| CTRI Number |
CTRI/2024/10/075232 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality Improvement Programme in Poisoning Management |
|
Scientific Title of Study
|
Development and Piloting of Stewardship Programme in Toxicological Management in Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veekshitha S Shetty |
| Designation |
Student |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of pharmacy practice, Manipal College Of Pharmaceutical Sciences, MAHE, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7483498426 |
| Fax |
|
| Email |
veekshithashettyy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Girish Thunga |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9880151127 |
| Fax |
|
| Email |
girish.thunga@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Girish Thunga |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9880151127 |
| Fax |
|
| Email |
girish.thunga@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education
Madhav Nagar, Manipal, Karnataka, India, 576104
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Girish Thunga |
Kasturba Hospital Manipal |
Room number 22 Emergency Department KMC Manipal Udupi KARNATAKA |
9880151127
girish.thunga@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T603||Toxic effect of herbicides and fungicides, (2) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, (3) ICD-10 Condition: T604||Toxic effect of rodenticides, (4) ICD-10 Condition: T630||Toxic effect of snake venom, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Phase I: Acute poisoning cases of Organophosphate, Paraquat, Snake bite and Zinc Phosphide admitted during the period of 2022-2023.
Phase IIa : Physicians in Emergency department who are willing to give consent.
Phase IIb: Panel members with clinical expertise and handling of acute poisoning cases.
Phase III: Acute poisoning cases with selected poisoning for stewardship programme, age above 18 years. |
|
| ExclusionCriteria |
| Details |
Phase IIa : Physicians who are not willing to give consent
Phase III: The study of unknown poisoning, mixed poisoning, children with acute poisoning, pregnancy, acute poisoning with incomplete information on the patient card, referral cases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The project focused on quality improvement of hospital with respect to the adherence to guideline and protocol and presented in terms of percentage. The deviations are noted and reported to physician accordingly. |
Two points
After 1 week and 2 weeks of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="314" Sample Size from India="314"
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)
|
01/02/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The initial management of poisoning cases is challenging due to lack of guidelines, laboratory investigation and diagnostic evaluation which could ultimately result in inappropriate therapeutic intervention during the admission of poisoned patients. Also, making decisions can be challenging due to lack of evidence from high quality antidote studies, variability in updating source and some regional variations in their use. The study is to understand the need for the development and implementation of toxicology stewardship programme in emergency setting of tertiary care hospital due to increasing pitfalls in the management of poisoning cases.
The study is conducted in three phases:
Phase I: Retrospective audit: Based on the frequency of admission, cases of Organophosphate, Paraquat, Snake bite and Zinc phosphide poisoning will be selected for the study. All the retrospective data such as physical examination, routine biochemical investigations, hematology, urine analysis, severity score and management of respective poisoning cases admitted during the period of 2022-2023 will be collected from medical record department based on ICD coding. Most four common poisoning cases with maximum admission rate will be selected for the audit purpose.
Phase IIa: Qualitative interview to get expert opinion: The Qualitative interview guide will be prepared based on the literature and it focused on important domains such as type of poison, involvement of Health care Professionals, opinion regarding training program, delivering feedbacks to physicians and evaluation of the stewardship program. The qualitative guide will be evaluated with five experts in the domain by protocol refinement method. The final interview guide will be administered among fifteen to twenty physicians after taking consent, telephonic or face to face interview for about thirty minutes till data saturation. The collected data will be stored in the investigator laptop with protected password and later transferred into verbatim. Themes will be generated by using Nvivo software and final themes are utilized for developing a stewardship plan.
Phase IIb: Development of a stewardship plan and its validation: Literature review will be done by thorough assessment of the available literature on stewardship plans to gather data and analyze the body of work in the field. Data will be extracted based on the relevance to our plan after a thorough reading and analysis. Based on the literature review and qualitative interview with physician, a draft of stewardship plan will be developed. A draft stewardship plan includes clinical assessment details such as Airway, Breathing and Circulation, requirement of oxygen, requirement of IV fluid administration, GI decontamination or any suitable method of decontamination, administration of Antibiotics, Antidote as per requirement of management of specific poison with respect to guideline or standard care procedure. The validation will be done using the Delphi methodology which includes selection of panel members, presenting the stewardship draft to the expert panel and lastly conducting delphi rounds. The finalized stewardship plan will be implemented in two cases of each selected poisoning cases and any modification with respect to availability of data or adding a new component will be noted and final validation will be done by focus group discussion.
Phase III: Piloting and implementation of stewardship plan: Two cases will be selected from each poisoning cases and checked for availability of the data and any major deviations observed will be incorporated in the stewardship plan accordingly with respect to the management of poisoning cases. These incorporated elements will be presented to the focus group discussion informally to finalize the stewardship plan. The final plan will be implemented in all the ICU settings after taking patient consent and patient will be followed from the day of admission to the day of discharge. The deviations, adherence and special actions taken will be noted and at the end all the findings will be concluded and presented to the physician to get their opinion. With the help of mutual agreement, a draft protocol will be prepared for selected poisoning and circulated among ICU doctors for final input. Validation of the protocol is done by selecting team of experts after taking appropriate consent. Briefly they have oriented for study procedures and its outcome. After obtaining consent, the final validated protocol will be circulated to them for input. Necessary changes will be incorporated, and final draft will be used as a reference copy for hospital with Medical Superintendent approval.
This project focused on quality improvement of hospital with respect to the adherence to guideline and protocol and presented in terms of percentage. The deviations are noted and reported to physician and ultimately achieving improvement in patient care.
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