Treatment Follow-up Study
Condition: Interactive Voice Response (IVR)
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effectiveness of a medication safety monitoring method utilizing
      interactive voice response technology for youth recently prescribed anti-depressant
      medication.
    

Detailed description: 
      Over a two year period, 800 children and adolescents between the ages of 6 - 17 years old who
      have received a new prescription for an antidepressant will be recruited from families
      receiving care at Nationwide Children's Hospital or Community Physician Practices affiliated
      with Nationwide Children's Hospital.

      At the baseline site visit, a research assistant will explain the study to the family and
      obtain written informed consent from the subject's parent/guardian and assent from the youth.
      In addition, consent for release of information will be obtained from the parent/guardian to
      communicate with the treating physician and other professionals involved in the youth's
      mental health care (if applicable) as well as to obtain medical records. Randomization to
      study condition will also be conducted by this RA and a description of the PhaST procedure
      will be given to the families randomized into that condition.

      Once informed consent and assent has been obtained, a second research assistant will
      administer our assessment battery to the family. This RA will serve as an independent
      research evaluator and will determine whether the patient has experienced an adverse event
      during the past month. A comprehensive assessment of adverse events will be conducted with
      individuals at study entry (baseline) and once a month following for three months. At each
      assessment, the primary parent informant and child will be interviewed separately and
      concurrently.

      For patients in the PhaST condition, PhaST will monitor the patient through a series of brief
      telephone calls following the FDA's recommendations for frequency of visits. There will be a
      total of seven calls over the same three-month period as the visits. The first four calls
      will be weekly. The next two calls will be every two weeks. The final call will be one month
      later. The monitoring call presents the 8-question PhaST screening assessment and lasts an
      average of only 2 minutes and 12 seconds. To ensure that the health data are secure, the
      patients or parents identify themselves with PINs at the beginning of an automated call.
      Parents answer the questions for children 12 years old or younger and teenagers answer for
      themselves. If a patient answers "no" to all the screening questions, the data are
      automatically stored and a report is routed to the patient's electronic health record and to
      the patient's clinician's electronic inbox. If a patient answers "yes" to any screening
      questions, the on-call PTS will immediately be paged.

      For any "yes" responses to a screening question, the PTS will follow-up and triage the
      severity of the problem using a semi-structured clinical interview. Based on the triage
      interview, the PTS decides whether action is warranted. If the screen is a false positive
      (meaning, no adverse event is occurring), the PTS logs the data to be included in a report
      sent to the patient's psychiatrist and clinician (if applicable). If she judges that the case
      requires further attention, she will talk with parent(s)/ guardian(s) and patient regarding
      the development of plan to address potential risk. If the youth has a developed safety plan,
      she will review the plan with the family and talk with them about implementing or modifying
      the plan to address any potential risk.

      If the PTS concludes that the case requires immediate further assessment, she will attempt to
      contact Nationwide Children's Hospital Psychiatry Consultation Service. If the psychiatrist
      on-call is not available and the child has a safety plan, the ongoing or on-call behavioral
      health provider(s) reflected in the safety plan will be contacted. If the professionals
      reflected in the safety plan are not available or the child does not have a safety plan, the
      Nationwide Children's Behavioral Health Crisis Team will be contacted. The professional who
      is reached by the PTS regarding the potential risk is responsible for managing the crisis.
    

Intervention name(s): PhaST IVR Calls
Intervention type(s): Behavioral
Intervention description(s): Participants in this condition receive 7 computer automated IVR calls.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Interactive Voice Response (IVR); Antidepressant