Chronic Kidney Diseases
Conditions
Keywords
Chronic Kidney Disease, Kidney Diseases, Access to care, Secondary Prevention
Brief summary
The objective of this initiative is to develop and evaluate a risk-based, provincial public health screening program for chronic kidney disease (CKD) that provides proactive care for adults at high-risk of kidney failure who have not previously been referred to a nephrologist, through risk stratification, triage, education, and follow-up. Overall, we aim to demonstrate that an integrated risk-based provincial public health screening program for CKD is feasible, and improves identification of high-risk individuals, subsequently creating a model of care that can be adopted by other jurisdictions.
Detailed description
A Parallel Group Randomized Controlled Trial will be conducted implementing our previously developed laboratory-based risk prediction models into a new provincial CKD surveillance system. Using administrative data through the Manitoba Centre for Health Policy (MCHP), we will identify all high-risk adults with CKD in Manitoba who had appropriate laboratory testing for CKD (i.e. at least 2 eGFR tests) completed in the 2 most recent years of available data, and who subsequently met nephrology referral criteria, but were never referred to a nephrologist. All individuals identified will be randomized to either: (1) receive a letter describing their results and an invitation for a consult with a clinical assistant and a nephrologist at Seven Oaks General Hospital, or (2) usual care (i.e. no letter and referral to nephrology based on their primary care physician/circle of care). The program will support the integration of risk-based care at a population-level, in turn providing opportunities that will prompt changes in further investigation, treatment, referral for education, and inform a personalized medicine approach for patient-provider discussions regarding prognosis. All outcomes will be collected using provincial administrative databases accessed through the Manitoba Centre for Health Policy (MCHP).
Interventions
OTHERLetter to participants
Individuals randomized to the intervention group will received a direct mailing consisting of: 1. A letter explaining the purpose of the study and the benefits of screening for CKD, with contact information for the study team at Seven Oaks General Hospital / Chronic Disease Innovation Centre, who they may contact to receive further information and to book a follow-up appointment with a Clinical Assistant/Nephrologist 2. A brief fact sheet on CKD A follow-up reminder letter will be sent at 3 months in individuals that do not respond to the initial invitation.
Sponsors
University of Manitoba
Can-SOLVE CKD Network
Seven Oaks Hospital Chronic Disease Innovation Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, blinding of participants, care providers, and investigators is not possible. Outcome assessors and analysts will be blinded
Intervention model description
Eligible participants will be randomly allocated to either the control group or the intervention group (mailing letter). The sequence will be randomly generated by a Data Analyst, and the allocation list will be concealed within the MCHP Virtual Private Network. Allocation will be in an equal 1:1 ratio for each sequence, stratified by age (\<65 years of age, ≥65 years of age), sex (male, female), location (urban, rural).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old * Resident of Manitoba / has Manitoba Health coverage * Either: * 2 eGFR \<15 mL/min/1.73m2 tests within a 2-year timeframe or * A greater than 10% 2-year kidney failure risk (at 2 separate timepoints within a 2-year timeframe) - using the 4-variable or 3-variable 2-year Kidney Failure Risk Equation (KFRE)
Exclusion criteria
* A previous billing claim from a nephrologist * Receiving palliative care within 3 months of randomization * Previous history of dialysis and/or kidney transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of kidney failure and all-cause mortality | within 12 months of letter mailout | Kidney failure defined as dialysis, kidney transplantation. Collected using provincial administrative databases accessed through the MCHP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| eGFR (mL/min/1.73 m²) | within 12 months of letter mailout | Collected using provincial administrative databases accessed through the MCHP |
| Urine albumin-to-creatinine ratio (mg/mmol) | within 12 months of letter mailout | Collected using provincial administrative databases accessed through the MCHP |
| 2-year Kidney Failure Risk Equation Score | within 12 months of letter mailout | Collected using provincial administrative databases accessed through the MCHP |
| The proportion of individuals starting a new prescription of RAAS inhibitors, SGLT2i, Ns-MRAs, Statins, and GLP-1 agonists | within 12 months of letter mailout | Collected using provincial administrative databases accessed through the MCHP |
| Attendance at a clinic visit with a nephrologist | within 12 months of letter mailout | Collected using provincial administrative databases accessed through the MCHP |
| Individual components of the composite primary outcome | within 12 months of letter mailout | Kidney failure (dialysis and/or transplantation) and all-cause mortality. Collected using provincial administrative databases accessed through the MCHP o All-cause mortality |
| Major adverse cardiac events | within 12 months of letter mailout | Major adverse cardiac events (MACE+, defined as myocardial infarction (MI), ischemic stroke, incident heart failure (a new heart failure diagnosis in a patient without evidence of heart failure at baseline), heart failure admission (an inpatient admission with a concurrent diagnosis of heart failure in patients with a history of heart failure), or cardiovascular death (death within the same or next calendar month as discharge from an inpatient hospital stay involving a diagnosis code for heart failure, stroke, or MI)). Collected using provincial administrative databases accessed through the MCHP |
| Alll-cause hospitalizations and emergency room visits | within 12 months of letter mailout | Collected using provincial administrative databases accessed through the MCHP |
Countries
Canada
Contacts
CONTACTOksana Harasemiw, MSc
PRINCIPAL_INVESTIGATORNavdeep Tangri, MD, PhD
University of Manitoba
Outcome results
None listed