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The Knowledge, Attitudes and Practices of Healthcare Workers on Drug Hypersensitivity Reactions in Children (KAPHWDHRC)

Primary Purpose

Adverse Drug Reactions

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Survey

About this trial

This is an interventional health services research trial for Adverse Drug Reactions focused on measuring Healthcare workers, Adverse drug reactions

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Doctor

Nurse

Dentist

Arm Description

Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children

Outcomes

Primary Outcome Measures

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). A triple variable scale was used for knowledge level (0 to 2: 0, false; 1, true; 2, do not know). 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) 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).

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

Secondary Outcome Measures

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

Participants'demographic questions regarding the age, gender, profession, duration in the profession, title and educational status of the participants may effect their surveys scores

Full Information

NCT ID

NCT04252326

First Posted

January 29, 2020

Last Updated

September 18, 2020

Sponsor

Saglik Bilimleri Universitesi

1. Study Identification

Unique Protocol Identification Number

NCT04252326

Brief Title

The Knowledge, Attitudes and Practices of Healthcare Workers on Drug Hypersensitivity Reactions in Children

Acronym

KAPHWDHRC

Official Title

The Knowledge, Attitudes and Practices of Healthcare Workers on Drug Hypersensitivity Reactions in Children: A Tertiary Center Experience

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

February 1, 2020 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study was carried out in a capital-located university hospital with a capacity of 1150 beds. Healthcare workers who are authorized to intervene in children (0-18 age group) including medical doctors, nurses and dentists were enrolled to study. In the evaluation of the knowledge, attitudes, and behaviors of the participants about drug hypersensitivity reactions in children, a study questionnaire was developed by pediatric allergy and immunology specialists and pediatric nurses by considering the other studies on the same subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adverse Drug Reactions

Keywords

Healthcare workers, Adverse drug reactions

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

354 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doctor

Arm Type

Active Comparator

Arm Description

Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children

Arm Title

Nurse

Arm Type

Active Comparator

Arm Description

Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children

Arm Title

Dentist

Arm Type

Active Comparator

Arm Description

Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children

Intervention Type

Other

Intervention Name(s)

Survey

Intervention Description

Doctors, Nurses and Dentists filled survey about adverse drug reractions

Primary Outcome Measure Information:

Title

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

Description

Time Frame

It is planned to fill the questionnaire in 2 hours.

Title

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

Description

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

Time Frame

It is planned to fill the questionnaire in 2 hours.

Secondary Outcome Measure Information:

Title

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

Description

Participants'demographic questions regarding the age, gender, profession, duration in the profession, title and educational status of the participants may effect their surveys scores

Time Frame

It is planned to fill the questionnaire in 2 hours.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nazlı Ercan, MD

Organizational Affiliation

Saglik Bilimleri Universitesi

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Ankara

State/Province

Etlik

ZIP/Postal Code

06010

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27743333

Citation

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.

Results Reference

background

PubMed Identifier

30094559

Citation

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.

Results Reference

result

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The Knowledge, Attitudes and Practices of Healthcare Workers on Drug Hypersensitivity Reactions in Children

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