Trial record 16 of 755 for:    pharmacogenomics OR pharmacogenetics

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+)

This study is not yet open for participant recruitment.
Verified January 2013 by Leumit Health Services
Sponsor:
Information provided by (Responsible Party):
Leumit Health Services
ClinicalTrials.gov Identifier:
NCT01765621
First received: January 9, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Healthcare
Other: DDI+ System and Pharmacogenetic Data

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Leumit Health Services:

Primary Outcome Measures:
  • Hospital Admissions [ Time Frame: up to 12 month post initiation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DDI+ and Pharmacogenetic data
DDI+ System and Pharmacogenetic data
Other: DDI+ System and Pharmacogenetic Data
No Intervention: Standard Care
Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765621

Contacts
Contact: Abraham Weizman, MD +972-50-7277123 AWeizman@clalit.org.il

Locations
Israel
Leumit Health Services Not yet recruiting
Tel-Aviv, Israel
Contact: Natan R Kahan, PhD    +972-50-5607187    nkahan@leumit.co.il   
Principal Investigator: Abraham Weizman, MD         
Sub-Investigator: Mati Berkowitz, MD         
Sponsors and Collaborators
Leumit Health Services
  More Information

No publications provided

Responsible Party: Leumit Health Services
ClinicalTrials.gov Identifier: NCT01765621     History of Changes
Other Study ID Numbers: LHS022013
Study First Received: January 9, 2013
Last Updated: January 9, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 15, 2014