| CTRI Number |
CTRI/2025/03/082061 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Interventions to compliance of high risk medications protocol in hospital to minimize risk associated with usage. |
|
Scientific Title of Study
|
Improving the compliance to high risk medication protocol among nurses working in PDHNH five arm interventional trial |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenu Jain |
| Designation |
Assistant Director Nursing |
| Affiliation |
P D Hinduja Hospital and Medical Research Centre |
| Address |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg Mahim Mumbai
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9833580037 |
| Fax |
|
| Email |
meenurishijain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenu Jain |
| Designation |
Assistant Director Nursing |
| Affiliation |
P D Hinduja Hospital and Medical Research Centre |
| Address |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg Mahim
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9833580037 |
| Fax |
|
| Email |
meenurishijain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenu Jain |
| Designation |
Assistant Director Nursing |
| Affiliation |
P D Hinduja Hospital and Medical Research Centre |
| Address |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg Mahim Mumbai
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9833580037 |
| Fax |
|
| Email |
meenurishijain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg Mahim Mumbai 400016 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 Meenu Jain |
Wards of West block inpatient department of P D Hinduja Hospital and Medical Research Center |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg Mahim Mumbai 400016 Maharashtra India
Mumbai
MAHARASHTRA |
9833580037
meenurishijain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee P D Hinduja Hospital and Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A
Frequency of checking outcome is every 8 hours
The intervention will be carried out for 4 months |
In double verification protocol two nurses checks the IR medication independently In double verification Assignment based system the nurse participating as a verifier in the process will be predefined in each shift in their assignment register by the nurse in charge
The verifier and assigned nurse details in each shift will be captured along with the patient medication details that is name dose frequency route no of HR medication prescribed for each enrolled patient |
| Intervention |
Group B
Frequency of checking outcome is every 8 hours
The intervention will be carried out for 4 months |
In in-patient units the patient drug prescription sheet is valid for 24 hours Currently it is from 7am to next day 7am
In this intervention the researcher will revised the time of validity from 10am to next day 10am
The time of availability of drug prescription sheet will be taken from the assigned nurse no of drugs administered on verbal order will be captured from the drug prescription sheet for each enrolled patient |
| Intervention |
Group C
Frequency of checking outcome is every 8 hours
The intervention will be carried out for 4 months |
In this intervention the researcher will revised the time of validity of drug prescription sheet from 10am to next day 10am along with training the selected floor nurses on the approved high risk medication post monitoring protocol twice at an interval of 5 days
The data will be collected on the time of availability of drug prescription sheet from the assigned nurse no of drugs given on verbal order will be captured from the drug prescription sheet time of administration of HR medication will be captured from administration record and time of monitoring will be captured from the patient records |
| Intervention |
Group D
Frequency of checking outcome is every 8 hours
The intervention will be carried out for 4 months |
In this arm the researcher will revised the time of validity of patient drug prescription sheet from 10am to next day 10am along with training the selected floor nurses on the approved high risk medication post monitoring protocol twice at an interval of 5 days
The double verification Assignment based system for HR medication will be implemented for the nurse participating as a verifier in the process will be predefined in each shift in their assignment register by the nurse in charge for timely verification
The data related to these components will be collected for each patient |
| Comparator Agent |
Group E
Frequency of checking outcome is every 8 hours
The control group assessment will be carried out for 4 months |
The investigator will capture the data on the standard care of practice without any modification |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having peripheral venous cannulation access for treatment therapy
2 patient admitted and staying for more than 24 hours |
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age.
Patient availing services in OPD A & E Day care and OT facility
Patient admitted in any location other than the study wards
Patient having peripheral line at the time of admission |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the incidence of thrombophlebitis in patients |
Every 8 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="1230"
Sample Size from India="1230"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response (Others) - Documents requested
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [meenurishijain@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2030?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Peripheral IV catheterization (PIC) is the most common invasive procedure performed on hospitalized patients. Phlebitis is an inflammation of the vein, which may bring with it pain, redness, swelling, hardening and/or a palpable thread by inflammation to the vein at a cannula access site. Phlebitis leads to increased discomfort for patients, longer hospital stays, and higher healthcare costs. Peripheral intravenous catheters (PIVCs) are required in almost 70% of patients hospitalised in acute care selling for vital medical therapies such as intravenous (IV) fluids and electrolytes, antibiotics, pain relief chemotherapy blood transfusions and nutrition. This study aims to reduce thrombophlebitis by implementing different interventions and compare and evaluate the effectiveness of each interventions.
|