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Chronic Kidney DiseaseNCT03365063

Integrating Risk-based Care for Patients With CKD

A study testing Active Knowledge Translation in people with Chronic Kidney Disease, run by University of Manitoba at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Chronic kidney disease (CKD) and its end stage of kidney failure are major public health problems in Canada and worldwide. In the primary care setting, accurate prediction of the risk of kidney failure in patients with CKD can improve patient provider communication, assist in appropriate nephrology referral, improve… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Active Knowledge Translation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,600 participants
Where
2 sitesCanada
Study dates
24 Aug 2018to 31 Dec 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary care clinics in Manitoba and Alberta who provide care to adults in the community and use an EMR that can integrate the KFRE and its associated decision aids for CKD management and referral.
  • All patients with CKD Stages G3-G5 who attend the 32 clinics.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Southern Alberta Primary Care Research Network (SAPCReN)

    Calgary, Alberta, T2N 4N1

  • University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

About this study

Official title: Integrating Risk-based Care for Patients With Chronic Kidney Disease (CKD) in the Community

Chronic kidney disease (CKD) and its end stage of kidney failure are major public health problems in Canada and worldwide. In the primary care setting, accurate prediction of the risk of kidney failure in patients with CKD can improve patient provider communication, assist in appropriate nephrology referral, improve dialysis treatment planning, and identify patients who are most likely to benefit from intervention. To aid in accurately predicting the risk of kidney failure requiring dialysis in patients with CKD, the primary investigator has developed and validated the kidney failure risk equation (KFRE), which is increasingly used in nephrology practices across Canada and the United States.

In this current study, a cluster randomized controlled trial (RCT) will be done in collaboration with the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). Primary care clinics that can integrate the KFRE into their electronic medical records will be randomized to receive the intervention (patients and providers receive individualized information explaining kidney failure risk, as well as risk-based criteria for referral, alongside usual care) versus usual care alone (no information on personalized risk and no risk-based referral). In both groups, the investigators will assess management of patients at high risk of kidney failure (patient), timing of referral for patients at high risk of kidney failure (health system), cost of CKD care (health system), CKD-specific health literacy (patient), trust in physician care (patient), and satisfaction with risk prediction tools (provider).

The objective of this research study is to develop, implement, and evaluate tools to guide the care of patients with CKD in the community, including appropriate referral using a risk-based approach. Specifically, this study will address the question: "Does providing patients (and their physicians) with information about their risk of kidney failure improve quality of care, health literacy, and trust in the care they are receiving?"

Read the detailed description

Patients with CKD and kidney failure have poor outcomes and consume a disproportionate share of health care resources. Therefore, early identification of incident cases by primary care physicians can delay progression and prevent adverse outcomes. However, the correct identification and intervention for patients having reduced kidney function is not necessarily done appropriately in all settings, often resulting in individuals at very low risk of progression being referred to a nephrologist, and in other cases, delayed referral of patients who are at the highest risk of kidney failure.

The investigators propose an integration of the Kidney Failure Risk Equation - a tool that accurately predicts the risk of kidney failure requiring dialysis in patients with CKD - in primary care practices by integrating the tool into existing reporting mechanisms. This will allow the delivery of kidney disease risk information to clinicians as part of a clinical decision aid to guide all aspects of CKD care, including management of vascular risk factors, intensity of follow up, and potential referral for specialist care. Patients and providers will benefit from the ability to share information about CKD, and their individual risk of kidney failure using interactive infographics, thereby improving CKD-specific health literacy.

The investigators will work with the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) to recruit and subsequently randomize 32 clinics to either the intervention or the control group. The clinics randomized to receive the intervention will see patients and providers receiving individualized information explaining kidney failure risk, as well as risk-based criteria for referral, alongside usual care. This will be executed through the integration of the KFRE in the CPCSSN Data Presentation Tool (DPT), audit and feedback, and in-person medical detailing. Clinical decision aids for both patients and physicians to guide CKD care and provide information about prognosis will be provided in the format of a static infographic, video, and interactive website. Those clinics randomized to the control group will receive the current standard of care - information on personalized risk and risk-based referral will not be provided.

