NCT07840222

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Nov 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 12, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

POLYMED

Outcome Measures

Primary Outcomes (1)

  • • Reduction in the prevalence of potentially inappropriate medication prescribing following OPIP Score integration, reassessed using the 2023 AGS Beers Criteria

    2 years

Study Arms (1)

OPIP Score-Guided Medication Review

EXPERIMENTAL

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)

Interventions

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.

Also known as: POLYMED AI Risk Calculator (OPIP Score)
OPIP Score-Guided Medication Review

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: A three-phase mixed-methods translational research design, integrating epidemiological evidence generation, digital health innovation, and real-world implementation evaluation
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2026

First Posted

September 24, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share