Effectiveness of Different Educational Strategies on the KAP, Psychological and Clinical Outcomes
Primary Purpose
Ventilator-associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator-associated Pneumonia focused on measuring educational strategies, KAP, psychological and clinical outcomes, intensive care unit, follow-up study, RCT
Eligibility Criteria
Inclusion Criteria:
- Holding a degree qualification as a registered nurse
- being a direct care provider (bedside)
Exclusion Criteria:
- Nurses with less than one year experience in critical care unit
- working less than whole study period were excluded
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
booklet Group
Oral presentations group
Clinical teaching in bedside Group
Arm Description
Outcomes
Primary Outcome Measures
VAP Occurrence
VAP Occurrence according to the clinical sings and symptoms and laboratory tests
Secondary Outcome Measures
Full Information
NCT ID
NCT02838160
First Posted
July 17, 2016
Last Updated
July 19, 2016
Sponsor
Baqiyatallah Medical Sciences University
Collaborators
Shahid Beheshti University, Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02838160
Brief Title
Effectiveness of Different Educational Strategies on the KAP, Psychological and Clinical Outcomes
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqiyatallah Medical Sciences University
Collaborators
Shahid Beheshti University, Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia
Keywords
educational strategies, KAP, psychological and clinical outcomes, intensive care unit, follow-up study, RCT
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
booklet Group
Arm Type
Experimental
Arm Title
Oral presentations group
Arm Type
Experimental
Arm Title
Clinical teaching in bedside Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Routine Care
Intervention Description
After baseline measurement, Group 1 did not receive any intervention or education.
Intervention Type
Behavioral
Intervention Name(s)
Routine care Plus the designed booklet
Intervention Description
Group 2 received only the designed booklet without any participation in the oral presentation.
Intervention Type
Behavioral
Intervention Name(s)
Routine care Plus the designed booklet Plus participation in oral presentations
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAP Occurrence
Description
VAP Occurrence according to the clinical sings and symptoms and laboratory tests
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Holding a degree qualification as a registered nurse
being a direct care provider (bedside)
Exclusion Criteria:
Nurses with less than one year experience in critical care unit
working less than whole study period were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Vahedian-azimi, Postdoc
Organizational Affiliation
Baqiyatallah Universiy of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Different Educational Strategies on the KAP, Psychological and Clinical Outcomes
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