Pediatric Intensive Care NursesNCT07078864
The Effect of the Model-Based Care Decision Support System in Pediatric Intensive Care on Nurses' Decision Making and Opinions
A study testing Nursing Care Decision Support System in people with Pediatric Intensive Care Nurses, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of the Model-Based Care Decision Support System in Pediatric Intensive Care on Nurses' Decision Making and Opinions Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Intensive Care Nurses
- What is being tested?
- Nursing Care Decision Support System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nurses with at least 6 months of experience in intensive care
- Nurses actively involved in direct patient care
- Nurses who voluntarily agree to participate in the study
Who cannot join
- Nurses who are temporarily on leave due to reasons such as maternity leave or unpaid leave
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Üniversity
Ankara
Bedriye AK, Assaociate Prof. DR, +905327633151, bedriye_ak@yahoo.com
Merve ERDEM, Lecturer, +905067037754, merve-ylmz@yandex.com
About this study
The Effect of the Model-Based Care Decision Support System in Pediatric Intensive Care on Nurses' Decision Making and Opinions
Read the detailed description
This study is designed as a mixed-method research aiming to determine the effect of using a Model-Based Care Decision Support System in Pediatric Intensive Care on nurses' perspectives and decision-making skills. The study is a semi-experimental and qualitative research conducted using a single-group pre-test/post-test design.
The study consists of two phases. The first phase involves the development of the Model-Based Care Decision Support System. The second phase aims to evaluate the impact of the developed Care Decision Support System on nurses' perspectives regarding the system and their decision-making skills. A qualitative research method will be used to determine nurses' views on the Care Decision Support System, and a single-group pre-test/post-test semi-experimental design will be used to assess the effect of the decision support system on nurses' clinical decision-making skills.
The population of the study will consist of 38 nurses working in the Pediatric Intensive Care Unit of a university hospital located in the city center of Ankara. A sampling method will not be used in this study; instead, the study group will consist of nurses who meet the inclusion criteria and voluntarily agree to participate in the study.
Phase One - Development of the Care Decision Support System In this phase, a Model-Based Nursing Care Decision Support System will be developed. The system will be based on the Family-Centered Care Model and Watson's Theory of Human Caring, as these aspects of care are often overlooked in pediatric intensive care units due to the high demands of physical care. The Family-Centered Care Model emphasizes principles such as respecting the child and family (including their ethnic, cultural, socioeconomic, and racial characteristics, as well as their coping mechanisms), recognizing and supporting the strengths of the family, guiding families by supporting their preferences and decisions through care approaches, and ensuring that policies align with the family's cultural values and beliefs. Watson's Theory of Human Caring includes three main components: interpersonal caring relationships, the caring moment, and the healing processes. The nursing care components to be included in the decision support system will be identified through a qualitative study involving nurses working in pediatric intensive care units. Using the snowball sampling method, in-depth individual interviews will be conducted with nurses who are not part of the main study population. These interviews will explore which nursing care interventions should be integrated into the system. Nurses participating in this phase will be purposively selected based on criteria such as clinical experience and educational background. Pediatric intensive care nurses known to the researcher through personal or professional networks will be invited to participate. Interviews will be conducted at a suitable time outside working hours using digital platforms (e.g., Zoom, Google Meet). Data collected from these interviews will be analyzed using content analysis, and the nursing interventions to be included in the system will be finalized. Following this, the care content for the Decision Support System will be created. Expert opinion (from academic and clinical pediatric nursing professionals) will be sought to finalize the interventions to be included in the system. A software company will then be commissioned to develop the digital interface. The Care Decision Support System will incorporate the nursing process and will support nurses in identifying nursing diagnoses and selecting appropriate interventions based on patient data. The system will begin with the data collection phase of the nursing process. It will guide nurses on which data should be collected, provide alerts and prompts during analysis, and assist in clustering data to suggest possible nursing diagnoses. If a nurse selects a diagnosis but patient data is incomplete, the system will issue an alert and prompt for missing data, thereby assisting the nurse in the data analysis process. After a diagnosis is confirmed, the system will offer a set of care interventions associated with that diagnosis. Similarly, in the evaluation phase, the system will guide nurses on which outcomes should be assessed.
This comprehensive system, encompassing data collection, diagnosis, implementation, and evaluation phases of the nursing process, is designed to support pediatric intensive care nurses in making accurate care decisions. Once the software is complete, a pilot test will be conducted to assess usability and clarity. The pilot will be carried out with nurses not included in the main study sample. Necessary adjustments will be made based on the pilot, and the second phase of the study will then begin.
