Development, Validation and Evaluation of a Deprescribing Tool

NCT ID: NCT07114094

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-09-30

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.

Conditions

Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

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.

Group Type: EXPERIMENTAL

Deprescribing Tool

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Johns Medical College Hospital, Bangalore, India

OTHER

Sponsor Role: collaborator

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ratinder Jhaj

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Jerin J Cherian, MD

Role: STUDY_CHAIR

Indian Council of Medical Research and Karolinska Institute, Sweden

Locations

St. John's Medical College, Bangalore, India

Bangalore, Karnataka, India

Site Status: RECRUITING

All India Institute of Medical Sciences Bhopal

Bhopal, Madhya Pradesh, India

Site Status: RECRUITING

Countries

India

Central Contacts

Ratinder Jhaj, DM

Role: CONTACT

rati.pharm@aiimsbhopal.edu.in

+917773002096

Dr. Atiya Faruqui, MD

Role: CONTACT

atiya.rf@stjohns.in

+91 9980018022

Facility Contacts

Dr. Atiya Faruqui Faruqui, MD

Role: primary

atiya.rf@stjohns.in

+91 9980018022

Dr. Dinesh Kumar Meena, PhD

Role: backup

dinesh.meena8989@gmail.com

+91 7094402215

Ratinder Jhaj, DM

Role: primary

rati.pharm@aiimsbhopal.edu.in

+917773002096

Dr. Shubham Atal, MD

Role: backup

shubham.pharm@aiimsbhopal.edu.in

+919926598685

References

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.

Reference Type: BACKGROUND

PMID: 34737705 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37139824 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34093207 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37256475 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25967540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33865310 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33694123 (View on PubMed)

Other Identifiers

20032

Identifier Type: -

Identifier Source: org_study_id