A Prospective Multicenter Cohort Study to Evaluate The Characteristics and Clinical Implications of a Clinical Decision Support System and of Pharmacogenomic Information Relevant to Polypharmacy Actions in Patients With Advanced Illness Who Are Receiving Multiple Drugs for Pain and Other Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinician Feasibility
研究概览
简要总结
The investigators propose to study the feasibility, acceptability, usability and outcomes of a new clinical decision support system for clinicians of opioid therapy in the context of specialist palliative care for serious chronic illness. The system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions. This clinical decision support system should improve the clinician's ability to identify the optimal pain medication and dosage, and reduce risks associated with multi-drug treatment. Investigators will conduct clinician survey's to collection information about the clinical decision support system. Investigators will also conduct patient related questionnaires to determine any benefits or improvements in quality of life and symptom management from the clinical decision support system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Clinicians will be eligible if:
- •Physicians or nurse practitioners who are practicing hospice and palliative care
- •Responsible for making and implementing decisions about opioid therapy for pain
- •Patients will be identified by their treating clinicians. Patients will be eligible if:
- •> 18 years of age
- •Palliative Performance Score ≥ 30%
- •Reside in the community or at a nursing home
- •Have >1 serious chronic illness
- •Have an assessed life-expectancy of at least 4 weeks
- •Have a history of pain and have been taking prescribed opioid medication with a regimen that provides a minimum dose of 20 mg morphine or equivalent per day in scheduled doses for at least one week prior to recruitment
- •Is expected to continue opioid therapy for the duration of study participation
- •Is taking > 4 non-opioid medications, each in a regimen providing continuous treatment of pain or another disorder
- •Is expected to continue drug therapy for the duration of study participation
- •Able to read, understand, and provide Informed Consent to participate
排除标准
- •There are no exclusion criteria for clinicians.
- •Patients will be excluded if:
- •Pregnant women or women trying to become pregnant or nursing. Women of childbearing potential must use an acceptable method of birth control for the duration of the study. (acceptable forms are oral birth control pills, condoms in combination with spermicide foam, IUD, transdermal patches, birth control implants, vaginal ring)
- •Palliative Performance Score <30%
- •Have taken an investigational product in the last 30 days
- •Current use of illicit substances
- •Immediate family members of site staff, or site staff may not be enrolled in the study without first obtaining IRB authorization
- •Any other medical or physical abnormality, disease, or disorder that would prohibit the patient from completing study procedures in the judgement of the investigator
研究组 & 干预措施
Clinical Decision Support System
The Clinical Decision Support System is composed of pharmacogenomic results and a pharmacist evaluated drug to drug interaction review. This system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions.
干预措施: Clinical Decision Support System (Other)
结局指标
主要结局
Clinician Feasibility
时间窗: through study completion, an average of 24 months
Clinical questionnaire to determine feasibility of the system
Clinician Usability
时间窗: through study completion, an average of 24 months
Clinical questionnaire to determine usability of the system
次要结局
- Patient Pain(through study completion, an average of 24 months)
- Patient Quality of Life(through study completion,an average of 24 months)