NCT00784381

Brief Summary

To evaluate the quality of orders for target drugs in old patients with impaired renal function, hospitalized or living in long stay units, and to improve these practices by means of a counselling system coupled to a computer prescribing system

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 19, 2012

Status Verified

October 1, 2008

Enrollment Period

1.6 years

First QC Date

October 27, 2008

Last Update Submit

November 16, 2012

Conditions

Impaired Renal Function

Keywords

Renal failureElderlyDrug Therapy Computer-AssistedQuality of carePatients With Impaired Renal FunctionInappropriateness of target drug prescribed

Outcome Measures

Primary Outcomes (1)

  • Comparison of the changes from baseline of proportions [patients with inappropriate target drug prescribing/patients with creatinine clearance<60 ml/mn] between control and intervention groups

    6 months

Secondary Outcomes (1)

  • Time-related improvement of target drug prescribing in intervention units

    9 months

Study Arms (2)

1

Device: computer-assisted counselling about target drugs

2

These units use the same electronic prescribing system, but had no counselling software

Device: computer-assisted counselling about target drugs

Interventions

computer-assisted counselling about target drugsDEVICE

implementation in experimental units of a software coupled to electronic prescribing system . This software is operating in patients with creatinine clearance below 60 ml/mn. When a target drug is prescribed to such a patient, the software checks if the drug is contraindicated due to impaired renal function, and if not checks if the dose is appropriate relatively to creatinine clearance value

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in geriatric units

You may qualify if:

  • geriatrics hospital units or nursing homes
  • using the same electronic prescribing system called ORDOCLIC
  • agreeing to participate in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hopital Charles Foix et Université Paris 6

Ivry-sur-Seine, 94 200, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Joel BELMIN, Prof

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2008

First Posted

November 3, 2008

Study Start

May 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 19, 2012

Record last verified: 2008-10

Locations

FR(1)