Evaluating the Effectiveness of a Personalized Therapeutics Clinic (PTC) Intervention on Drug-Drug Interactions (DDIs) and Drug-Gene Interactions (DGIs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •for Participants
- •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.
- •Inclusion of Women, Minorities, and Other Underrepresented Populations Individuals of all races and ethnic groups and genders are eligible for this trial.
研究组 & 干预措施
Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles
Group one consists of subjects who will participate in the Personalized Therapeutics Clinic where in which study doctors will make recommendations based on information found in both the subject's drug-drug interaction and drug-gene profiles. These recommendations will be given to participating providers. These recommendations will be communicated to healthcare providers who are directing the subject's care. These providers may work in hospitals, primary care, oncology, geriatrics, and mental and behavioral health. Each provider will have separately agreed to participate in this study. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff.
Participants will randomly (like by a flip of the coin) assigned to a group.
干预措施: Drug-Drug Interaction Profile (Other)
Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles
Group one consists of subjects who will participate in the Personalized Therapeutics Clinic where in which study doctors will make recommendations based on information found in both the subject's drug-drug interaction and drug-gene profiles. These recommendations will be given to participating providers. These recommendations will be communicated to healthcare providers who are directing the subject's care. These providers may work in hospitals, primary care, oncology, geriatrics, and mental and behavioral health. Each provider will have separately agreed to participate in this study. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff.
Participants will randomly (like by a flip of the coin) assigned to a group.
干预措施: Drug-Gene Interaction Profile (Other)
Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction Profiles
Group two consists of subjects who will participate in the Personalized Therapeutics Clinic where study doctors will make recommendations based on information only found in the subject's drug-drug interaction profile. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff.
Participants will randomly (like by a flip of the coin) assigned to a group.
干预措施: Drug-Drug Interaction Profile (Other)
Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions)
Group three consists of subjects who will not participate in the Personalized Therapeutics Clinic or receive recommendations. These subjects will not have any recommendations from regarding their drug-drug interaction or drug-gene profiles. Both drug-drug interaction and drug-gene profiles will be kept hidden from all of their treating providers-regardless of whether the providers directing their care have agreed to participate in this research. Subjects in this group will not learn about their drug-drug interaction or drug-gene profiles during educational visits with clinic staff.
Participants will randomly (like by a flip of the coin) assigned to a group.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants
时间窗: 9 months
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.
次要结局
- Rate of Reported Adverse Events as Assessed by Clinical Records(9 months)
- Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)(9 months)
- Rate of Emergency Department Visits(9 months)
- Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results(9 months)
- Participants At High-Risk for Drug-Drug and Drug-Gene Interactions(9 months)
- Rate of Hospitalizations(9 months)
- Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results(9 months)