Nervous System DiseasesNCT04970147
Development of Evidence-Based Nursing Care Bundle in Gastrostomy Care
A study testing Gastrostomy care bundle in people with Nervous System Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The concept of care bundle; It was developed by the American Institute for Healthcare Improvement (IHI) in 2001 to provide the best care safely in order to achieve desired results in patient care, increase compliance with standard procedures, improve patient safety and quality of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nervous System Diseases
- What is being tested?
- Gastrostomy care bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Dec 2021to 5 Oct 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the patient;
- Patients with gastrostomy over the age of 18 who receive treatment and care in the brain and neurosurgery intensive care unit, For the nurse;
- Nurses working in the brain and neurosurgery intensive care unit,
Who cannot join
- For the patient;
- Patients who are treated in the brain and neurosurgery intensive care unit but do not have gastrostomy,
- Patients under the age of 18,
- Not giving consent to the study. For the nurse;
- Leaving the brain and neurosurgery intensive care unit before the work process is completed,
- Not filling out data collection forms at any stage of the study,
- Not participating in the semi-structured in-depth individual interview,
- Not giving consent to the study.
Trial locations and contacts
1 site in 1 country.
About this study
The concept of care bundle; It was developed by the American Institute for Healthcare Improvement (IHI) in 2001 to provide the best care safely in order to achieve desired results in patient care, increase compliance with standard procedures, improve patient safety and quality of care. Ensuring that nurses perform gastrostomy care correctly and according to the guidelines published in international standards will minimize the development of problems that may arise in gastrostomy care. The aim of this study was to development and implementation the gastrostomy care bundle for gastrostomy care.
Read the detailed description
The concept of care bundle; It was developed by the American Institute for Healthcare Improvement (IHI) in 2001 to provide the best care safely in order to achieve desired results in patient care, increase compliance with standard procedures, improve patient safety and quality of care. Ensuring that nurses perform gastrostomy care correctly and according to the guidelines published in international standards will minimize the development of problems that may arise in gastrostomy care.
Method: The research was planned as a mixed type research design in order to development and implementation the gastrostomy care bundle for gastrostomy care. The study was planned to be carried out in Hacettepe University Adult Hospital Brain and neurosurgery intensive care unit between September 2021 and September 2022. In the quantitative phase of the research; The development of the gastrostomy care bundle will be carried out using the care bundle development approach in line with the recommendations of the Institute for Healthcare Improvement (IHI) and expert opinions will be taken. Nurses working in the brain and neurosurgery intensive care unit will be trained on the gastrostomy care bundle and will be expected to practice care bundle. Before the training, nurses will be asked to fill in the "Nurse Introductory Information Form", "Evidence-Based Attitude Scale towards Nursing" and "Gastrostomy Care Questionnaire (pre-test)". The nurse population of the research will consist of 14 nurses working in the brain and neurosurgery intensive care unit. At this stage, the sample selection will not be made, and it will be tried to reach all of the working nurses. The "Gastrostomy Care bundle" form will be used by the nurses in the gastrostomy care in the brain and Neurosurgery intensive care unit between September 2021 and September 2022 , which is determined for the patient sample. Nurses' compliance with the care bundle will be evaluated by the researcher with the "Gastrostomy Care Bundle Compliance Evaluation Control Form" by making daily visits to the intensive care unit. At the end of the period determined for the use of the care bundle in the intensive care unit, the nurses will be asked to fill in the "Evidence-Based Attitude Scale towards Nursing" and "Gastrostomy Care Questionnaire (post-test)". In the qualitative phase of the research, nurses working in the brain and neurosurgery intensive care unit will be interviewed about their experiences with the use of gastrostomy care bundle. At the end of the study, nurses' compliance with the use of care bundle, the effect of gastrostomy care bundle use/gastrostomy education on nurses' knowledge levels and attitudes towards evidence-based nursing, and nurses' views on gastrostomy care bundle will be evaluated.
- Conditions
- Nervous System Diseases
- Being tested
- Gastrostomy care bundle
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrostomy care bundleOther
Gastrostomy care bundle
| Study group | Role | What they receive |
|---|---|---|
| there are not arm for this study. | Other | there is not a control group for this study. Receives: Other: Gastrostomy care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with the use of the care bundle
Nurses' compliance with the use of the care bundle will be considered successful if the rate in the calculation is 95% or more
Measured: 6 months
Knowledge levels of nurses about gastrostomy care
Data to be obtained from the Gastrostomy Care Questionnaire (pre-test) to be administered before the training to be given to nurses for the evidence-based nursing, gastrostomy, gastrostomy care bundle, and the Gastrostomy Care Questionnaire (post-test) to be administered after the training and use of the gastrostomy care bundle.
Measured: 6 months
Attitude Scale towards Evidence-Based Nursing
Data to be obtained from the "Attitude Scale towards Evidence-Based Nursing" to be administered before the training to be given to the nurses for the evidence-based nursing, gastrostomy and gastrostomy care bundle, and the "Attitude Scale towards Evidence-Based Nursing" to be administered after the training and the use of the gastrostomy care bundle a survey using a 5-point Likert scale.
Measured: 6 months
Secondary outcomes (1)
Nurses' views on the use of care bundle
"For the Use of Gastrostomy Care Bundle" to be conducted with nurses in order to evaluate the post-application views of the nurses who applied the care bundle.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start28 Dec 2021
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elcin SEZER CEREN, Hacettepe University
- Investigators
- Rana Elcin SEZER CEREN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970147
- Sponsor's protocol ID
- KA-21029
- Status last verified
- Oct 2022
- First submitted
- 16 Jul 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Evidence-Based Nursing Care Bundle in Gastrostomy Care
- ClinicalTrials.gov ID
- NCT04970147
- Acronym / sponsor ID
- KA-21029
- Conditions
- Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 21 Jul 2021 (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.
The concept of care bundle; It was developed by the American Institute for Healthcare Improvement (IHI) in 2001 to provide the best care safely in order to achieve desired results in patient care, increase compliance with standard procedures, improve patient safety and quality of care. Ensuring that nurses perform gastrostomy care correctly and according to the guidelines published in international standards will minimize the development of problems that may arise in gastrostomy care. The aim of this study was to development and implementation the gastrostomy care bundle for gastrostomy care.
Detailed description
The concept of care bundle; It was developed by the American Institute for Healthcare Improvement (IHI) in 2001 to provide the best care safely in order to achieve desired results in patient care, increase compliance with standard procedures, improve patient safety and quality of care. Ensuring that nurses perform gastrostomy care correctly and according to the guidelines published in international standards will minimize the development of problems that may arise in gastrostomy care.
Method: The research was planned as a mixed type research design in order to development and implementation the gastrostomy care bundle for gastrostomy care. The study was planned to be carried out in Hacettepe University Adult Hospital Brain and neurosurgery intensive care unit between September 2021 and September 2022. In the quantitative phase of the research; The development of the gastrostomy care bundle will be carried out using the care bundle development approach in line with the recommendations of the Institute for Healthcare Improvement (IHI) and expert opinions will be taken. Nurses working in the brain and neurosurgery intensive care unit will be trained on the gastrostomy care bundle and will be expected to practice care bundle. Before the training, nurses will be asked to fill in the "Nurse Introductory Information Form", "Evidence-Based Attitude Scale towards Nursing" and "Gastrostomy Care Questionnaire (pre-test)". The nurse population of the research will consist of 14 nurses working in the brain and neurosurgery intensive care unit. At this stage, the sample selection will not be made, and it will be tried to reach all of the working nurses. The "Gastrostomy Care bundle" form will be used by the nurses in the gastrostomy care in the brain and Neurosurgery intensive care unit between September 2021 and September 2022 , which is determined for the patient sample. Nurses' compliance with the care bundle will be evaluated by the researcher with the "Gastrostomy Care Bundle Compliance Evaluation Control Form" by making daily visits to the intensive care unit. At the end of the period determined for the use of the care bundle in the intensive care unit, the nurses will be asked to fill in the "Evidence-Based Attitude Scale towards Nursing" and "Gastrostomy Care Questionnaire (post-test)". In the qualitative phase of the research, nurses working in the brain and neurosurgery intensive care unit will be interviewed about their experiences with the use of gastrostomy care bundle. At the end of the study, nurses' compliance with the use of care bundle, the effect of gastrostomy care bundle use/gastrostomy education on nurses' knowledge levels and attitudes towards evidence-based nursing, and nurses' views on gastrostomy care bundle will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| there are not arm for this study. | Other | Other: Gastrostomy care bundlethere is not a control group for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For the patient;
- Patients with gastrostomy over the age of 18 who receive treatment and care in the brain and neurosurgery intensive care unit, For the nurse;
- Nurses working in the brain and neurosurgery intensive care unit,
Key exclusion criteria (8 listed)
- For the patient;
- Patients who are treated in the brain and neurosurgery intensive care unit but do not have gastrostomy,
- Patients under the age of 18,
- Not giving consent to the study. For the nurse;
- Leaving the brain and neurosurgery intensive care unit before the work process is completed,
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 |
|---|---|---|
| Gastrostomy care bundleGastrostomy care bundle | Other | there are not arm for this study. |
Primary outcome
Compliance with the use of the care bundle
Time frame: 6 months
Nurses' compliance with the use of the care bundle will be considered successful if the rate in the calculation is 95% or more
Knowledge levels of nurses about gastrostomy care
Time frame: 6 months
Data to be obtained from the Gastrostomy Care Questionnaire (pre-test) to be administered before the training to be given to nurses for the evidence-based nursing, gastrostomy, gastrostomy care bundle, and the Gastrostomy Care Questionnaire (post-test) to be administered after the training and use of the gastrostomy care bundle.
Attitude Scale towards Evidence-Based Nursing
Time frame: 6 months
Data to be obtained from the "Attitude Scale towards Evidence-Based Nursing" to be administered before the training to be given to the nurses for the evidence-based nursing, gastrostomy and gastrostomy care bundle, and the "Attitude Scale towards Evidence-Based Nursing" to be administered after the training and the use of the gastrostomy care bundle a survey using a 5-point Likert scale.
1 secondary outcome
Nurses' views on the use of care bundle
Time frame: 6 months
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 6 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Rana Elcin SEZER CEREN principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrostomy care bundle in people with Nervous System Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 8 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 6 Oct 2022. 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 Turkey (Türkiye). 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?
Compliance with the use of the care bundle (time frame: 6 months). 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?
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 6 Oct 2022.