Ventilator-associated PneumoniaNCT02838160
Effectiveness of Different Educational Strategies on the KAP, Psychological and Clinical Outcomes
A study testing Routine Care, Routine care Plus the designed booklet and Routine care Plus the designed booklet Plus participation in oral presentations in people with Ventilator-associated Pneumonia, run by Baqiyatallah Medical Sciences University.
Trial summary
A randomized controlled triple blinded clinical trial with repeated measurements. The reporting of this study complies with the CONSORT (Consolidated Standards of Reporting Trials) statement for trials of non-pharmacological treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- What is being tested?
- Routine Care, Routine care Plus the designed booklet and Routine care Plus the designed booklet Plus participation in oral presentations
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jun 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Holding a degree qualification as a registered nurse
- being a direct care provider (bedside)
Who cannot join
- Nurses with less than one year experience in critical care unit
- working less than whole study period were excluded
About this study
Official title: Effectiveness of Different Educational Strategies on the Knowledge, Attitude, and Practice ( KAP), Psychological and Clinical Outcomes in Intensive Care Unit: A Triple-blinded Randomized Controlled Follow-up Study
A randomized controlled triple blinded clinical trial with repeated measurements. The reporting of this study complies with the CONSORT (Consolidated Standards of Reporting Trials) statement for trials of non-pharmacological treatments.
The first aim of the study was to evaluate the effectiveness of the three competing interventions on the critical care nurses' knowledge of, attitudes toward and adherence to 17 ventilator bundle components; the second aim was to determine the effectiveness of adherence to 17 ventilator bundle components with pre-defined ventilator bundle on the psychological factors of critical care nurses including nurses' stressors in intensive care unit (ICU), perceived stress, trait and state anxieties; the third aim was to evaluate their impact on the clinical outcomes; and the fourth aim was comparing KAP and psychological factors with clinical outcomes.
Read the detailed description
The multi-center study was conducted in four academic teaching hospitals in Tehran, Iran. The study consisted of a 3-month baseline observation period (October 2011-December 2011, Period 1), followed by a 6-month intervention period (January 2012 to June 2012) and a 3 (July 2012-September 2012, Period 2), 15 (October 2012-December 2013, Period 3) and 21-months (January 2014-June 2015, Period 4) follow-up periods. The protocol for Evidence based guidelines (EBGs) for preventing VAP remained unchanged throughout the study period in every ICU.
Consecutive adult patients (age ≥18 years) who were admitted to the mixed medical-surgical ICUs (>72 hours) and received invasive ventilation (>48 hours) were enrolled and monitored daily for the development of ventilator-associate pneumonia (VAP) until ICU discharge or death. Patients with any limitation of code status were excluded from the study. Convenience sample of critical care nurses were recruited through letters and telephone and face-to-face invitations. Inclusion criteria were holding a degree qualification as a registered nurse and being a direct care provider (bedside). Nurses with less than one year experience in critical care unit or working less than whole study period were excluded. An investigator at each participating medical center was responsible for initial screening and enrollment.
The sample size was determined through power analysis, which revealed that a sample size of 40 participants was required to detect a 20% difference between VAP rates in each group (α = 0.05, 1-β = 0.9; dropout = 20%). The estimation of the effect size based on a previous VAP surveillance, conducted from March 2010 to December 2010 (unpublished data).
Included nurses were randomly assigned to control or one of the three competing intervention group (allocation ratio of 1:4). Randomization was accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc.). Block randomization was performed by a computer-generated randomization list prepared by blinded biostatistician who had no clinical involvement in the trial. All nurses, data collectors, and statistician were blinded to group assignment.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- Routine Care, Routine care Plus the designed booklet, Routine care Plus the designed booklet Plus participation in oral presentations, Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside
- Keywords
- educational strategies, KAP, psychological and clinical outcomes, intensive care unit, follow-up study, RCT
- 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.
Routine CareBehavioural
After baseline measurement, Group 1 did not receive any intervention or education.
Routine care Plus the designed bookletBehavioural
Group 2 received only the designed booklet without any participation in the oral presentation.
Routine care Plus the designed booklet Plus participation in oral presentationsBehavioural
Group 3 participated in oral presentations 14 days after completing self-study booklet. Interactive, standardized and mandatory oral presentations were held five times to ensure maximum attendance of the three nursing shifts.
Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedsideBehavioural
The Group 4 received clinical teaching in bedside after completing self-study booklet and a series of interactive, standardized and mandatory 90-120-minute oral presentations.
