NCT00446615

Brief Summary

In 2001, an estimated 1.9 million Canadians had chronic renal disease and the number of patients being treated for end stage renal disease climbed by nearly 20% in 5 years. Many medications commonly used in elderly patients are excreted by the kidney. Failure to adjust doses in those with impaired renal function can result in medication overdose, leading to potentially serious morbidity and mortality. Studies in hospitals and long term care facilities have found a 19-67% rate of non-compliance with guidelines for medication dose adjustment in patients with renal insufficiency and in ambulatory care one study found a 69% rate of non-compliance. Since primary care physicians write 80% of prescriptions for those aged 65 years, there is a need for interventions to improve prescribing to patients with renal impairment in primary care. This study will develop an audit tool and electronic decision support tool that will be incorporated into the electronic medical record in a large academic family health centre. It is seen as a preliminary step in a project to assess the effectiveness of a multifaceted intervention including chart audit, personalized feedback to prescribers, a pharmacist-facilitated group learning session and the use of an electronic decision support tool incorporated into the electronic medical record.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
Last Updated

March 13, 2007

Status Verified

March 1, 2007

First QC Date

March 9, 2007

Last Update Submit

March 9, 2007

Conditions

Keywords

computer decision supportprimary carekidney disease, chronicprescribing

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be a change in the number of appropriately written prescriptions for the targeted medications 3 and 6 months after the educational intervention and introduction of the clinical decision support tool.

Secondary Outcomes (2)

  • Prescribers' perception of their knowledge of and comfort with adjusting doses of medications as measured in a Likert scale and their assessement of the ease of use of the decision support tool

  • , cost savings, time for prescribers to use the decision support tool, number of times the decision support tool was used.

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients 65 years or older who have been prescribed one or more of the targeted medications and who have a creatinine from within the previous year on record will be included.

You may not qualify if:

  • Patients on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stonechurch Family Health Centre

Hamilton, Ontario, L8W 3J6, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Imaan Bayoumi

    McMaster University

    PRINCIPAL INVESTIGATOR
  • Lisa McCarthy

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imaan Bayoumi, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 13, 2007

Study Start

March 1, 2007

Study Completion

March 1, 2007

Last Updated

March 13, 2007

Record last verified: 2007-03

Locations