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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+)

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ClinicalTrials.gov Identifier: NCT01765621
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Healthcare Other: DDI+ System and Pharmacogenetic Data

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 973 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : January 2013
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Hospital Admissions [ Time Frame: up to 12 month post initiation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765621


Locations
Israel
Leumit Health Services
Tel-Aviv, Israel
Sponsors and Collaborators
Leumit Health Services
More Information

Responsible Party: Leumit Health Services
ClinicalTrials.gov Identifier: NCT01765621     History of Changes
Other Study ID Numbers: LHS022013
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Leumit Health Services:
health care expenditure
drug drug interactions
electronic decision support systems
pharmacogenetics
Potential Reduction