| Study group | Role | What they receive |
|---|---|---|
| booklet Group | Experimental | Not described Receives: Behavioral: Routine Care; Behavioral: Routine care Plus the designed booklet |
| Oral presentations group | Experimental | Not described Receives: Behavioral: Routine Care; Behavioral: Routine care Plus the designed booklet; Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations |
| Clinical teaching in bedside Group | Experimental | Not described Receives: Behavioral: Routine Care; Behavioral: Routine care Plus the designed booklet; Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations; Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP Occurrence
VAP Occurrence according to the clinical sings and symptoms and laboratory tests
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated PneumoniaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University, Tehran University of Medical Sciences
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
- Investigators
- Amir Vahedian-azimi, Postdoc, Principal investigator, Baqiyatallah Universiy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838160
- Sponsor's protocol ID
- VAP BMSU
- Status last verified
- Jul 2016
- First submitted
- 17 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Educational Strategies on the Knowledge, Attitude, and Practice ( KAP), Psychological and Clinical Outcomes in Intensive Care Unit: A Triple-blinded Randomized Controlled Follow-up Study
- ClinicalTrials.gov ID
- NCT02838160
- Acronym / sponsor ID
- VAP BMSU
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- educational strategies, KAP, psychological and clinical outcomes, intensive care unit, follow-up study, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Shahid Beheshti University, Tehran University of Medical Sciences
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
A randomized controlled triple blinded clinical trial with repeated measurements. The reporting of this study complies with the CONSORT (Consolidated Standards of Reporting Trials) statement for trials of non-pharmacological treatments.
The first aim of the study was to evaluate the effectiveness of the three competing interventions on the critical care nurses' knowledge of, attitudes toward and adherence to 17 ventilator bundle components; the second aim was to determine the effectiveness of adherence to 17 ventilator bundle components with pre-defined ventilator bundle on the psychological factors of critical care nurses including nurses' stressors in intensive care unit (ICU), perceived stress, trait and state anxieties; the third aim was to evaluate their impact on the clinical outcomes; and the fourth aim was comparing KAP and psychological factors with clinical outcomes.
Detailed description
The multi-center study was conducted in four academic teaching hospitals in Tehran, Iran. The study consisted of a 3-month baseline observation period (October 2011-December 2011, Period 1), followed by a 6-month intervention period (January 2012 to June 2012) and a 3 (July 2012-September 2012, Period 2), 15 (October 2012-December 2013, Period 3) and 21-months (January 2014-June 2015, Period 4) follow-up periods. The protocol for Evidence based guidelines (EBGs) for preventing VAP remained unchanged throughout the study period in every ICU.
Consecutive adult patients (age ≥18 years) who were admitted to the mixed medical-surgical ICUs (>72 hours) and received invasive ventilation (>48 hours) were enrolled and monitored daily for the development of ventilator-associate pneumonia (VAP) until ICU discharge or death. Patients with any limitation of code status were excluded from the study. Convenience sample of critical care nurses were recruited through letters and telephone and face-to-face invitations. Inclusion criteria were holding a degree qualification as a registered nurse and being a direct care provider (bedside). Nurses with less than one year experience in critical care unit or working less than whole study period were excluded. An investigator at each participating medical center was responsible for initial screening and enrollment.
The sample size was determined through power analysis, which revealed that a sample size of 40 participants was required to detect a 20% difference between VAP rates in each group (α = 0.05, 1-β = 0.9; dropout = 20%). The estimation of the effect size based on a previous VAP surveillance, conducted from March 2010 to December 2010 (unpublished data).
Included nurses were randomly assigned to control or one of the three competing intervention group (allocation ratio of 1:4). Randomization was accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc.). Block randomization was performed by a computer-generated randomization list prepared by blinded biostatistician who had no clinical involvement in the trial. All nurses, data collectors, and statistician were blinded to group assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| booklet Group | Experimental | Behavioral: Routine Care, Behavioral: Routine care Plus the designed booklet |
| Oral presentations group | Experimental | Behavioral: Routine Care, Behavioral: Routine care Plus the designed booklet, Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations |
| Clinical teaching in bedside Group | Experimental | Behavioral: Routine Care, Behavioral: Routine care Plus the designed booklet, Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations, Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Holding a degree qualification as a registered nurse
- being a direct care provider (bedside)
Key exclusion criteria (2 listed)
- Nurses with less than one year experience in critical care unit
- working less than whole study period were excluded
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 |
|---|---|---|
| Routine CareAfter baseline measurement, Group 1 did not receive any intervention or education. | Behavioural | Clinical teaching in bedside Group, Oral presentations group, booklet Group |
| Routine care Plus the designed bookletGroup 2 received only the designed booklet without any participation in the oral presentation. | Behavioural | Clinical teaching in bedside Group, Oral presentations group, booklet Group |
| Routine care Plus the designed booklet Plus participation in oral presentationsGroup 3 participated in oral presentations 14 days after completing self-study booklet. Interactive, standardized and mandatory oral presentations were held five times to ensure maximum attendance of the three nursing shifts. | Behavioural | Clinical teaching in bedside Group, Oral presentations group |
| Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedsideThe Group 4 received clinical teaching in bedside after completing self-study booklet and a series of interactive, standardized and mandatory 90-120-minute oral presentations. | Behavioural | Clinical teaching in bedside Group |
Primary outcome
VAP Occurrence
Time frame: One year
VAP Occurrence according to the clinical sings and symptoms and laboratory tests
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 Jul 2016.
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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.
Amir Vahedian-azimi, Postdoc principal investigator
Baqiyatallah Universiy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care, Routine care Plus the designed booklet and Routine care Plus the designed booklet Plus participation in oral presentations in people with Ventilator-associated Pneumonia, run by Baqiyatallah Medical Sciences University.
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 2 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 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Occurrence (time frame: One year). 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 20 Jul 2016.