Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Antidepressants Causing Adverse Effects in Therapeutic Use
- Sponsor
- University of Michigan
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Count of Participants Prescribed Antidepressant Medication
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Lorraine Buis
Assistant Professor, Family Medicine Assistant Professor of Information, School of Information
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Count of Participants Prescribed Antidepressant Medication
Time Frame: Baseline, 3 months, 6 months, and 9 months
Count of participants who have been prescribed antidepressant medications which are not contraindicated
Secondary Outcomes
- 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)