Appropriate management of patients at high risk of kidney failure will be determined using information from electronic medical records (EMRs), for all patients with CKD G3-G5 attending each clinic (approximately 13,470 patients from all 32 clinics). Appropriate referral for patients at high risk of kidney failure will be determined through comparison with provincial guidelines. Direct costs of care will be estimated using linkages with provincial administrative data. For those clinics in the intervention group, satisfaction with the risk prediction tools (provider) will be measured using a Likert scale. Additionally,10 patients from each of the 32 clinics will be surveyed about their CKD-specific health literacy and trust in physician care (320 patients in total).

The investigators' hypothesis and specific aims are as follows:

Hypothesis: The investigators hypothesizes that integration of this approach to CKD care can improve the patient-provider dialogue by:

  1. Increasing health literacy and trust, and therefore reduce anxiety for those at low risk.
  2. Providing early and appropriate referral to nephrology for those at higher risks of kidney failure.

Aim 1 - Determine whether providing patients and primary care providers with a patients' predicted risk for kidney failure and risk-based criteria for referral increases appropriate management of and referral for patients at low and high risk for kidney failure, compared to usual care without personalized risk information.

Aim 2 - Determine whether providing patients with individualized information on their risk of progression increases CKD-specific health literacy and improves trust in the patient-provider relationship.

Aim 3 - Determine the cost-effectiveness of the risk-based care paradigm

Study Design: A matched cluster randomized design of 32 primary care clinics in Manitoba and Alberta, evaluating the feasibility and effectiveness of the integration of the KFRE in the CPCSSN DPT, as well as the efficacy of a KT intervention targeting patients with advanced CKD. The unit of observation will be both at the patient and provider level, and the unit of randomization will be at the level of the clinic.

Team: The investigators' study team includes experts in the clinical epidemiology of CKD and kidney failure, local opinion leaders, as well experts in knowledge translation and cluster randomized design. In addition to the investigators' collaboration with CPCSSN, the investigators are part of and working with the Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) Network. This network includes individuals with CKD and those affected by CKD (i.e., caregivers, family members, etc.); they are the investigators' patient partners, and will make up the patient engagement panel. They will help guide the study to ensure that its findings are relevant to direct patient care.

Research Significance: Since most patients with CKD are managed in primary care, the next step to reduce the burden of this disease on the population is to implement a strategy for the Kidney Failure Risk Equation to be used in this setting. The investigators believe that the integration of a KFRE based care paradigm can improve management of CKD risk factors and health literacy, and ultimately, downstream patient and health system outcomes.

Being tested
Active Knowledge Translation
Keywords
Knowledge Translation, Chronic Kidney Disease, Matched Cluster Randomized Trial
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.

  • Active Knowledge TranslationOther

    1. Integration of the KFRE in the CPCSSN DPT - The DPT will report the output from the KFRE for all patients with CKD Stages G3-G5 from the clinic sites. The risk output will include interpretation and automated categorized risk of progression to kidney failure, and will recommend actions based on the KFRE risk based care pathway.
    2. Audit and Feedback - Providers at CPCSSN clinics receive sentinel feedback reports on a panel of chronic conditions and quality improvement targets. The investigators will add CKD to the feedback report for the intervention sites, and provide detailed feedback on the practices' risk profile.
    3. Medical Detailing - The intervention CPCSSN clinics will receive a standardized presentation to clinic staff by the principal investigator, who will provide the evidence for the accuracy of the KFRE and guidance on implementation of a risk based treatment pathway, as well as describe the supporting visual aids.
Study groups in NCT03365063
Study groupRoleWhat they receive
Active Knowledge Translation GroupExperimentalPrimary care clinics receiving the active knowledge translation intervention.
Receives: Other: Active Knowledge Translation
Control GroupNo interventionPrimary care clinics receiving the current standard of care. Information on personalized risk and risk-based referral will not be provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of CKD patients in each clinic who have albuminuria (albumin-creatinine ratio (ACR)) tested

    This will be determined using data extracted from each clinic's EMR.

    Measured: 1 year after intervention

  2. The percentage of patients who are appropriately managed with an ACEi or ARB, and who either have CKD and diabetes, or who have CKD and a urine ACR >30 mg/mmol.

    This will be determined using data extracted from each clinic's EMR.

