Improving Care for Patients With Chronic Kidney Disease Using EMRALD

Improving Care for Patients With Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: CKD feedback and tools

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.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CKD feedback and tools; 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	Behavioral: CKD feedback and tools; people in the intervention arm will receive feedback on ckd quality indicators and tools to help in the detection and management of ckd
No Intervention: No Intervention; Physicians in these clinics/clusters will not receive CKD feedback or tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients at high risk screened for CKD with an eGFR and/or ACR	compare baseline rates to end of intervention rates	24 months
Proportion of patients with an initial eGFR <60 and a f/u eGFR or an ACR	compare baseline rates to end of intervention rates	24 months
Proportion of patients with diabetes and albuminuria and on an ACE or ARB	compare baseline rates to end of intervention rates	24 months
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	24 months
Proportion of patients with an ACR in the past 18 months and meeting bp targets	compare baseline rates to end of intervention rates	24 months
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	24 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Ontario Renal Network
• Investigators: Principal Investigator: Karen Tu, MD, MSc, ICES/Sunnybrook

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 074-2013-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, final results will be aggregate although as part of the trial individual participants do receive individual level feedback