Phase Two - Implementation of the Care Decision Support System In this phase, data will be collected using the Descriptive Information Form, the Nurse Decision-Making Scale (as a pre-test), and the Semi-Structured Interview Form designed to explore nurses' views regarding the Decision Support System. Training will be provided to the nurses on how to use the Decision Support System, which was developed for use in providing continuous 24-hour nursing care for pediatric patients. To ensure participation, training sessions will be conducted in two groups, aligning with the nurses' work shifts so as not to disrupt clinical operations. The training will consist of two sessions totaling four hours. Topics covered will include the importance and use of the clinical decision support system, potential challenges, and suggested solutions. The system will then be introduced to the sample nurses (who meet the inclusion criteria) through hands-on application. Before full implementation in the clinical setting, a one-week trial period will be conducted to address any questions nurses may have about using the system. During this trial, the researcher will respond to all usage-related questions. A WhatsApp group including the participating nurses and the researcher will also be created to provide support throughout the implementation period.
Nurses will be required to use the system for a minimum of 15 days. Due to the time limitations of the doctoral dissertation, the maximum usage period will be 30 days. Fifteen days after the implementation ends, the post-test will be conducted using the Nurse Decision-Making Scale and a Semi-Structured Interview Form designed to evaluate the effectiveness and possible improvements of the Model-Based Nursing Care Decision Support System.
- Conditions
- Pediatric Intensive Care Nurses
- Being tested
- Nursing Care Decision Support System
- Keywords
- Decision support system, Watson human care model, Family-centered care model, Pediatric Intensive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Care Decision Support SystemOther
Phase Two involves implementing the Nursing Care Decision Support System. Data will be collected using a Descriptive Information Form, the Nurse Decision-Making Scale (pre-test), and a Semi-Structured Interview Form to explore nurses' views. Nurses will receive two training sessions (totaling 4 hours) covering system use, importance, challenges, and solutions. Training will be held in two groups based on shift schedules. A one-week trial will follow, with the researcher answering questions and providing support via a WhatsApp group. Nurses must use the system for at least 15 days (maximum 30 days due to dissertation timeline). Fifteen days after use ends, the Nurse Decision-Making Scale (post-test) and interviews will assess the system's effectiveness and areas for improvement.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Intensive Care Nurses | Other | Not described Receives: Other: Nursing Care Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurse Decision-Making Scale
The scale was developed by Lauri and Salanterä in 2002 . The Turkish version's validity and reliability study was conducted by Demir and Yılmaz in 2021. The scale consists of 24 items and is unidimensional. It is rated on a five-point Likert scale: "Always-5, Frequently-4, Sometimes-3, Rarely-2, Never-1." The total score ranges from 24 to 120, with higher scores indicating better decision-making skills. The Cronbach's alpha coefficient of the original scale was .84 , while it was found to be .97 in the Turkish version.
Measured: two week
Secondary outcomes (1)
Semi-Structured Interview Form for the Implementation of the Decision Support System
This form was also prepared by the researchers and finalized in line with expert feedback. It will be used twice-before and after the implementation of the Decision Support System. The form includes four open-ended questions designed to assess nurses' opinions on the system. The post-implementation version focuses specifically on evaluating the effectiveness and potential improvements of the system.
Measured: two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Jun 2026 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
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 Pediatric Intensive Care NursesStudies of the same condition, open and under way.
- 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
- Model description
- The study is a quasi-experimental and qualitative study in a single-group pre-post test model
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedriye AK, Abant Izzet Baysal University
- Investigators
- Bedriye AK, Associate Prof. Dr., Study director, Bolu Abant İzzet Baysal ÜniversityMerve Erdem, Lecturer, Principal investigator, Ankara Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078864
- Sponsor's protocol ID
- AİBÜ-HEM- BA-02
- Status last verified
- May 2026
- First submitted
- 13 Jul 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will prepare the study as a thesis and then publish it in an international scientific journal.
Publications
Zhao Y, Hu J, Gu Y, Wan Y, Liu F, Ye C, Zhang X. Development and Implementation of a Pediatric Nursing-Clinical Decision Support System for Hyperthermia: A Pre- and Post-test. Comput Inform Nurs. 2021 Aug 4;40(2):131-137. doi: 10.1097/CIN.0000000000000812.
PubMed 34347639Tripathi, K. P. Decision support system is a tool for making better decisions in the organization. Indian Journal of Computer Science and Engineering (IJCSE),2021: 2(1), 112-117
Demir Ş, Akman Yılmaz A. Hemşire Karar Verme Ölçeğinin Türkçeye uyarlanması: geçerlik ve güvenirlik çalışması. Sağlık ve Hemşirelik Yönetimi Dergisi. 2021;8(3):407-417.
Lauri S, Salantera S. Developing an instrument to measure and describe clinical decision making in different nursing fields. J Prof Nurs. 2002 Mar-Apr;18(2):93-100. doi: 10.1053/jpnu.2002.32344.
PubMed 11977007
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Model-Based Care Decision Support System in Pediatric Intensive Care on Nurses' Decision Making and Opinions
- ClinicalTrials.gov ID
- NCT07078864
- Acronym / sponsor ID
- AİBÜ-HEM- BA-02
- Conditions
- Pediatric Intensive Care Nurses
- Keywords
- Decision support system, Watson human care model, Family-centered care model, Pediatric Intensive Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 22 Jul 2025 (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 Effect of the Model-Based Care Decision Support System in Pediatric Intensive Care on Nurses' Decision Making and Opinions
Detailed description
This study is designed as a mixed-method research aiming to determine the effect of using a Model-Based Care Decision Support System in Pediatric Intensive Care on nurses' perspectives and decision-making skills. The study is a semi-experimental and qualitative research conducted using a single-group pre-test/post-test design.
The study consists of two phases. The first phase involves the development of the Model-Based Care Decision Support System. The second phase aims to evaluate the impact of the developed Care Decision Support System on nurses' perspectives regarding the system and their decision-making skills. A qualitative research method will be used to determine nurses' views on the Care Decision Support System, and a single-group pre-test/post-test semi-experimental design will be used to assess the effect of the decision support system on nurses' clinical decision-making skills.
The population of the study will consist of 38 nurses working in the Pediatric Intensive Care Unit of a university hospital located in the city center of Ankara. A sampling method will not be used in this study; instead, the study group will consist of nurses who meet the inclusion criteria and voluntarily agree to participate in the study.
Phase One - Development of the Care Decision Support System In this phase, a Model-Based Nursing Care Decision Support System will be developed. The system will be based on the Family-Centered Care Model and Watson's Theory of Human Caring, as these aspects of care are often overlooked in pediatric intensive care units due to the high demands of physical care. The Family-Centered Care Model emphasizes principles such as respecting the child and family (including their ethnic, cultural, socioeconomic, and racial characteristics, as well as their coping mechanisms), recognizing and supporting the strengths of the family, guiding families by supporting their preferences and decisions through care approaches, and ensuring that policies align with the family's cultural values and beliefs. Watson's Theory of Human Caring includes three main components: interpersonal caring relationships, the caring moment, and the healing processes. The nursing care components to be included in the decision support system will be identified through a qualitative study involving nurses working in pediatric intensive care units. Using the snowball sampling method, in-depth individual interviews will be conducted with nurses who are not part of the main study population. These interviews will explore which nursing care interventions should be integrated into the system. Nurses participating in this phase will be purposively selected based on criteria such as clinical experience and educational background. Pediatric intensive care nurses known to the researcher through personal or professional networks will be invited to participate. Interviews will be conducted at a suitable time outside working hours using digital platforms (e.g., Zoom, Google Meet). Data collected from these interviews will be analyzed using content analysis, and the nursing interventions to be included in the system will be finalized. Following this, the care content for the Decision Support System will be created. Expert opinion (from academic and clinical pediatric nursing professionals) will be sought to finalize the interventions to be included in the system. A software company will then be commissioned to develop the digital interface. The Care Decision Support System will incorporate the nursing process and will support nurses in identifying nursing diagnoses and selecting appropriate interventions based on patient data. The system will begin with the data collection phase of the nursing process. It will guide nurses on which data should be collected, provide alerts and prompts during analysis, and assist in clustering data to suggest possible nursing diagnoses. If a nurse selects a diagnosis but patient data is incomplete, the system will issue an alert and prompt for missing data, thereby assisting the nurse in the data analysis process. After a diagnosis is confirmed, the system will offer a set of care interventions associated with that diagnosis. Similarly, in the evaluation phase, the system will guide nurses on which outcomes should be assessed.
This comprehensive system, encompassing data collection, diagnosis, implementation, and evaluation phases of the nursing process, is designed to support pediatric intensive care nurses in making accurate care decisions. Once the software is complete, a pilot test will be conducted to assess usability and clarity. The pilot will be carried out with nurses not included in the main study sample. Necessary adjustments will be made based on the pilot, and the second phase of the study will then begin.
