Preventing Adverse Drug Events With PatientSite

February 24, 2013 updated by: Saul N. Weingart, MD, PhD, Dana-Farber Cancer Institute
This is a study to better understand the nature and extent of adverse drug events (ADEs), defined as injuries due to prescription medications, in primary care. We will study whether PatientSite (an internet-based communication program for patients and health care providers) can improve clinicians' ability to detect adverse drug events among primary care patients and to mitigate the consequences by sending electronic queries to patients after they receive new medication prescriptions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • A drug safety module called MedCheck was developed for PatientSite. This allows physicians to query patients automatically 10 days after they receive a new prescription asking them questions about their new prescription. In this study new enhancements will be tested.
  • Participants will be assigned at random to the intervention group or control group. The intervention group will receive a single electronic PatientSite message asking them questions about the new prescription which is then forwarded to their physician. The control group will receive a generic message about medication safety.
  • To identify adverse drug events, a telephone survey and medical record review will be conducted of patients in the intervention group and controls.
  • This study will run for 12 months.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients >18
  • Patients that receive a new prescription
  • Proficient in spoken and written english

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MedCheck
Electronic medication safety queries via PatientSite portal
Other: Medcheck message
Participants selected at random will receive one email message asking them questions about their prescription which will be forwarded to their physician
No Intervention: Usual care
No electronic medication safety messages via PatientSite portal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To prevent adverse drug events with PatientSite.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improve patient satisfaction
Time Frame: 3 years
3 years
better utilization of services
Time Frame: 3 years
3 years
improve patient-clinician communication
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Beth Israel Deaconess Medical Center
Blue Cross Blue Shield
Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Saul N Weingart, MD, PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

February 26, 2013

Last Update Submitted That Met QC Criteria

February 24, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-061
  • Weingart - K08HS11644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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