Ventilator-Associated Pneumonia Prevention and Intensive Care Nursing CareTSEP-VAP-2026NCT07820826
Theory-Based Educational Program for VAP Prevention and Nursing Care in Intensive Care Units
A study testing Theory-Based Structured Educational Program in people with Ventilator-Associated Pneumonia Prevention and Intensive Care Nursing Care, run by JAWAD AHMAD ABU-SHENNAR at 1 site in Jordan.
Trial summary
Ventilator-associated pneumonia (VAP) is an important challenge in intensive care and requires nurses to apply evidence-based preventive practices consistently in mechanically ventilated patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ventilator-Associated Pneumonia Prevention and Intensive Care Nursing Care
- What is being tested?
- Theory-Based Structured Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2025to 1 Sep 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Registered nurses employed by a participating Ministry of Health hospital in Jordan.
- Nurses assigned to a participating adult intensive care unit (ICU).
- Nurses providing direct patient care to mechanically ventilated or critically ill patients.
- Nurses with sufficient clinical experience to participate in the study procedures.
- Willingness to participate voluntarily and provide written informed consent.
Who cannot join
- Administrative nurses without direct bedside responsibilities.
- Nurses on extended leave during the intervention period.
- Nurses expected to leave the participating ICU before completion of the immediate post-intervention assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Theory-Based Structured Educational Program on VAP Prevention Knowledge, Reflective Nursing Practice, Quality of Nursing Care, and Family Satisfaction With ICU Care: A Multicenter Cluster-Randomized Controlled Trial
Ventilator-associated pneumonia (VAP) is an important challenge in intensive care and requires nurses to apply evidence-based preventive practices consistently in mechanically ventilated patients. This multicenter cluster-randomized controlled trial evaluates the effectiveness of a theory-based structured educational program designed to improve VAP prevention knowledge, reflective nursing practice related to invasive mechanical ventilation, quality of nursing care, and family satisfaction with intensive care unit (ICU) care. The program integrates evidence-based VAP prevention education with clinical decision-making, case-based learning, simulation, reflective exercises, structured debriefing, and practice-improvement planning. Adult ICU nurses working in Ministry of Health hospitals in Jordan are assigned by ICU cluster to either the educational intervention or usual care. Outcomes are assessed at baseline, immediately after the intervention, and six months after completion to evaluate immediate effects and sustainability. VAP prevention knowledge is the primary outcome, while reflective nursing practice, quality of nursing care, and family satisfaction with ICU care are secondary outcomes.
Read the detailed description
This study is a national, multicenter, two-arm, parallel-group cluster-randomized controlled trial evaluating a theory-based structured educational program for nurses working in adult intensive care units (ICUs) affiliated with the Ministry of Health in Jordan. Cluster randomization is conducted at the ICU level to reduce contamination among nurses working within the same clinical environment.
The educational program is theoretically grounded in Schön's Reflective Practice Theory and was developed to support the integration of evidence-based VAP prevention knowledge with clinical reasoning and reflective nursing practice. The program consists of four weekly educational sessions, each lasting approximately three hours, for a total of approximately 12 contact hours. Educational strategies include interactive lectures, case-based learning, group discussion, clinical scenarios, demonstration, simulation-based learning, reflective exercises, structured debriefing, and practice-improvement planning.
The first session focuses on VAP prevention knowledge and clinical decision-making, including VAP risk factors, mechanisms contributing to VAP development, evidence-based preventive practices, oral care, positioning, airway and secretion management, aspiration prevention, hand hygiene, and relevant ventilator-care bundle components. The second session addresses nursing care of mechanically ventilated patients and the integration of reflective practice into routine ICU care. The third session uses simulation-based clinical scenarios involving mechanically ventilated patients and is followed by structured reflective debriefing. The fourth session integrates the major concepts, addresses barriers to implementation, and supports the development of individualized practice-improvement plans.
Participants in the control group receive usual institutional care and education. Routine institutional education and patient-safety procedures are not withheld. The study-specific structured educational program is not provided to control ICUs during the active intervention period.
Study outcomes are assessed at three prespecified time points: baseline (T0), immediately after completion of the educational program (T1), and six months after intervention completion (T2). The primary outcome is VAP prevention knowledge. Secondary nurse-level outcomes include reflective nursing practice related to invasive mechanical ventilation and quality of nursing care. Family satisfaction with ICU care is evaluated as a family-level secondary outcome using the FS-ICU 24R. Family respondents are recruited independently of participating nurses and are linked to the relevant ICU and assessment period rather than to individual nurses.
The primary treatment effect is evaluated by examining the difference in change between intervention and control groups over time, with particular emphasis on the group-by-time interaction from baseline to the immediate post-intervention assessment. The six-month assessment evaluates retention and sustainability of intervention effects. Longitudinal analyses account for the clustered nature of the trial and repeated measurements.
The study was conducted among attending nurses working in intensive care units affiliated with the Ministry of Health (MOH), Jordan, during the period from August 2025 to February 2026.
- Being tested
- Theory-Based Structured Educational Program, Usual Care
- Keywords
- Ventilator-Associated Pneumonia, VAP Prevention, Intensive Care Unit, Critical Care Nursing, Nursing Education, Reflective Nursing Practice, Invasive Mechanical Ventilation, Quality of Nursing Care, Family Satisfaction, Simulation-Based Education, Cluster-Randomized Controlled Trial
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory-Based Structured Educational ProgramBehavioural
A standardized, theory-based structured educational program developed for ICU nurses and grounded in Schön's Reflective Practice Theory. The program consists of four weekly sessions, each lasting approximately three hours, for approximately 12 total contact hours. The sessions integrate evidence-based VAP prevention education, clinical decision-making, invasive mechanical ventilation nursing care, case-based learning, simulation-based learning, reflective exercises, structured debriefing, and practice-improvement planning. The intervention is designed to support the application of VAP prevention knowledge through clinical reasoning and reflective nursing practice.
Usual CareBehavioural
Usual institutional care and education provided to ICU nurses according to routine hospital policies and clinical practices. Routine institutional education, patient-safety procedures, and standard clinical care are not withheld. The study-specific theory-based structured educational program is not provided to control ICUs during the active intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Theory-Based Structured Educational Program | Experimental | Participants in ICUs assigned to the intervention group receive a theory-based structured educational program designed to improve VAP prevention knowledge, reflective nursing practice related to invasive mechanical ventilation, and quality of nursing care. The program consists of four weekly sessions of approximately three hours each and incorporates interactive education, case-based learning, clinical scenarios, simulation, reflective exercises, structured debriefing, and practice-improvement planning. Receives: Behavioral: Theory-Based Structured Educational Program |
| Usual Care | Active comparator | Participants in ICUs assigned to the control group receive usual institutional care and education. Routine institutional education, clinical policies, and patient-safety procedures are not withheld. The study-specific structured educational program is not provided to control ICUs during the active intervention period. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP Prevention Knowledge
VAP prevention knowledge among ICU nurses, assessed using the validated VAP knowledge questionnaire developed by Labeau et al. Higher scores indicate greater knowledge regarding VAP prevention.
Measured: Baseline (T0) to immediately post-intervention (T1), with a six-month follow-up assessment (T2) to evaluate retention and sustainability.
Secondary outcomes (3)
Reflective Nursing Practice Related to Invasive Mechanical Ventilation
Reflective nursing practice related to invasive mechanical ventilation, assessed using the Questionnaire for Reflective Practice of Nursing Involving Invasive Mechanical Ventilation (Q-RPN-IMV). Higher scores indicate a greater level of reflective nursing practice.
Measured: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).
Quality of Nursing Care in the Intensive Care Unit
Quality of nursing care in the ICU, assessed using the Quality of Nursing Care Scale-ICU. Higher scores indicate better quality of nursing care according to the instrument's established scoring framework.
Measured: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).
Family Satisfaction with ICU Care
Family satisfaction with ICU care, assessed at the family level using the Family Satisfaction in the ICU (FS-ICU 24R). The outcome reflects family members' satisfaction with ICU care, including satisfaction with care and decision-making and communication.
Measured: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Aug 2025
- Primary completion1 Feb 2026
- Study completion1 Sep 2026
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 Ventilator-Associated Pneumonia Prevention and Intensive Care Nursing CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, parallel-group cluster-randomized controlled trial in which intensive care units (ICUs) are the units of randomization. Eligible ICUs are randomly allocated in a 1:1 ratio to either the theory-based structured educational program or usual care. Nurses within each ICU receive the intervention assigned to their cluster. Cluster randomization is used to minimize contamination among nurses working within the same ICU.
