Preventing Adverse Drug Events With PatientSite

This study has been completed.
Sponsor:
Collaborators:
Blue Cross Blue Shield
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Saul N. Weingart, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00140504
First received: August 30, 2005
Last updated: February 24, 2013
Last verified: February 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Blue Cross Blue Shield
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Saul N Weingart, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided by Dana-Farber Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saul N. Weingart, MD, PhD, VP for Quality Improvement and Patient Safety, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00140504     History of Changes
Other Study ID Numbers: 05-061, Weingart - K08HS11644
Study First Received: August 30, 2005
Last Updated: February 24, 2013
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

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014