Chronic Kidney DiseaseNCT02274298
Improving Care for Patients With Chronic Kidney Disease Using EMRALD
A study testing CKD feedback and tools in people with Chronic Kidney Disease, run by Sunnybrook Health Sciences Centre.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- CKD feedback and tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Updated data available at the time of study commencement
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- CKD feedback and tools
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD feedback and toolsBehavioural
people in the intervention arm will receive feedback on ckd quality indicators and tools to help in the detection and management of ckd
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: CKD feedback and tools |
| No Intervention | No intervention | Physicians in these clinics/clusters will not receive CKD feedback or tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (6)
Proportion of patients at high risk screened for CKD with an eGFR and/or ACR
compare baseline rates to end of intervention rates
Measured: 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
Measured: 24 months
Proportion of patients with diabetes and albuminuria and on an ACE or ARB
compare baseline rates to end of intervention rates
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Renal Network
- Responsible party
- Principal investigator, Dr. Karen Tu, Sunnybrook Health Sciences Centre
- Investigators
- Karen Tu, MD, MSc, Principal investigator, ICES/Sunnybrook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274298
- Sponsor's protocol ID
- 074-2013-2
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No, final results will be aggregate although as part of the trial individual participants do receive individual level feedback
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.
PubMed 28607686
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Patients With Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02274298
- Acronym / sponsor ID
- 074-2013-2
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Ontario Renal Network
- Study start
- Oct 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD feedback and tools | Active comparator | Behavioral: CKD feedback and toolsPhysicians 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 |
| No Intervention | No intervention | –Physicians in these clinics/clusters will not receive CKD feedback or tools |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Updated data available at the time of study commencement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD feedback and toolspeople in the intervention arm will receive feedback on ckd quality indicators and tools to help in the detection and management of ckd | Behavioural | CKD feedback and tools |
Primary outcome
Proportion of patients age 50-80 with Stage 3+ CKD and a statin prescription
Time frame: 24 months
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
6 secondary outcomes
Proportion of patients at high risk screened for CKD with an eGFR and/or ACR
Time frame: 24 months
Proportion of patients with an initial eGFR <60 and a f/u eGFR or an ACR
Time frame: 24 months
Proportion of patients with diabetes and albuminuria and on an ACE or ARB
Time frame: 24 months
Proportion of patients meeting eGFR criteria for CKD and documentation of CKD in the cumulative patient profile (CPP)
Time frame: 24 months
Proportion of patients with an ACR in the past 18 months and meeting bp targets
Time frame: 24 months
Proportion of patients age less than 80 years and an eGFR<30 being seen by or with a referral to a Nephrologist
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Derived from this study: PubMed 28607686Nash 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.
- Individual participant dataSharing planned: No. No, final results will be aggregate although as part of the trial individual participants do receive individual level feedback
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Tu, MD, MSc principal investigator
ICES/Sunnybrook
Questions about this trial
What is this clinical trial studying?
A study testing CKD feedback and tools in people with Chronic Kidney Disease, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients age 50-80 with Stage 3+ CKD and a statin prescription (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02274298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.