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

Healthcare Clinical Trial

— DDI+  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765621
• Other study ID #: LHS022013
• Status: Completed
• Phase: N/A
• First received: January 9, 2013
• Last updated: October 20, 2014
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Leumit Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 973
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthcare

Intervention

Other:
• DDI+ System and Pharmacogenetic Data

Locations

Country	Name	City	State
Israel	Leumit Health Services	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Leumit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Admissions		up to 12 month post initiation	Yes