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



Status:Enrolling by invitation
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:11/22/2018
Start Date:October 14, 2018
End Date:September 8, 2019

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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.

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.

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.
We found this trial at
1
site
Rochester, Minnesota 55905
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Rochester, MN
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