Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
The purpose of this study is to determine whether a consultation with a Personalized Therapeutics Clinic, or PTC, will help participants lower the risk for side effects (drug-drug interactions and drug-gene interactions) when taking many medications and help providers improve prescribing decisions for participants. A PTC is a clinical that will test your genes to gather information about your health that may help guide prescribing advice and offer you new information about your prescriptions. Doctors leading this study will look for variations (differences) in your genes that may suggest that you are at greater risk of having side effects or a greater chance of benefiting from certain medications. Individuals in this study will participate for roughly 9 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult participants cared for by a participating provider at University of Chicago Medical Center.
Participants must be at least 18 years of age.
Participants prescribed 5 or medication medications and taking a perpetrator drug or a drug with actionable pharmacogenomic information.
Disqualifiers
Participants who have undergone, or are being actively considered for, liver or kidney transplantation.
Participation in another pharmacogenomic study.
Participants who have previously received genotyping from another source.
Inability to understand and give informed consent to participate.
Trial design
Design model
Parallel
Treatments tested in this trial
Drug-Drug Interaction Profile
Other interventionA profile based on genetic testing that shows information about how the participant's medications they are taking interact with each other.
Drug-Gene Interaction Profile
Other interventionA profile based on genetic testing that shows information about how the participant's genes interact with/respond to certain medications they are taking.
Standard of Care
Other interventionThe standard treatment and prescribing for the participant's specific type of cancer.
Treatment groups
1,300 Participants
are divided into 3 treatment groupsGroup A: Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene ProfilesExperimental treatment 2 interventions
Group B: Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction ProfilesExperimental treatment 1 intervention
Group C: Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants
The change in the composite rate of drug-drug interactions (DDIs) and drug-gene interactions (DGIs) from baseline (at beginning of study) and after each intervention compared between all three arms.
Time frame
9 monthsSecondary outcomes
1
Participants At High-Risk for Drug-Drug and Drug-Gene Interactions
Reported as a percentage of total hospitalized participants
Time frame
9 months2
Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)
An implementation strategy for a site-specific Personalized Therapeutic Clinic (PTC) as assessed by evaluating which mediators and moderators who may be able to adopt PTC recommendations.
Time frame
9 months3
Rate of Hospitalizations
The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.
Time frame
9 months4
Rate of Emergency Department Visits
Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.
Time frame
9 monthsSponsors and contacts
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Source ClinicalTrials.gov