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临床试验/CTRI/2022/11/047241
CTRI/2022/11/047241尚未招募不适用

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

Dr Priya Mehta1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年1月12日最近更新:

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.

 â€¢      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

  1. Mental Health Trigger Tool
  2. IHI trigger tool for psychiatry patients

•      For Causality Assessment:

  1. World Health Organization-UMC causality criteria
  2. Naranjo scale

•      For Severity Assessment:

  1. Modified Hartwig and Seigel severity scale

•      For Preventability Assessment:

  1. 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)

研究者

发起方
Dr Priya Mehta
申办方类型
Other [self]

研究点 (1)

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