Pharmaceutical Safety Tracking (PhaST): Managing Medications for Patient Safety

Research Inst Nationwide Children'S Hosp, Columbus OH

Investigators

Abstract

PhaST is a health information system that assists clinicians? management of medications[unreadable] in ambulatory settings. PhaST seeks to protect outpatients taking drugs that have[unreadable] recognized side effect risks even when those drugs are correctly prescribed. Existing[unreadable] clinical strategies for monitoring risky drugs rely on frequent office visits. Such strategies[unreadable] might succeed for families with access to a system that can supply the requisite visits.[unreadable] However, for many families, the financial or organizational burden of frequent visits is[unreadable] high. The result is that many patients are exposed to inadequate outpatient medication[unreadable] safety monitoring, with those having least access to health services likely to experience[unreadable] the least monitoring. The PhaST system is an automated system for monitoring of[unreadable] medication adherence, side effects, and patient symptoms. PhaST uses research-based[unreadable] assessment procedures administered using interactive voice response (IVR) telephony.[unreadable] When a patient reports a problem with a medication on an IVR call, PhaST alerts a[unreadable] nurse trained to triage the problem, to counsel the patient or family, and when necessary[unreadable] to contact the patient?s prescribing clinician or the hospital emergency services. PhaST[unreadable] is built within a hospital data warehouse and integrates fully with the electronic medical[unreadable] record and computerized physician order-entry system, so clinicians have real-time[unreadable] information on the patient?s experience with the medication.[unreadable] Our target medication is the pediatric use of anti-depressants. The growing use of[unreadable] psychoactive medications in children and adolescents has greatly increased the public[unreadable] health relevance of medication-related adverse events, including suicidality and manic[unreadable] activation. To compare PhaST and usual care, we propose a randomized trial in a large[unreadable] urban specialty mental health system serving a primarily Medicaid population. We will[unreadable] enroll 800 youths receiving new prescriptions for anti-depressants. We will assess the[unreadable] patients for adverse events during home visits at baseline and 1, 2, and 3 months. We[unreadable] will compare chart-documented adverse events against adverse events as determined[unreadable] by an examiner blind to the patient?s randomization. We predict higher agreement[unreadable] between chart-documented adverse events and examiner-determined adverse events in[unreadable] the PhaST condition. We will also compare PhaST and usual care on measures of[unreadable] patient and provider satisfaction, patient outcomes, and measures of the quality of[unreadable] medication management such as rates of patient medication non-adherence.