NCT02856529

Brief Summary

Considering the importance of infection control practices, Madinah Public Health Department launched a new license program for healthcare workers, the Basic Infection Control Skills License program (BICSL). BICSL has been launched to train healthcare workers all over the region in a scientific standardized way. To assess BICSL effectiveness, a non-randomized control study will be conducted in two of the general hospitals in Madinah. An electronic bilingual self-administrated valid and reliable questionnaire will be used to evaluate the workers knowledge and practices before and after three and six months of the intervention. The knowledge and practice answers were scored and the scores were categorized to facilitate the comparison. A BICSL certified trainer will be conducting the intervention, a one to one training session. A SPSS program will be used to analyze the data. Administrative and ethical approval was obtained from Madinah health authority. The participants will complete an electronic consent before they fill the questionnaire. Confidentiality and privacy as well as freedom to participate or not will be insured to all participants. This study will assess the license effectiveness in improve knowledge and compliance.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

June 18, 2016

Last Update Submit

August 2, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Self administered knowledge

    will be measured by questionnaire

    3 months

  • Self administered practice

    will be measured by questionnaire

    3 months

Secondary Outcomes (2)

  • Self administered knowledge

    3 months

  • Self administred practices

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

A BICSL certified trainer conduct the intervention. It includes hand on training session standardized in a scientific way. The participants trained on hand hygiene and use of PPE. Also, it includes meningitis and influenza vaccination as well as fit test to verify the correctly fitting of the respirator.

Other: Training

Control

ACTIVE COMPARATOR

A general session about the basic of infection control was conducted for this group. The lecture performed in the same way of the regular training fulfill.

Other: General session

Interventions

The Basic Infection Control Skills License program (BICSL) includes meningitis and influenza vaccination as well as fit test to verify the correctly fitting of the respirator. Also, the license program includes training on hand hygiene and the use of personal protective equipment (PPE). To get the license, each participants must get the vaccination and attend one to one training session with a program trainer 34.

Intervention

A general session about the basic of infection control was conducted for this group. The lecture performed in the same way of the regular training fulfill.

Control

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working in the chosen hospitals.
  • Health care worker (Physician, nurse or technician) of any gender, age, or experience.

You may not qualify if:

  • Refuse to participate in the study.
  • Have BICSL certificate before the study implemented.
  • On leave during study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2016

First Posted

August 5, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share