Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 19, 2023
Date Accepted: Jan 31, 2024
Assessing the efficacy of the ARMOR Tool-Based Deprescribing Intervention on Fall Risk Reduction in Geriatric Patients on Fall Risk-Increasing Drugs: Study Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Falls in elderly patients can lead to serious health complications and increased healthcare costs. Fall Risk-Increasing Drugs (FRIDs) are group of drugs may induce falls or increase the tendency of fall (fall risk).Deprescribing is the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing poly-pharmacy and improving outcomes.
Objective:
This study aims to assess the effectiveness of an ARMOR (Assess, Review, Minimize, Optimize, Reassess) tool-based deprescribing intervention in reducing the risk of falls in elderly patients and evaluate the cost-effectiveness of deprescribing of Fall Risk-Increasing Drugs (FRIDs).
Methods:
This is an open label, parallel group randomized controlled. Geriatric individuals (60-80 years) taking five or more prescribed drugs, including at least one FRID, will be recruited. Demographic data, medical conditions, medication lists, orthostatic hypotension, and fall history will be collected. Fall risk will be assessed using the Fall Efficacy Scale, Timed Up and Go test, and Tinetti Performance-Oriented Mobility Assessment Tool. Rationality of prescription drugs will be evaluated using WHO core indicators. The ARMOR tool will guide deprescribing, with physicians randomly assigned to usual care or intervention arms via stratified randomization by seniority. Randomized physicians will implement the ARMOR tool for patients on FRIDs. Participants will maintain diaries, and monthly phone follow-ups will monitor falls and adverse events. Physical assessments every three months for a year will evaluate fall risk.
Results:
The study has received grant for ICMR- SRUM in Oct 2023. The study is scheduled to commence in April 2025 and conclude by 2026. Efficacy will be measured by fall frequency and changes in fall risk scores. Cost-effectiveness analysis will calculate the Incremental Cost-Effectiveness Ratio. Adverse events related to deprescription will be recorded. Rationality of the prescription will be assessed by WHO prescription indicators
Conclusions:
This trial will provide essential insights into the efficacy of the ARMOR tool in reducing falls among the geriatric population on FRIDs. Additionally, it will contribute valuable information on the cost-effectiveness of deprescribing practices, offering significant implications for improving the well-being of elderly patients and optimizing healthcare resource allocation. The findings from this study will be pertinent for healthcare professionals, policy-makers, and researchers focused on geriatric care and fall prevention strategies. Clinical Trial: The trial is registered with clinical trial registry India and the registration number is CTRI/2023/12/060516.
Citation
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Copyright
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