An interventional study of Intervention arm - automated call and phone-based pharmacist counseling in Diabetes, Depression and Insomnia, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-08-04.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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.
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.
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Browse Hypertension studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
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Exclusion Criteria:
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
Behavioral: Intervention arm - automated call and phone-based pharmacist counseling
Intervention patients are matched with control patients; control patients have only chart review completed.
patients receive automated phone call with questions about side effects and an opportunity to speak with a pharmacist
Discontinuation of mediation
Was medication thought to be associated with adverse drug reaction discontinued in the patient chart?
Time frame: 6-8 months after initial recruitment
Adverse drug reaction awareness
evidence of adverse drug reaction awareness in patient chart - ADR discussed with provider, dose changed, medication switched.
Time frame: 6-8 months following recruitment
Call metrics
How many people were successfully counseled on the phone by the pharmacist about medications - adherence, safety, side effects. How many people reported a side effect but chose not to speak with the pharmacist. How many people completed a partial survey via phone.
Time frame: Ongoing assessment as part of quality assurance and quality improvment; final call disposition to be assigned to each patient 1-2 weeks following the 1st IVRS call (4-6 weeks following initiation of target drug) and the 2nd IVR call (4-6 months later)
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital