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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02274298
Other study ID # 074-2013-2
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 6, 2014
Last updated October 13, 2016
Start date October 2014
Est. completion date April 2017

Study information

Verified date October 2016
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 221
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre Ontario Renal Network

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary Proportion of patients with diabetes and albuminuria and on an ACE or ARB compare baseline rates to end of intervention rates 24 months No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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