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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
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 17, 2016
    Last Updated
    July 19, 2016
    Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Shahid Beheshti University, Tehran University of Medical Sciences
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    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

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    Effectiveness of Different Educational Strategies on the KAP, Psychological and Clinical Outcomes

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