Development, Validation and Evaluation of a Deprescribing Tool

Not Applicable

Recruiting

• Conditions: Elderly

• Registration Number: NCT07114094
• Lead Sponsor: Indian Council of Medical Research

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)

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 Timeline

• Study Start: 2025-05-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-09
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-02
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1650

Inclusion Criteria

• Elderly patients (≥ 60 years) of either sex, visiting the General Medicine/ Community and Family Medicine OPD of the study sites

Exclusion Criteria

• Patients not willing to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in Proportion of prescriptions with at least one PIM	From enrollment to end of consultation at 30 minutes to 1 hour	Proportion of prescriptions with at least one PIM in the control arm minus proportion of prescriptions with at least one PIM in the intervention arm.; Proportion= Number of prescriptions with at least one PIM ÷Total number of prescriptions included in the respective arm (intervention/control)

Secondary Outcome Measures

Name	Time	Method
Change in Average number of PIMs per prescription	From enrollment to the end of consultation at 30 minutes to 1 hour	Average number of PIMs in control arm minus Average number of PIMs in intervention arm; Average = Number of PIMs ÷ Total number of prescriptions included in the respective arm (intervention/control)
Change in Proportion of prescriptions in which at least one PIM was deprescribed	From enrollment to the end of consultation at 30 minutes to 1 hour	Proportion of prescriptions in which at least one PIM was deprescribed in the intervention arm minus Proportion of prescriptions in which at least one PIM was deprescribed in the control arm; Proportion=Number of prescriptions in which at least one PIM was deprescribed ÷Total number of prescriptions included in the respective arm (intervention/control)
Change in Average number of Potential ADRs, Drug- Drug Interactions and Drug- Disease Interactions	From enrollment to the end of consultation at 30 minutes to 1 hour	Average number of Potential ADRs, Drug- Drug Interactions and Drug- Disease Interactions in the control arm minus Average number of Potential ADRs, Drug- Drug Interactions and Drug- Disease Interactions in the intervention arm; Average: Number of Potential ADRs, Drug- Drug Interactions and Drug- Disease Interactions ÷ Total number of patients in the respective arm (intervention/control)
Change in Average number of Adverse Events at one month	1 month	Average number of Adverse Events in the control arm minus Average number of Adverse Events in the intervention arm Average: Number of Adverse Events÷ Total number of patients in the respective arm (intervention/control)

Trial Locations

Locations (2)

St. John's Medical College, Bangalore, India; 🇮🇳 Bangalore, Karnataka, India

All India Institute of Medical Sciences Bhopal; 🇮🇳 Bhopal, Madhya Pradesh, India