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Development, Validation and Evaluation of a Deprescribing Tool

ConditionElderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIndian Council of Medical Research

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients not willing to participate in the study

Trial design

Design model

Sequential

Treatments tested in this trial

  • Deprescribing Tool

    Other intervention

    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.

Treatment groups

1,650 Participants
are divided into 2 treatment groups
Group A: Control ArmNo intervention 0 interventions
Group B: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

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)

Time frame
From enrollment to the end of consultation at 30 minutes to 1 hour
2

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)

Time frame
From enrollment to the end of consultation at 30 minutes to 1 hour
3

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)

Time frame
From enrollment to the end of consultation at 30 minutes to 1 hour
4

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)

Time frame
1 month

Other outcomes

Sponsors and contacts

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Indian Council of Medical Research

Lead sponsor

All India Institute of Medical Sciences

Sponsor institution

St Johns Medical College Hospital, Bangalore, India

Collaborator

Source ClinicalTrials.gov
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