Clinical and Economic Impact of an Electronic Medical Record Interfaced Decision Support System Reinforced With Patient Specific Pharmacogenetic Data for Minimizing Severe Drug-Drug Interactions (DDI+)

October 20, 2014 updated by: Leumit Health Services

Clinical and Economic Impact of a Web Based, Electronic Medical Record Interfaced Electronic Decision Support System Incorporating Pharmacogenetic Evaluation for Physicians Intended, Mainly for Drug-drug Interaction. A Controlled Study in an Ambulatory Health Maintenance Organization Population

Leumit Health Services, an health maintenance organization operating in Israel, will incorporate a web-based, decision support system for handling drug-drug interactions and drug information, termed DDI+ reinforced with patient specific pharmacogenetic data. The investigators hypothesize that implementing such a system will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

973

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Leumit Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Number of chronic concomitant drugs ≥5
  • treated with 1 or more drugs with a well established interaction with 1 or more of the following CYP450 enzymes: 2c9, 2c19, 2d6

Exclusion Criteria:

  • Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DDI+ and Pharmacogenetic data
DDI+ System and Pharmacogenetic data
Other: DDI+ System and Pharmacogenetic Data
No Intervention: Standard Care
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital Admissions
Time Frame: up to 12 month post initiation
up to 12 month post initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leumit Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LHS022013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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