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

Ventilator-associated Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838160
• Other study ID #: VAP BMSU
• Status: Completed
• Phase: N/A
• First received: July 17, 2016
• Last updated: July 19, 2016
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2016
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Behavioral:
• Routine Care
After baseline measurement, Group 1 did not receive any intervention or education.
• Routine care Plus the designed booklet
Group 2 received only the designed booklet without any participation in the oral presentation.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University	Shahid Beheshti University, Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAP Occurrence	VAP Occurrence according to the clinical sings and symptoms and laboratory tests	One year	Yes