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Multifaceted Intervention to Improve Prescribing in Patients With Chronic Kidney Disease
This study is not yet open for participant recruitment.
Verified by McMaster University, March 2007
Sponsors and Collaborators: Hamilton Health Sciences
National Research System-College of Family Physicians of Canada
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00446615
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Behavioral: computer decision support tool
Behavioral: audit and feedback
Behavioral: group learning session

U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Multifaceted Intervention to Improve Prescribing of Medications Requiring Dose Adjustment in Patients With Chronic Kidney Disease

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Study Start Date: March 2007
Estimated Study Completion Date: March 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients on dialysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446615

Contacts
Contact: Imaan Bayoumi, MD 905 575-1300 bayoumi@mcmaster.ca
Contact: Lisa McCarthy 905 575-1300 lmccart@mcmaster.ca

Locations
Canada, Ontario
Stonechurch Family Health Centre
Hamilton, Ontario, Canada, L8W 3J6
Sponsors and Collaborators
Hamilton Health Sciences
National Research System-College of Family Physicians of Canada
Investigators
Principal Investigator: Imaan Bayoumi McMaster University
Principal Investigator: Lisa McCarthy McMaster University
  More Information

Study ID Numbers: CR-168
Study First Received: March 9, 2007
Last Updated: March 9, 2007
ClinicalTrials.gov Identifier: NCT00446615  
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
computer decision support
primary care
kidney disease, chronic
prescribing

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009