Preventing Adverse Drug Events With PatientSite

Adverse Drug Event Clinical Trial

Official title:

Preventing Adverse Drug Events With PatientSite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140504
• Other study ID #: 05-061
• Secondary ID: Weingart - K08HS
• Status: Completed
• Phase: N/A
• First received: August 30, 2005
• Last updated: February 24, 2013
• Start date: April 2003
• Est. completion date: December 2004

Study information

• Verified date: February 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients >18

• Patients that receive a new prescription

• Proficient in spoken and written english

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Agency for Healthcare Research and Quality (AHRQ), Beth Israel Deaconess Medical Center, Blue Cross Blue Shield

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To prevent adverse drug events with PatientSite.		3 years	No
Secondary	Improve patient satisfaction		3 years	No
Secondary	better utilization of services		3 years	No
Secondary	improve patient-clinician communication		3 years	No