Preventing Adverse Drug Events With PatientSite - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Agency for Healthcare Research and Quality (AHRQ) Blue Cross Blue Shield of Massachusetts Beth Israel Deaconess Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00140504

Purpose

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.

Condition	Intervention
Adverse Drug Event	Other: Medcheck message

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Preventing Adverse Drug Events With PatientSite

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To prevent adverse drug events with PatientSite. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improve patient satisfaction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
better utilization of services [ Time Frame: 3 years ] [ Designated as safety issue: No ]
improve patient-clinician communication [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	April 2003
Estimated Study Completion Date:	April 2008
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MedCheck: Experimental 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
Usual care: No Intervention No electronic medication safety messages via PatientSite portal

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140504

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Agency for Healthcare Research and Quality (AHRQ)

Blue Cross Blue Shield of Massachusetts

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Saul N Weingart, MD, PhD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Saul Weingart, MD )
Study ID Numbers:	05-061, Weingart - K08HS11644
Study First Received:	August 30, 2005
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00140504
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Adverse drug event
Patient safety
Internet portal

PatientSite
Preventive health
Primary care

Study placed in the following topic categories:

Drug Toxicity
Poisoning
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 13, 2009