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CTRI Number  CTRI/2022/11/047241 [Registered on: 11/11/2022] Trial Registered Prospectively
Last Modified On: 10/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Use of Trigger Tools to detect harmful events and reactions in tertiary care hospital. 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya Mehta 
Designation  1st Year Resident Pharmacology 
Affiliation  Government Medical College,Bhavnagar 
Address  Department of Pharmacology, Government Medical College, Bhavnagar,gujarat-364001

Bhavnagar
GUJARAT
364001
India 
Phone  9726758223  
Fax    
Email  dr.priyamehta26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhargav Purohit 
Designation  Associate Professor and I/C Head 
Affiliation  Government Medical College,Bhavnagar 
Address  Department of Pharmacology, Government Medical College, Bhavnagar,gujarat-364001

Bhavnagar
GUJARAT
364001
India 
Phone  9725024978  
Fax    
Email  drbhargavpurohit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priya Mehta 
Designation  1st Year Resident Pharmacology 
Affiliation  Government Medical College,Bhavnagar 
Address  Department of Pharmacology, Government Medical College, Bhavnagar,gujarat-364001

Bhavnagar
GUJARAT
364001
India 
Phone  9726758223  
Fax    
Email  dr.priyamehta26@gmail.com  
 
Source of Monetary or Material Support  
Medical Record Section,Department of Psychiatry,Sir T Hospital,Bhavnagar 
 
Primary Sponsor  
Name  Dr Priya Mehta 
Address  Department of Pharmacology, Government medical College, Bhavnagar 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priya Mehta  Sir T Hospital,Bhavnagar  Medical record section,psychiatry ward, Sir t hospital,bhavnagar
Bhavnagar
GUJARAT 		 9726758223

dr.priyamehta26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Comittee GMC Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients ≥ 18 years of age.
 
 
ExclusionCriteria 
Details  Patient being discharged in less than 24 hours of admission or stayed more than 90 days.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ADR And AE  @ baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Causality assessment,severity,preventability,age and gender wise distribution  @ baseline 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 .

•      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

 

 
 
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