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Preventing Adverse Drug Events With PatientSite

Primary Purpose

Adverse Drug Event

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medcheck message
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adverse Drug Event focused on measuring Adverse drug event, Patient safety, Internet portal, PatientSite, Preventive health, Primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MedCheck

Usual care

Arm Description

Electronic medication safety queries via PatientSite portal

No electronic medication safety messages via PatientSite portal

Outcomes

Primary Outcome Measures

To prevent adverse drug events with PatientSite.

Secondary Outcome Measures

Improve patient satisfaction
better utilization of services
improve patient-clinician communication

Full Information

First Posted
August 30, 2005
Last Updated
February 24, 2013
Sponsor
Dana-Farber Cancer Institute
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Blue Cross Blue Shield, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00140504
Brief Title
Preventing Adverse Drug Events With PatientSite
Official Title
Preventing Adverse Drug Events With PatientSite
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Blue Cross Blue Shield, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Event
Keywords
Adverse drug event, Patient safety, Internet portal, PatientSite, Preventive health, Primary care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MedCheck
Arm Type
Experimental
Arm Description
Electronic medication safety queries via PatientSite portal
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No electronic medication safety messages via PatientSite portal
Intervention Type
Other
Intervention Name(s)
Medcheck message
Intervention Description
Participants selected at random will receive one email message asking them questions about their prescription which will be forwarded to their physician
Primary Outcome Measure Information:
Title
To prevent adverse drug events with PatientSite.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Improve patient satisfaction
Time Frame
3 years
Title
better utilization of services
Time Frame
3 years
Title
improve patient-clinician communication
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients >18 Patients that receive a new prescription Proficient in spoken and written english Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saul N Weingart, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23965840
Citation
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.
Results Reference
derived

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Preventing Adverse Drug Events With PatientSite

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