Association of Triggers with Adverse Drugs Reactions and Adverse Events based on Mental Health Trigger Tool(MHTT) And IHI Trigger Tool in Psychiatry Indoor Patients of Tertiary Care Hospital: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- ADR And AE
研究概览
简要总结
Introduction
⮚Traditional efforts to detect adverse events(AEs) and adverse drug reactions(ADRs) have focused on voluntary reporting and tracking of errors.
⮚However, public health researchers have established that only 10 to 20 percent of them are ever reported.
⮚Trigger tool provides an easy-to-use method for accurately identifying adverse events and adverse reactions and measuring the rate of adverse outcomes over time.
⮚The Trigger Tool methodology is a review of a random sample records of inpatient hospital cases using “triggers†(or clues) to identify possible adverse events and reactions.
⮚It’s easy, cheap and less time consuming method for ADRs and AEs reporting, which can be used by nursing staff and other paramedical staff also after training.
⮚It can become a useful method and ADRs and AEs reporting rate could be increased using this tool.
Why this study is essential?
⮚Many studies have been done to find out ADRs and AEs using Global Trigger Tool in past in general and critical care patients records.
⮚Very less work has been done in psychiatric patient records.
⮚This tools can be used to measure the trend of ADRs and AEs in psychiatry setup of our hospital .
Association of triggers with ADRs and AEs can be measured .
| • Inclusion criteria: |
⮚ Patients ≥ 18 years of age.
• Exclusion criteria:
⮚ Patient being discharged in less than 24 hours of admission or stayed more than 90 days.
Procedure
Ø At the end of the month from all the discharged patients’ case records,20 cases every month (according to IHI guideline) will be randomly selected by using Microsoft excel.
Ø Each case records will be thoroughly checked for triggers using MHTT and ISI trigger tool and also for ADRs or AEs.
Ø Expert opinion will be final to decide whether trigger caused ADRs or AEs or not.
Ø Proportion of ADR, AE and each triggers will be calculated Also, comparison of ADRs and triggers based on age and gender will be done.
Ø Appropriate statistical analysis carried out depending upon type of data collected.
⮚ Tools/scales to be used for measuring outcomes/variables
• For finding Triggers
- Mental Health Trigger Tool
- IHI trigger tool for psychiatry patients
• For Causality Assessment:
- World Health Organization-UMC causality criteria
- Naranjo scale
• For Severity Assessment:
- Modified Hartwig and Seigel severity scale
• For Preventability Assessment:
- Modified Schumock and Thornton adverse drug reaction preventability scale
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients ≥ 18 years of age.
排除标准
- •Patient being discharged in less than 24 hours of admission or stayed more than 90 days.
结局指标
主要结局
ADR And AE
时间窗: @ baseline
次要结局
- Causality assessment,severity,preventability,age and gender wise distribution(@ baseline)
