Development, Validation and Evaluation of a Deprescribing Tool

NCT07114094 | Recruiting

• 1 other identifier: 20032
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 2

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)

Conditions

Elderly

Keywords

Deprescribing Tool; Polypharmacy; Elderly

Outcome Measures

Primary Outcomes (1)

• Change in Proportion of prescriptions with at least one PIM

  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)

  From enrollment to end of consultation at 30 minutes to 1 hour

Secondary Outcomes (4)

• Change in Average number of PIMs per prescription

  From enrollment to the end of consultation at 30 minutes to 1 hour

• 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

• 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

• Change in Average number of Adverse Events at one month

  1 month

Study Arms (2)

Control Arm

NO INTERVENTION

Prescribers in this arm will not use the Deprescribing Tool, and will prescribe as per routine practice.

Intervention Arm

EXPERIMENTAL

Prescribers in this arm will be trained in the use of the Deprescribing Tool and provided the Tool 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.

Other: Deprescribing Tool

Interventions

Deprescribing Tool OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients not willing to participate in the study

Sponsors & Collaborators

• Indian Council of Medical Research: lead
• St Johns Medical College Hospital, Bangalore, India: collaborator

Study Sites (2)

St. John's Medical College, Bangalore, India

Bangalore, Karnataka, 560034, India

RECRUITING

All India Institute of Medical Sciences Bhopal

Bhopal, Madhya Pradesh, 462020, India

RECRUITING

Related Publications (7)

• Candeias C, Gama J, Rodrigues M, Falcao A, Alves G. Potentially Inappropriate Medications and Potential Prescribing Omissions in Elderly Patients Receiving Post-Acute and Long-Term Care: Application of Screening Tool of Older People's Prescriptions/Screening Tool to Alert to Right Treatment Criteria. Front Pharmacol. 2021 Oct 19;12:747523. doi: 10.3389/fphar.2021.747523. eCollection 2021.

  PMID: 34737705 BACKGROUND

• By the 2023 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria(R) for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023 Jul;71(7):2052-2081. doi: 10.1111/jgs.18372. Epub 2023 May 4.

  PMID: 37139824 BACKGROUND

• Bhagavathula AS, Vidyasagar K, Chhabra M, Rashid M, Sharma R, Bandari DK, Fialova D. Prevalence of Polypharmacy, Hyperpolypharmacy and Potentially Inappropriate Medication Use in Older Adults in India: A Systematic Review and Meta-Analysis. Front Pharmacol. 2021 May 19;12:685518. doi: 10.3389/fphar.2021.685518. eCollection 2021.

  PMID: 34093207 BACKGROUND

• O'Mahony D, Cherubini A, Guiteras AR, Denkinger M, Beuscart JB, Onder G, Gudmundsson A, Cruz-Jentoft AJ, Knol W, Bahat G, van der Velde N, Petrovic M, Curtin D. STOPP/START criteria for potentially inappropriate prescribing in older people: version 3. Eur Geriatr Med. 2023 Aug;14(4):625-632. doi: 10.1007/s41999-023-00777-y. Epub 2023 May 31.

  PMID: 37256475 BACKGROUND

• Renom-Guiteras A, Meyer G, Thurmann PA. The EU(7)-PIM list: a list of potentially inappropriate medications for older people consented by experts from seven European countries. Eur J Clin Pharmacol. 2015 Jul;71(7):861-75. doi: 10.1007/s00228-015-1860-9. Epub 2015 May 14.

  PMID: 25967540 BACKGROUND

• Ibrahim K, Cox NJ, Stevenson JM, Lim S, Fraser SDS, Roberts HC. A systematic review of the evidence for deprescribing interventions among older people living with frailty. BMC Geriatr. 2021 Apr 17;21(1):258. doi: 10.1186/s12877-021-02208-8.

  PMID: 33865310 BACKGROUND

• Pazan F, Wehling M. Polypharmacy in older adults: a narrative review of definitions, epidemiology and consequences. Eur Geriatr Med. 2021 Jun;12(3):443-452. doi: 10.1007/s41999-021-00479-3. Epub 2021 Mar 10.

  PMID: 33694123 BACKGROUND

Study Officials

• Dr. Jerin J Cherian, MD

  Indian Council of Medical Research and Karolinska Institute, Sweden

  STUDY CHAIR

Central Study Contacts

Ratinder Jhaj, DM

CONTACT

+917773002096; rati.pharm@aiimsbhopal.edu.in

Dr. Atiya Faruqui, MD

CONTACT

+91 9980018022; atiya.rf@stjohns.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster Randomized ( Participating Prescribers are randomized, not patients) Open Label, Delayed or Sequential Intervention Trial. Intervention arm will begin after completion of Control arm

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)