Evaluation and Optimization of Materiovigilance Activities in a Tertiary Care Teaching Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 789
- 试验地点
- 1
- 主要终点
- 1. This study will collect and analyze data & estimate the incidence rate of medical device-related adverse events based on risk-based classification.
研究概览
简要总结
This study is a three year prospective mixed methods study that aims to evaluate and optimize materiovigilance activities in a tertiary care teaching hospital. The project is divided into two parts: a prospective observational study on patients experiencing adverse events related to medical devices and a prospective interventional study assessing healthcare professionals knowledge attitude and practice using mixed method approach.
The study will explore usage patterns and estimate the incidence of medical device-related adverse events. It will also assess healthcare professionals’ knowledge, attitudes, and practices (KAP) regarding materiovigilance using qualitative and quantitative surveys. To enhance knowledge and reporting practices, the project involves developing and validating video-based training modules for healthcare professionals. The effectiveness of video-based interventions will be assessed by comparing pre and post training outcomes. Recruitment will be stratified across departments and professional categories to ensure appropriate sample representation. Validated tools such as the Medical Device Adverse Event Reporting Form WHO UMC causality scales, and Common Terminology Criteria for Adverse Events will be utilized. Thematic analysis will be employed for qualitative data while quantitative analysis will use SPSS.
Expected outcomes include improved awareness and reporting of device related adverse events, enhanced patient safety and evidence based recommendations for better regulatory frameworks. This study addresses a major research gap in India following the Medical Device Rules 2017 and represents the first comprehensive mixed methods assessment of materiovigilance among healthcare professionals in the Indian context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •For Observational Study
- •Patients who have experienced an Adverse Event
- •Patients greater than 18 year both genders who are willing to participate will be included in the study For Interventional Study
- •Pharmacists Physicians nurses and Allied Technicians with a registered OR completed degree, who provide written informed consent will be eligible to participate in the study.
- •We will include the HCP with at least 1 year of experience.
排除标准
- •For Observational Study
- •Patients who are unwilling to sign the Informed Consent and unwilling to participate in the study will be excluded.
- •Patients who are terminally ill or in a coma will be excluded.
- •For Interventional Study
- •The HCPs who are not willing to participate in the study.
- •Pharmacists, medical practitioners nurses and Allied Technicians having less than 1 year of experience are ineligible to participate in the study.
结局指标
主要结局
1. This study will collect and analyze data & estimate the incidence rate of medical device-related adverse events based on risk-based classification.
时间窗: 1. This study will collect and analyze data & estimate the incidence rate of medical device-related adverse events based on risk-based classification is an observational study conducted for 3 Year data will be collected daily by visiting the department. | 2. The implementation of video-based training modules (VBTM) is expected to boost the knowledge, attitudes, and practices (KAP) regarding materiovigilance among healthcare professionals. This is an interventional study which will be conducted in Three phases. | Phase I: Pre-Interventional Phase: Gap Analysis by using a mixed-method approach (conducting qualitative and quantitative surveys) qualitative survey 6 months data collection), followed by quantitative survey for 6 months data collection. | Phase II: Interventional Phase: Development of video-based interventional training modules for healthcare professionals. (6 months for preparing video and validation) | Phase III: Post-interventional Phase: Assessment of the impact of the video-based training modules using a mixed-method approach (qualitative and quantitative surveys). (Qualitative survey for 6 months data collection) (Quantitative Survey for 6 months data collection)
2. The implementation of video-based training modules (VBTM) is expected to boost the knowledge, attitudes, and practices (KAP) regarding materiovigilance among healthcare professionals. This will help to create awareness in the healthcare professionals on the significance of materiovigilance.
时间窗: 1. This study will collect and analyze data & estimate the incidence rate of medical device-related adverse events based on risk-based classification is an observational study conducted for 3 Year data will be collected daily by visiting the department. | 2. The implementation of video-based training modules (VBTM) is expected to boost the knowledge, attitudes, and practices (KAP) regarding materiovigilance among healthcare professionals. This is an interventional study which will be conducted in Three phases. | Phase I: Pre-Interventional Phase: Gap Analysis by using a mixed-method approach (conducting qualitative and quantitative surveys) qualitative survey 6 months data collection), followed by quantitative survey for 6 months data collection. | Phase II: Interventional Phase: Development of video-based interventional training modules for healthcare professionals. (6 months for preparing video and validation) | Phase III: Post-interventional Phase: Assessment of the impact of the video-based training modules using a mixed-method approach (qualitative and quantitative surveys). (Qualitative survey for 6 months data collection) (Quantitative Survey for 6 months data collection)
次要结局
未报告次要终点
研究者
Ashutosh Vishwas Bhosale
Manipal College of Pharmaceutical Sciences, Manipal