NCT01765621

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
973

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

January 9, 2013

Last Update Submit

October 20, 2014

Conditions

Healthcare

Keywords

health care expendituredrug drug interactionselectronic decision support systemspharmacogeneticsPotential Reduction

Outcome Measures

Primary Outcomes (1)

  • Hospital Admissions

    up to 12 month post initiation

Study Arms (2)

DDI+ and Pharmacogenetic data

EXPERIMENTAL

DDI+ System and Pharmacogenetic data

Other: DDI+ System and Pharmacogenetic Data

Standard Care

NO INTERVENTION

Control

Interventions

DDI+ System and Pharmacogenetic DataOTHER
DDI+ and Pharmacogenetic data

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leumit Health Services

Tel Aviv, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

IL(1)