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- JAWAD AHMAD ABU-SHENNAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JAWAD AHMAD ABU-SHENNAR, Jerash Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820826
- Sponsor's protocol ID
- VAP-ICU-JORDAN-2025
- Acronym
- TSEP-VAP-2026
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
PMID 28008700
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Theory-Based Structured Educational Program on VAP Prevention Knowledge, Reflective Nursing Practice, Quality of Nursing Care, and Family Satisfaction With ICU Care: A Multicenter Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07820826
- Acronym / sponsor ID
- TSEP-VAP-2026 / VAP-ICU-JORDAN-2025
- Keywords
- Ventilator-Associated Pneumonia, VAP Prevention, Intensive Care Unit, Critical Care Nursing, Nursing Education, Reflective Nursing Practice, Invasive Mechanical Ventilation, Quality of Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- JAWAD AHMAD ABU-SHENNARUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 15 Sep 2026 (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.
Ventilator-associated pneumonia (VAP) is an important challenge in intensive care and requires nurses to apply evidence-based preventive practices consistently in mechanically ventilated patients. This multicenter cluster-randomized controlled trial evaluates the effectiveness of a theory-based structured educational program designed to improve VAP prevention knowledge, reflective nursing practice related to invasive mechanical ventilation, quality of nursing care, and family satisfaction with intensive care unit (ICU) care. The program integrates evidence-based VAP prevention education with clinical decision-making, case-based learning, simulation, reflective exercises, structured debriefing, and practice-improvement planning. Adult ICU nurses working in Ministry of Health hospitals in Jordan are assigned by ICU cluster to either the educational intervention or usual care. Outcomes are assessed at baseline, immediately after the intervention, and six months after completion to evaluate immediate effects and sustainability. VAP prevention knowledge is the primary outcome, while reflective nursing practice, quality of nursing care, and family satisfaction with ICU care are secondary outcomes.
Detailed description
This study is a national, multicenter, two-arm, parallel-group cluster-randomized controlled trial evaluating a theory-based structured educational program for nurses working in adult intensive care units (ICUs) affiliated with the Ministry of Health in Jordan. Cluster randomization is conducted at the ICU level to reduce contamination among nurses working within the same clinical environment.
The educational program is theoretically grounded in Schön's Reflective Practice Theory and was developed to support the integration of evidence-based VAP prevention knowledge with clinical reasoning and reflective nursing practice. The program consists of four weekly educational sessions, each lasting approximately three hours, for a total of approximately 12 contact hours. Educational strategies include interactive lectures, case-based learning, group discussion, clinical scenarios, demonstration, simulation-based learning, reflective exercises, structured debriefing, and practice-improvement planning.
The first session focuses on VAP prevention knowledge and clinical decision-making, including VAP risk factors, mechanisms contributing to VAP development, evidence-based preventive practices, oral care, positioning, airway and secretion management, aspiration prevention, hand hygiene, and relevant ventilator-care bundle components. The second session addresses nursing care of mechanically ventilated patients and the integration of reflective practice into routine ICU care. The third session uses simulation-based clinical scenarios involving mechanically ventilated patients and is followed by structured reflective debriefing. The fourth session integrates the major concepts, addresses barriers to implementation, and supports the development of individualized practice-improvement plans.
Participants in the control group receive usual institutional care and education. Routine institutional education and patient-safety procedures are not withheld. The study-specific structured educational program is not provided to control ICUs during the active intervention period.
Study outcomes are assessed at three prespecified time points: baseline (T0), immediately after completion of the educational program (T1), and six months after intervention completion (T2). The primary outcome is VAP prevention knowledge. Secondary nurse-level outcomes include reflective nursing practice related to invasive mechanical ventilation and quality of nursing care. Family satisfaction with ICU care is evaluated as a family-level secondary outcome using the FS-ICU 24R. Family respondents are recruited independently of participating nurses and are linked to the relevant ICU and assessment period rather than to individual nurses.
