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CTRI Number  CTRI/2024/06/069220 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Other 
Public Title of Study   Multi-departmental Collaborative review to reduce inappropriate medication use in hospitalised elderly population.  
Scientific Title of Study   Implementation of inter-departmental collaborative medication review to reduce potentially inappropriate medication use in the hospitalized elderly patients: A mixed method study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Rajesh Kumar Konduru 
Designation  PROFESSOR AND HEAD 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Community Medicine, Basic Sciences building , 2nd floor, Pondicherry Institute of Medical Sciences, Kalathumettupathai, Ganapathichettikulam, Village no. 20, Kalapet, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9994959041  
Fax  91-413-2656273  
Email  drkonduru1977@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rajesh Kumar Konduru 
Designation  PROFESSOR AND HEAD 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Community Medicine, Basic Sciences Building, 2nd floor, Pondicherry Institute of Medical Sciences, Kalathumettupathai, Ganapathichettikulam, Village no. 20, Kalapet, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9994959041  
Fax  91-413-2656273  
Email  drkonduru1977@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Rajesh Kumar Konduru 
Designation  PROFESSOR AND HEAD 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Community Medicine, Basic Sciences Building, 2nd floor, Pondicherry Institute of Medical Sciences, Kalathumettupathai, Ganapathichettikulam, Village no. 20, Kalapet, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9994959041  
Fax  91-413-2656273  
Email  drkonduru1977@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anusha N  Jawaharlal Institute of Postgraduate Medical Education & Research  JIPMER campus road, Gorimedu, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY 		 9659879322

anushanatarajan29@gmail.com 
Dr Rajesh Kumar Konduru  Pondicherry Institute of Medical Sciences  Kalathumettupathai, Ganapathichettikulam, Village no. 20, Kalapet, Puducherry
Pondicherry
PONDICHERRY 		 9994959041

drkonduru1977@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human studies) for observational studies  Approved 
PIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inter-departmental Collaborative Medication Review  Healthcare professionals, such as pharmacists and physicians, work together to review a patients medication regimen to optimize medication therapy by identifying and resolving medication-related problems, such as drug interactions, inappropriate dosages, and adverse effects. 
Comparator Agent  There is no comparator group  This is a Quasi-experimental pre & post intervention study without any comparator group 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All hospitalised elderly patients aged above 60 years 
 
ExclusionCriteria 
Details  1. Those patients who will get discharged against medical advice before the completion of the treatment.
2. Patients who will be referred to other hospitals for varied reasons.
3. Those patients or patients’ kin who refuse to give consent to participate in the study.
4. Readmissions and emergency department visits other than DRPs. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Facilitators and barriers in the implementation of inter-departmental Collaborative Medication Review to reduce potentially inappropriate medications
 		 Medication charts will be reviewed every 3rd day since admission until discharge of the patient
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Costs involved in the implementation of CMR in Indian healthcare settings (tertiary health care settings perspective)
2. Change in number of potentially inappropriate medications from hospital admission to discharge due to CMR.
3. Change in the MAI score from hospital admission to discharge due to CMR.
4. Number of medication related hospital admissions from the day of discharge to 30 days post- discharge. 		 Medication charts will be reviewed every 3rd day since admission until discharge of the patient 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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)   12/08/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkonduru1977@gmail.com].

  6. For how long will this data be available start date provided 03-06-2024 and end date provided 03-06-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rationale: The inappropriate use of multiple medications, known as polypharmacy, is a growing concern for the elderly population in India, who are often prescribed multiple medications due to comorbid conditions. This can lead to serious adverse health outcomes, increased healthcare costs, and reduced quality of life. Screening tools, such as Medication Appropriateness Index and START/STOPP criteria, can help identify potentially inappropriate medications (PIMs), and interventions, such as medication review clinics and prescribing audits, can help improve 

appropriateness. Collaborative medication review involving a team approach is important to ensure that patients receive the best possible care. However, cost of these interventions remains a concern, especially in a country where healthcare spending is high for the elderly population.

Primary Objective: To assess the feasibility of implementation of inter-departmental Collaborative Medication Review (CMR) to reduce potentially inappropriate medications (PIMs) in the hospitalised elderly patients.
Secondary Objectives:

a) To explore the facilitators and barriers in the implementation of inter-departmental CMR from the healthcare providers perspective
b) To determine the costs involved in the implementation of inter-departmental CMR from health system perspective

c) To find out the efficacy of interdepartmental CMR using medication appropriateness index (MAI), post discharge adverse events and number of medication related admissions.

Methods: This study design will be a mixed method study, where the qualitative component will assess the feasibility of the collaborative medication review using in-depth interview and Focussed Group Discussion to explore the challenges in the implementation of interdepartmental collaborative medication review to reduce PIMs in the hospitalised elderly patients and the quantitative component of the study will estimate the costs incurred for the implementation of CMR in healthcare settings and reduction in the percentage of potentially inappropriate medications using START/STOPP criteria, medication appropriateness index (MAI) and post discharge adverse events. AT-HARM10 tool will be used to identify hospital admissions related to medications. A total of 280 hospitalised elderly participants’ prescriptions will be analysed in both the study sites from the admission day till 30 days post discharge by the CMR team members.

Expected Study outcomes:

• Facilitators and barriers in implementing CMR in different types of Indian healthcare setting 

 
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