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Multifaceted Intervention to Improve Prescribing in Patients With Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
computer decision support tool
audit and feedback
group learning session
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease focused on measuring computer decision support, primary care, kidney disease, chronic, prescribing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stonechurch Family Health Centre

Outcomes

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.

Full Information

First Posted
March 9, 2007
Last Updated
March 9, 2007
Sponsor
Hamilton Health Sciences Corporation
Collaborators
National Research System-College of Family Physicians of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00446615
Brief Title
Multifaceted Intervention to Improve Prescribing in Patients With Chronic Kidney Disease
Official Title
Multifaceted Intervention to Improve Prescribing of Medications Requiring Dose Adjustment in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
National Research System-College of Family Physicians of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
computer decision support, primary care, kidney disease, chronic, prescribing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
computer decision support tool
Intervention Type
Behavioral
Intervention Name(s)
audit and feedback
Intervention Type
Behavioral
Intervention Name(s)
group learning session
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
, cost savings, time for prescribers to use the decision support tool, number of times the decision support tool was used.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imaan Bayoumi, MD
Phone
905 575-1300
Email
bayoumi@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa McCarthy
Phone
905 575-1300
Email
lmccart@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imaan Bayoumi
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa McCarthy
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stonechurch Family Health Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8W 3J6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imaan Bayoumi
Phone
905 575-1300
Email
bayoumi@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Lisa McCarthy
Phone
905 575-1300
Email
lmccart@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Imaan Bayoumi
First Name & Middle Initial & Last Name & Degree
Lisa McCarthy
First Name & Middle Initial & Last Name & Degree
David Chan

12. IPD Sharing Statement

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Multifaceted Intervention to Improve Prescribing in Patients With Chronic Kidney Disease

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