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:
Leumit Health Services
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
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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 May 22, 2013