training package program application to critical care nurses as follows; firstly, the researchers will assess the nurses' roster, then the researchers will classify the subjects into groups in order to conduct the training package for a group of them while the other subjects taking care of the patients in the intensive care units and repeat the same session to the others in the same manner. | Behavioural | Intensive Care Nurses' Training Package, comparison group |
Primary outcome
Intensive Care Nurses' Awareness of the Critically Ill Geriatric Patients' Safety Culture Questionnaire
Time frame: 2 weeks
This tool will assess the intensive care nurses' awareness of critically ill geriatric patients' safety culture. It will include items that will be categorized into four subscales namely, intensive care nurses' knowledge, attitude, and practices of caring for critically ill geriatric patients and the critical care unit work environment. The nurses have to respond to the items using a 3-point Likert scale. The total score of the items will be summed and higher scores will indicate greater nurses' awareness of critically ill geriatric patients' safety culture.
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 20 Jun 2023.
- Background: PubMed 21906383Nguyen YL, Angus DC, Boumendil A, Guidet B. The challenge of admitting the very elderly to intensive care. Ann Intensive Care. 2011 Aug 1;1(1):29. doi: 10.1186/2110-5820-1-29.
- Background: PubMed 19930244Laake JH, Dybwik K, Flaatten HK, Fonneland IL, Kvale R, Strand K. Impact of the post-World War II generation on intensive care needs in Norway. Acta Anaesthesiol Scand. 2010 Apr;54(4):479-84. doi: 10.1111/j.1399-6576.2009.02170.x. Epub 2009 Nov 23.
- Background: PubMed 19335921Bagshaw SM, Webb SA, Delaney A, George C, Pilcher D, Hart GK, Bellomo R. Very old patients admitted to intensive care in Australia and New Zealand: a multi-centre cohort analysis. Crit Care. 2009;13(2):R45. doi: 10.1186/cc7768. Epub 2009 Apr 1.
- Background: PubMed 17404703Boumendil A, Somme D, Garrouste-Orgeas M, Guidet B. Should elderly patients be admitted to the intensive care unit? Intensive Care Med. 2007 Jul;33(7):1252. doi: 10.1007/s00134-007-0621-3. Epub 2007 Apr 3.
- Individual participant dataSharing planned: No
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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.
Eman Taha study chair
Egypt Faculty of Nursing Alexandria, Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Care Nurses' Training Package in people with Safety, run by Alexandria University at 2 sites in Egypt.
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: finished, as of the sponsor's last update on 20 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Intensive Care Nurses' Awareness of the Critically Ill Geriatric Patients' Safety Culture Questionnaire (time frame: 2 weeks). 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 NCT05910918, which also lists 4 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 20 Jun 2023.