NCT04252326

Brief Summary

Adverse drug reactions are an important public health consern that affects physician prescriptions and practice. The responsibilities of healthcare professionals in monitoring, prevention, treatment and reporting of drug hypersensitivity reactions and drug allergies are essential for patient safety. Providing drug safety must be one of the main goals to be achieved for every member of our society. In our study, we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients and to determine the risk factors that may affect them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

January 29, 2020

Last Update Submit

September 18, 2020

Conditions

Keywords

Healthcare workersAdverse drug reactions

Outcome Measures

Primary Outcomes (2)

  • we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients

    1. The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know). A triple variable scale was used for knowledge level (0 to 2: 0, false; 1, true; 2, do not know). 2. The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement (1 to 5; 1 strongly disagree; 2, disagree; 3, uncertain; 4, agree; 5, strongly agree) 3. The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices (1 - 5: 1, never; 2, very rarely; 3, sometimes; 4, often; 5, always).

    It is planned to fill the questionnaire in 2 hours.

  • we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients

    The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know). 2\. The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices

    It is planned to fill the questionnaire in 2 hours.

Secondary Outcomes (1)

  • to determine the risk factors that may affect the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patient

    It is planned to fill the questionnaire in 2 hours.

Study Arms (3)

Doctor

ACTIVE COMPARATOR

Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children

Other: Survey

Nurse

ACTIVE COMPARATOR

Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children

Other: Survey

Dentist

ACTIVE COMPARATOR

Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children

Other: Survey

Interventions

SurveyOTHER

Doctors, Nurses and Dentists filled survey about adverse drug reractions

DentistDoctorNurse

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The study included healthcare workers including medical doctors, nurses and dentists who perform interventions on children (0-18 years of age).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

Related Publications (2)

  • Dorji C, Tragulpiankit P, Riewpaiboon A, Tobgay T. Knowledge of Adverse Drug Reaction Reporting Among Healthcare Professionals in Bhutan: A Cross-Sectional Survey. Drug Saf. 2016 Dec;39(12):1239-1250. doi: 10.1007/s40264-016-0465-2.

    PMID: 27743333BACKGROUND
  • Seid MA, Kasahun AE, Mante BM, Gebremariam SN. Healthcare professionals' knowledge, attitude and practice towards adverse drug reaction (ADR) reporting at the health center level in Ethiopia. Int J Clin Pharm. 2018 Aug;40(4):895-902. doi: 10.1007/s11096-018-0682-0. Epub 2018 Aug 9.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nazlı Ercan, MD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Allergy and Immunology Specialist

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 5, 2020

Study Start

January 1, 2020

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations