Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-06 @ 8:04 PM
Study NCT ID:
NCT07114094
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development, Validation and Evaluation of a Deprescribing Tool
Sponsor:
Indian Council of Medical Research
Organization:
Study Overview
Official Title:
Development and Validation of a Deprescribing Tool Relevant to the Indian Context and Evaluation of Its Effectiveness in Reducing Inappropriate Polypharmacy in the Elderly
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if a deprescribing tool can help in reducing prescriptions with potentially inappropriate medications (PIMs), in the Indian elderly population. The main question it aims to answer is- Can inappropriate polypharmacy in elderly patients be reduced through development and implementation of a deprescribing tool relevant to the Indian context? Researchers will compare control arm outcome parameters to see if there is a reduction in Proportion of prescriptions with at least one PIM ( Primary outcome parameter).
Participating Prescribers ( Physicians) will be randomized to Control or Intervention arms. Particpating patients will not be randomized, and will receive routine consultation with a Physician who does not use the Deprescribing Tool (Control arm) or a prescriber who uses the Deprescribing tool ( Intervention Arm)
Participating Prescribers ( Physicians) will be randomized to Control or Intervention arms. Particpating patients will not be randomized, and will receive routine consultation with a Physician who does not use the Deprescribing Tool (Control arm) or a prescriber who uses the Deprescribing tool ( Intervention Arm)
Detailed Description:
Rationale: Polypharmacy is common in the elderly and is associated with increased risk of serious adverse events, including falls, cognitive impairment, functional decline, hospitalization, and death. In addition, some of the prescribed drugs may be potentially inappropriate medications (PIM), whose risks outweigh their benefits. It is therefore necessary to review medication intake of the elderly and discontinue or reduce the dose of the ones that are no longer required. This process, termed deprescribing, can reduce prescription of PIMs, improving prescription quality and minimize risks due to potential adverse effects and drug-disease or drug-drug interactions, as well as cost of therapy. Novelty: Although there are many tools for deprescribing, none of these tools has been developed for the Indian context, where there is widespread use of fixed dose combinations (FDCs), use of medicines from different systems of medicines, and high out of pocket expenditure on medicines. Also, some of the medications listed in existing tools are not marketed in India, while some which are commonly prescribed in the country are not listed in the tools. We therefore propose to develop and validate a deprescribing tool for the Indian elderly population, evaluate its impact on prescription quality and risk minimization, as well as explore the facilitators and barriers in the implementation of the tool. Study Design: Multicenter multi-method study. Deprescribing tool will be developed through a modified Delphi method. Prescribers will then be enrolled and randomised to either the control or intervention arm. Prescribers in control arm will prescribe as routine practice, without the aid of the tool. Prescribers in the intervention arm will use the deprescribing tool for medication review and deprescription, if indicated. Elderly patients (≥ 60 years old) of either sex, will be identified by research staff at the OPD registration counter, and approached to consent for the study. Prescriptions of consenting patients (≥ 60 years) will be photographed after consultation with prescriber in either arm. Prescriptions from both arms will be compared for assessment of outcome parameters. Sample size: 1650 (825 per study site) patients will be included evaluation of effectiveness of the tool. To evaluate barriers and facilitators to implementation, in depth interviews will be held with all 30 prescribers (15 at each site). Follow-up: Patients will be followed up at one month telephonically (or in person in case of a routine follow up visit at one month) to inquire about any adverse events, including hospitalization due to any cause. Patients will also be provided with the contact number of a study staff to be contacted in case of any problem within or after the one month follow up period. Expected Outcome: Improved quality of prescribing in the elderly, with reduction in proportion of prescriptions with PIMs, reduction in average number of PIMs prescribed per prescription and reduction of ADRs, drug-disease and drug-drug interactions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: