- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05192967
Development and Efficiency Evaluation of a Respiratory Disease Pandemics Preparedness Training Program for Pre-Hospital Emergency Healthcare Workers
Pre-hospital emergency health workers, who are on the front line among healthcare workers, are at greater risk in epidemic situations, as they are the first team to come into contact with the patient and are responsible for making necessary interventions by staying in close contact with the patient during the transfer process (1, 2). Health workers need to improve their knowledge, attitudes and skills during the pandemic process; on the other hand, they experience mental and communicative problems more strikingly. It is essential to increase the continuity of development, mental resilience, and communication of healthcare professionals(3). A randomised controlled study was planned to prepare a training program to improve pre-hospital emergency health workers' knowledge, attitudes, and skills about pandemic preparations and evaluate its effectiveness.
The intervention study was conducted among pre-hospital emergency health workers in Eskişehir between July 2020 and December 2021. Ethics committee approval and administrative permissions were obtained. In the study, when the type 1 (α) error was 5%, and the type 2 error (1-β) was 95%, the effect size was accepted as 0.5, and it was calculated with the G*Power 3.1 statistical program that there should be at least 47 people in the groups. The study population consists of paramedics and emergency medical technicians(EMT) (N=420) in Eskişehir city, Turkey. Each participant in the study population was given a score by propensity score matching analysis according to age, gender, occupational group (paramedic and EMT), working time (year) variables. The study list was arranged according to the initials of their surnames, and the drawing method was used while assigning those with similar scores to four groups (experimental 1, experimental 2, control 1, control 2). Four groups, two interventions and two controls, were included in the study.
The work consisted of five stages:
- Determining the needs in education,
- Development of educational materials,
- Making pre-training measurements,
- Implementation of the training program,
- Performing post-training measurements. As a result of the evaluation, the subjects that healthcare professionals need to train were determined as knowledge, attitude, skills, infection control measures, communication skills, psychological resilience and attitudes of healthcare professionals to the patient in a simulated case and pandemic. The appropriate data collection form was chosen after the training program's content was determined. Before the intervention, the first measurements were taken via the COVID-19 knowledge, attitude, skills, and perceived barriers to infection control questionnaire, the communication competence scale, the psychological resilience scale, and the data collection form, including the simulated case approach. After the training program's content was determined, training was given to the intervention group with a video screening and the control group with the classical training method. After the training program, a post-test was applied after a four-week follow-up.
연구 개요
상태
상세 설명
The intervention study was conducted among pre-hospital emergency health workers in Eskişehir between July 2020 and December 2021. Ethics committee approval and administrative permissions were obtained. In the study, when the type 1 (α) error was 5%, and the type 2 error (1-β) was 95%, the effect size was accepted as 0.5, and it was calculated with the G*Power 3.1 statistical program that there should be at least 47 people in the groups. The study population consists of paramedics and emergency medical technicians (N=420) in Eskişehir city, Turkey. Each participant in the study population was given a score by propensity score matching analysis according to age, gender, occupational group (paramedic and ATT), working time (year) variables. The study list was arranged according to the initials of their surnames, and the drawing method was used while assigning those with similar scores to four groups (experimental 1, experimental 2, control 1, control 2). Four groups, two interventions and two controls, were included in the study. The work consisted of five stages:
- Determining the needs in education,
- Development of educational materials,
- making pre-training measurements,
- Implementation of the training program,
- Performing post-training measurements. As a result of the evaluation, the training needs of healthcare professionals were determined as knowledge, attitude, skills, infection control measures, communication skills, psychological resilience and approach to COVID-19 positive case. After the training program's content was determined, training was given to the intervention group with a video screening and the control group with the classical training method.
Measurement tools used in the study:
- Questionnaire on knowledge, skills, attitudes and perceived barriers in infection control about COVID-19: Adapting the questionnaire named "Knowledge, attitude, practice and perception barriers among healthcare professionals regarding COVID-19", developed by Saqlain et al., into Turkish, and conducting a reliability and validity study It was made by Caliskan Pala et al. in 2021 (4, 5).
- Simulated case checklist: It was created to evaluate the case approach of healthcare professionals during the pandemic process. The template of events for applied and critical healthcare simulation (Teach Sim) and The Simulation team assessment tool (STAT) created simulated cases. According to START, which is the most widely used triage system, a total of 111 cases were developed, with cases according to green, yellow, and red triage codes. (6). The approach of each participant to a COVID-19 positive case with a green code ( Minor injuries), one yellow ( Non-life-threatening injury ), and one red ( Life-threatening injury ) was evaluated. Each scenario consisted of six steps, 20 questions regarding infection control measures, patient history and physical examination, preliminary diagnosis, medical intervention, communication, and delivering the patient to the health institution. Each item on the scale was scored according to its completion status. The score that can be obtained according to the number of questions in the steps was standardised.
- communication skills: This scale, which aims to measure the communication skills of individuals in general, was developed by Wiemann in 1977 and adapted into Turkish by Koca and Erigüç in 2017 (7, 8). The scale consists of eight sub-dimensions: "Social Behavior Competence", "Individual aspects in communication", "Empathy competency", "Adaptability", "Sensitivity Competence", "Communication Encouragement Competence", "Human Relations", "Listening Competence".
- psychological resilience: The scale was developed by Friborg et al. in 2003, and Basım and Çetin established Turkish validity and reliability in 2011 (9, 10). The structural style consists of six sub-areas: future perception, family harmony, self-perception, and social competence.
Hypotheses:
- Is the pandemic preparedness training program effective in developing knowledge, attitudes and skills in pre-hospital emergency health workers compared to the control group trained with the classical method?
- Is the pandemic preparedness training program effective in developing communication competence in prehospital emergency health workers compared to the control group trained with the classical method?
- Is the pandemic preparedness training program effective in developing psychological resilience in prehospital emergency health workers compared to the control group trained with the classical method?
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Eskisehir, 칠면조, 26200
- Eskisehir Osmangazi University
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:Being a pre-hospital emergency health worker(paramedic or EMT) -
Exclusion Criteria:not completing the stages of the study
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental 1
The training program determined to the experimental group was applied with video. Training program content:
|
A training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a video demonstration.
|
|
실험적: Experimental 2
The training program determined to the experimental group was applied with video. Training program content:
|
A training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a video demonstration.
|
|
다른: Control 1
The training program determined to the control group was applied with classical method. Training program content:
|
A training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a classical method.
|
|
다른: Control 2
The training program determined to the control group was applied with classical method. Training program content:
|
A training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a classical method.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Knowledge, attitude, practice and perceived barriers among healthcare workers regarding COVID-19 Questionnaire
기간: One month
|
One month
|
|
|
Simulated case checklist
기간: One month
|
One month
|
|
|
Communication skills
기간: One month
|
Measurement was made with the communication competence scale
|
One month
|
|
Psychological resilience
기간: One month
|
Measurement was made with the psychological resilience scale
|
One month
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Seval CALISKAN PALA, ESOGU
- 수석 연구원: Selma METİNTAS, ESOGU
- 연구 의자: Engin OZAKIN, ESOGU
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .