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

NCT02087293 | Unknown

• 1 other identifier: 2012-P000210
• Study Type: interventional
• Target: 38,400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Depression; Insomnia; Hypertension

Outcome Measures

Primary Outcomes (1)

• Discontinuation of mediation

  Was medication thought to be associated with adverse drug reaction discontinued in the patient chart?

  6-8 months after initial recruitment

Secondary Outcomes (1)

• Adverse drug reaction awareness

  6-8 months following recruitment

Other Outcomes (1)

• Call metrics

  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)

Study Arms (2)

Intervention group, IVR call, RPh counseling

EXPERIMENTAL

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

Control

NO INTERVENTION

Intervention patients are matched with control patients; control patients have only chart review completed.

Interventions

Intervention arm - automated call and phone-based pharmacist counseling BEHAVIORAL

patients receive automated phone call with questions about side effects and an opportunity to speak with a pharmacist

Intervention group, IVR call, RPh counseling

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• Haas JS, Klinger E, Marinacci LX, Brawarsky P, Orav EJ, Schiff GD, Bates DW. Active pharmacovigilance and healthcare utilization. Am J Manag Care. 2012 Nov 1;18(11):e423-8.

  PMID: 23198749 BACKGROUND

• Haas JS, Amato M, Marinacci L, Orav EJ, Schiff GD, Bates DW. Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting. Drug Saf. 2012 Aug 1;35(8):623-8. doi: 10.2165/11630650-000000000-00000.

  PMID: 22764754 BACKGROUND

• Linder JA, Haas JS, Iyer A, Labuzetta MA, Ibara M, Celeste M, Getty G, Bates DW. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf. 2010 Dec;19(12):1211-5. doi: 10.1002/pds.2027.

  PMID: 21155192 BACKGROUND

• Haas JS, Iyer A, Orav EJ, Schiff GD, Bates DW. Participation in an ambulatory e-pharmacovigilance system. Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):961-9. doi: 10.1002/pds.2006.

  PMID: 20623512 BACKGROUND

• Schiff GD, Klinger E, Salazar A, Medoff J, Amato MG, John Orav E, Shaykevich S, Seoane EV, Walsh L, Fuller TE, Dykes PC, Bates DW, Haas JS. Screening for Adverse Drug Events: a Randomized Trial of Automated Calls Coupled with Phone-Based Pharmacist Counseling. J Gen Intern Med. 2019 Feb;34(2):285-292. doi: 10.1007/s11606-018-4672-7. Epub 2018 Oct 5.

  PMID: 30291602 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Depression; Sleep Initiation and Maintenance Disorders; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gordon Schiff, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Project Manager

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 14, 2014
• Study Start: June 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

US (1)