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

July 19, 2016 updated by: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: booklet Group
Behavioral: Routine Care
After baseline measurement, Group 1 did not receive any intervention or education.
Behavioral: Routine care Plus the designed booklet
Group 2 received only the designed booklet without any participation in the oral presentation.
EXPERIMENTAL: Oral presentations group
Behavioral: Routine Care
After baseline measurement, Group 1 did not receive any intervention or education.
Behavioral: Routine care Plus the designed booklet
Group 2 received only the designed booklet without any participation in the oral presentation.
Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations
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.
EXPERIMENTAL: Clinical teaching in bedside Group
Behavioral: Routine Care
After baseline measurement, Group 1 did not receive any intervention or education.
Behavioral: Routine care Plus the designed booklet
Group 2 received only the designed booklet without any participation in the oral presentation.
Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations
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.
Behavioral: Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAP Occurrence
Time Frame: One year
VAP Occurrence according to the clinical sings and symptoms and laboratory tests
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baqiyatallah Medical Sciences University

Collaborators

Shahid Beheshti University
Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

July 17, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (ESTIMATE)

July 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAP BMSU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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