The primary treatment effect is evaluated by examining the difference in change between intervention and control groups over time, with particular emphasis on the group-by-time interaction from baseline to the immediate post-intervention assessment. The six-month assessment evaluates retention and sustainability of intervention effects. Longitudinal analyses account for the clustered nature of the trial and repeated measurements.
The study was conducted among attending nurses working in intensive care units affiliated with the Ministry of Health (MOH), Jordan, during the period from August 2025 to February 2026.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm, parallel-group cluster-randomized controlled trial in which intensive care units (ICUs) are the units of randomization. Eligible ICUs are randomly allocated in a 1:1 ratio to either the theory-based structured educational program or usual care. Nurses within each ICU receive the intervention assigned to their cluster. Cluster randomization is used to minimize contamination among nurses working within the same ICU.
| Arm | Type | Receives |
|---|---|---|
| Theory-Based Structured Educational Program | Experimental | Behavioral: Theory-Based Structured Educational ProgramParticipants in ICUs assigned to the intervention group receive a theory-based structured educational program designed to improve VAP prevention knowledge, reflective nursing practice related to invasive mechanical ventilation, and quality of nursing care. The program consists of four weekly sessions of approximately three hours each and incorporates interactive education, case-based learning, clinical scenarios, simulation, reflective exercises, structured debriefing, and practice-improvement planning. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants in ICUs assigned to the control group receive usual institutional care and education. Routine institutional education, clinical policies, and patient-safety procedures are not withheld. The study-specific structured educational program is not provided to control ICUs during the active intervention period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Registered nurses employed by a participating Ministry of Health hospital in Jordan.
- Nurses assigned to a participating adult intensive care unit (ICU).
- Nurses providing direct patient care to mechanically ventilated or critically ill patients.
- Nurses with sufficient clinical experience to participate in the study procedures.
- Willingness to participate voluntarily and provide written informed consent.
Key exclusion criteria (3 listed)
- Administrative nurses without direct bedside responsibilities.
- Nurses on extended leave during the intervention period.
- Nurses expected to leave the participating ICU before completion of the immediate post-intervention assessment.
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 |
|---|---|---|
| Theory-Based Structured Educational ProgramA standardized, theory-based structured educational program developed for ICU nurses and grounded in Schön's Reflective Practice Theory. The program consists of four weekly sessions, each lasting approximately three hours, for approximately 12 total contact hours. The sessions integrate evidence-based VAP prevention education, clinical decision-making, invasive mechanical ventilation nursing care, case-based learning, simulation-based learning, reflective exercises, structured debriefing, and practice-improvement planning. The intervention is designed to support the application of VAP prevention knowledge through clinical reasoning and reflective nursing practice. | Behavioural | Theory-Based Structured Educational Program |
| Usual CareUsual institutional care and education provided to ICU nurses according to routine hospital policies and clinical practices. Routine institutional education, patient-safety procedures, and standard clinical care are not withheld. The study-specific theory-based structured educational program is not provided to control ICUs during the active intervention period. | Behavioural | Usual Care |
Primary outcome
VAP Prevention Knowledge
Time frame: Baseline (T0) to immediately post-intervention (T1), with a six-month follow-up assessment (T2) to evaluate retention and sustainability.
VAP prevention knowledge among ICU nurses, assessed using the validated VAP knowledge questionnaire developed by Labeau et al. Higher scores indicate greater knowledge regarding VAP prevention.
3 secondary outcomes
Reflective Nursing Practice Related to Invasive Mechanical Ventilation
Time frame: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).
Quality of Nursing Care in the Intensive Care Unit
Time frame: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).
Family Satisfaction with ICU Care
Time frame: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).
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 15 Sep 2026.
- BackgroundPMID 28008700
- Official FS-ICU website providing information on the Family Satisfaction in the ICU (FS-ICU 24R) survey version used in this study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory-Based Structured Educational Program in people with Ventilator-Associated Pneumonia Prevention and Intensive Care Nursing Care, run by JAWAD AHMAD ABU-SHENNAR at 1 site in Jordan.
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 5 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 15 Sep 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 Jordan. 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?
VAP Prevention Knowledge (time frame: Baseline (T0) to immediately post-intervention (T1), with a six-month follow-up assessment (T2) to evaluate retention and sustainability.). 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 NCT07820826, 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 15 Sep 2026.