NCT00995696

Treatment Follow-up Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Interactive Voice Response (IVR)

Interventions

Type	Name	Description
BEHAVIORAL	PhaST IVR Calls	Participants in this condition receive 7 computer automated IVR calls.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-12-01
• Completion: 2011-05-01
• First posted: 2009-10-15
• Last updated: 2011-06-22

Locations

2 sites across 1 country: United States