ElderlyNCT07114094
Development, Validation and Evaluation of a Deprescribing Tool
A study testing Deprescribing Tool in people with Elderly, run by Indian Council of Medical Research at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Deprescribing Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,650 participants
- Where
- 2 sitesIndia
- Study dates
- 1 May 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients (≥ 60 years) of either sex, visiting the General Medicine/ Community and Family Medicine OPD of the study sites
Who cannot join
- Patients not willing to participate in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
St. John's Medical College, Bangalore, India
Bangalore, Karnataka, 560034
Dr. Atiya Faruqui Faruqui, MD, +91 9980018022, atiya.rf@stjohns.in
Dr. Dinesh Kumar Meena, PhD, +91 7094402215, dinesh.meena8989@gmail.com
- Recruiting
All India Institute of Medical Sciences Bhopal
Bhopal, Madhya Pradesh, 462020
Ratinder Jhaj, DM, +917773002096, rati.pharm@aiimsbhopal.edu.in
Dr. Shubham Atal, MD, +919926598685, shubham.pharm@aiimsbhopal.edu.in
About this study
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
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)
Read the 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
- Being tested
- Deprescribing Tool
- Keywords
- Deprescribing Tool, Polypharmacy, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deprescribing ToolOther
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-
- Immediate discontinuation of a drug, e.g., a duplicate drug
- Initiation of gradual tapering of a drug e.g., an anxiolytic, which is no longer indicated
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Deprescribing Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to end of consultation at 30 minutes to 1 hour
Secondary outcomes (4)
Change in Average number of PIMs per prescription
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)
Measured: 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
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)
Measured: 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
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)
Measured: From enrollment to the end of consultation at 30 minutes to 1 hour
Change in Average number of Adverse Events at one 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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 May 2025
- Primary completionFeb 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cluster Randomized ( Participating Prescribers are randomized, not patients) Open Label, Delayed or Sequential Intervention Trial. Intervention arm will begin after completion of Control arm
- Masking
- None (open label)
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indian Council of Medical Research
- Sponsor type
- Other government
- Collaborators
- St Johns Medical College Hospital, Bangalore, India
- Responsible party
- Principal investigator, Ratinder Jhaj, All India Institute of Medical Sciences
- Investigators
- Dr. Jerin J Cherian, MD, Study chair, Indian Council of Medical Research and Karolinska Institute, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114094
- Sponsor's protocol ID
- 20032
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34737705By 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.
PubMed 37139824Bhagavathula 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.
PubMed 34093207O'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.
PubMed 37256475Renom-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.
PubMed 25967540Ibrahim 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.
PubMed 33865310Pazan 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.
PubMed 33694123
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07114094
- Acronym / sponsor ID
- 20032
- Conditions
- Elderly
- Keywords
- Deprescribing Tool, Polypharmacy, Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Indian Council of Medical ResearchOther government
- Collaborators
- St Johns Medical College Hospital, Bangalore, India
- Study start
- 1 May 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized ( Participating Prescribers are randomized, not patients) Open Label, Delayed or Sequential Intervention Trial. Intervention arm will begin after completion of Control arm
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Prescribers in this arm will not use the Deprescribing Tool, and will prescribe as per routine practice. |
| Intervention Arm | Experimental | Other: Deprescribing ToolPrescribers 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly patients (≥ 60 years) of either sex, visiting the General Medicine/ Community and Family Medicine OPD of the study sites
Key exclusion criteria (1 listed)
- Patients not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deprescribing ToolDeprescribing 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. | Other | Intervention Arm |
Primary outcome
Change in Proportion of prescriptions with at least one PIM
Time frame: 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)
4 secondary outcomes
Change in Average number of PIMs per prescription
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of consultation at 30 minutes to 1 hour
Change in Average number of Adverse Events at one month
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 34737705Candeias 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.
- Background: PubMed 37139824By 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.
- Background: PubMed 34093207Bhagavathula 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.
- Background: PubMed 37256475O'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.
- Background: PubMed 25967540Renom-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.
- Background: PubMed 33865310Ibrahim 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.
- Background: PubMed 33694123Pazan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Jerin J Cherian, MD study chair
Indian Council of Medical Research and Karolinska Institute, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprescribing Tool in people with Elderly, run by Indian Council of Medical Research at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ratinder Jhaj, DM (+917773002096, rati.pharm@aiimsbhopal.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proportion of prescriptions with at least one PIM (time frame: From enrollment to end of consultation at 30 minutes to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07114094, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.