Clinical trial NCT03748355: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Disorder
Keywords: Polypharmacy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Reduction of Potential Drug Interactions
timeFrame: 30 days
Secondary outcomes:
measure: Reduction of Side Effects
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Simon Kung, MD
role: PRINCIPAL_INVESTIGATOR
References: