NCT02274298

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

October 6, 2014

Last Update Submit

October 13, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Proportion of patients at high risk screened for CKD with an eGFR and/or ACR

    24 months

  • Proportion of patients with an initial eGFR <60 and a f/u eGFR or an ACR

    24 months

  • Proportion of patients with diabetes and albuminuria and on an ACE or ARB

    24 months

  • Proportion of patients meeting eGFR criteria for CKD and documentation of CKD in the cumulative patient profile (CPP)

    24 months

  • Proportion of patients with an ACR in the past 18 months and meeting bp targets

    24 months

  • +1 more secondary outcomes

Study Arms (2)

CKD feedback and tools

ACTIVE COMPARATOR

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

No Intervention

NO INTERVENTION

Physicians in these clinics/clusters will not receive CKD feedback or tools

Interventions

people in the intervention arm will receive feedback on ckd quality indicators and tools to help in the detection and management of ckd

CKD feedback and tools

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Updated data available at the time of study commencement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karen Tu, MD, MSc

    ICES/Sunnybrook

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 24, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

No, final results will be aggregate although as part of the trial individual participants do receive individual level feedback