Improving Care for Patients With Chronic Kidney Disease Using EMRALD
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CKD feedback and tools
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Family physicians participating in EMRALD, on the EMR for >=2 years, roster size >=100 patients
- Patient criteria, rostered and actively seeing an EMRALD physician, on the EMR for .=1 year
Exclusion Criteria:
- Updated data available at the time of study commencement
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CKD feedback and tools
No Intervention
Arm Description
Physicians in these clinics/clusters will receive feedback on their performance for screening and managing CKD quality indicators as well as EMR tools to aid in their performance
Physicians in these clinics/clusters will not receive CKD feedback or tools
Outcomes
Primary Outcome Measures
Proportion of patients age 50-80 with Stage 3+ CKD and a statin prescription
Comparison of proportion of patients age 50-80 years with Stage 3+ CKD (no dialysis or renal transplant) and receiving a statin prescription at baseline and at the end of the trial
Secondary Outcome Measures
Proportion of patients at high risk screened for CKD with an eGFR and/or ACR
compare baseline rates to end of intervention rates
Proportion of patients with an initial eGFR <60 and a f/u eGFR or an ACR
compare baseline rates to end of intervention rates
Proportion of patients with diabetes and albuminuria and on an ACE or ARB
compare baseline rates to end of intervention rates
Proportion of patients meeting eGFR criteria for CKD and documentation of CKD in the cumulative patient profile (CPP)
compare baseline rates to end of intervention rates
Proportion of patients with an ACR in the past 18 months and meeting bp targets
compare baseline rates to end of intervention rates
Proportion of patients age less than 80 years and an eGFR<30 being seen by or with a referral to a Nephrologist
compare baseline rates to end of intervention rates
Full Information
NCT ID
NCT02274298
First Posted
October 6, 2014
Last Updated
October 13, 2016
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Ontario Renal Network
1. Study Identification
Unique Protocol Identification Number
NCT02274298
Brief Title
Improving Care for Patients With Chronic Kidney Disease Using EMRALD
Official Title
Improving Care for Patients With Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Ontario Renal Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pragmatic cluster randomized controlled trial will test the impact of feedback and a toolkit aimed at improving the management of chronic kidney disease (CKD) in the primary care setting. This trial will use family physicians in Ontario participating in the Electronic.
Detailed Description
This trial will use family physicians in Ontario participating in the Electronic Medical Record Administrative data Linked Database (EMRALD) and receiving the System for Audit and Feedback to Improve caRE (SAFIRE) along with other decision support tools. Performance on CKD quality indicators for family physicians receiving the CKD feedback and tools will be compared to physicians not receiving the CKD feedback or tools.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CKD feedback and tools
Arm Type
Active Comparator
Arm Description
Physicians in these clinics/clusters will receive feedback on their performance for screening and managing CKD quality indicators as well as EMR tools to aid in their performance
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Physicians in these clinics/clusters will not receive CKD feedback or tools
Intervention Type
Behavioral
Intervention Name(s)
CKD feedback and tools
Intervention Description
people in the intervention arm will receive feedback on ckd quality indicators and tools to help in the detection and management of ckd
Primary Outcome Measure Information:
Title
Proportion of patients age 50-80 with Stage 3+ CKD and a statin prescription
Description
Comparison of proportion of patients age 50-80 years with Stage 3+ CKD (no dialysis or renal transplant) and receiving a statin prescription at baseline and at the end of the trial
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Proportion of patients at high risk screened for CKD with an eGFR and/or ACR
Description
compare baseline rates to end of intervention rates
Time Frame
24 months
Title
Proportion of patients with an initial eGFR <60 and a f/u eGFR or an ACR
Description
compare baseline rates to end of intervention rates
Time Frame
24 months
Title
Proportion of patients with diabetes and albuminuria and on an ACE or ARB
Description
compare baseline rates to end of intervention rates
Time Frame
24 months
Title
Proportion of patients meeting eGFR criteria for CKD and documentation of CKD in the cumulative patient profile (CPP)
Description
compare baseline rates to end of intervention rates
Time Frame
24 months
Title
Proportion of patients with an ACR in the past 18 months and meeting bp targets
Description
compare baseline rates to end of intervention rates
Time Frame
24 months
Title
Proportion of patients age less than 80 years and an eGFR<30 being seen by or with a referral to a Nephrologist
Description
compare baseline rates to end of intervention rates
Time Frame
24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Family physicians participating in EMRALD, on the EMR for >=2 years, roster size >=100 patients
Patient criteria, rostered and actively seeing an EMRALD physician, on the EMR for .=1 year
Exclusion Criteria:
Updated data available at the time of study commencement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Tu, MD, MSc
Organizational Affiliation
ICES/Sunnybrook
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No, final results will be aggregate although as part of the trial individual participants do receive individual level feedback
Citations:
PubMed Identifier
28607686
Citation
Nash DM, Ivers NM, Young J, Jaakkimainen RL, Garg AX, Tu K. Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol. Can J Kidney Health Dis. 2017 Apr 5;4:2054358117699833. doi: 10.1177/2054358117699833. eCollection 2017.
Results Reference
derived
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Improving Care for Patients With Chronic Kidney Disease Using EMRALD
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