Development, Validation and Evaluation of a Deprescribing Tool
NCT07114094 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1650
Last updated 2025-08-14
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)
Conditions
- Elderly
Interventions
- OTHER
-
Deprescribing Tool
Deprescribing Tool will be used for medication review during patient consultation. The prescriber will be encouraged to refer to the tool for medication review of elderly patients aged ≥ 60 years and take deprescribing decision if indicated. Deprescribing may take place in any of the following ways- 1. Immediate discontinuation of a drug, e.g., a duplicate drug 2. Initiation of gradual tapering of a drug e.g., an anxiolytic, which is no longer indicated 3. Reduction in dose of a drug, e.g., lower dose of an NSAID for relief of symptoms of rheumatoid arthritis Only 1-3 medicines will be deprescribed at a time. Medicines with overlapping indications will not be deprescribed at the same time so it is clear which medicine is responsible if withdrawal effects occur.
Sponsors & Collaborators
-
St Johns Medical College Hospital, Bangalore, India
collaborator OTHER -
Indian Council of Medical Research
lead OTHER_GOV
Principal Investigators
-
Dr. Jerin J Cherian, MD · Indian Council of Medical Research and Karolinska Institute, Sweden
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-02-28
- Completion
- 2026-09-30
Countries
- India
Study Locations
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