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

Primary Purpose

Psychiatric Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacogentic Analysis
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychiatric Disorder focused on measuring Polypharmacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pharmacogenetic Analysis

Arm Description

A pharmacogenetic analysis will be completed for each participant upon inclusion into the study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 18, 2018
Last Updated
March 10, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03748355
Brief Title
Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects
Official Title
Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 14, 2018 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: The patient's current medication list. The patient's 24 item questionnaire measuring medication side effects. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder
Keywords
Polypharmacy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacogenetic Analysis
Arm Type
Other
Arm Description
A pharmacogenetic analysis will be completed for each participant upon inclusion into the study
Intervention Type
Genetic
Intervention Name(s)
Pharmacogentic Analysis
Other Intervention Name(s)
OneOme Pharmacogentic Analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of Potential Drug Interactions
Description
Reduction of potential drug interactions risk measured by the numbers in low, medium and high categories.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Reduction of Side Effects
Description
Reduction of side effects as measured by side effects rating scale. Improvement of patient's self-assessment via the questionnaire item.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Kung, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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