The purpose of this study is to assess the feasibility of a comprehensive medication review and PGx initiative as part of the care process for individuals in the care of CP Unlimited. This initiative may help improve management of medications and overall health and well-being for participating individuals. Please note that in the context of the research being conducted, all information will remain confidential and deidentified for analyses.
Under the proposed study protocol, CP Unlimited, in partnership with pharmacists at GalenusRx, will implement and assess a comprehensive medication safety and PGx initiative. Almost three quarters of all clinical trials have eligibility criteria resulting in the exclusion of adults with IDD. This study will help address ongoing health practice disparity. As indicated above, the investigators are requesting the authorization of the guardian or representative, on behalf of the participant under their supervision, to enroll this individual in the proposed study because she/he is currently prescribed medications or may eventually receive prescribed or over-the-counter medications. Hereinafter, the denomination "he/she, him/her, his/her or them/their" will be used to refer to the individual with IDD.
The response to medication can be affected by variations in our genes and by other medications and various disease conditions. Information contained in our genes can vary from one patient to another patient and this can explain why we all can respond differently to medications. Genetic testing and a review of his/her medications can help to determine if the medication will work for him/her. PGx is how his/her genes affect the way he/she responds to specific drugs. PGx can tell if he/she is more or less likely to feel bad reactions to a drug, or if a drug is likely to benefit him/her and be safe for him/her to take. Knowing his/her genetic information and all medicines that he/she is taking can help his/her pharmacist and his/her doctor find the combination of medicines that will work the best for him/her, now and in the future.
Beneficiary with IDD
Reside in a CP Unlimited facility, NY state
At least 21 years of age
Pregnant
Medical or physical abnormality that prevents cheek swab collection
All persons residing in CPU facilities during the study period will be included in the study, except those who are under 21 years of age, in whom a cheek swab cannot be obtained, and those who for whom no valid consent for participation is in place. Beneficiaries will be identified by the CMO and/or the medical care team of the project. The number of persons excluded and the reasons for exclusion will be reported and analyzed. All residents have current consent for standard medical care, subject to individual 'carve-outs.' Any procedures or analyses performed on any individual in the course of this research project.
Cohort
Retrospective
Cheek swab for PGx testing
Other interventionPharmacogenetic 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.
Medication safety review
Other interventionA 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.
Measure the Feasibility of PGx Testing in IDD Population
Measure feasibility of a PGx testing program calculating the number of pharmacogenetic tests / medication safety reviews completed.
Measure the Acceptability of Implementing a PGx Program
Measure the acceptability of implementing a PGx program by examining the recommendations accepted and transferred to a dispensing pharmacy.
Identify the PGx Profile of CP Unlimited Patients
The PGx profile of CP Unlimited patients will be measured by quantifying the frequencies of which genes in drug-gene interactions are observed.
Identify Drug and Drug Classes of Drug-Gene and Drug-Drug-Gene Interactions
Drug and drug classes will be identified by quantifying the frequency in which drug-gene and drug-drug-gene interactions are associated with recommendations.
Program Feasibility Considering Data Collection
Program feasibility will be measured by the examining the ratio of cheek swabs completed to the the percentage of samples requiring a second review.
Personalized Medication Safety Management, Genetic Results, and Acceptance
To explore the relationship between PMSM, genetic results and acceptance using an investigator developed clinician satisfaction survey. Likert scales will be used, where the higher score indicates higher satisfaction.
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GalenusRx, Inc.
Lead sponsor
CP Unlimited
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
