University of Manitoba
Winnipeg, Manitoba, R3T 2N2, Canada
NCT Number: NCT07724288
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R3T 2N2, Canada
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals randomized to the intervention group will received a direct mailing consisting of:
Time frame: within 12 months of letter mailout
Kidney failure defined as dialysis, kidney transplantation. Collected using provincial administrative databases accessed through the MCHP
Time frame: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
Time frame: 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
Time frame: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
Time frame: 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
Time frame: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
Time frame: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
Contact information is provided by the study sponsor or research team.
University of Manitoba
Other
Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety Net)
Acronym: CKD Safety-Net
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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