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临床试验/NCT03270891
NCT03270891已完成不适用

Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care

University of Michigan1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Count of Participants Prescribed Antidepressant Medication

研究概览

简要总结

This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to manage antidepressant use will be enrolled. Patients of these DFM physicians who are adults with a new prescription for a target antidepressant will also be enrolled.

详细描述

This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM). We will enroll physicians practicing at a UM DFM clinical site who are willing to utilize PGx test results in conjunction with treating patients prescribed certain antidepressants. We will also enroll patients of these DFM physicians who are adults with a new prescription for an antidepressant (within the past 4 weeks) including patients who have switched to a new antidepressant from another antidepressant or have added on a new antidepressant to current antidepressant therapy. Patients are excluded if taking an antidepressant for more than 4 weeks or if they have had PGx testing in the past. Patients will be randomized to either an intervention or control group. Patients in the intervention group will have PGx test results available soon after enrollment while the control patients will have test results available 3 months after the first visit. All patients will complete a baseline, 3-, and 6-month assessment; control patients will have an additional 9-month assessment. Data to be collected include symptoms and severity (PHQ-8, GAD7), functional health status (SF-12), PGx knowledge, work status changes, demographic information, physician and emergency department visits, adverse effects, and medication alterations and adherence.

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

  • •Physician participants
  • •Inclusion criteria:
  • •Be a practicing physician at a University of Michigan Department of Family Medicine clinic
  • •Be willing to use PGx test results for their patients enrolled in the study
  • •Be willing to allow study staff to contact their patients
  • •Self-report that they are willing to prescribe antidepressants

排除标准

  • •Do not meet inclusion criteria
  • •Patient Participants
  • •Be a patient of a participating physician
  • •Have a new prescription for one of the following antidepressant medications: citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Prozac Weekly, Rapiflux, Sarafem, Selfemra), fluvoxamine (Luvox, Luvox CR), paroxetine (Paxil, Paxil CR), sertraline (Zoloft), duloxetine (Cymbalta, Irenka), venlafaxine (Effexor), venlafaxine XR (Effexor XR), nortriptyline (Aventyl, Pamelor), bupropion (Forfivo XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL), mirtazapine (Remeron, Remeron Soltab), or vortioxetine (Trintellix)
  • •Be willing to undergo PGx testing via single tube blood draw
  • •Do not speak English
  • •Have previously undergone PGx testing
  • •Are unable to provide their own consent to participate in the study
  • •Have been taking the new antidepressant prescription for longer than 4 weeks (prior to screening)

研究组 & 干预措施

Delayed intervention (control arm)

Active Comparator

Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment

干预措施: PGx test (Diagnostic Test)

PGx Test

Experimental

Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.

干预措施: PGx test (Diagnostic Test)

结局指标

主要结局

Count of Participants Prescribed Antidepressant Medication

时间窗: Baseline, 3 months, 6 months, and 9 months

Count of participants who have been prescribed antidepressant medications which are not contraindicated

次要结局

  • Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)(Baseline and 6 months)
  • Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)(Baseline and 6 months)
  • Change in Adherence to Refills and Medication Scale (ARMS) Scores(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorraine Buis

Assistant Professor, Family Medicine Assistant Professor of Information, School of Information

University of Michigan

研究点 (1)

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