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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014