Use of Trigger Tools to detect harmful events and reactions in tertiary care hospital.
- Conditions
- Other specified disorders of nervous system in diseases classified elsewhere,
- Registration Number
- CTRI/2022/11/047241
- Lead Sponsor
- Dr Priya Mehta
- Brief Summary
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 .
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|• **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**
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 240
Patients ≥ 18 years of age.
Patient being discharged in less than 24 hours of admission or stayed more than 90 days.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ADR And AE @ baseline
- Secondary Outcome Measures
Name Time Method Causality assessment,severity,preventability,age and gender wise distribution @ baseline
Trial Locations
- Locations (1)
Sir T Hospital,Bhavnagar
🇮🇳Bhavnagar, GUJARAT, India
Sir T Hospital,Bhavnagar🇮🇳Bhavnagar, GUJARAT, IndiaDr Priya MehtaPrincipal investigator9726758223dr.priyamehta26@gmail.com