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

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.

Study Overview

• Status: Completed
• Conditions: Psychiatric Disorder
• Intervention / Treatment: Genetic: Pharmacogentic Analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Pharmacogenetic Analysis; A pharmacogenetic analysis will be completed for each participant upon inclusion into the study

Genetic: Pharmacogentic Analysis; Participant will complete a buccal swab and it will be sent off to OneOme for analysis. When the results are available, the study investigators will review the medications for potential drug-drug and drug-genotype interactions. The risk for interactions will be classified as low, medium or high. The investigators will then communicate to the clinical team taking care of the patient these results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions.; Other Names: OneOme Pharmacogentic Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Potential Drug Interactions	Reduction of potential drug interactions risk measured by the numbers in low, medium and high categories.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Side Effects	Reduction of side effects as measured by side effects rating scale. Improvement of patient's self-assessment via the questionnaire item.	30 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Simon Kung, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2018
• Primary Completion (Actual): January 2, 2020
• Study Completion (Actual): January 2, 2020

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 18, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Polypharmacy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Chemically-Induced Disorders; Problem Behavior; Mental Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 18-006182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No