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
|
|
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
|
|
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
|
|
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
- 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
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