Phase Two - Implementation of the Care Decision Support System In this phase, data will be collected using the Descriptive Information Form, the Nurse Decision-Making Scale (as a pre-test), and the Semi-Structured Interview Form designed to explore nurses' views regarding the Decision Support System. Training will be provided to the nurses on how to use the Decision Support System, which was developed for use in providing continuous 24-hour nursing care for pediatric patients. To ensure participation, training sessions will be conducted in two groups, aligning with the nurses' work shifts so as not to disrupt clinical operations. The training will consist of two sessions totaling four hours. Topics covered will include the importance and use of the clinical decision support system, potential challenges, and suggested solutions. The system will then be introduced to the sample nurses (who meet the inclusion criteria) through hands-on application. Before full implementation in the clinical setting, a one-week trial period will be conducted to address any questions nurses may have about using the system. During this trial, the researcher will respond to all usage-related questions. A WhatsApp group including the participating nurses and the researcher will also be created to provide support throughout the implementation period.
Nurses will be required to use the system for a minimum of 15 days. Due to the time limitations of the doctoral dissertation, the maximum usage period will be 30 days. Fifteen days after the implementation ends, the post-test will be conducted using the Nurse Decision-Making Scale and a Semi-Structured Interview Form designed to evaluate the effectiveness and possible improvements of the Model-Based Nursing Care Decision Support System.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a quasi-experimental and qualitative study in a single-group pre-post test model
| Arm | Type | Receives |
|---|---|---|
| Pediatric Intensive Care Nurses | Other | Other: Nursing Care Decision Support System |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Nurses with at least 6 months of experience in intensive care
- Nurses actively involved in direct patient care
- Nurses who voluntarily agree to participate in the study
Key exclusion criteria (1 listed)
- Nurses who are temporarily on leave due to reasons such as maternity leave or unpaid leave
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 |
|---|---|---|
| Nursing Care Decision Support SystemPhase Two involves implementing the Nursing Care Decision Support System. Data will be collected using a Descriptive Information Form, the Nurse Decision-Making Scale (pre-test), and a Semi-Structured Interview Form to explore nurses' views. Nurses will receive two training sessions (totaling 4 hours) covering system use, importance, challenges, and solutions. Training will be held in two groups based on shift schedules. A one-week trial will follow, with the researcher answering questions and providing support via a WhatsApp group. Nurses must use the system for at least 15 days (maximum 30 days due to dissertation timeline). Fifteen days after use ends, the Nurse Decision-Making Scale (post-test) and interviews will assess the system's effectiveness and areas for improvement. | Other | Pediatric Intensive Care Nurses |
Primary outcome
Nurse Decision-Making Scale
Time frame: two week
The scale was developed by Lauri and Salanterä in 2002 . The Turkish version's validity and reliability study was conducted by Demir and Yılmaz in 2021. The scale consists of 24 items and is unidimensional. It is rated on a five-point Likert scale: "Always-5, Frequently-4, Sometimes-3, Rarely-2, Never-1." The total score ranges from 24 to 120, with higher scores indicating better decision-making skills. The Cronbach's alpha coefficient of the original scale was .84 , while it was found to be .97 in the Turkish version.
1 secondary outcome
Semi-Structured Interview Form for the Implementation of the Decision Support System
Time frame: two week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 34347639Zhao Y, Hu J, Gu Y, Wan Y, Liu F, Ye C, Zhang X. Development and Implementation of a Pediatric Nursing-Clinical Decision Support System for Hyperthermia: A Pre- and Post-test. Comput Inform Nurs. 2021 Aug 4;40(2):131-137. doi: 10.1097/CIN.0000000000000812.
- Results publicationTripathi, K. P. Decision support system is a tool for making better decisions in the organization. Indian Journal of Computer Science and Engineering (IJCSE),2021: 2(1), 112-117
- Results publicationDemir Ş, Akman Yılmaz A. Hemşire Karar Verme Ölçeğinin Türkçeye uyarlanması: geçerlik ve güvenirlik çalışması. Sağlık ve Hemşirelik Yönetimi Dergisi. 2021;8(3):407-417.
- Results publication: PubMed 11977007Lauri S, Salantera S. Developing an instrument to measure and describe clinical decision making in different nursing fields. J Prof Nurs. 2002 Mar-Apr;18(2):93-100. doi: 10.1053/jpnu.2002.32344.
- Individual participant dataSharing planned: Yes. We will prepare the study as a thesis and then publish it in an international scientific journal.
Related trials for Pediatric Intensive Care Nurses
Not yet recruiting
Smart Mind Maps in Promoting Safe Administration of High-Alert Medications
PICU, Nurses
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.
Bedriye AK, Associate Prof. Dr. study director
Bolu Abant İzzet Baysal Üniversity
Merve Erdem, Lecturer principal investigator
Ankara Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Care Decision Support System in people with Pediatric Intensive Care Nurses, run by Abant Izzet Baysal 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 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: opening soon, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bedriye AK, Associate Prof. Dr. (05327633151, bedriye_ak@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurse Decision-Making Scale (time frame: two week). 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 NCT07078864, 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 22 May 2026.