NCT00140504

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

February 26, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

August 30, 2005

Last Update Submit

February 24, 2013

Conditions

Adverse Drug Event

Keywords

Adverse drug eventPatient safetyInternet portalPatientSitePreventive healthPrimary care

Outcome Measures

Primary Outcomes (1)

  • To prevent adverse drug events with PatientSite.

    3 years

Secondary Outcomes (3)

  • Improve patient satisfaction

    3 years

  • better utilization of services

    3 years

  • improve patient-clinician communication

    3 years

Study Arms (2)

MedCheck

EXPERIMENTAL

Electronic medication safety queries via PatientSite portal

Other: Medcheck message

Usual care

NO INTERVENTION

No electronic medication safety messages via PatientSite portal

Interventions

Medcheck messageOTHER

Participants selected at random will receive one email message asking them questions about their prescription which will be forwarded to their physician

MedCheck

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Weingart SN, Carbo A, Tess A, Chiappetta L, Tutkus S, Morway L, Toth M, Davis RB, Phillips RS, Bates DW. Using a patient internet portal to prevent adverse drug events: a randomized, controlled trial. J Patient Saf. 2013 Sep;9(3):169-75. doi: 10.1097/PTS.0b013e31829e4b95.

    PMID: 23965840DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Saul N Weingart, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VP for Quality Improvement and Patient Safety

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

April 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

February 26, 2013

Record last verified: 2013-02

Locations

US(1)