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Clinical Trials/NCT03748355
NCT03748355
Completed
N/A

Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects

Mayo Clinic1 site in 1 country80 target enrollmentOctober 14, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychiatric Disorder
Sponsor
Mayo Clinic
Enrollment
80
Locations
1
Primary Endpoint
Reduction of Potential Drug Interactions
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers want to find out whether subjects will have fewer side effects if they take different medications based on their pharmacogenomics profile.

Detailed Description

The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers are doing this in order to assess the number of potential genotype-based drug interactions and side effects in patients with polypharmacy as well as to assess the number of potential individualized (based on the patient's genotype) drug interactions and side effects in these patients. After completing the OneOme genetic testing and relaying those results to the patients care team, the Researchers will then assess, at 30 days post-recommendations, whether the medication recommendations to reduce individualized drug interactions and adverse effects were followed, and (2) whether the adverse effects decrease compared to admission. Patients will be recruited from the inpatient units listed in the inclusion criteria and, upon admission, each patient will complete a 24 item questionnaire measuring medication side effects, have a review of their medications for potential drug-drug and drug-genotype interactions (classified as low, medium or high risk), and then undergo the buccal swab to collect the DNA cells which will then be sent to OneOme for analysis. When the results are available, the study investigators will review the medications again for potential drug-drug and drug-genotype interactions and then communicate to the patients clinical team those results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions. Thirty days after the recommendations are communicated to the patient's clinical team, the patient will be contacted by phone. During this phone call, the following information will be obtained: 1. The patient's current medication list. 2. The patient's 24 item questionnaire measuring medication side effects. 3. The patient's one item self rating of improvement Once this phone call is completed, the research team will determine whether the medication recommendations were followed by the patient's clinical team, whether the adverse effects decreased compared to hospital admission, and whether the patient reported improvement.

Registry
clinicaltrials.gov
Start Date
October 14, 2018
End Date
January 2, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Simon Kung

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Ages 18 and older
  • Hospitalized on Generose 2E (Acute Care Psychiatry), 3E (Medical and Geriatric Psychiatry), or 3W (Mood Disorders Unit).
  • A voluntary patient
  • Having 5 or more medications (scheduled or as needed) on their medication list.
  • Ability to give informed consent

Exclusion Criteria

  • Patient with cognitive impairments such as moderate to severe dementia.
  • Patients who do not communicate in English or cannot comprehend the rating scales used.
  • Patients who have had pharmacogenetics testing performed within the previous 5 years.

Outcomes

Primary Outcomes

Reduction of Potential Drug Interactions

Time Frame: 30 days

Reduction of potential drug interactions risk measured by the numbers in low, medium and high categories.

Secondary Outcomes

  • Reduction of Side Effects(30 days)

Study Sites (1)

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