Multifaceted Intervention to Improve Prescribing in Patients With Chronic Kidney Disease

March 9, 2007 updated by: Hamilton Health Sciences Corporation

Multifaceted Intervention to Improve Prescribing of Medications Requiring Dose Adjustment in Patients With Chronic Kidney Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study Design:

This descriptive study will develop and pilot test the tools for a multifaceted intervention to improve prescribing to patients with renal impairment in primary care. These tools include a chart audit tool, development of a group learning session and an electronic clinical decision support tool that will be incorporated into the electronic medical record.

Setting:

This study will be conducted at Stonechurch Family Health Centre, an academic family practice teaching site of McMaster University. Stonechurch Family Health Centre currently provides primary care to about 16,000 patients. There are three interdisciplinary clinical teams that include academic and community family physicians, nurse practitioners, registered nurses, RPNs, a pharmacist, social workers and other professionals. Approximately 9.5% of the patient population is elderly.

Stonechurch Family Health Centre uses the Open Source Clinical Application Resource (OSCAR) system as its electronic medical record (EMR). OSCAR was developed by Dr. David Chan and colleagues and has the benefit of integrating clinical practice with clinical knowledge and delivering necessary tools including pharmaceutical and other clinical reference at the point of care. OSCAR has been used at Stonechurch since April 2002 and the transition from paper chart to electronic records has been successfully completed for all practices within the practice site

Patient Sample Inclusion: Patients over age 65 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.

Exclusions: patients on dialysis.

Intervention:

The proposed multifaceted intervention employs a combination of high and low technology strategies. Following a pre-intervention chart audit, personalized feedback about prescribing practices will be provided to prescribers. This data will be used to design a curriculum for a pharmacist-facilitated group learning session for providers about dose adjustments for patients with renal impairment. Principles from the educational session will be reinforced through an electronic medical record decision support tool. The tool will consist of a calculator that will allow prescribers to estimate creatinine clearance. Electronically delivered lab data will be used to populate appropriate fields in the creatinine clearance calculator in order to improve the ease of use of this decision support tool. Users will be prompted to supply missing data and will be advised about necessary dose adjustments for the targeted medications. The targeted medications are those that have already been determined through a consensus panel at the Centre for Evaluation of Medicines, McMaster University and for which dose adjustment guidelines are available and that are being utilized for another related project to improve dosing of medications in the long term care setting. The list of included medications and recommended dose adjustments are attached (Appendix 1).

Measurements:

Targetted prescriptions:

The number of prescriptions written for the targeted medications will be collected. Each prescription will be reviewed and categorized as appropriate or inappropriate by examining the drug regimen and creatinine clearance for the patient. Two people will independently review each prescription and discrepancies will be resolved through concensus. The appropriateness rating process will be pilot tested.

Number of patients for whom a prescription for the target drug was written, number of times the electronic decision support tool was accessed and the time between initiation of the decision support tool and electronic prescribing of the precriotion will be collected.

Prescriber knowledge and comfort with adjusting doses of medications will be measured in a Likert scale before and after the teaching session. Prescriber assessement of the ease of use of the decision support tool will be measured through a brief useability survey.

Outcomes:

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 will include:

  • 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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8W 3J6
        • Stonechurch Family Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

National Research System-College of Family Physicians of Canada

Investigators

  • Principal Investigator: Imaan Bayoumi, McMaster University
  • Principal Investigator: Lisa McCarthy, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

March 9, 2007

First Submitted That Met QC Criteria

March 9, 2007

First Posted (ESTIMATE)

March 13, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2007

Last Update Submitted That Met QC Criteria

March 9, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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