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

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ClinicalTrials.gov Identifier: NCT03748355
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Simon Kung, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Psychiatric Disorder Genetic: Pharmacogentic Analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects
Actual Study Start Date : October 14, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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 Name: OneOme Pharmacogentic Analysis




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Reduction of Side Effects [ Time Frame: 30 days ]
    Reduction of side effects as measured by side effects rating scale. Improvement of patient's self-assessment via the questionnaire item.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748355


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Simon Kung, MD Mayo Clinic

Additional Information:
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Responsible Party: Simon Kung, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03748355     History of Changes
Other Study ID Numbers: 18-006182
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Kung, Mayo Clinic:
Polypharmacy
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Mental Disorders
Problem Behavior
Behavioral Symptoms
Chemically-Induced Disorders