PGx Medication Safety Reviews of Persons With IDD

Not yet recruitingOBSERVATIONAL
Enrollment

700

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

January 31, 2028

Conditions
Intellectual Disability, MildIntellectual Disability, Mild to ModerateDevelopmental Disability
Interventions
OTHER

Cheek swab for PGx testing

Pharmacogenetic test kits will be provided to each CPU residence. An order will be issued to obtain samples for the study - a cheek swab - to be collected by residence direct care providers or nursing staff, trained in the procedure for obtaining the sample, and preparing and submitting it for transport. Failures to collect and submit valid samples, the number of samples submitted that cannot be processed, and the reasons for failure, will be recorded. If a submitted sample cannot be processed, another sample can be obtained and submitted.

OTHER

Medication safety review

A medication reconciliation will be performed by a GalenusRx pharmacist on all included residents. Medication data for enrolled participants will be collected by the GalenusRx pharmacist from the unique pharmacy provider and/or the medication records from the facility and a medication reconciliation will be conducted with the nurse of the residents' facility. GalenusRx pharmacists will apply a CDSS to patients' medication regimens, screening for drug interactions, assess medication related risks, and consider pharmacogenomic type and phenoconversion results in recommending appropriate drug selection and dosage to prescribing clinicians.

Trial Locations (2)

10460

CP Unlimited, The Bronx

34756

GalenusRx, Inc., Montverde

All Listed Sponsors
collaborator

CP Unlimited

UNKNOWN

lead

GalenusRx, Inc.

INDUSTRY

NCT07092852 - PGx Medication Safety Reviews of Persons With IDD | Biotech Hunter | Biotech Hunter