Designing and Implementing a Safety Net Surveillance Program for High Risk CKD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letter to participants.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety Net)
Overview
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
- Other Letter 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 mon
Primary outcome measures
- Composite of kidney failure and all-cause mortality [Time frame: within 12 months of letter mailout]
Secondary outcome measures (6)
- Attendance at a clinic visit with a nephrologist [Time frame: within 12 months of letter mailout]
- Individual components of the composite primary outcome [Time frame: within 12 months of letter mailout]
- Alll-cause hospitalizations and emergency room visits [Time frame: within 12 months of letter mailout]
- Major adverse cardiac events [Time frame: within 12 months of letter mailout]
- eGFR, urine ACR, KFRE at follow-up [Time frame: within 12 months of letter mailout]
- The proportion of individuals starting a new prescription of RAAS inhibitors, SGLT2i, Ns-MRAs, Statins, and GLP-1 agonists [Time frame: within 12 months of letter mailout]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Canada · 1 center
- University of Manitoba — Winnipeg
Identifiers
NCT: NCT07724288 · HS25871 (H2023:052)