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

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Pharmaceutical Safety Tracking (PhaST): Managing Medications for Patient Safety - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health Information Technology (IT) (R18)
  • Grant Number: 
    R18 HS 017258
  • Project Period: 
    September 2007 - May 2011
  • AHRQ Funding Amount: 
    $1,156,142
  • PDF Version: 
    (PDF, 202.5 KB)

Summary: Pharmaceutical Safety Tracking (PhaST) is a health information system that assists clinicians' management of medications in ambulatory settings. It is an automated system for monitoring medication adherence, side effects, and patient symptoms using research-based assessment procedures administered via interactive voice response (IVR) telephony. The PhaST system was developed to improve monitoring efforts of pediatric antidepressant use. This project compared PhaST to usual care on measures of patient and provider satisfaction, patient outcomes, and measures of the quality of medication management, such as rates of patient medication non-adherence.

To compare the use of PhaST to usual care, the project conducted a randomized trial in a large, urban, and specialty mental health system that primarily serves a Medicaid population. The project enrolled youths who were receiving new prescriptions for antidepressants to assess them for adverse events at baseline and 1-, 2-, and 3-month milestones. Patients were recruited based on physician referral and included 153 families of children aged 6-17 years who had been prescribed an antidepressant in the past week. Families were randomized to a PhaST or treatment-as-usual (TAU) regimen. PhaST families received seven IVR screening calls over 3 months.

Because the monitoring calls were able to screen for potential concerns and provide routine reports, on-call triage, and patient contact, subsequent physician contact or action was needed only when an immediate risk was detected. The technology also simplified the monitoring process for the patient's family, since calls were conveniently scheduled and additional transportation or treatment costs occurred only if medically required.

The goal of PhaST was not to replace clinician visits with telephone calls, but to improve safety and remediate access problems by augmenting communication channels already available to families.

Specific Aims:

  • Determine whether PhaST is superior to usual care on measures of system process. (Achieved)
  • Determine whether PhaST is superior to usual care on measures of patient and provider outcomes. (Achieved)

2011 Activities: Obtaining complete medical records on study participants had been a challenge in early phases of the project. The project team exercised the remainder of a 6-month no-cost extension period to focus on obtaining complete records on all remaining study participants, organize the analytical data, develop a final report, and lastly, disseminate findings in a manuscript titled An automated clinical monitoring system benefits patients, lightens loads on families and providers and published in the November 2010 volume of Behavioral Healthcare. As last self-reported in the AHRQ Research Reporting System, project progress was on track and project budget spending was on target. The project concluded in May 2011.

Impact and Findings: Dr. Gardner and his study team tracked all call attempts and call completions in the PhaST group (by design, no calls were made in the TAU group). Of the 76 PhaST children, the team reached 74 (97 percent) at least once. Of the 74 participants contacted, the number of completed calls ranged from 3 to 13 (M = 6.6, SD = 1.2). Thus, the average number of successful calls was close to the desired target.

Overall, the system was shown to maintain and establish contact with patients, and it achieved its targeted rate of followup supervision. The screen has strong psychometric properties, and families used it to report significant rates of mental health problems. This information increased the amount of data on children's mental health condition available to clinicians, as shown through medical record reviews. Preliminary analyses showed that PhaST enables clinicians to have substantially increased information about patients, without the burden of significant additional tasks. Dr. Gardner is pursuing additional analyses into the comparison of chart-documented adverse events against adverse events as determined by an examiner blind to the patient's randomization. He will also compare PhaST and usual care on measures of patient and provider satisfaction, patient outcomes, and measures of the quality of medication management such as rates of patient medication non-adherence.

Target Population: Medicaid, Mental Health/Depression, Pediatric*

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Implementation and Use

* This target population is one of AHRQ's priority populations.

Pharmaceutical Safety Tracking (PhaST): Managing Medications for Patient Safety - 2010

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-006: Ambulatory Safety and Quality Program: Improving Quality Through Clinician Use of Health Information Technology (IQHIT)
  • Grant Number: 
    R18 HS 017258
  • Project Period: 
    September 2007 – May 2011, Including No-Cost Extension
  • AHRQ Funding Amount: 
    $1,156,142
  • PDF Version: 
    (PDF, 300.53 KB)


Target Population: Medicaid, Mental Health/Depression, Pediatric*

Summary: Pharmaceutical Safety Tracking (PhaST) is a health information system that assists clinicians’ management of medications in ambulatory settings. It is an automated system for monitoring medication adherence, side effects, and patient symptoms using research-based assessment procedures administered via interactive voice response (IVR) telephony. PhaST seeks to protect outpatients taking medications that have recognized side-effect risks even when those drugs are correctly prescribed.

When a patient reports a problem with a medication on an IVR call, PhaST alerts a psychiatric social worker trained to triage the problem, counsel the patient or family, and when necessary, contact the patient’s prescribing clinician or the hospital emergency services. The goal of PhaST is not to replace clinician visits with telephone calls, but to improve safety and remediate access problems by augmenting communication channels already available to families. PhaST communicates data about patients to clinicians using e-mail. PhaST does not directly store information in an electronic health record (EHR) system. Rather, copies of the e-mailed PhaST reports are filed in paper charts. This is primarily due to the fact that the complete EHR system has not yet been fully implemented for the behavioral health clinics, which are the primary source of patient referrals, and because PhaST serves patients across systems with independent health record systems.

The target medications for this project are pediatric antidepressants. To compare the use of PhaST to usual care, the project is conducting a randomized trial in a large, urban, specialty mental health system that serves a primarily Medicaid population. The project seeks to enroll youths who are receiving new prescriptions for antidepressants to assess them for adverse events at baseline and 1-, 2-, and 3-month milestones. Patients are recruited based on physician referral. A total of 200 to 250 patient recruits are anticipated by the project end. The project will compare chart-documented adverse events to adverse events that have been determined by an examiner who is blind to the patients’ randomization. It is predicted that there will be higher agreement between chart-documented adverse events and examiner-determined adverse events when PhaST is used. The project is also comparing PhaST to usual care on measures of patient and provider satisfaction, patient outcomes, and measures of the quality of medication management, such as rates of patient medication non-adherence.

Specific Aims:
  • Determine whether PhaST is superior to usual care on measures of system process. (Ongoing)
  • Determine whether PhaST is superior to usual care on measures of patient and provider outcomes. (Ongoing)

2010 Activities: The primary focus of activity was on finalizing and deploying the production version of the PhaST software. The ongoing recruitment of study participants was another important focus. The final deployment of the highly-automated system was a gradual process which began in June 2010, and as confidence in the system grew, less supervision was required. While the revised system requires significantly less supervision than it did initially, minimal supervision continues to be required due to the inherent security environment that a Web-based program faces when interacting outside the hospital system. The remainder of the project will be spent completing patient followup, data analysis, and summarizing the results.

Grantee’s Most Recent Self-Reported Quarterly Status (as of December 2010): The project is mostly on track in meeting all its aims and milestones. Moderate underspending in the budget will help facilitate the no-cost extension period, during which time the data analysis and manuscript writing will occur.

Preliminary Impact and Findings: There are no findings to report at this time. Initial recruitment was slower than originally planned, but participant retention is relatively high. Although the overall sample size may be smaller than anticipated and some questions may be harder to answer, this is not anticipated to significantly impact the analysis. Anecdotally, despite lower-than-expected physician adoption of the software, physicians who use the software provide very positive feedback. The system has also been very reliable, with virtually no downtime.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to improve the quality and safety of medication management via the integration and utilization of medication management systems and technologies.

Business Goal: Implementation and Use

*AHRQ Priority Population.

Project Details - Ended

Project Categories

Summary:

This project evaluated the Pharmaceutical Safety Tracking (PhaST) system, which monitors medication safety in children and adolescents who are taking antidepressants. The use of these medications in this group has grown as significant benefits have been recognized. With known risks of suicidality and manic activation, close monitoring of these individuals is critical. Because of the lack of availability of an automated monitoring system such as PhaST, clinicians are forced to rely on frequent face-to-face office visits to accomplish this. Many families, however, are unable to visit their clinicians at the desired frequency due to financial, organizational, and geographic barriers. These children and adolescents may not receive adequate medication safety monitoring, since those with the least access to services have the least supervision.

A main feature of PhaST is an interactive voice response (IVR) telephony component that automates the monitoring of adherence, side effects, and symptoms. If a problem with a medication is reported by a patient on an IVR call, the system automatically alerts a nurse trained to triage issues who will counsel the patient or their family, contact the patient’s physician, or activate emergency services as warranted. The main objectives of this project were to:

  • Determine whether PhaST is superior to usual care on measures of system process.
  • Determine whether PhaST is superior to usual care on measures of patient and provider outcomes.

The project evaluated PhaST via a randomized clinical trial that compared the use of the automated system to usual treatment. Participants included families with children aged 6-17 years who were newly prescribed an antidepressant. On average, those families randomized to the PhaST arm received approximately seven IVR screening calls over a period of 3 months. During the calls, respondents were asked eight screening questions that focused on potential side effects of their medication, medication adherence, worsening of clinical state, suicidality, and unusual changes in behavior.

The PhaST system was able to reach its targeted rate of followup supervision. Significantly higher rates of mental health problems were reported by study families to PhaST. The information collected increased the amount of information available to clinicians on the mental health condition of their patients without burdening them with additional tasks.

Pharmaceutical Safety Tracking (PhaST): Managing Medications for Patient Safety - Final Report

Citation:
Gardner W. Pharmaceutical Safety Tracking (PhaST): Managing Medications for Patient Safety - Final Report. (Prepared by Children's Research Institute under Grant No. R18 HS017258). Rockville, MD: Agency for Healthcare Research and Quality, 2012. (PDF, 333.33 KB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
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