Preventing Adverse Drug Events With PatientSite

NCT ID: NCT00140504

Last Updated: 2013-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adverse Drug Event

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MedCheck

Electronic medication safety queries via PatientSite portal

Group Type EXPERIMENTAL

Medcheck message

Intervention Type OTHER

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 electronic medication safety messages via PatientSite portal

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medcheck message

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients \>18
* Patients that receive a new prescription
* Proficient in spoken and written english
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Blue Cross Blue Shield

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Saul N. Weingart, MD, PhD

VP for Quality Improvement and Patient Safety

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saul N Weingart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23965840 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Weingart - K08HS11644

Identifier Type: -

Identifier Source: secondary_id

05-061

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RxConnect User Testing Study
NCT05493072 COMPLETED NA