Health Condition 1: C10- Malignant neoplasm of oropharynx Health Condition 2: I70- Atherosclerosis Health Condition 3: M20-M25- Other joint disorders
Conditions
Interventions
Intervention1: Educational Intervention: To develop and validate a Video-Based Training Module (VBTM) as an educational intervention to enhance knowledge and adverse event (AE) reporting practices amo
Sponsors
Manipal Academy of Higher Education
Eligibility
Inclusion criteria
Inclusion criteria: For Observational Study 1. Patients who have experienced an Adverse Event 2. Patients greater than 18 year both genders who are willing to participate will be included in the study For Interventional Study 1. 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. 2. We will include the HCP with at least 1 year of experience.
Exclusion criteria
Exclusion criteria: For Observational Study 1. Patients who are unwilling to sign the Informed Consent and unwilling to participate in the study will be excluded. 2. Patients who are terminally ill or in a coma will be excluded. For Interventional Study 1. The HCPs who are not willing to participate in the study. 2. Pharmacists, medical practitioners nurses and Allied Technicians having less than 1 year of experience are ineligible to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. This study will collect and analyze data & estimate the incidence rate of medical device-related adverse events based on risk-based classification. 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.Timepoint: 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Rajesh R
Manipal College of Pharmaceutical Sciences, Manipal
Outcome results
None listed