e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse Reactions

Status unconfirmed · Not applicable

Conditions studied: Diabetes, Depression, Insomnia, Hypertension

In brief

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.

Key facts

Study ID

NCT02087293

Run by

Brigham and Women's Hospital

People needed

38400

Starts

2013-06-01

Expected to finish

2016-08-01

Last updated by the study team

2015-08-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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