Evaluation Of Educational Intervention To Create Awareness about Adverse Event Reporting Of Medical Devices among Medical Interns and Post graduates in a tertiary care Hospital-A Quasi-Experimental Pre-Test Post-test Study
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary outcome was the change in knowledge scores regarding materiovigilance and adverse event reporting of medical devices between the pretest and posttest assessments.
研究概览
简要总结
Materiovigilance, the systematic monitoring of adverse events related to medical devices, is an essential component of patient safety. Awareness among healthcare professionals, especially interns and postgraduate residents, remains suboptimal. Educational interventions may improve knowledge, attitude and practice (KAP) regarding device safety reporting.
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 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Population: Medical Interns and Postgraduate residents currently posted at the tertiary-care hospital during the study period
- •Departmental scope: Participants from clinical, paraclinical, or preclinical medical departments
- •Availability: Able to attend the educational session and both assessments(pretest and posttest within the specified post-intervention window(1-2 weeks
- •Consent: Provides written informed consent.
- •Language/format: Comfortable with the language of instruction and questionnaire format used in the study.
排除标准
- •Prior formal training/ exposure: Attended a dedicated workshop/course/seminar focused on materiovigilance in the past 6-12 months
- •Role conflict: Members of the Institutional Materiovigilance Committee or those actively involved in device safety surveillance/teaching
- •Non-medical cadres: Nursing, Dental, Physiotherapy, Allied-Health students/staff, administrative personnel, and faculty
- •Non-participation/attrition: Declines consent, absent for the educational session, Incomplete data, logistical exclusion.
结局指标
主要结局
The primary outcome was the change in knowledge scores regarding materiovigilance and adverse event reporting of medical devices between the pretest and posttest assessments.
时间窗: T0-Pretest (Baseline): Immediately before the educational session (same day, within 0-30 min before start) | T1-Immediate Posttest (Primary endpoint) Right after the session (same day, within 0-30 min of completion.
次要结局
- Secondary Outcomes included:(1.Change in attitude scores toward materiovigilance)
- 2. Change in practice scores(T0 (Baseline Pretest))
- 3. Comparison between groups: Difference in magnitude of improvement(T0 (Baseline Pretest))
- 4. Retention of knowledge by follow-up posttest at 4 weeks after the intervention(T2 -Retention Posttest (4 weeks after the session))
- 5. Satisfaction/ feedback with the educational intervention(T1 (Immediate Posttest))
研究者
PRIYANKA S
KIMS Bangalore