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Integrating Risk-based Care for Patients With CKD

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ClinicalTrials.gov Identifier: NCT03365063
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Canadian Primary Care Sentinel Surveillance Network
Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease
Information provided by (Responsible Party):
Navdeep Tangri, University of Manitoba

Brief 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 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?"


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Active Knowledge Translation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Integrating Risk-based Care for Patients With Chronic Kidney Disease (CKD) in the Community
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Active Knowledge Translation Group
Primary care clinics receiving the active knowledge translation intervention.
Other: Active Knowledge Translation
  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.

No Intervention: Control Group
Primary care clinics receiving the current standard of care. Information on personalized risk and risk-based referral will not be provided.



Primary Outcome Measures :
  1. Proportion of patients in each clinic who have albuminuria (albumin-creatinine ratio (ACR)) tested [ Time Frame: 1 year after intervention ]
    This will be determined using data extracted from each clinic's EMR.

  2. Proportion of patients with albuminuria in each clinic who are receiving treatment (ACEi/angiotensin receptor blockers (ARB)) [ Time Frame: 1 year after intervention ]
    This will be determined using data extracted from each clinic's EMR.


Secondary Outcome Measures :
  1. Diabetes management for CKD patients [ Time Frame: 1 year after intervention ]
    Measured as the proportion of CKD patients who have a hemoglobin A1C in target (i.e. <8%).

  2. Hypertension management for CKD patients [ Time Frame: 1 year after intervention ]
    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).

  3. Management of cardiovascular risk factors for CKD patients [ Time Frame: 1 year after intervention ]
    Measured as the proportion of CKD patients who have a statin prescription listed on their EMR.

  4. Drug safety for CKD patients [ Time Frame: 1 year after intervention ]
    Measured as the proportion of CKD patients who have a non-steroidal anti-inflammatory drug (NSAID) listed on their EMR.

  5. eGFR function for CKD patients [ Time Frame: 2 years after intervention ]
    Measured as the proportion of CKD patients who have a >30% decline in eGFR function.

  6. Appropriate referral for patients at high risk for kidney failure [ Time Frame: 1 year after intervention ]
    Determined through comparisons with provincial guidelines.

  7. Total Health Care Costs [ Time Frame: 1 year after intervention ]
    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.

  8. Clinical provider's satisfaction with the risk prediction tools and clinical decision aids. [ Time Frame: 6 months after intervention ]
    Measured by the number of points as a result of the clinical providers' answers on a Likert scale.

  9. Patient's CKD-specific health literacy [ Time Frame: 6 months after intervention ]
    Measured by the number of points as a result of participants' answers to the validated Kidney Knowledge Survey (KiKS).

  10. Patient's trust in physician care [ Time Frame: 6 months after intervention ]
    Measured by the number of points as a result of participants' answers to the validated Trust in Physician Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 30 clinics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365063


Contacts
Contact: Oksana Harasemiw, MSc 1-204-632-3541 oharasemiw@sogh.mb.ca
Contact: Navdeep Tangri, MD PhD FRCPC 1-204-631-3834 ntangri@sogh.mb.ca

Locations
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Contact: Oksana Harasemiw, MSc    1-204-632-3541    oharasemiw@sogh.mb.ca   
Sponsors and Collaborators
University of Manitoba
Canadian Primary Care Sentinel Surveillance Network
Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease
Investigators
Principal Investigator: Navdeep Tangri, MD PhD FRCPC University of Manitoba

Additional Information:
Responsible Party: Navdeep Tangri, Associate Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT03365063     History of Changes
Other Study ID Numbers: H2017:050
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Navdeep Tangri, University of Manitoba:
Knowledge Translation
Chronic Kidney Disease
Matched Cluster Randomized Trial

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency