Genetic Evaluation for Medication Selection (GEMS) Study

"1:1 randomization schedule for delayed knowledge of pharmacogenomic results to clinician and patient. Results are released to prescriber at \<1 week (unblinded) or 12 weeks (blinded). When genomic results are available upon receipt, unblinded clinicians select an FDA-approved drug from the recommended drugs when possible. Blinded prescribers provide the intended prescription when notified of blinded status. At 4 weeks, 1° outcome measures, NPI-Q and side effects ratings are collected. Clinicians make a GO/NO-GO decision for continuation based on those measures. A NO-GO decision is unblinding and an alternative drug may be prescribed. At 12 weeks, 1° outcomes are collected again. Previously blinded clinicians will be unblinded and may decide to continue or revise the treatment plan based on the clinical outcomes and the genetic results. After the 12 week visit, results of the genetic tests will be entered in the EHR. Further clinical follow-up is based on need."