    Measured: 1 year after intervention

Secondary outcomes (10)
  1. Diabetes management for CKD patients

    Measured as the proportion of CKD patients who have a hemoglobin A1C in target (i.e. <8.5%), as well as the proportion of individuals who have been prescribed an SGLT2 inhibitor.

    Measured: 1 year after intervention

  2. Hypertension management for CKD patients

    Measured as the proportion of CKD patients who have a normal blood pressure (BP), taken as part of regular clinic visit (office BP <130/80 for patients with diabetes, 140/90 for those without).

    Measured: 1 year after intervention

  3. Management of cardiovascular risk factors for CKD patients

    Measured as the proportion of CKD patients who have a statin prescription listed on their EMR.

    Measured: 1 year after intervention

  4. Appropriate medication usage

    Measured as the proportion of CKD patients who have been prescribed a non-steroidal anti-inflammatory drug (NSAID).

    Measured: 1 year after intervention

  5. eGFR function for CKD patients

    Measured as the proportion of CKD patients who have a >30% decline in eGFR function.

    Measured: 2 years after intervention

  6. Appropriate referral for patients at high risk for kidney failure

    Determined through comparisons with provincial guidelines.

    Measured: 1 year after intervention

  7. Total Health Care Costs

    Direct health care costs will be estimated for both groups of patients taking a health care payor perspective, and estimated using linkages with provincial administrative data.

    Measured: 1 year after intervention

  8. Clinical provider's satisfaction with the risk prediction tools and clinical decision aids.

    Measured by the number of points as a result of the clinical providers' answers on a Likert scale.

    Measured: 6 months after intervention

  9. Patient's CKD-specific health literacy

    Measured by the number of points as a result of participants' answers to the validated Kidney Knowledge Survey (KiKS).

    Measured: 6 months after intervention

  10. Patient's trust in physician care

    Measured by the number of points as a result of participants' answers to the validated Trust in Physician Scale.

    Measured: 6 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2017
  2. Study start24 Aug 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Why it stopped: The study was terminated early due to COVID-19 restrictions at participating clinics, which made continuation unfeasible.

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03365063
Sponsor's protocol ID
H2017:050
Status last verified
Jul 2025
First submitted
28 Nov 2017
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Harasemiw O, Drummond N, Singer A, Bello A, Komenda P, Rigatto C, Lerner J, Sparkes D, Ferguson TW, Tangri N. Integrating Risk-Based Care for Patients With Chronic Kidney Disease in the Community: Study Protocol for a Cluster Randomized Trial. Can J Kidney Health Dis. 2019 May 29;6:2054358119841611. doi: 10.1177/2054358119841611. eCollection 2019.

    PubMed 31191908
  • Bello AK, Ronksley PE, Tangri N, Kurzawa J, Osman MA, Singer A, Grill A, Nitsch D, Queenan JA, Wick J, Lindeman C, Soos B, Tuot DS, Shojai S, Brimble S, Mangin D, Drummond N. Prevalence and Demographics of CKD in Canadian Primary Care Practices: A Cross-sectional Study. Kidney Int Rep. 2019 Jan 21;4(4):561-570. doi: 10.1016/j.ekir.2019.01.005. eCollection 2019 Apr.

    PubMed 30993231
  • Bello AK, Ronksley PE, Tangri N, Kurzawa J, Osman MA, Singer A, Grill AK, Nitsch D, Queenan JA, Wick J, Lindeman C, Soos B, Tuot DS, Shojai S, Brimble KS, Mangin D, Drummond N. Quality of Chronic Kidney Disease Management in Canadian Primary Care. JAMA Netw Open. 2019 Sep 4;2(9):e1910704. doi: 10.1001/jamanetworkopen.2019.10704.

    PubMed 31483474

Questions about this trial

What is this clinical trial studying?

A study testing Active Knowledge Translation in people with Chronic Kidney Disease, run by University of Manitoba at 2 sites in Canada.

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 0 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: stopped early, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was stopped early (reason given: The study was terminated early due to COVID-19 restrictions at participating clinics, which made continuation unfeasible.). 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 CKD patients in each clinic who have albuminuria (albumin-creatinine ratio (ACR)) tested (time frame: 1 year after intervention). The study lists 2 primary outcomes in all. 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 NCT03365063, which also lists 3 linked publications.

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 23 Jul 2025.

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