This trial is active, not recruiting.

Conditions diabetes, depression, insomnia, hypertension
Treatment intervention arm - automated call and phone-based pharmacist counseling
Sponsor Brigham and Women's Hospital
Start date June 2013
End date March 2015
Trial size 38400 participants
Trial identifier NCT02087293, 2012-P000210


Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the safety and effectiveness of treatment for patients taking FDA-approved medications for one of four common chronic conditions (diabetes, hypertension, insomnia, depression), with integrated management support by a pharmacist.

Specific Aim 2: To measure the reach, effectiveness, adoption and implementation of this integrated module for adult primary care patients in the Brigham and Women's Primary Care Practice-Based Research Network.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Group receives interactive voice response automated call asking about side effects of newly prescribed medications; has opportunity to speak with study pharmacist via phone about medication
intervention arm - automated call and phone-based pharmacist counseling
patients receive automated phone call with questions about side effects and an opportunity to speak with a pharmacist
(No Intervention)
Intervention patients are matched with control patients; control patients have only chart review completed.

Primary Outcomes

Discontinuation of mediation
time frame: 6-8 months after initial recruitment

Secondary Outcomes

Adverse drug reaction awareness
time frame: 6-8 months following recruitment

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - receives primary care at one of the Brigham-affiliated ambulatory care clinics - has received a new prescription for an oral agent to treat diabetes, hypertension, depression, or insomnia - prescribed new target drug within last month by a provider at one of the participating clinics Exclusion Criteria: - not a true "new start," i.e. patient new to clinic/health system - patient prescribed the drug for short term use, i.e. less than a week's dose - patient prescribed same drug less than 2 years prior

Additional Information

Official title e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse Reactions
Principal investigator Gordon Schiff, MD
Description The study team has wide experience surveying primary care patients about medication problems, and has established that this is an important component of detecting and understanding ADEs among ambulatory patients. In the first study, 18% of primary care patients reported a problem due to a medication during the previous year, but this was documented in only 3% of medical records. A subsequent study found that 27% of patients reported a medication-related symptom, but that only 69% of patients discussed this symptom with their physician. Upon being notified via this automated pharmacovigilance, physicians changed therapy in response to 76% of these symptoms, and 21% symptoms that had not been previously discussed resulted in a preventable ADE and 2% resulted in a preventable ADE. During the prior CERT, the investigators developed an interactive voice response system (IVRS) that interoperates with the health system EHR, and demonstrated that IVRS can be used to monitor ambulatory patients to assess adherence, medication related symptoms, and ADEs. This study builds on that initial work. The safety of prescription drugs represents an ongoing public health concern. A study by the US General Accounting Office (GAO) found that 51% of all approved drugs have at least one serious ADE that was not recognized during the approval process, reflecting the careful selection and limited number of patients who participate in pre-approval trials. While pre-market studies detect commonly occurring ADEs and efficacy in rigorously selected participants, they are not designed to assess safety and effectiveness in the broader population of eventual users. While the FDA maintains a passive adverse event reporting system, it is estimated that only about 1% of all ADEs and 10% of serious ADEs are reported, and these case reports lack accurate denominators to estimate incidence. While efforts are underway to substantially expand capacity for active surveillance using electronic health records and claims data, these data may not fully capture the patient experience, as clinicians often do not fully document patients' symptoms. Accurate ascertainment of ADEs and effectiveness in clinical practice requires real-time systems that integrate patient-reported information with clinician decision-making. Telephonic IVRS are a low-cost, sustainable way of reaching out to primary care populations, independent of a visit. In addition to monitoring for ADEs, this technology could be used to systematically assess treatment outcomes that are not commonly documented in the medical chart such as functional status, sleep, and mood. This 5 year project will have three phases: (1) development and pilot testing of the integrated pharmacovigilance system; (2) implementation; and (3) assessment of the translation and dissemination of the system, including data collection from both patients and providers. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) conceptual model provides a framework to examine the success of translation and dissemination of this system, and will be used for the third phase of the project.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.