Designing and Implementing a Safety Net Surveillance Program for High Risk CKD
ConditionChronic Kidney Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old
Resident of Manitoba / has Manitoba Health coverage
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)
Disqualifiers
A previous billing claim from a nephrologist
Receiving palliative care within 3 months of randomization
Previous history of dialysis and/or kidney transplantation
Trial design
Design model
Parallel
Treatments tested in this trial
Letter to participants
Other interventionIndividuals 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.
Treatment groups
972 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Composite of kidney failure and all-cause mortality
Kidney failure defined as dialysis, kidney transplantation. Collected using provincial administrative databases accessed through the MCHP
Time frame
within 12 months of letter mailoutSecondary outcomes
1
Attendance at a clinic visit with a nephrologist
Collected using provincial administrative databases accessed through the MCHP
Time frame
within 12 months of letter mailout2
Individual components of the composite primary outcome
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 mailout3
Alll-cause hospitalizations and emergency room visits
Collected using provincial administrative databases accessed through the MCHP
Time frame
within 12 months of letter mailout4
Major adverse cardiac events
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 mailoutSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manitoba
Lead sponsor
Can-SOLVE CKD Network
Collaborator
Seven Oaks Hospital Chronic Disease Innovation Centre
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: