A Digital Tool to Help Doctors and Pharmacists Prescribe Medicines More Safely for Older Adults in Oman (POLYMED)

September 21, 2026 updated by: Oman Ministry of Health

POLYMED: A Triphasic Explainable AI-Assisted Potentially Inappropriate Prescribing Risk Calculator to Optimize Medication Safety and Pharmaceutical Efficiency Among Elderly Patients in Oman

This is a prospective, multi-phase interventional study evaluating the clinical utility and efficacy of POLYMED-a bilingual (Arabic/English) web-based, explainable-AI medication risk calculator-on optimizing geriatric medication safety in Muscat primary care. The primary objective is to evaluate whether deploying this clinical decision support software at the point of care systematically reduces potentially inappropriate prescribing (PIP) and polypharmacy among elderly patients.

The study protocol integrates baseline parameterization with an active clinical intervention:

  • Phase 1 & 2 (Baseline & Tool Validation): A baseline cross-sectional assessment of elderly patients is conducted to quantify local prescribing burdens via international criteria (2023 AGS Beers / STOPP/START v3). These prospective baseline data are used to calibrate and validate the OPIP Score engine powering the POLYMED calculator.
  • Phase 3 (Active Intervention Phase): A prospective before-and-after trial evaluates the direct clinical effect of the tool. Clinicians are assigned by the study protocol to actively deploy the POLYMED calculator at the point of care during consultations. The trial measures the resulting changes in polypharmacy burden and medication spending compared to standard, routine care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Rationale and Design Framework Geriatric prescribing safety represents a critical health services focus. This protocol evaluates an investigator-assigned digital health intervention designed to systematically intercept prescribing risks at the point of care. While the protocol includes a baseline run-in period to parameterize the software, the study functions globally as a prospective interventional trial. It measures the clinical efficacy of an AI-assisted clinical decision support system (CDSS) within an active primary care workflow.

Phase 1: Baseline Assessment & Parameterization The study initiates with a prospective baseline assessment of a primary care patient cohort aged 65 or older. Investigators systematically extract data regarding active medication regimens, clinical diagnoses, and health expenditures. This phase applies the 2023 AGS Beers Criteria and STOPP/START v3 criteria to establish a strict pre-intervention standard-of-care baseline for polypharmacy prevalence, PIP rates, and associated medication costs.

Phase 2: Intervention Engineering & System Validation Data derived from Phase 1 are immediately used to program, calibrate, and validate the proprietary OPIP Score engine. This engine drives the bilingual (Arabic/English) POLYMED web calculator. The software applies machine learning algorithms to generate an explainable-AI narrative. This narrative visually highlights specific pharmacological risk vectors to actively prompt clinicians during patient evaluations.

Phase 3: Prospective Interventional Workflow The core interventional component of the protocol utilizes a prospective before-and-after design to evaluate the tool's clinical impact.

  1. Protocol-Mandated Assignment: The investigator actively assigns participating primary care clinicians to integrate the POLYMED calculator into their clinical consultations. For all prospectively enrolled participants in this phase, clinicians are required by the study protocol to execute the web calculator at the point of care during the patient visit.
  2. Clinical Action and Decision Support: The software functions as an active advisory system. Upon receiving the real-time, explainable-AI risk alerts, clinicians are required by the study workflow to conduct a structured medication review. While clinicians maintain complete medical autonomy over final prescribing modifications, the review process itself is forced by the trial protocol.
  3. Justification for Interventional Framework: This study is classified as interventional because the systematic application of this specific AI-driven risk calculator is explicitly mandated by the investigator's protocol to alter clinical behavior and evaluate its direct effect on patient health outcomes. This intensive workflow and real-time risk feedback loop are not part of routine medical care in Oman and would not occur outside the context of this clinical trial. The study evaluates the resulting differences in prescribing patterns, safety metrics, and medication costs between the baseline standard of care and the active intervention phase.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Aged 65 years or older at the time of recruitment

    • Registered in a chronic disease clinic in a participating primary healthcare centre
    • Receiving at least one long-term prescribed medication for chronic disease management
    • Able to provide informed consent independently

Exclusion Criteria:

  • • Cognitive impairment or severe communication limitations precluding informed consent

    • Currently receiving palliative care
    • Currently admitted as an inpatient during the recruitment period
    • Major medication regimen change within the preceding four weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OPIP Score-Guided Medication Review

A prospective, single-arm cohort of primary care clinicians and their elderly patients (65 years or older) attending chronic disease clinics. The investigator assigns participating clinicians to systematically integrate the OPIP Score calculator into their active workflow. For all prospectively enrolled patients in this phase, pharmacists are required by protocol to utilize the full dashboard and family physicians are prompted via a lightweight prescribing alert to guide structured medication reviews. Clinical and prescribing outcomes from this active intervention phase are evaluated against each patient's own pre-intervention Phase 1 baseline data
Device: OPIP Score Calculator (Oman Potentially Inappropriate Prescribing Risk Score)

A bilingual (Arabic/English) web-based clinical decision support tool designed to systematically intercept prescribing risks. The software features a three-layer architecture: a rule-based engine executing the 2023 AGS Beers Criteria (incorporating drug-drug interactions and renal dosing alerts), a risk-scoring model calibrated to local Omani clinical data, and an explainable-AI narrative providing explicit, prioritized recommendations. Per the interventional study protocol, clinicians are mandated to deploy this tool at the point of care during consultations to trigger real-time medication reviews. While clinicians maintain final medical autonomy over prescribing modifications, the systematic application of the tool and the mandatory documentation of clinical overrides are driven prospectively by the investigator's study design to alter and optimize the standard care pathway.

Other Names:
  • POLYMED AI Risk Calculator (OPIP Score)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
• Reduction in the prevalence of potentially inappropriate medication prescribing following OPIP Score integration, reassessed using the 2023 AGS Beers Criteria
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oman Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MoH/CSR/26/32760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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